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Abstract of dissertation entitled
“Effectiveness of antenatal pelvic floor muscle exercise in stress
urinary incontinence during pregnancy and after delivery”
Submitted by
Wong Yik Kei
For the degree of Master of Nursing
at The University of Hong Kong
August 2015
Stress urinary incontinence is a common health problem in antenatal and postnatal
women. Although pelvic floor muscle exercise is regarded as a first-line conservative
method for prevention and treatment of this urological problem, it is not
comprehensively included in antenatal services in Hong Kong.
This thesis introduces evidenced-based guidelines for antenatal pelvic floor muscle
exercise to improve incontinence during pregnancy and after delivery. Based on
available evidence, the guidelines aim to decrease the rate of stress urinary
incontinence. The transferability and feasibility of application of the guidelines
clinically will be assessed. The implementation plan and evaluation plan will be
discussed.
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“Effectiveness of antenatal pelvic floor muscle exercise in stress
urinary incontinence during pregnancy and after delivery”
By
Wong Yik Kei
A thesis submitted in partial fulfillment of the requirements for
The Degree of Master of Nursing
At The University of Hong Kong.
August 2015
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Declaration
I declare that this thesis represents my own work, except where due acknowledgement
is mode, and it has not been previously included in a thesis, dissertation or report
submitted to the University or to any other institution or a degree, diploma or other
qualification.
Signed _________________________
Wong Yik Kei
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Acknowledgements
I would like to express my greatest gratitude to Dr. Marie Tarrant, my dissertation
supervisor, for her continuous support and guidance throughout my master studies. Dr.
Tarrant definitely helped and guided me to overcome a lot of challenges.
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Table of Contents
Abstract………………………………………………………………………………...i
Declaration……………………………………………………………………………iii
Acknowledgement…………………………………………………………………….iv
Table of contents………………………………………………………………………v
Chapter 1: Introduction…………………………………………………………..……1
1.1 Background……………………………………………………………………..1
1.2 Affirming the need……………………………………………………………...2
1.3 Objectives and significance……………………………………………………..4
Chapter 2: Critical Appraisal…………………………………………………………..6
2.1 Search and appraisal strategies…………………….……………………………6
2.2 Results………………………………………………………………….……….8
2.3 Summary and synthesis……………..…………………………………………14
Chapter 3: Translation and Application………………………………………………22
3.1 Introduction……………………………………………………………………22
3.2 Target audience/setting………………………………………………………...22
3.3 Assessing implementation potential…………………………………………...23
Chapter 4: Development Evidence-based Practice Guidelines………………………31
4.1 Guideline title…………………………………………………….……………31
4.2 Aims and objectives……………………………………...……………………31
4.3 Target group…………………………………….………………………….…..31
4.4 Recommendations…………………………………………………….……….32
Chapter 5: Implementation Plan……………………….….................………………36
5.1 Introduction....…………………………………………………………………36
5.2 Communication plan……………………………………………….………….36
5.3 Pilot testing.....…………………………………………………………………40
Chapter 6: Evaluation Plan………… ……………………………………………..…42
6.1 Intervention outcomes and outcome measurement……………………………42
6.2 Nature and number of clients involved………………………………………..44
6.3 Data analysis…………………….…………………………………………….45
6.4 Criteria for effectiveness………………………………………………………45
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Conclusion…………………………………………………..………………………..46
Reference………………………………..……………………………………………47
Appendices…………………………………………………….……………………..53
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Chapter 1: Introduction
1.1 Background
The International Continence Society defines stress urinary incontinence (SUI) as
‘the involuntary leakage of urine on effort or exertion, or on sneezing or coughing'
(Abrams et al., 2002). It is a distressing and common health complaint during
pregnancy and postpartum. Pregnancy and childbirth are risk factors for developing
SUI since they may weaken and cause damage to the pelvic floor muscles and
ligaments controlling the bladder neck and the urethra (Morkved, Bø, Schei &
Salvesen, 2003). The prevalence of SUI during pregnancy and after childbirth in
Chinese women varies from 18.6%to 37.8% and 6.9% to 25.9% respectively in
studies (Chan, Cheung, Yiu, Lee & Chung, 2012; Zhu et al., 2012; Yang et al., 2010).
SUI adversely affects quality of life by interfering with women's social, physical,
occupational and leisure activities. However, this health condition is not considered a
problem by health care professionals, and pregnant and postpartum women often
perceive it as normal, which inhibit seeking help (Cardozo & Cutner, 1997). Among
current interventions, pelvic floor muscle exercise (PFME) is regarded as a first-line
conservative method for prevention and treatment of SUI, as it helps strengthen the
periurethral muscles and improves the efficiency of sphincter function (Berghmans et
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al., 1998). Antenatal PFME is therefore recommended for all women during
pregnancy to reduce the incidence of SUI during pregnancy and in the postpartum
period (National Institute of Clinical Excellence, 2006).
1.2 Affirming the Need
In Hong Kong, the Maternal and Child Health Centers (MCHC) of the Department
of Health (DH) are the major service providers offering maternal services for women.
At a MCHC, pregnant women have shared antenatal care with Hospital Authority
(HA) hospitals, and postnatal follow-up is done mainly in MCHCs. Although urinary
incontinence (UI) is a distressing problem during pregnancy and after delivery and
affects the quality of life of women (Tozun, Ayranci, & Unsal, 2009), information on
its prevention and treatment is not comprehensively included in antenatal service.
Antenatal classes are given for pregnant women and their partners to help them better
prepare for labor and birth. These workshops only focused on breastfeeding, child
care and parenthood. It is known that PFME is effective in dealing with SUI, however,
there are no structured antenatal programs teaching women the correct way to perform
these exercises. The problem of UI is neglected by nurses as they perceive it as an
inevitable condition result of pregnancy and delivery (Kocaoz, Eroğlu, & Sivaslıoğlu,
2013). The significance of PFME is usually underestimated in the primary health care
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setting of the MCHC.
There is no evidence-based protocol in the MCHC for the management of antenatal
and postnatal SUI. Leaflets on PFME are distributed routinely at the first antenatal
visit and postnatal checkup. Verbal advice is given only if a client complains of
incontinence. However, the practice of instructing PFME is inconsistent among staff
as there are no guidelines or protocol for internal reference. Clients are only taught
verbally about PFME with a brief introduction in related pamphlets and are not
offered practical training sessions. Since the effectiveness of PFME highly depends
on the correctness and continuity of muscle contraction, it is vital that clients be
instructed in the technique of relaxation and contraction of pelvic floor muscles
(Mason, Glenn, Walton & Hughes, 2001). Frequent monitoring is recommended to
ensure the accuracy of and compliance with the exercise (Franchi, Ciolli, Greco,
Piserà, & Russo, 1999). An evidence-based protocol for an antenatal PFME program
is necessary to replace the current inconsistent practice.
In one study, the majority of women interviewed about their personal experience
with antenatal PFME agreed that these programs helped improve UI during pregnancy
and after delivery (Chiarelli, Murphy & Cockburn, 2003). A well-structured training
program on PFME was more effective than verbal advice from health care providers
in managing antenatal and postnatal incontinence condition ((Mason, Glenn, Walton
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& Hughes, 2001; Miquelutti, Cecatti, & Makuch 2013). However, since not many
systematic reviews have been done on this subject, it is necessary to conduct a review
in order to formulate a protocol and implement it into clinical settings.
1.3 Objectives and Significance
The study question is: Is antenatal PFME effective in reducing the incidence of
stress urinary incontinence during pregnancy and after delivery? The objectives of
this study are: 1) to determine the role of antenatal PFME in reducing the incidence of
SUI during pregnancy and after delivery; 2) to compare the different antenatal PFME
programs in reducing the incidence of SUI during pregnancy and after delivery; 3) to
construct an evidence-based protocol and evaluate the feasibility of the
implementation. It is hypothesized that following instructions on PFME via a
structured training program during the antenatal period, the incidence of SUI during
pregnancy and after delivery would decrease.
This study will benefit pregnant women and women who have given birth by
reducing the incidence, severity and frequency of SUI through a well-structured
antenatal PFME program. It will also help nurses in the MCHC instruct pregnant
women about PFME in a systematic and consistent way following the evidence-based
protocol. By reviewing and comparing relevant studies, weaknesses in training
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program may be discovered. This is significant since the findings of the study are the
basis for formulating evidence-based practice with ongoing evaluation and
modification to strengthen the program.
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Chapter 2: Critical Appraisal
2.1 Search and Appraisal Strategies
Search Strategies
A search for relevant studies was done through the electronic database including
PubMed (from 1992 to 2014), the British Nursing Index (from 1999 to 2014),
CINAHL (from 1982 to 2014), Cochrane Library and ProQuest. Reference lists of
relevant articles were also searched for suitable trials. The keywords 'pelvic floor
muscle exercise', 'pelvic floor exercises', 'pelvic floor training', 'antenatal', ‘pregnant
women’, 'pregnancy', 'postnatal', 'postpartum’, 'urinary incontinence', 'stress urinary
incontinence', 'clinical trial', 'controlled trial' and randomized controlled trial' were
used to search the above databases.
Inclusion criteria
Types of studies
Randomized controlled trials (RCTs) and quasi-experimental controlled studies were
included.
Types of participants
Studies that recruited primigravidae or nulliparous antenatal women, with or
without UI symptoms, were included. Studies of women with and without a risk of
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bladder neck mobility were included.
Types of intervention
Trials in which PFME programs were used to improve UI symptoms, to prevent UI,
or both, were included in the review. PFME was defined as a repetition of voluntary
contraction and relaxation of pelvic floor muscles taught and supervised by health
care providers such as nurses and physiotherapists. PFME programs were included
regardless of the number and length of follow-up sessions, the number of participants
in the class, the number and length of contractions, and the purpose of the training
program.
Types of outcome measures
Outcome measures included self-reported SUI, and the quantification of symptoms
such as frequency and severity. Studies with other outcomes including quality of life,
pelvic floor muscle strength and socioeconomics were also considered.
Exclusion criteria
Trials with interventions such as drug therapy combined with pelvic floor muscle
training (PFMT) were excluded. Restrictions on language of publication and
publication status were not imposed.
Data extraction
Relevant information and data from each study were extracted and recorded in a
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'Table of Evidence' with columns including bibliographic citation, study type, level of
evidence, subject characteristics, intervention, comparison, length of follow up,
outcome measures, effect size, source of funding and quality rating.
Appraisal strategies
The Scottish Intercollegiate Guidelines Network (SIGN) framework was used as a
tool for appraisal of the quality of the included studies. SIGN guidelines are based on
a systemic review of evidence undertaken by a guideline development group to
critically assess the quality of studies with different study designs.
2.2 Results
The period of the search was from April 1, 2014 to July 20, 2015. The detailed
search process is shown in Appendix I. The search yielded nine eligible studies
(Kocaoz et al., 2013; Reilly et al., 2002; Stafne, Salvesen, Romundstad, Torjusen &
Mørkved, 2012; Ko et al., 2010; Morkved et al., 2003; Pelaez, Gonzalez-Cerron,
Montejo & Barakat, 2014; Sangsawang & Serisathien, 2011; Dinc, Beji & Yalcin,
2009; Sampselle et al., 1998). Tables of evidence of the relevant studies are attached
in Appendix II. The results are highlighted in the following section.
Study Characteristics
Two of the nine studies were conducted in Turkey (Kocaoz et al., 2013; Dinc et al.,
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2009), two in Norway (Stafine et al., 2012; Morkved et al., 2003), one in the United
Kingdom (Reilly et al., 2002), one in Taiwan (Ko et al., 2010), one in Spain (Pelaez et
al., 2014), one in Thailand (Sangsawang & Serisathien, 2011) and one in the United
States (Sampselle et al., 1998). Seven studies were RCTs (Reilly et al., 2002; Stafne et
al., 2012; Ko et al., 2010; Morkved et al., 2003; Pelaez et al., 2014; Dinc et al., 2009;
Sampselle et al., 1998). Two were quasi-experimental studies (Kocaoz et al., 2013;
Sangsawang & Serisathien, 2011).
Sample characteristics such as gestational age, age and body mass index (BMI)
were collected in all studies. Three studies only included subjects without UI (Kocaoz
et al., 2013; Reilly et al., 2002; Pelaez et al., 2014), while two studies included
subjects with UI (Sangsawang & Serisathien, 2011; Dinc et al., 2009). The other four
trials included subjects with or without UI (Stafne et al., 2012; Ko et al., 2010;
Morkved et al., 2003; Sampselle et al., 1998).
All studies included antenatal PFME training as their interventions. Six studies
offered regular training sessions in a given period (Reilly et al., 2002; Stafne et al.,
2012; Ko et al., 2010; Morkved et al., 2003; Pelaez et al., 2014; Sangsawang &
Serisathien 2011). One study offered a one-off training session (Kocaoz et al., 2013).
The remaining two did not mention the number of training sessions (Dinc et al., 2009;
Sampselle et al., 1998).
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Eight studies used the rate of SUI as an outcome measure and Sampselle et al.(1998)
used the severity of SUI. In addition, five studies also reported the frequency of SUI
(Kocaoz et al., 2002; Stafne et al., 2012; Pelaez et al., 2014; Sangsawang &
Serisathien, 2011; Dinc et al., 2009). Three studies assessed the outcome in the
antenatal period only (Stafne et al., 2012; Pelaez et al., 2014; Sangsawang &
Serisathien, 2011 ) while one included only the postpartum period (Reilly et al., 2002).
The other five included both periods (Kocaoz et al., 2013; Ko et al., 2010; Morkved et
al., 2003; Dinc et al., 2009; Sampselle et al., 1998).
Level of Evidence
With reference to the SIGN (2011) guidelines, two studies were ranked as RCTs
with a very low risk of bias (Reilly et al., 2002; Morkved et al., 2003). Three studies
were ranked as RCTs with a low risk bias (Stafne et al., 2012; Ko et al., 2010;
Sampselle et al., 1998). Two studies were RCTs with a high risk of bias (Pelaez et al.,
2014; Dinc et al., 2009). The other two studies were high quality control studies with
a very low risk of bias and a high probability that the relationship was causal (Kocaoz
et al., 2013; Sangsawang & Serisathien, 2011).
Quality Assessment
The methodological quality of each study was assessed using the methodology
checklists for randomized controlled trials (SIGN). Tables 1 and 2 summarize the
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internal validity assessment and the overall quality assessment of the selected studies.
Checklists of the assessment are shown in Appendix III.
Table 1: Internal Validity Assessment of Selected Studies
Clearly
Focused
Question
Random
Allocation
Adequate
Concealment
Double
Blind
Treatment
Allocation
Groups
Comparable
Only
Difference
is
Treatment
Valid
Measurement
of Outcomes
Drop-out
Rate
Intention
-to-Treat
analysis
Comparable
Results From
all Sites
Kocaoz et al.,
2013 + NA NA NA + + +
23% IG
26% CG – NA
Reilly et al.,
2002 + + + – + + +
13.7% IG
14.7% CG + NA
Stafne et al.,
2012 + + + – + + +
7.7% IG
14.3% CG + NR
Ko et al., 2010 + NR + NR + + + 4.8% + NA
Morkved et
al., 2003 + + + – + + +
1.7% IG
2.3% CG + NA
Pelaez et al.,
2014 + + – NR + + +
13.7% IG
7.3% CG – NA
Sangsawang &
Serisathien,
2011
+ NA NA NA + + + 11.4% IG
0% CG – NA
Dinc et al.,
2009 + NR + NR + + +
10.9% IG
15.2% CG – NA
Sampselle et
al., 1998 + + + – + + + 36.1% + NA
Covered (+); Not Covered (–); Not Reported (NR); Not Applicable (NA) Intervention Group (IG);
Control Group (CG)
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High Quality Studies
Four of the nine trials achieved a high quality rating (Reilly et al., 2002; Stafne et
al., 2012; Morkved et al., 2003; Sampselle et al., 1998). Although the research
questions were not mentioned in the four studies, the aims and objectives were stated
clearly with 'PICO' components. Three studies used computer generated allocation for
randomization (Reilly et al., 2002; Stafne et al., 2012; Sampselle et al., 1998) while
Morkved et al. (2003) performed block randomization. Allocation concealment was
Table 2: Overall Quality Assessment of the Selected Studies
Bias
Minimized
Direction of Bias Effect due to
Intervention
Results
Applicable to
Target Group
Overall quality
Rating
Kocaoz et al., 2013 + No randomization used. Yes Yes Fair (+)
Reilly et al., 2002 ++ Chance of selection bias. Only included
women with existing bladder neck mobility.
Yes Yes High (++)
Stafne et al., 2012
++ Subjects and investigators were not blinded to
treatment allocation. Significant difference in
severe SUI between groups, more frequent in
control group, which may have led to
overestimation of effect.
Yes Yes High (++)
Ko et al., 2010 + Randomization of assignment of subjects was not reported.
Yes Yes Fair (+)
Morkved et al.,
2003
++ Low drop-out rate and intention-to-treat
analysis minimized bias.
Yes Yes High (++)
Pelaez et al., 2014 + Inadequate concealment method used. Yes Yes Fair (+)
Sangsawang &
Serisathien, 2011
+ No randomization adopted. Short duration of
intervention and small sample size may have
led to overestimation of measured effects.
Yes Yes Fair (+)
Dinc et al., 2009 + If intention-to-treat analysis was applied, the
effect size would be overestimated.
Yes Yes Fair (+)
Sampselle et al.,
1998
++ High drop-out rate due to long study period
which affected effect size.
Yes Yes High (++)
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done by centralized allocation or using opaque sealed envelopes. Single-blinding
where investigators or assessors were blinded was used in three studies. The study of
Stafne et al. (2012) did not use blinding. Bias could be expected as result of
overestimation of the effect size.
The characteristics of subjects in both the intervention and control groups were
similar at the beginning of the trial in four studies (Reilly et al., 2002; Stafne et al.,
2012; Morkved et al., 2003; Sampselle et al., 1998). It was clearly stated that the only
difference between groups was the intervention. The overall drop-out rates were
acceptable, ranging from 1.7% to 14.7%. However, Sampselle et al. (1998) had a high
rate of 36.1% which may have been due to the long follow-up period. All studies
performed intention-to-treat analysis to analyze all subjects as randomized regardless
of the drop-out rate.
Moderate Quality Studies
The quality of the five remaining studies was rated as moderate. (Kocaoz et al.,
2013; Ko et al., 2010; 2003; Pelaez et al., 2014; Sangsawang & Serisathien, 2011;
Dinc et al., 2009). The aims and objectives of the studies were addressed clearly in all
trials. As Kocaoz et al. (2002) and Sangsawang & Serisathien (2011) were
quasi-experimental studies, randomization was not applicable. The randomization
method was only reported by Pelaez et al. (2014) who used a computer generated
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program. Two studies (Ko et al., 2010; Dinc et al., 2009) didn't mention the method of
randomization but reported they used sealed envelopes for concealment. Blinding was
not mentioned in any of the studies.
All studies reported subject characteristics to ensure there were no significant
differences between the intervention and control groups. All studies ensured that the
only difference between groups was the intervention under investigation. The
drop-out rates were between 0% and 26%. Intention-to-treat analysis was only
addressed in one study (Ko et al., 2010), which contributed to a lower quality rating.
The overall effects in the nine studies were attributed to the study interventions, and
all of them were directly applicable to the targeted patient group.
2.3 Summary and Synthesis
Characteristics of the Interventions
All studies used different combinations of antenatal PFMT instructions as their
interventions. All of the interventions were well-structured and taught by nurses or
physiotherapists. The correct methods of contraction of pelvic floor muscles were
taught while the duration and frequency of exercising were indicated following a
strength-training protocol. Home exercises were included as part of the training
program. Three of the studies (Morkved et al., 2003; Pelaez et al., 2014; Stafne et al.,
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2012) included PFME in an antenatal exercise program comprising general aerobic
exercises. All interventions were delivered face-to-face. The majority of them were
done on a group basis (2-15 participants) (Stafne et al., 2012; Ko et al., 2010;
Morkved et al., 2003; Pelaez et al., 2014; Sangsawang & Serisathien, 2011); one was
conducted on a one-to-one basis (Reilly et al., 2002); the other three studies (Kocaoz
et al., 2013; Dinc et al., 2009; Sampselle et al., 1998) did not report this. The
intervention periods ranged from 6 weeks to 22 weeks, with the mode 12 weeks. Most
of the interventions were comprised of weekly follow-up sessions, the frequency
ranging from three times a week to once a month; only Kocaoz et al. (2013)
conducted a one -off intervention. The duration of each training session ranged from
45 to 60 minutes in the five studies which reported it (Stafne et al., 2012; Ko et al.,
2010; Morkved et al., 2003; Pelaez et al., 2014; Sangsawang & Serisathien, 2011).
Effectiveness of the Interventions
All reviewed studies concluded that antenatal PFMT is effective in preventing or
treating SUI during pregnancy or after delivery. Except for Reilly et al (2002) who
assessed SUI after delivery, all studies showed that the incidence of SUI in the
antenatal period was significantly lower in the intervention groups than in the control
groups. Pelaez et al. (2014) and Sangsawang & Serisathien (2011) showed more
significant results compared with the others. Pelaez et al. (2014) reported a 4.8 %
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incidence of SUI in the 36th
gestational week in the intervention group compared with
39.3% in the control group (p=0.0001). Sangsawang & Serisathien (2011) reported an
incidence of 38.7% in the 26th
to 36th
gestational week in the intervention group and
100% in the control group (p=0.001). Five studies reported a statistically significant
difference in the frequency of SUI between the two groups (Kocaoz et al., 2013;
Stafne et al., 2012; Pelaez et al., 2014; Sangsawang & Serisathien, 2011; Dinc et al.,
2009). However, Kocaoz et al. (2013) reported insignificant results for the frequency
of SUI 'once a week or less' in the 28th
and 32nd
gestational weeks ( 3.85% in the
intervention group (IG) vs 2% in the CG and 7.69% in the IG vs 6% in the CG
respectively, with no P-value reported).
All six studies with postnatal evaluations reported significant differences between
the IG and CG in terms of the incidence, frequency and severity of SUI (Kocaoz et al.,
2013; Reilly et al., 2002; Ko et al., 2010; Morkved et al., 2003; Dinc et al., 2009;
Sampselle et al., 1998). However, Ko et al. (2010) reported insignificant results in the
incidence of SUI 3 days and 6 weeks postpartum (30% in the IG vs 41% in the CG
and 25% in the IG vs 35% in the CG, respectively). Sampselle et al (1998) evaluated
the severity of SUI 6 weeks, 6 months and 12 months postpartum. The difference
between groups at 12 months was insignificant with no P-value reported (+0.006
[mean; score assessing severity] in the IG vs +0.025 [mean; score assessing severity]
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in the CG).
Summary of the Evidence
From the reviewed studies, Pelaez et al. (2014) showed more statistically
significant differences between groups in the incidence of SUI in the antenatal period
(4.8 % in the IG vs 39.3% in the CG [p=0.001]). This might be because that study had
an intensive follow- up program with the longest intervention period among all
studies. Participants attended exercise sessions three times a week for 22 weeks. This
intensive training program provided continuous monitoring and supervision of the
correctness and continuum of pelvic floor exercises resulting in better effects. The
study of Sangsawang & Serisathien (2011) also showed a significant reduction in the
rate of SUI in the antenatal period. The study included subjects with UI at the
beginning of the trial. Only 38.7% of participants in the IG reported SUI compared
with 100% in the CG (p=0.001). Training sessions with smaller groups of 2-5
participants were adopted. This could ensure that every participant in the group was
supervised closely which increased the effectiveness of the intervention. A supervised
pelvic floor exercise intervention on a one-to one basis was used in the study of Reilly
et al. (2002). This might have been more effective than group instruction and
therefore there was a significant difference between the IG and CG (19.2% in the IG
vs 32.7% in the CG [p=0.023; 95% CI 0.37-0.92]).
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Kocaoz et al. (2013) reported insignificant results in the frequency of SUI in the
28th
and 32nd
gestational weeks (3.85% in the IG vs 2% in the CG and 7.69% in the
IG vs 6% in the CG, respectively, with no P-value reported). This might be attributed
to the short intervention in which a one-off training session was given without further
follow up. The high chance of discontinuity and inaccuracy of pelvic muscle exercise
might have led to the small effect size. In addition, the high dropout rate (23% in the
IG and 26% in the CG) might have contributed to the larger effect size as intention-
to- treat analysis was not adopted. Ko et al. (2010) demonstrated insignificant results
in the early postpartum ( 3 days postpartum: 30% in the IG vs 41% in the CG
[p=0.07]; 6 weeks postpartum: 25% in the IG vs 35% in the CG [p=0.06]). Vaginal
delivery might damage the pelvic floor muscles, which need time to heal in the early
postpartum period. Therefore, the outcome was insignificant in the early postpartum.
Sampselle et al. (1998) reported that the difference in the severity of SUI between
groups was not significant at 12 months postpartum. Despite the high dropout rate in
the study (36%) which reduced the power of the results as only a small sample was
included, bias was reduced by appropriate randomization and adherence to
intention-to-treat analysis. Since the other eight reviews only evaluated the outcomes
in a relatively short period (from the antenatal period until 6 months postpartum),
the benefits of PFME in SUI could not be well interpreted beyond this time period.
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Sampselle et al. (1998) provided evidence for the effect of PFME in SUI in a long
term follow- up after delivery in a reliable way, which could be taken into account in
the establishment of the evidence- based protocol.
Implications for Practice
To develop evidence-based guidelines, recommendations were made according to
the above information.
Most of the reviewed studies included pregnant women in the second trimester
(14th
to 24th
week), either with or without UI, depending on whether the studies aimed
at prevention, treatment or both. It is recommended that pregnant women in their
early second trimester be targeted. Basic characteristics such as parity, mode of
delivery, urinary symptoms, age and BMI will be assessed as these impose a direct
effect on the outcome measures. It will be difficult to recruit only pregnant women
with UI as it may be unfair to others without UI, as the MCHCs are supposed to
provide equal services to the public. To make the recruitment process easier, women
will be considered regardless of whether they have UI or not.
Studies suggest that a well-structured PFME program supervised by health care
professionals is more effective than verbal advice with written materials (Miquelutti
et al., 2013; Mason et al., 2001). The PFME intervention should include skills in
contraction and relaxation of pelvic floor muscles and guidelines on home exercises
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supervised and taught by trained nurses with optional supplementation with printed
material. Three studies had weekly interventions, for 12 weeks (Stafne et al., 2012;
Ko et al., 2010; Morkved et al., 2003). Each training session should be 45 to 60
minutes (Stafne et al., 2012; Ko et al., 2010; Morkved et al., 2003; Pelaez et al., 2014;
Sangsawang & Serisathien, 2011). A small group with approximately 8-12
participants should be considered (Morkved et al., 2003; Pelaez et al., 2014).
Although a one-to-one basis was used by Reilly et al. (2002), it may not be cost
effective in the MCHCs.
All studies evaluated the incidence of SUI in late pregnancy and/or postpartum.
The frequency of SUI was assessed in five studies (Kocaoz et al., 2013; Stafne et al.,
2012; Pelaez et al., 2014; Sangsawang & Serisathien, 2011; Dinc et al., 2009). These
two outcomes may be considered in the protocol. Evaluations in the 36th
gestational
week and 6 months postpartum are preferable.
Some concerns will be considered in the development of guidelines.
Misconceptions about UI among pregnant women should be clarified in the program.
Most pregnant women perceive UI as normal during pregnancy and after delivery
(Cardozo & Cutner, 1997). This may keep women in the intervention group from
performing PFME according to instructions. Information about the nature and adverse
effects of UI as well as preventive measures and treatment methods should be
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highlighted in the program (Mason et al., 2001). In addition, as pelvic floor training
involves home exercises, increasing motivation and monitoring should be carried out
in order to encourage and ensure the participants comply well with the program
(Franchi et al., 1999).
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Chapter 3: Translation and Application
3.1 Introduction
SUI in the antenatal and postnatal periods is common in Hong Kong women, and
adversely affects various aspects of their quality of life. Healthcare professionals often
underestimate the problem as few of them have insight into this urological issue.
Neglecting early prevention and treatment and improper instruction of PFME may
lead to poor progress in incontinence in women. The literature on this health issue
shows that antenatal PFMT is essential to improve SUI during pregnancy and after
delivery. The implementation potential will be assessed in three areas, the
transferability of the findings, the feasibility and the cost-benefit ratio of the
innovation, before translating the literature guidelines into the targeted setting.
3.2 Target audience/setting
The innovation will be implemented in a MCHC. In the local setting, about 150
pregnant women register for their first antenatal checkup each month. It is known that
SUI is a common problem in pregnant women in Hong Kong, and it usually persists
in the postpartum period. Nonofficial observational data in 2010 in the local setting
reported a rate of urinary incontinence of about 20% among pregnant and postnatal
women. During antenatal checkups, many pregnant women express concerns about
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their urological condition and especially UI. This shows the need to establish
well-structured PFMT for the target audience.
3.3 Assessing implementation potential
Transferability of findings
As shown by the Table of Evidence in Appendix II, PFMT will be launched in
antenatal clinics or antenatal wards for primigravida or nulliparous pregnant women
with or without a history of UI in their first or second trimester of pregnancy. The
local MCHCs provides antenatal checkup services for pregnant women, regardless of
UI status or parity. The similarity of characteristics of the target audience and setting
in the reviewed studies and those in the MCHC suggests that the proposed innovation
can be implemented in the local setting.
PFME improves the quality of life and physical well-being of women, as it is
effective in preventing and treating UI (Berghmans et al., 1998). The mission of the
DH is to 'safeguard the health of the people of Hong Kong through promotive,
preventive, curative and rehabilitative services' (Department of Health, 2013a). The
vision of the Family Health Service is to 'promote the health and well-being of ......
women and families', and its mission is 'to empower individuals, families and
communities to improve their health' (Department of Health, 2013b). As MCHCs are
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under the Family Health Service of the Department of Health, the philosophy
concerning decreasing the rate and frequency of UI is consistent with the philosophy
of care in the proposed setting.
PFME training is recommended for all pregnant women. In 2013, 1854 pregnant
women registered for routine antenatal checkups at the targeted MCHC. The number
of clients in the practice setting who can benefit from the innovation is sufficient.
The training programs in all of the reviewed studies in Appendix II were conducted
in the first and second trimesters of pregnancy. Two reviewed studies had 45-minute
training sessions. (Ko et al., 2010; Sangsawang & Serisathien, 2011). One study had
one- off sessions (Kocaoz et al., 2013) while another suggested three sessions
(Sangsawang & Serisathien, 2011). It is proposed that the training be launched in two
45-minute sessions in the early second trimester. The proposed outcome, the rate and
frequency of SUI will be evaluated in the 36th
gestational week and 6 months
postpartum, as suggested in the literature (Stafne et al., 2012; Ko et al., 2010;
Morkved et al., 2003; Sampselle et al., 1998).
Feasibility
Organizational norms in relation to willingness to change affect the implementation
of innovations (Durlak & DuPre, 2008). In the local setting, nurses are free to carry
out innovations and are encouraged to bring up new ideas in clinical practice.
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Schemes to reward staff for constructive and creative innovations encourage
implementation of new programs in the Department of Health. Termination of
undesirable innovations depends on the considerations of frontline staff. In the local
setting, a two-year program of monthly breastfeeding support groups was terminated
at the center level because of poor attendance rates and negative feedback from staff
and clients. These examples show that nurses are free to carry out and terminate
innovations. This shared decision-making practice, which refers to the extent to which
relevant parties collaborate in determining what will be implemented and how, makes
an implementation proceed more smoothly (Gottfredson & Gottfredson, 2002).
The new program will be implemented more effectively if it fits with the
organization’s current mission, priorities, and existing practices (Richard et al., 2004).
The organizational climate is conducive to evidence-based practice. There is a
bimonthly journal club in the local setting for staff to share the latest research.
Health care professionals are encouraged to bring up new ideas during the discussion.
Current services and interventions provided in the clinic setting, such as breastfeeding
support and postnatal counseling services, are mainly based on evidence from studies.
Some obstacles such as duty arrangement and staff training can be foreseen at the
administrative level. Physiotherapists and nursing specialists in urology in the DH
will be invited to train the staff in the proper methods of pelvic muscle training.
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Coordination with other parties can bring different perspectives, skills, and resources
to bear on program implementation (Hahn, Noland, Rayens & Christie, 2002). The
new project will gain support from these parties as the department is planning
innovations to provide better health education for women.. The department will
support the innovation once administrative personnel approve. Measures to overcome
predicted obstacles will be discussed in later chapters.
Currently, antenatal PFMT is taught with videos. In each antenatal session, PFMT
videos are shown to clients having routine antenatal checkups. One nurse is
responsible for answering questions and responding to queries in this 30-45 minute
health education session. Verbal feedback from clients during routine interviews
shows that more interaction between nurses and clients is preferred. In the innovation,
the same manpower and the same period of time will be used to conduct PFMT in a
small group. Minimal interference with manpower is expected. However, the
workload of the staff will increase slightly because more nursing staff will be needed
for face-to-face training than for showing videos. Evaluation of the innovation will be
done using pre-test and post-test questionnaires on the outcome measures, the rate and
frequency of SUI. Additional statistical processing is needed for evaluation, which
could increase the staff workload. Resistance may be encountered in carrying out the
innovation.
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Nurses in the local setting are well equipped with basic knowledge of urological
problems in pregnant and postpartum women continuing education and training on
related health issues are provided by the department. Most nurses are experienced in
educating clients about PFME, as they currently provide this service antenatally. It is
still recommended that all staff attend training sessions on conducting the innovation
to consolidate knowledge with practical experience. Collaboration with
physiotherapists and nursing specialists in urology is recommended for skills
assistance and instruction. The success of the implementation depends on the skill
proficiency of the providers. Service providers with better requisite skills are more
willing to implement an innovation at higher levels of dosage or fidelity (Ringwalt et
al., 2003). As the training courses increase nursing staff proficiency, the department
will be willing to support the innovation by releasing staff for training during office
hours.
No special equipment is needed for the innovation. Materials such as posters and
leaflets will be supplied directly by the department. The outcomes of the innovation
are the rate and frequency of SUI, which can be obtained using a questionnaire with a
self- reported severity index, a measuring tool created by Sandvik et al. (1993). It
comprises two questions assessing the frequency of urinary incontinence and the
amount of leakage. After multiplying the scores of the two questions, the resulting
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value is categorized into slight, moderate and severe (Appendix IV). Published
evidence suggests the severity index is a valid measure of UI in women and it is
recommended for routine use (Hanley, Capewell & Hagen, 2001; Sandvik et al., 1993;
Sandvik, Seim, Vanvik & Hunskaar, 2000). Since pregnant women first come to the
MCHC around the 12th
gestational week, PFMT will be launched in two sessions in
the second trimester at the antenatal clients. Outcomes will be measured in the 36th
gestational week and 6 months postpartum.
Cost-benefit ratio of the innovation
In a previous review, evaluation of PFME for stress incontinence was done by
examining costs and quality-adjusted life years The study showed that appropriate
pelvic floor training in a patient with incontinence lowers National Health Service
costs and improves the benefits of treatment and quality of life (Costantini et al.,
2014).
The cost-benefit ratio of the implementation will be assessed. The innovation
benefits clients in different ways. PFME prevents and treats SUI by improving the
efficiency of sphincter function (Berghmans et al., 1998). With ta decrease in the
incidence of SUI in the antenatal and postnatal periods, quality of life improves as
clients are able to resume normal social, physical, occupational and leisure activities.
Other benefits are expected from implementing the program. Staff can better equip
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themselves in professional knowledge of health promotion skills and related
gynecological health issues through participation in staff training sessions. Through
active contribution and discussion in the construction phase of the program, staff can
gain job satisfaction in decision making. It is expected that the program will be
effective in the prevention and treatment of SUI in the targeted women. Staff will feel
satisfied with the positive feedback from clients and favorable outcomes, which may
increase staff morale.
The innovation is recommended as there are risks in maintaining current practice.
Currently, pelvic floor muscle exercise is taught by a video. This passive method of
delivering health messages does not ensure that clients understand and perform the
exercises correctly (Sandvik et al., 1993). Since there are no follow-up sessions
afterwards, clients have no way to ask questions and clarify misconceptions, which
increases the risk of performing PFME incorrectly (De Oliveira, Lopes, Carla Longo e
Pereira & Zugaib, 2007). The overall decrease in the rate of SUI in current practice is
lower than that expected with the innovation. In addition, as the current method is not
very effective in treating and preventing SUI, negative feedback from clients may
lower staff morale and negatively affect the image of the department.
The costs of implementing the innovation have to be taken into account to
calculate the cost-benefit ratio. Material costs include staff training and posters placed
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in the clinic. In addition to these set-up costs, operational costs are important in
determining the cost-effectiveness of the new practice. Operational costs include
written information for clients, the cost of conducting PFME training sessions and the
cost of evaluation. Total material costs per year will be $76,307. Details of the
calculations can be seen in Appendix V.
Non-material costs may arise from the innovation. Instead of waiting for queries
from the audience, as is done in current practice, nurses are active in PFMT. This may
increase the workload of staff as they need to have better preparation before launching
the health education sessions. Staff morale may be negatively affected and sick leave
may increase due to intentional absenteeism. Moreover, the staff turnover rate in the
clinic may increase if the increased workload causes resignations (Michie & Williams,
2003).
To conclude, the innovation is transferable, feasible and cost- effective and can be
implemented in the proposed local setting.
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Chapter 4: Developing Evidence-based Practice Guidelines
4.1 Guideline title
Pelvic floor muscle exercise training for antenatal clients
4.2 Aims and objectives
The aim of this protocol is to decrease the rate and frequency of SUI by providing
structured PFME training.
The objectives are: 1) to provide a rational guideline based on scientific evidence
for the staff in providing antenatal PFME education; 2) to improve the quality of care
by reducing variations in practice by acting as a quality control; and 3) to promote
efficient use of resources in providing antenatal education in MCHCs.
4.3 Target group
Target users
Nurses of all levels in MCHCs providing PFME in antenatal clients.
Target patient population covered
Women attending MCHCs for antenatal checkups, in the second trimester of
pregnancy, without contraindications for performing PFME (e.g. high-risk of preterm
labor, pregnancy complications, twin pregnancies, pain during pelvic floor
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contraction).
Target setting
Maternal and Child Health Centres of the Department of Health.
4.4 Recommendations
The protocol provides practical instructions for PFME training. Recommendations
on assessment, intervention and evaluation are made with the support of evidence and
are relevant to clinical practice. The levels of evidence and grades of
recommendations are appraised using SIGN (2011) guidelines (Appendix VI).
Assessment
1.1 Assess client’s health condition and pregnancy risk before recruitment.
Evidence:
Prior to recruitment, nurses must screen patients to exclude women with
contraindications to performing PFME during pregnancy, such as twin
pregnancies, a high risk of preterm delivery and pain during contraction when
doing PFME, which will affect the treatment effect. (Martin et al., 2006;
Sampselle et al., 1998) (1+; 1+)
Grade of Recommendation: A
1.2 Assess urinary incontinence before training using self-reported
questionnaires.
Evidence:
The status of SUI in early pregnancy will affect the outcome of PFME in the
antenatal period, since this will affect whether PFME is a preventive measure or
used for treatment purposes. (Boyle, Hay-Smith, Cody, & Mørkved, 2012;
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Cooper & Cook, 2011) (1++; 1++)
A pretest self-report questionnaire will be used to evaluate outcomes. (De
Oliveira et al., 2007) (2+)
Grade of Recommendation: A
Intervention
2.1 Pelvic floor muscle training should be done in groups of 12.
Evidence:
It would be less time-consuming, more cost-effective and possibly more
motivating if pelvic floor exercise can be taught in a group setting compared
with individual training. (Bø & Haakstad, 2011) (1+)
Grade of Recommendation: B
2.2 The training should be conducted
a) early in the second trimester;
b) in two sessions: and
c) for 45 minutes.
Evidence:
PFMT during the second half of pregnancy reduced the prevalence of UI in late
pregnancy. (Mørkved et al., 2003; Reilly et al., 2002; Sampselle et al., 1998;
Stafne et al., 2012) (1++; 1++; 1+; 1+)
b) It is estimated that 30% of women are unable to contract the pelvic floor
muscles on a first attempt. Follow-up is important to increase the success rate.
(Bump, Hurt, Fantl & Wyman, 1991) (2-)
b) Monitoring of adherence to the training program in the follow up session is
more important than the total number of sessions. (Ko et al., 2011) (1+)
c) Training for PFME can be done within 45 minutes. (Ko et al., 2011;
Sangsawang & Serisathien, 2011) (1+; 2++)
Grade of Recommendation: A
2.3 The exercise regimen should comprise three repetitions of eight contractions,
each held for 6 seconds, with 2 minutes rest between repetitions. These should be
repeated twice daily at home.
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Evidence:
This is a common regimen suggested by National Institute for Health and
Clinical Excellence guidelines for the management of UI in women, and it
significantly improves SUI in women. (Bø, 1995; Ko et al., 2011; Kocaoz, et al.,
2013; National Institute for Health and Clinical Excellence, 2006; Reilly et al.,
2002) (1+; 1+; 2++; 4; 1++)
Grade of Recommendation: A
2.4 Educational handbooks containing simple, clear instructions should be
distributed to participants.
Evidence:
Nurses should provide information about UI and PFME for pregnant women
verbally combined with handbooks for review at home. (Kocaoz et al., 2013;
Sangsawang & Serisathien., 2011) (2++; 2++)
Educational brochures on UI and PFME increase women’s awareness of the
subject, and stimulate interest and attract the attention of pregnant women.
Women will be able to understand the causes and treatment of SUI during
pregnancy and enhance their understanding of the benefits of PFME to minimize
the severity of SUI. (Kocaoz, et al., 2013; Sangsawang & Serisathien., 2011)
(2++; 2++)
Grade of Recommendation: B
Evaluation
3.1 Evaluations should be done in the 36th
gestational week and 6 months
postpartum.
Evidence:
Both the prevalence and severity of SUI increase throughout pregnancy and
PFME leads to less self-reported incontinence in late pregnancy. (Sampselle et
al., 1998; Sun, Chen, Chang & Chen, 2005; Thorp et al., 1999) (1+; 3; 2+)
Vaginal delivery might contribute to pelvic floor damage through muscular,
fascial, and nerve injuries. Tissue damage takes time to heal in the early
postpartum period. It is possible that an episiotomy will interfere with PFME in
the immediate postpartum period. Therefore, evaluation in the early postpartum
period is not suggested. (Ko et al., 2011) (1+)
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The benefits of performing PFME in pregnancy are only evident up to six
months postpartum. This may be because of a lack of compliance with exercises
postpartum, or a result of birth trauma damaging the muscle and surrounding
structures. (Boyle et al., 2012; Cooper & Cook, 2011; Sampselle et al., 1998)
(1++; 1++; 1+)
Grade of Recommendation: A
3.2 Mode of delivery should be considered in evaluating outcomes.
Evidence:
Vaginal delivery is associated with a significantly higher postpartum UI rate than
cesarean delivery. (Ko et al., 2011) (1+)
Participants who had a cesarean birth were omitted from comparisons of pelvic
muscle strength because pelvic muscle damage would not be expected to occur.
(Sampselle et al., 1998) (1+)
Grade of Recommendation: A
3.3 Self-report outcomes are measured.
Evidence:
Speculum measures are not preferred compared with survey questions on
incontinence as there are contraindications to vaginal examination, such as
vaginitis and equipment malfunction. Pad tests can induce urinary tract infection
in pregnant women and women complain of discomfort when undergoing
urodynamic assessment. (Martin et al., 2006; Mørkved et al., 2003; Sampselle et
al., 1998) (1+; 1++; 1+)
Self-reports to evaluate the treatment effect cause minimal discomfort and
embarrassment for participants. (Mørkved et al., 2003) (1++)
The severity index is a simple, valid, reliable, and sensitive measure of UI in
women and therefore is recommended for routine use. (Hanley et al., 2001;
Sandvik et al., 1993; Sandvik et al., 2000) (1-; 1+; 1+)
Grade of Recommendation: A
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Chapter 5: Implementation Plan
5.1 Introduction
PFME is suggested to be cost-effective and beneficial in the treatment of UI, since
this is a common health issue in the antenatal and postnatal periods. The
transferability of the research findings, feasibility and cost benefit ratio of the
innovation using PFMT in pregnant women had been assessed in previous chapters.
The communication and pilot testing plans were identified to facilitate the
implementation of the evidence-based protocol.
5.2 Communication plan
Potential stakeholders
Stakeholders are people who are affected by a proposed innovation because of the
expected results of the changes (Polit & Beck, 2012). Administrators such as nursing
officers, senior nursing officers and senior medical officers in the head offices are
potential stakeholders in the implementation of the innovation as they have decision
-making responsibilities for distribution of finances and resources and arrangement of
manpower. The frontline staff including nurse specialists in urology, doctors and
nurses will be affected by the changes in protocol. They may support or oppose the
innovation since their workloads and of work routines will be changed.
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Communication process and methods
A team of health care professionals will be recruited to implement the new protocol.
Under the DH, four nursing officers are in charge of the targeted MCHC.
Recommendations for changes in guidelines and protocols in the workplace must first
be approved by the nursing officer in-charge. Senior nursing officers in the region will
be informed through the nursing officer for further approval. The implementation
team members will include two registered nurses, one nursing officer, one senior
nursing officer and one nurse specialist in urology. The team will participate in the
whole process of implementation and will function as resource and support persons,
auditors and trainers. Making sure the correct people are involved in the project
ensures individuals with appropriate skill sets and experts in the content of the
innovation are included (Dogherty, Harrison, Baker & Graham, 2012).
The implementation team will approach the administrators and convince them to
support the innovation. A one -hour presentation will be used to report evidence from
the studies. The prevalence and severity of UI in pregnant and postpartum women and
its effects on their quality of life will be highlighted in the presentation. The current
practice of showing a PFME program on video will be compared with the structured
training program in the innovation and the pros and cons will be discussed. The
administrators will be shown evidence from the literature supporting that antenatal
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PFMT is significant in reducing the rate of SUI in the late antenatal and postnatal
periods. The feasibility and cost-benefit ratio, which have been discussed in the
previous chapter, will be addressed in the meeting. A detailed transparent explanation
of the process of implementation will be provided (Harrison et al., 2013).
With the approval and support of the administrators, nurses in the targeted center
involved in carrying out the innovation will be informed about the changes in the
protocol. A presentation will be given by the implementation team members to
explain the need for change and the significance of the new guideline. The timeline of
the implementation, workload, and benefits for staff and patients will be explained
to gain support from frontline staff. Misconceptions will be clarified. Counseling and
interviews will be offered for those with serious concerns about the changing protocol
and those who oppose or resist the new program. Studies emphasize the importance of
being organized and prepared for meetings so that group members’ time is not seen as
wasted and the work is not delayed (Graham & Harrison, 2005).
Training workshops will be held by the implementation team. Nurses in charge of
antenatal and postnatal services in the center will be trained to teach the PFME
program first. After that, these trained nurses will hold training workshops in small
groups to familiarize all nurses in the center with the information and flow of the new
protocol. Trainer nurses will be role models who allow other nurses to sit in on the
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pelvic floor exercise program. Trainer nurses will also act as troubleshooters to
address concerns from other staff about mastering the new skills and the extra
workload.
Additional support will be provided through an updated resource kit and pocket
guide. The resource kit will be available in the clinic for staff reference. The pocket
guide, consisting of a summary of the new protocol and practical tips for launching
the new pelvic floor training program, will be given to all nurses.
Sustaining the change process
According to Harrison et al. (2013), guideline adaptation should not be considered
an episodic activity but part of a continuum in the evidence-informed practice journey.
Various measures are suggested to sustain the change process to ensure its
effectiveness and efficiency. The implementation team will evaluate the adequacy of
facilitation of the new practice guidelines (Dogherty, Harrison, Graham &
Keeping-Burke, 2014). Extra time will be allowed for staff to equip themselves with
the new skills and information. Additional training workshops will be provided if
necessary. This will ensure that all nurses are very familiar with the new protocol.
Compliance with the new guideline will be assessed by an audit system (Dogherty et
al., 2014). The ability of nurses to perform the new protocol will be audited by the
trainer nurses. Feedback will be given to the nurses after auditing.
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Patient outcomes in terms of the rate of SUI and feedback from clients will be
monitored to modify the protocol. Success stories and nurses’ experiences s will be
shared in clinic meetings. Regular close contact will be maintained to ensure the right
individuals are informed and receive appropriate materials for a more complex
awareness of the updated issues (Dogherty et al., 2012). Revisions according to
updates l from the literature will be done frequently and guidelines will be modified
according to the latest review of evidence.
5.3 Pilot testing
A pilot study will be carried out after the communication process and staff training.
The aim of pilot testing is to determine the feasibility of the proposed change in the
PFME program in MCHCs to avoid unexpected difficulties and challenges before full
implementation (Polit & Beck, 2012; Van Teijlingen, Rennie, Hundley & Graham,
2001).
The new evidence-based practice guideline for the PFME program for pregnant
women will be applied in the target setting – the MCHC. Pilot testing will last two
weeks; two well trained nurses will run the program. One hour training will be given
to the nurses before the implementation. Posters will be placed in the waiting room
and leaflets will be distributed for each client to take home. The pilot test consists of
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two 45 minutes sessions. The first session will introduce pelvic floor exercise and the
second will be a follow-up session. Twelve clients will be recruited and they will be
required to attend both sessions.
The process and outcome of the pilot test will be evaluated and the new guideline
will be modified accordingly. Modifications and additions to the process and support,
e.g. a heightened focus with more information and guidance on implementation, will
be provided (Fervers et al., 2011).
For the process outcome, interviews will be conducted with nurses to review the
logistics and difficulties in implementation. Nurses' compliance with the innovation
will be evaluated. For the outcome evaluation, client and healthcare provider
outcomes will be reviewed using the client satisfaction questionnaire and healthcare
provider questionnaire (Appendix VIII & IX).
The timeline of the communication plan is shown in Appendix VII.
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Chapter 6: Evaluation Plan
The aim of the evaluation plan is to assess e the effectiveness of the new protocol
for the PFME training program in improving SUI in pregnant and postpartum women
in the local setting. Intervention outcomes will be measured and data will be analyzed
to assess the effectiveness.
6.1 Intervention outcomes and outcome measurement
The innovation will be assessed in terms of patient outcomes and healthcare
provider outcomes. Based on the identified evaluated studies in chapter 2, the
anticipated time of the intervention to take effect will be the measurement point for
the identified outcomes.
Patient outcome
The primary outcomes are the rate and frequency of SUI in late pregnancy and
postpartum. The secondary outcome is the satisfaction level of the participants. These
proposed outcomes will be evaluated in the 36th
gestational week and 6 months
postpartum, which is suggested in the literature (Stafne et al., 2012; Ko et al., 2010;
Morkved et al., 2003; Sampselle et al., 1998).
The primary outcomes will be determined by self-report. The measuring tool, the
severity index, will be adopted to assess the outcome. It comprises two questions
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assessing the frequency of UI and the amount of leakage. After multiplying the scores
of the two questions, the resulting value is categorized into slight, moderate and
severe (Appendix IV). Published evidence suggests the severity index is a valid
measure of urinary incontinence in women and it is recommended it for routine use
(Hanley et al, 2001; Sandvik et al., 1993; Sandvik et al., 2000). Data will be collected
in the 36th
gestational week by self-reported questionnaires distributed during
antenatal checkups in the MCHC, and 6 months postpartum by telephone follow up
by nurses.
A self-reported questionnaire with a 5-point Likert Scale will be used to assess the
secondary outcome, the satisfaction level of the participants (Appendix VIII). Data
will be collected at the end of the follow- up session of the PFMT program.
Healthcare provider outcomes
Evaluation of the satisfaction level, skills and knowledge of the healthcare
providers will continue to ensure compliance and acceptance by the staff. The
satisfaction level will be evaluated every two months. A simple questionnaire
(Appendix IX) with a 5-level Likert Scale will be used for evaluation (Likert, 1932).
Nurses’ knowledge and skills in performing the new protocol will be audited by the
trainer nurses every half year and feedback will be given to the nurses after auditing.
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6.2 Nature and number of clients involved
Eligibility criteria
All primigravida and nulliparous women attending the MCHC for antenatal
checkups in the early second trimester of pregnancy, with or without UI symptoms
without contraindications to performing PFME (e.g. high risk of preterm labor,
pregnancy complications, twin pregnancies, pain during pelvic floor contraction) will
be recruited.
Sample size calculation
Convenience sampling will be adopted to collect data from clients. The primary
outcome of the innovation is the rate of SUI. According to local estimates, the rate of
SUI is about 15% in pregnant women and 20% in postpartum women. From the
literature review in Chapter 2, a significant decrease in the rate of SUI after a PFMT
program ranges from around 10% to 20%. A decrease of 10% in the rate of SUI in
the 36th
gestational week and 6 months postpartum suggests that the new protocol is
effective.
The research question is a hypothesis test to determine the rate of SUI after
implementation of the innovation. Russ Lenth's power and sample size calculation
software will be used. The two-tailed Z-test for one proportion will be performed
(Lenth, 2010).
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The settings will be as follows: null value = 0.2; actual value = 0.1; alpha = .05 and
power = .80. The sample size needed is 108. In the literature review, the dropout rate
from PFMT programs ranged from 1.7% to 36%. It is assumed that the dropout rate in
the local setting will be 10% for various reasons, mainly loss to follow-up. Therefore
120 clients must be recruited. It will take 8 weeks to recruit enough participants to
evaluate the effectiveness (Table 3).
Table 3: Estimation of time to recruit participants
New cases per week 36
Not fitting eligibility criteria 2
Total eligible cases per week 34
If 50% of antenatal clients agree to join the program, 17 women will participate.
Time to recruit 120 women
(12 clients per group)
120/17 = 7.1
= 8 weeks
6.3 Data analysis
SPSS version 23 for Windows was used for data analysis. In order to assess the
effectiveness of the program, the rate and frequency of SUI in participants will be
compared with existing statistics. The two-tailed z-test for one proportion will be used
to compare the rate of SUI in current and new practice.
6.4 Criteria for effectiveness
Based on the identified outcomes, criteria will be set to determine the effectiveness
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of the innovation in the local setting. For patient outcomes, the literature review
shows that the average significant decrease in the rate of SUI after PFME training is
around 10-20%. Therefore, a decrease of 10% in the rate of SUI in in the 36th
gestational week and 6 months postpartum will reflect effectiveness of the innovation.
For the satisfaction level of clients and healthcare providers, the target is that more
than 70% will respond ‘Strongly agree’ or ‘Agree’ to corresponding questions in the
questionnaires. The new evidence -based practice protocol will be considered
effective for implementation if all the above criteria are met.
Conclusion
Well-structured antenatal PFMT is effective in reducing the incidence of SUI
during pregnancy and postpartum. The innovation for the pelvic floor training
program based on available evidence is considered to be transferrable, feasible and
cost-effective for implementation in the local setting. An evidence-based guideline
has been recommended for implementation, and an evaluation plan has been
discussed. Continuous review of updated research is suggested for modification of the
protocol.
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Reference
Abrams, P., Cardozo, L., Fall, M., Griffiths, D., Rosier, P., Ulmsten, et al. (2002). The
standardization of terminology of lower tract function: report from the
Standardization Sub-committee of the International Continence Society. Neurourology
& Urodynamics, 21, 167–178.
Berghmans, L. C., Hendriks, H. J., Bo, K., Hay-Smith, E. J., de Bie, R. A. & van
Waalwijk van Doorn, E. S. (1998). Conservative treatment of stress urinary
incontinence in women: a systematic review of randomized clinical trials. British
Journal of Urology, 82, 181-191.
Bø, K. (1995). Pelvic floor muscle exercise for the treatment of stress urinary
incontinence. An exercise physiology prospective. International Urogynecology
Journal, 6, 282– 291.
Bø, K. & Haakstad, L. A. (2011). Is pelvic floor muscle training effective when taught
in a general fitness class in pregnancy? A randomized controlled trial. Physiotherapy,
97, 190-195.
Boyle, R., Hay-Smith, E. J. C., Cody, J. D. & Mørkved, S. (2012). Pelvic floor muscle
training for prevention and treatment of urinary and fecal incontinence in antenatal
and postnatal women. Cochrane Database of Systematic Reviews.
Bump, R. C., Hurt, W. G., Fantl, J. A. & Wyman, J. F. (1991). Assessment of Kegel
pelvic muscle exercise performance after brief verbal instruction. American Journal of
Obstetrics and Gynecology, 165, 322–327.
Cardozo, L. & Cutner, A. (1997). Lower urinary tract symptoms in pregnancy. British
Journal of Urology: 80(1), 14-23.
Ciolli, P., Franchi, M., Greco, E., Piserà, A. & Russo, R.(1999). The role of antenatal
courses in preventing the onset of altered pelvic statics and urinary incontinence.
Minerva Ginecologica, 51(4), 135-138. [Article in Italian]
Chan, S. S. C., Cheung, R. Y. K., Yiu K.W., Lee L. & Chung, T. K. H. (2012).
Prevalence of urinary and fecal incontinence in Chinese women during and after their
first pregnancy. International Urogynecology Journal, 24(9), 1473-1479.
Page 54
- 48 -
Chiarelli, P., Murphy, B. & Cockburn, J.. (2003). Women’s knowledge, practices, and
intentions regarding correct pelvic floor exercises. Neurourology and Urodynamics,
22(3), 246-249.
Cooper, H. E. & Cook, T. (2011). Antenatal pelvic floor muscle exercises for the
prevention and treatment of urinary incontinence in the antenatal and early postnatal
period: a critical appraisal of the evidence. Journal of the Association of Chartered
Physiotherapists in Women’s Health, 109, 5–13.
Costantini, E., Lazzeri, M., Bini, V., Zucchi, A., Scarponi, E. & Porena, M. (2014).
Managing female urinary incontinence: a regional prospective analysis of cost-utility
ratios (curs) and effectiveness. Archives of Italian Urology and Andrology,
86(2),112-117.
De Oliveira, C., Lopes, M. A. B., Carla Longo e Pereira, L. & Zugaib, M. (2007).
Effects of pelvic floor muscle training during pregnancy. Clinics (Sao Paulo), 62,
439–446.
Department of Health. (2013a). Retrieved from
http://www.dh.gov.hk/emglish/aboutus/aboutus_mv/aboutus_mn.html
Department of Health. (2013b). Retrieved from
http://www.fhs.gov.hk/english/about_us/vision/vision.html
Dinc, A., Beji, N. K. & Yalcin, O. (2009). Effect of pelvic floor muscle exercises in
the treatment of urinary incontinence during pregnancy and the postpartum period.
International Urogynecology Journal, 20, 1223-1231.
Dogherty, E. J., Harrison, M. B., Baker, C. & Graham, I. D. (2012). Following a
natural experiment of guideline adaptation and early implementation: a mixed
methods study of facilitation. Implementation Science, 7, 9.
Dogherty, E. J., Harrison, M., Graham, I. D. & Keeping-Burke, L. (2014). Examining
the use of facilitation within guideline dissemination and implementation studies in
nursing. International Journal of Evidence-Based Healthcare: 12(2), 105-27.
Page 55
- 49 -
Durlak, J. A. & DuPre, E. P. (2008). Implementation matters: a review of research
on the influence of implementation on program outcomes and the factors affecting
implementation. American Journal of Community Psychology, 41:3, 327-350.
Fervers, B., Burgers, J. S., Voellinger, R., Brouwers, M., Browman, G. P., Graham, I.
D. et al. (2011). Guideline adaption: An approach to enhance efficiency in guideline
development and improve utilization. British Medical Journal Quality & Safety, 20,
28-236.
Franchi, M., Ciolli, P., Greco, E., Piserà, A. & Russo, R. (1999). The role of antenatal
courses in preventing the onset of altered pelvic statics and urinary incontinence.
Minerva Ginecologica, 51(4), 135-8.
Gottfredson, D. C. & Gottfredson, G. D. (2002). Quality of school based prevention
programs: Results from a national survey. Journal of Research in Crime and
Delinquency, 39, 3–35.
Graham, I. D. & Harrison, M. B. (2005). Evaluation and adaption of clinical practice
guidelines. Evidence Based Nursing, 8, 68-72.
Hahn, E. J., Noland, M. P., Rayens, M. K. & Christie, D. M. (2002). Efficacy of
training and fidelity of implementation of the life skills training program. Journal of
School Health, 72, 282–287.
Hanley, J., Capewell, A. & Hagen, S. (2001). Validity study of the severity index, a
simple measure of urinary incontinence in women. British Medical Journal, 322,
1096–1097.
Harrison, M. B., Graham, I. D., van den Hoek , J., Dogherty, E. J., Carley, M., E. &
Angus, V. (2013). Guideline adaption and implantation planning: a prospective
observational study. Implementation Science, 8:8(49), 1-14.
Kocaoz, S., Eroğlu, K. & Sivaslıoğlu, A. A. (2013). Role of pelvic floor muscle
exercises in the prevention of stress urinary incontinence during pregnancy and the
postpartum period. Gynecologic and Obstetrics Investigation, 75, 34-40.
Ko, P. O., Liang, C. C., Chang, S. D., Lee, J. T., Chao, A. S. & Cheng, P. J. (2011). A
randomized controlled trial of antenatal pelvic floor exercises to prevent and treat
Page 56
- 50 -
urinary incontinence. International Urogynecology Journal, 22, 17–22.
Lenth, R. V. (2010). Java Applets for Power and Sample Size [Computer program].
Retrieved April 6, 2015, from http://homepage.stat.uiowa.edu/~rlenth/Power
Likert, R. (1932). A technique for the measurement of attitudes. Archives of
Psychology, 140, 1-55.
Martin, J. L., Williams, K. S., Abrams, K. R., Turner, D. A., Sutton, A. J., Chapple, C.,
et al (2006). Systematic review and evaluation of methods of assessing urinary
incontinence. Health Technology Assessment, 10(6), 1-132.
Mason. L., Glenn, S., Walton, I. & Hughes, C. (2001). The instruction in pelvic floor
exercises provided to women during pregnancy or following delivery. Midwifery,
17(1), 55-64.
Michie, S. & Williams, S. (2003). Reducing work related psychological ill health and
sickness absence: a systematic literature review. Occupational and Environmental
Medicine, 60, 3-6.
Miquelutti, M. A. ,Cecatti, J. G. & Makuch, M. Y. (2013). Evaluation of a birth
preparation program on lumbopelvic pain, urinary incontinence, anxiety and exercise:
a randomized controlled trial. BMC Pregnancy & Childbirth, 13, 154.
Mørkved, S., Bø, K., Schei, B. & Salvesen, K. Å . (2003). Pelvic floor muscle training
during pregnancy to prevent urinary incontinence: a single-bind randomized
controlled trial. Obstetrics and Gynecology, 101(2), 313-319.
National Institute for Health and Clinical Excellence: Urinary Incontinence: the
management of Urinary Incontinence in Women. Guideline 40. (2006). National
Institute for Health and Clinical Excellence.
Pelaez, M., Gonzalez-Cerron, S., Montejo, R. &Barakat, R. (2014). Pelvic floor
muscle training included in a pregnancy exercise program is effective in primary
prevention of urinary incontinence: a randomized controlled trial. Neurourology and
Urodynamics 33, 67–71.
Polit, D. F. & Beck, C. T. (2012). Nursing research: Generating and assessing
Page 57
- 51 -
evidence for nursing practice (9th
ed.). Philadephia: Lippincott.
Reilly, E. T. C., Freeman, R. M., Waterfield, M. R., Waterfield, A. E., Steggles, P. &
Pedlar, F. (2002). Prevention of postpartum stress incontinence in primigravidae with
increased bladder neck mobility: a randomised controlled trial of antenatal pelvic
floor exercises. International Journal of Obstetrics & Gynaecology, 109(1), 68–76.
Richard, L., Lehoux, P., Breton, E., Denis, J., Labrie, L., & Leonard, C. (2004).
Implementing the ecological approach in tobacco control programs: Results of a case
study. Evaluation and Program Planning, 27, 409–421.
Ringwalt, C. L., Ennett, S., Johnson, R., Rohrbach, L. A., Simons Rudolph, A., Vincus,
A., et al. (2003). Factors associated with fidelity to substance use prevention
curriculum guides in the nation’s middle schools. Health Education & Behavior, 30,
375–391.
Sampselle, C. M., Miller, J. M., Mims, B. L., Delancey, J. O. L., Ashton-Miller, J. A.
& Antonakos, C. L. (1998). Effect of pelvic muscle exercise on transient incontinence
during pregnancy and after birth. Obstetrics & Gynecology, 91(3), 406-412.
Sandvik, H., Hunskaar, S., Seim, A., Hermstad, R., Vanvik, A. & Bratt, H. (1993).
Validation of a severity index in female urinary incontinence and its implementation
in an epidemiological survey. Journal of Epidemiology and Community Health, 47,
497-499.
Sandvik, H., Seim, A., Vanvik, A. & Hunskaar, S. (2000). A severity index for
epidemiological surveys of female urinary incontinence: comparison with 48-hour
pad-weighing tests. Neurourology and Urodynamics, 19, 137–145.
Sangsawang, B. & Serisathien., Y. (2011). Effect of pelvic floor muscle exercise
programme on stress urinary incontinence among pregnant women. Journal of
Advanced Nursing 68(9), 1997–2007.
Sun, M. J., Chen, G. D., Chang, S. Y., Lin, R. C. & Chen, S. Y. (2005). Prevalence of
lower urinary tract symptoms during pregnancy in Taiwan. Journal of the Formosan
Medical Association, 104(3), 185–189.
Stafne, S. N., Salvesen, K. A., Romundstad, P. R., Torjusen, I. H. & Mørkved, S.
Page 58
- 52 -
(2012). Does regular exercise including pelvic floor muscle training prevent urinary
and anal incontinence during pregnancy? A randomized controlled trial. British
Journal of Obstetrics & Gynaecology, 119, 1270-1280.
Thorp, J. M. Jr., Norton, P. A., Wall, L. L., Kuller, J. A., Eucker, B. & Wells, E. (1999).
Urinary incontinence in pregnancy and the puerperium: a prospective study. American
Journal of Obstetrics and Gynecology, 181, 266–273.
Tozun, M. Ayranci, U. & Unsal, A. (2009). Prevalence of urinary incontinence among
women and its impact on quality of life in a semirural area of western Turkey.
Gynecologic & Obstetric Investigation, 67, 241-249.
Van Teillingen, E. R., Rennie, A. M., Hundley, V. & Graham, W. (2001). The
importance of conducting and reporting pilot studies: the example of the Scottish
Births Survey. Journal of Advanced Nursing, 34(3), 289-295.
Yang, X., Zhang, H. X, Yu H.Y., Gao X. L., Yang H. X. & Dong Y. (2010). The
prevalence of fecal incontinence and urinary incontinence in primiparous postpartum
Chinese women. European Journal of Obstetrics, Gynecology, and Reproductive
Biology, 152(2), 214-217.
Zhu, L., Li, L., Lang, J. H. & Xu, T. (2012). Prevalence and risk factors for peri- and
postpartum urinary incontinence in primiparous women in China: a prospective
longitudinal study. International Urogynecology Journal, 23(5), 563-72.
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Appendix I
Search Strategy and Results for Selecting Studies in the Review
Database selection: PubMed, British Nursing Index, CINAHL, Cochrane Library, ProQuest
Keyword selection:
‘Urinary incontinence’ OR’ stress urinary incontinence’ AND ‘Pelvic floor muscle exercise’ OR ‘pelvic floor exercise’ OR ‘pelvic floor training’ AND
‘antenatal’ OR ‘pregnant women’ OR ‘pregnancy’ OR ‘postnatal’ OR ‘postpartum’
Limit: clinical trials, randomized controlled trials
No. of articles identified through database search:
PubMed: 32 BMI: 14 CINAHL: 208
Cochrane Library: 210 ProQuest: 201
No. of articles after duplicates removed:
PubMed: 28 BMI: 11 CINAHL: 78
Cochrane Library: 45 ProQuest: 81
No. of articles after screened by title:
PubMed: 12 BMI: 8 CINAHL: 6
Cochrane Library: 4 ProQuest: 10
No. of articles after screened by abstract:
PubMed: 8 BMI: 3 CINAHL: 3
Cochrane Library: 2 ProQuest: 4
No. of articles after screened by full text:
PubMed: 3 BMI: 2 CINAHL: 2
Cochrane Library: 1 ProQuest: 1
Total articles for review: 9
422 studies excluded after duplicates removed
203 articles excluded by title
20 articles excluded by abstract
11 articles excluded by full text
Page 60
54
Appendix II
Table of Evidence
Bibiographic
Citation /
Study Type/
Country of
Study
E-
Level
Subject
Characteristic
Intervention Comparison Length
of
Follow
Up
Outcome Measures Effect Size Source of
Funding
Qua
-lity
Rati
-ng
Kocaoz et al.,
2013
Quasi
-experimental
Study
Turkey
2++ Pregnant women in
14th-20th gestational
weeks without UI; age
(mean + SD):
26.01+4.6; age range:
20-34
One-off AN
PFME training
session + home
exercises
(n=52)
AN routine
care + verbal
advice on
PFME
(n=50)
38wks (1) SUI at:
(a) AN 28th week (%)
(b) AN 32nd week (%)
(c) PN 12th week (%)
(2) Frequency of SUI at:
(a) AN 28th week:
(i) once a week or less (%)
(ii) several times a week or more (%)
(b) AN 32nd week:
(i) once a week or less (%)
(ii) several times a week or more (%)
(c) PN 12th week:
(i) once a week or less (%)
(ii) several times a week or more (%)
(1) SUI at:
(a) 5.8% in IG VS 30% in CG (P=0.002)
(b) 17.3% in IG VS 48% in CG (P=0.002)
(c) 1.9% in IG VS 18% in CG (P=0.007)
(2)(a) (i) 3.85% in IG VS 2% in CG **
(ii) 1.92% in IG VS 28% in CG *
(b) (i) 7.69% in IG VS 6% in CG **
(ii) 9.62% in IG VS 42% in CG*
(c) (i) 1.92% in IG VS 4% in CG*
(ii) 0% in IG VS 14% in CG*
* Sig. result, No P value reported
** Insig. Result, No P-value reported
NIL +
Page 61
55
Reilly et al.,
2002
RCT
UK
1++ Primigravidae
pregnant women in
20th gestational
weeks, with high risk
of bladder neck
mobility without UI;
age (mean): 28; age
range: 16-47: BMI
(km/m2) (mean +
SD): 24.5 + 4.25
Monthly one to
one basis AN
PFME training
session from
20th week until
delivery + home
exercises
(n=139)
AN routine
care with
information
and verbal
advice on
PFME
(n=129)
32weeks SUI at PN 3 months (%)
19.2% in IG VS 32.7% in CG (P=0.023;
95% CI 0.37-0.92)
Funded by a
grant from
Wellbeing
++
Page 62
56
Stafne et al.,
2002
RCT
Norway
1+ Pregnant women in
18th-22nd gestational
week, age (mean +
SD): 30.45+4.35;
BMI (km/m2) (mean
+ SD): 24.85 + 3.2;
nulliparous (%): 57
*Sig. difference in
severe SUI, more
frequent in CG (5% in
IG VS 10% in CG)
12- week, 60
minutes weekly
AN exercise
program
including
aerobics, PFME
and balance
exercise in
group basis
(8-15) + home
exercises
(n=429)
AN routine
care with
information
and advice on
PFME
(n=426)
16weeks (1) SUI at AN 32nd -36th week (%)
(2) Frequency of SUI at AN 32nd -36th
week: > once a week (%)
(1) 28% in IG VS 37% in CG (P=0.02; 95%
CI 0.5, 0.9)
(2) 7% in IG VS 13% in CG (P=0.03; 95%
CI 0.3, 0.9)
Funded by the
Norwegain
Fund for
Postgraduate
Training in
Physiotherapy;
the Liaison
Committee for
central Norway
Regional Health
Authority;
Norweigan
University of
Science and
Technology
++
Ko et al.,
2010
RCT
Taiwan
1+ Nulliparous pregnant
women in 16th-24th
gestational week, age
(mean + SD): 31.48 +
3.6; BMI (km/m2)
(mean + SD): 21.98 +
3.74
12-week,
45minutes
weekly AN
PFME training
session in group
basis + home
exercises
(n=150)
AN routine
care
(n=150)
48weeks SUI at:
(1) AN 36th week (%)
(2) PN 3 days (%)
(3) PN 6 weeks (%)
(4) PN 6 months (%)
(1) 34% in IG VS 51% in CG (P<0.01))
(2) 30% in IG VS 41% in CG (P=0.07)
(3) 25% in IG VS 35% in CG (P=0.06)
(4) 16% in IG VS27% in CG (P=0.04)
Supported by
Medical
Research
Project, Chang
Gung Memorial
Hospital
+
Page 63
57
Morkved et
al., 2003
RCT
Norway
1++ Nulliparous
pregnant women in
18th gestational
weeks, age (mean +
SD): 27.45 + 4.45;
BMI (km/m2) (mean
+ SD): 23.25+3.25)
12-week, 60
minutes weekly
AN exercise
program
including PFME
and general
exercises in
group basis
(10-15)
+ home
exercises
(n=148)
AN routine
care with
information
on PFME
(n=153)
32weeks SUI at:
(1) AN 36th week (%)
(2) PN 3 months (%)
(1) 32% in IG VS 48% in CG (P=0.007;
95% CI 0.5, 0.89)
(2) 20% in IG VS 32% in CG (P=0.018;
95% CI 0.4, 0.9)
Funded by the
Norwegain
Fund for
Postgraduate
Training in
Physiotherapy
and the
Norwegian
Women’s Public
Health
Association
++
Pelaez et al.,
2014
RCT
Spain
1- Primigarous pregnant
women with 10th –
14th gestational week
without UI, age (mean
+ SD): 29.5+ 3.9;
BMI (km/m2) (mean
+ SD): 23.15+4.05)
22-week, three
times a week,
55-60 minutes
AN ex. program
including PFME
and aerobics in
group basis
(8-12)
(n=63)
AN routine
care with
information
on PFME
(n=89)
29weeks (1) SUI at AN 36th week (%)
(2) Frequency of SUI at AN 36th week:
(a) once a week (%)
(b) 2-3 times a week (%)
(c) once a day (%)
(d) several times a day (%)
(1) 4.8% in IG VS 39.3% in CG (P=0.0001)
(2) (a) 4.8% in IG VS 20.2% in CG
(P=0.0001)
(b) 0% in IG VS 10.1% in CG (P=0.0001)
(c) 0% in IG VS 7.9% in CG (P=0.0001)
(d) 0% in IG VS 1.1% in CG (P=0.0001)
Technical
assistance of
Gynecology and
Obstetrics
Service of
Fuenlabrada
University
Hosiptal
+
Page 64
58
Sangsawang
et al., 2011
Quasi
-experimental
Study
Thailand
2++ Pregnant women with
20th -30th gestational
week with UI, age
(mean): 29.85; age
range: 18-43; BMI
(km/m2) (mean): 22.1
6-week, once
every 2 weeks,
45 minutes AN
PFME training
session in group
basis (2-5) +
home exercise
(n=31)
AN routine
care with
information
on PFME
(n=35)
6weeks (1) SUI at AN 26th -36th week (%)
(2) Frequency of SUI at AN 26th -36th week
(times/week):
(a) Range
(b) Mean+ SD
(1) 38.7% in IG VS 100% in CG (P=0.001)
(2) (a) 0-20 in IG VS 1.0-35.0 in CG
(P<0.001)
(b) 2.45 + 3.8 in IG VS 14.7 + 9.4 in CG
(P<0.001)
Funded by
Nursing Council
of Thailand
+
Dine et al.,
2009
RCT
Turkey
1- Pregnant women with
20th -34th gestational
week with UI, age
(mean + SD): 26.88 +
6.0
AN PFME
training session
+ home exercise
(n=46)
AN routine
care with
information
on PFME
(n=46)
28weeks (1) SUI at:
(a) AN 36th -38th week (%)
(b) PN 6-8 weeks (%)
(2) Frequency of SUI (no. of episodes in a
day):
(a) AN 36th -38th week (mean + SD)
(b) PN 6-8 weeks (mean + SD)
(1) (a) 43.2% in IG VS 71.4% in CG
(P<0.05)
(b) 17.1% in IG VS 38.4% in CG (P<0.05)
(2) (a)1.62+0.79 in IG VS 2.14+0.85in CG*
(b) 1.22+0.55 in IG VS 1.79+0.89 in CG *
*Sig. result, No P-value reported)
Funded by
University of
Istanbul
+
Sampselle et
al., 1998
RCT
US
1+ Primigarous pregnant
women with 20th
gestational week, age
(mean): 27.2+5.5
AN PFME
training session
+ home exercise
(n=34)
AN routine
care (n=38)
68weeks Severity of SUI (questionnaire assessing
symptoms) at:
(1) AN 35th week (mean)
(2) PN 6 weeks (mean)
(3) PN 6 months (mean)
(4) PN 12 months (mean)
(1) -0.025 in IG VS +0.188 in CG(p=0.043)
(2) -0.05 in IG VS +0.225 in CG (P=0.032)
(3) -0.063 in IG VS +0.038 in CG(P=0.044)
(4) +0.006 in IG VS +0.025 in CG
(Insig. result, No P-value reported)
Funded by
National
Institutes of
Health grants
++
Page 65
59
Appendix III
Methodology Checklist
S I G N
Methodology Checklist 2: Controlled Trials
Study identification (Include author, title, year of publication, journal title, pages)
Kocaoz, S., Eroğlu, K. & Sivaslıoğlu, A. A. Role of pelvic floor muscle exercises in the prevention of stress urinary incontinence during pregnancy
and the postpartum period. Gynecology and Obstetrics Investment, 75, 34-40.
Guideline topic: Antenatal pelvic floor muscle exercise Key Question No: 1 Reviewer: Y.K.Wong
Section 1: Internal validity
In a well conducted RCT study… Does this study do it?
1.1 The study addresses an appropriate and clearly focused question. Yes
Can’t say
No
1.2 The assignment of subjects to treatment groups is randomised.
Yes
Can’t say
No
N.A
1.3 An adequate concealment method is used.
Yes
Can’t say
No
N.A
1.4 Subjects and investigators are kept ‘blind’ about treatment allocation.i Yes
Can’t say
No
N.A
1.5 The treatment and control groups are similar at the start of the trial. Yes
Can’t say □
No
1.6 The only difference between groups is the treatment under investigation. Yes
Can’t say
No
1.7 All relevant outcomes are measured in a standard, valid and reliable way. Yes
Can’t say
No
1.8 What percentage of the individuals or clusters recruited into each treatment arm of the
study dropped out before the study was completed?
IG: 23%
CG: 26%
1.9 All the subjects are analysed in the groups to which they were randomly allocated (often
referred to as intention to treat analysis).
Yes
Can’t say
No
Does not apply
1.10 Where the study is carried out at more than one site, results are comparable for all sites.
Yes
Can’t say
No
Does not apply
SECTION 2: OVERALL ASSESSMENT OF THE STUDY
2.1 How well was the study done to minimise bias?
Code as follows: High quality (++) Acceptable (+)Unacceptable – reject 0
2.2 Taking into account clinical considerations, your evaluation of the
methodology used, and the statistical power of the study, are you
certain that the overall effect is due to the study intervention?
Yes
2.3 Are the results of this study directly applicable to the patient group
targeted by this guideline?
Yes
2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own assessment of the study, and the extent to which it
answers your question and mention any areas of uncertainty raised above.
PFME are effective for prevention of SUI in AN and PN period. Only one-off session was provided without continuous supervision on the
correctness and compliance of performing exercise at home.
Page 66
60
S I G N
Methodology Checklist 2: Controlled Trials
Study identification (Include author, title, year of publication, journal title, pages)
Reilly, E. T. C., Freeman, R. M., Waterfield, M. R., Waterfield, A. E., Steggles, P. & Pedlar, F. (2002). Prevention of postpartum stressincontinence
in primigravidae with increased bladder neck mobility: a randomised controlled trial of antenatal pelvic floor exercises. International Journal of
Obstetrics and Gynaecology, 109(1), 68–76.
Guideline topic: Antenatal pelvic floor muscle exercise Key Question No: 2 Reviewer: Y.K.Wong
Section 1: Internal validity
In a well conducted RCT study… Does this study do it?
1.1 The study addresses an appropriate and clearly focused question.
Yes
Can’t say
No
1.2 The assignment of subjects to treatment groups is randomised.
Yes
Can’t say
No
1.3 An adequate concealment method is used.
Yes
Can’t say
No
1.4 Subjects and investigators are kept ‘blind’ about treatment allocation.1 Yes
Can’t say
No
1.5 The treatment and control groups are similar at the start of the trial. Yes
Can’t say □
No
1.6 The only difference between groups is the treatment under investigation. Yes
Can’t say
No
1.7 All relevant outcomes are measured in a standard, valid and reliable way. Yes
Can’t say
No
1.8 What percentage of the individuals or clusters recruited into each treatment arm of the study
dropped out before the study was completed?
IG: 13.7%
CG: 14.7%
1.9 All the subjects are analysed in the groups to which they were randomly allocated (often
referred to as intention to treat analysis).
Yes
Can’t say
No
Does not apply
1.10 Where the study is carried out at more than one site, results are comparable for all sites.
Yes
Can’t say
No
Does not
apply
SECTION 2: OVERALL ASSESSMENT OF THE STUDY
2.1 How well was the study done to minimise bias?
Code as follows:
High quality (++) Acceptable (+) Unacceptable – reject 0
2.2 Taking into account clinical considerations, your evaluation of the
methodology used, and the statistical power of the study, are you
certain that the overall effect is due to the study intervention?
Yes
2.3 Are the results of this study directly applicable to the patient group
targeted by this guideline?
Yes
2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own assessment of the study, and the extent to which it
answers your question and mention any areas of uncertainty raised above.
AN PFME are effective in reducing the risk of PN SUI in primigravidae with bladder neck mobility. The study only included women with
exiting bladder neck mobility.
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S I G N
Methodology Checklist 2: Controlled Trials
Study identification (Include author, title, year of publication, journal title, pages)
Stafne, S. N., Salvesen, K. A., Romundstad, P. R., Torjusen, I. H. & Mørkved, S. (2012). Does regular exercise including pelvic floor muscle training
prevent urinary and anal incontinence during pregnancy? A randomised controlled trial. International Journal of Obstetrics and Gynaecology, 119,
1270-1280.
Guideline topic: Antenatal pelvic floor muscle exercise Key Question No: 3 Reviewer: Y.K.Wong
Section 1: Internal validity
In a well conducted RCT study… Does this study do it?
1.1 The study addresses an appropriate and clearly focused question.
Yes
Can’t say
No
1.2 The assignment of subjects to treatment groups is randomised.
Yes
Can’t say
No
1.3 An adequate concealment method is used.
Yes
Can’t say
No
1.4 Subjects and investigators are kept ‘blind’ about treatment allocation.i Yes
Can’t say
No
1.5 The treatment and control groups are similar at the start of the trial. Yes
Can’t say □
No
1.6 The only difference between groups is the treatment under investigation. Yes
Can’t say
No
1.7 All relevant outcomes are measured in a standard, valid and reliable way. Yes
Can’t say
No
1.8 What percentage of the individuals or clusters recruited into each treatment arm of the study
dropped out before the study was completed?
IG: 7.7%
CG: 14.3%
1.9 All the subjects are analysed in the groups to which they were randomly allocated (often
referred to as intention to treat analysis).
Yes
Can’t say
No
Does not apply
1.10 Where the study is carried out at more than one site, results are comparable for all sites.
Yes
Can’t say
No
Does not apply
SECTION 2: OVERALL ASSESSMENT OF THE STUDY
2.1 How well was the study done to minimise bias?
Code as follows:
High quality (++) Acceptable (+) Unacceptable – reject 0
2.2 Taking into account clinical considerations, your evaluation of the
methodology used, and the statistical power of the study, are you
certain that the overall effect is due to the study intervention?
Yes
2.3 Are the results of this study directly applicable to the patient group
targeted by this guideline?
Yes
2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own assessment of the study, and the extent to which it answers
your question and mention any areas of uncertainty raised above.
Thorough instructed PFME is important to prevent and treat SUI in late pregnancy.
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S I G N
Methodology Checklist 2: Controlled Trials
Study identification (Include author, title, year of publication, journal title, pages)
Ko, P. O., Liang, C. C., Chang, S. D., Lee, J. T., Chao, A. S. & Cheng, P. J. (2011). A randomized controlled trial of antenatal pelvic floor
exercises to prevent and treat urinary incontinence. International Urogynecology Journal, 22, 17–22.
Guideline topic: Antenatal pelvic floor muscle exercise Key Question No: 4 Reviewer: Y.K.Wong
Section 1: Internal validity
In a well conducted RCT study… Does this study do it?
1.1 The study addresses an appropriate and clearly focused question.
Yes
Can’t say
No
1.2 The assignment of subjects to treatment groups is randomised.
Yes
Can’t say
No
1.3 An adequate concealment method is used.
Yes
Can’t say
No
1.4 Subjects and investigators are kept ‘blind’ about treatment allocation.i Yes
Can’t say
No
1.5 The treatment and control groups are similar at the start of the trial. Yes
Can’t say □
No
1.6 The only difference between groups is the treatment under investigation. Yes
Can’t say
No
1.7 All relevant outcomes are measured in a standard, valid and reliable way. Yes
Can’t say
No
1.8 What percentage of the individuals or clusters recruited into each treatment arm of the study
dropped out before the study was completed?
4.8%
1.9 All the subjects are analysed in the groups to which they were randomly allocated (often
referred to as intention to treat analysis).
Yes
Can’t say
No
Does not apply
1.10 Where the study is carried out at more than one site, results are comparable for all sites.
Yes
Can’t say
No
Does not
apply
SECTION 2: OVERALL ASSESSMENT OF THE STUDY
2.1 How well was the study done to minimise bias?
Code as follows:
High quality (++)
Acceptable (+)
Unacceptable – reject 0
2.2 Taking into account clinical considerations, your evaluation of the
methodology used, and the statistical power of the study, are you
certain that the overall effect is due to the study intervention?
Yes
2.3 Are the results of this study directly applicable to the patient group
targeted by this guideline?
Yes
2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own assessment of the study, and the extent to which it
answers your question and mention any areas of uncertainty raised above.
The positive effect of AN PFME may persist to PN period.
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S I G N
Methodology Checklist 2: Controlled Trials
Study identification (Include author, title, year of publication, journal title, pages)
Mørkved, S., Bø, K., Schei, B. & Salvesen, K. Å . (2003). Pelvic floor muscle training during pregnancy to prevent urinary incontinence: a
single-bind randomized controlled trial. Obstetrics and Gynecology, 101(2), 313-319.
Guideline topic: Antenatal pelvic floor muscle exercise Key Question No: 5 Reviewer: Y.K.Wong
Section 1: Internal validity
In a well conducted RCT study… Does this study do it?
1.1 The study addresses an appropriate and clearly focused question.
Yes
Can’t say
No
1.2 The assignment of subjects to treatment groups is randomised.
Yes
Can’t say
No
1.3 An adequate concealment method is used.
Yes
Can’t say
No
1.4 Subjects and investigators are kept ‘blind’ about treatment allocation.i Yes
Can’t say
No
1.5 The treatment and control groups are similar at the start of the trial. Yes
Can’t say □
No
1.6 The only difference between groups is the treatment under investigation. Yes
Can’t say
No
1.7 All relevant outcomes are measured in a standard, valid and reliable way. Yes
Can’t say
No
1.8 What percentage of the individuals or clusters recruited into each treatment arm of the study
dropped out before the study was completed?
IG: 1.7%
CG: 2.3%
1.9 All the subjects are analysed in the groups to which they were randomly allocated (often
referred to as intention to treat analysis).
Yes
Can’t say
No
Does not apply
1.10 Where the study is carried out at more than one site, results are comparable for all sites.
Yes
Can’t say
No
Does not
apply
SECTION 2: OVERALL ASSESSMENT OF THE STUDY
2.1 How well was the study done to minimise bias?
Code as follows:
High quality (++)
Acceptable (+)
Unacceptable – reject 0
2.2 Taking into account clinical considerations, your evaluation of the
methodology used, and the statistical power of the study, are you
certain that the overall effect is due to the study intervention?
Yes
2.3 Are the results of this study directly applicable to the patient group
targeted by this guideline?
Yes
2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own assessment of the study, and the extent to which it
answers your question and mention any areas of uncertainty raised above.
Intensive PFMT during AN prevents UI during AN and PN period.
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S I G N
Methodology Checklist 2: Controlled Trials
Study identification (Include author, title, year of publication, journal title, pages)
Pelaez, M., Gonzalez-Cerron, S., Montejo, R. & Barakat, R. (2014). Pelvic floor muscle training included in a pregnancy exercise program is
effective in primary prevention of urinary incontinence: a randomized controlled trial. Neurourology and Urodynamics 33, 67–71.
Guideline topic: Antenatal pelvic floor muscle exercise Key Question No: 6 Reviewer: Y.K.Wong
Section 1: Internal validity
In a well conducted RCT study… Does this study do it?
1.1 The study addresses an appropriate and clearly focused question.
Yes
Can’t say
No
1.2 The assignment of subjects to treatment groups is randomised.
Yes
Can’t say
No
1.3 An adequate concealment method is used.
Yes
Can’t say
No
1.4 Subjects and investigators are kept ‘blind’ about treatment allocation.i Yes
Can’t say
No
1.5 The treatment and control groups are similar at the start of the trial. Yes
Can’t say □
No
1.6 The only difference between groups is the treatment under investigation. Yes
Can’t say
No
1.7 All relevant outcomes are measured in a standard, valid and reliable way. Yes
Can’t say
No
1.8 What percentage of the individuals or clusters recruited into each treatment arm of the study
dropped out before the study was completed?
IG: 13.7%
CG: 7.3%
1.9 All the subjects are analysed in the groups to which they were randomly allocated (often
referred to as intention to treat analysis).
Yes
Can’t say
No
Does not apply
1.10 Where the study is carried out at more than one site, results are comparable for all sites.
Yes
Can’t say
No
Does not apply
SECTION 2: OVERALL ASSESSMENT OF THE STUDY
2.1 How well was the study done to minimise bias?
Code as follows:
High quality (++) Acceptable (+) Unacceptable – reject 0
2.2 Taking into account clinical considerations, your evaluation of the
methodology used, and the statistical power of the study, are you
certain that the overall effect is due to the study intervention?
Yes
2.3 Are the results of this study directly applicable to the patient group
targeted by this guideline?
Yes
2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own assessment of the study, and the extent to which it answers
your question and mention any areas of uncertainty raised above.
PFMT in general ex. class with former assessment of ability to perform the correct extraction was effective in primary of UI in primiporius
pregnant women.
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S I G N
Methodology Checklist 2: Controlled Trials
Study identification (Include author, title, year of publication, journal title, pages)
Sangsawang, B. & Serisathien., Y. (2011). Effect of pelvic floor muscle exercise programme on stress urinary incontinence among pregnant
women. Journal of Advanced Nursing 68(9), 1997–2007.
Guideline topic: Antenatal pelvic floor muscle exercise Key Question No: 7 Reviewer: Y.K.Wong
Section 1: Internal validity
In a well conducted RCT study… Does this study do it?
1.1 The study addresses an appropriate and clearly focused question.
Yes
Can’t say
No
1.2 The assignment of subjects to treatment groups is randomised.
Yes
Can’t say
No
N.A
1.3 An adequate concealment method is used.
Yes
Can’t say
No
N.A
1.4 Subjects and investigators are kept ‘blind’ about treatment allocation.i Yes
Can’t say
No
N.A
1.5 The treatment and control groups are similar at the start of the trial. Yes
Can’t say □
No
1.6 The only difference between groups is the treatment under investigation. Yes
Can’t say
No
1.7 All relevant outcomes are measured in a standard, valid and reliable way. Yes
Can’t say
No
1.8 What percentage of the individuals or clusters recruited into each treatment arm of the study
dropped out before the study was completed?
IG: 11.4%
CG: 0%
1.9 All the subjects are analysed in the groups to which they were randomly allocated (often
referred to as intention to treat analysis).
Yes
Can’t say
No
Does not apply
1.10 Where the study is carried out at more than one site, results are comparable for all sites.
Yes
Can’t say
No
Does not apply
SECTION 2: OVERALL ASSESSMENT OF THE STUDY
2.1 How well was the study done to minimise bias?
Code as follows:
High quality (++)
Acceptable (+)
Unacceptable – reject 0
2.2 Taking into account clinical considerations, your evaluation of
the methodology used, and the statistical power of the study,
are you certain that the overall effect is due to the study
intervention?
Yes
2.3 Are the results of this study directly applicable to the patient
group targeted by this guideline?
Yes
2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own assessment of the study, and the extent to which it
answers your question and mention any areas of uncertainty raised above.
6 wks PFME decreases the severity of symptoms in pregnant women with UI
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S I G N
Methodology Checklist 2: Controlled Trials
Study identification (Include author, title, year of publication, journal title, pages)
Dinc, A., Beji, N. K. & Yalcin, O. (2009). Effect of pelvic floor muscle exercises in the treatment of urinary incontinence during pregnancy and the
postpartum period. International Urogynecology Journal, 20, 1223-1231.
Guideline topic: Antenatal pelvic floor muscle exercise Key Question No: 8 Reviewer: Y.K.Wong
Section 1: Internal validity
In a well conducted RCT study… Does this study do it?
1.1 The study addresses an appropriate and clearly focused question. Yes
Can’t say
No
1.2 The assignment of subjects to treatment groups is randomised.
Yes
Can’t say
No
1.3 An adequate concealment method is used.
Yes
Can’t say
No
1.4 Subjects and investigators are kept ‘blind’ about treatment allocation.i Yes
Can’t say
No
1.5 The treatment and control groups are similar at the start of the trial. Yes
Can’t say □
No
1.6 The only difference between groups is the treatment under investigation. Yes
Can’t say
No
1.7 All relevant outcomes are measured in a standard, valid and reliable way. Yes
Can’t say
No
1.8 What percentage of the individuals or clusters recruited into each treatment arm of the study
dropped out before the study was completed?
IG: 10.87%
CG: 15.2%
1.9 All the subjects are analysed in the groups to which they were randomly allocated (often
referred to as intention to treat analysis).
Yes
Can’t say
No
Does not apply
1.10 Where the study is carried out at more than one site, results are comparable for all sites.
Yes
Can’t say
No
Does not
apply
SECTION 2: OVERALL ASSESSMENT OF THE STUDY
2.1 How well was the study done to minimise bias?
Code as follows:
High quality (++)
Acceptable (+)
Unacceptable – reject 0
2.2 Taking into account clinical considerations, your evaluation of the
methodology used, and the statistical power of the study, are you certain that
the overall effect is due to the study intervention?
Yes
2.3 Are the results of this study directly applicable to the patient group targeted
by this guideline?
Yes
2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own assessment of the study, and the extent to which it
answers your question and mention any areas of uncertainty raised above.
PFME are effective in PFM strength and treatment of UI
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S I G N
Methodology Checklist 2: Controlled Trials
Study identification (Include author, title, year of publication, journal title, pages)
Sampselle, C. M., Miller, J. M., Mims, B. L., Delancey, J. O. L., Ashton-miller, J. A. & Antonakos, C. L. (1998). Effect of pelvic muscle exercise on
transient incontinence during pregnancy and after birth. Obstetrics & Gynecology, 91(3), 406-412.
Guideline topic: Antenatal pelvic floor muscle exercise Key Question No: 9 Reviewer:
Y.K.Wong
Section 1: Internal validity
In a well conducted RCT study… Does this study do it?
1.1 The study addresses an appropriate and clearly focused question.
Yes
Can’t say
No
1.2 The assignment of subjects to treatment groups is randomised.
Yes
Can’t say
No
1.3 An adequate concealment method is used.
Yes
Can’t say
No
1.4 Subjects and investigators are kept ‘blind’ about treatment allocation.i Yes
Can’t say
No
1.5 The treatment and control groups are similar at the start of the trial. Yes
Can’t say □
No
1.6 The only difference between groups is the treatment under investigation. Yes
Can’t say
No
1.7 All relevant outcomes are measured in a standard, valid and reliable way. Yes
Can’t say
No
1.8 What percentage of the individuals or clusters recruited into each treatment arm of the study dropped
out before the study was completed?
36.1%
1.9 All the subjects are analysed in the groups to which they were randomly allocated (often referred to as
intention to treat analysis).
Yes
Can’t say
No
Does not
apply
1.10 Where the study is carried out at more than one site, results are comparable for all sites.
Yes
Can’t say
No
Does not
apply
SECTION 2: OVERALL ASSESSMENT OF THE STUDY
2.1 How well was the study done to minimise bias?
Code as follows:
High quality (++)
Acceptable (+)
Unacceptable – reject 0
2.2 Taking into account clinical considerations, your evaluation of the
methodology used, and the statistical power of the study, are you certain
that the overall effect is due to the study intervention?
Yes
2.3 Are the results of this study directly applicable to the patient group targeted
by this guideline?
Yes
2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own assessment of the study, and the extent to which it
answers your question and mention any areas of uncertainty raised above.
High drop out rate possibly due to long study period. Only severity of UI, and not the prevalence of UI at baseline and after
intervention was recorded.
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Appendix IV
Severity Index of urinary incontinence
Questions used to assess the degree or urinary incontinence in women:
(1) How often do you experience urinary leakage?
1 Less than once a month
2 One or several times a month
3 One or several times a week
4 Every day and/or night
(2) How much urine do you lose each time?
1 Drops or little
2 More
The severity index is created by multiplying the results of
Questions (1) and (2):
1-2=slight
3-4=moderate
6-8=severe
Source:
Sandvik, H., Hunskaar, S., Seim, A., Hermstad, R., Vanvik, A. & Bratt, H. (1993).
Validation of a severity index in female urinary incontinence and its implementation
in an epidemiological survey. Journal of Epidemiology and Community Health, 47,
497-499.
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Appendix V
Material costs of implementing new innovation
1. Set up cost
Training cost
(1 hour staff training session consists of lecture and Q & A session. A total of 3 training sessions will be launched to train all 21
staff in the clinic)
Cost of training venue Nil. Training will be conducted in health education room in clinic.
Cost of trainer (Nurse Specialists in
Urology of DH)
$322 (hourly pay) x 3 training sessions = $966
Cost of participants Average monthly salary of nurse in setting is $32562
Average hourly pay is: $32562/44 hours/4weeks = $185
Cost of participants is: $185 x 21 = $3885
Information poster(will be posted in clinic hall and health education room for promotion)
Cost of poster Nil. All posters will be directly supplied by headquarter of Department of Health.
Total set up cost (per year) is: $966 + $3885 = $4851
2. Operational cost
Written information for clients
Cost of booklets Nil. All booklets will be directly supplied by headquarter of Department of Health.
Cost of conducting PFME training session (Consists of two 45 minutes sessions)
Average manpower cost Average monthly salary of nurse in setting is $32562
Average manpower cost for 1 group of 45 minutes session is: $32562/44 hours/4weeks x
45minutes = $138.8
In 2013, there are 1854 new antenatal clients in unit. Assuming all clients consent to
attend, arranging in groups of 12,
No. of PFME sessions per year is: 1854/12 x 2 = 309 sessions
Average manpower cost per year is: $185 x 309 = $57165
Cost of evaluation
(Evaluation consists of two parts. Questionnaires will be given at AN 36 week visit, and one telephone follow up will be
conducted at PN 6 months.)
Average manpower cost (at first
evaluation)
Nil. No additional manpower is used.
Average manpower cost (telephone
follow up at PN 6 month)
30 minutes for asking the participants about their SUI condition.
Average manpower cost for 1 session is: $32562/44 hours/4weeks x 0.5hour = $92.5
Average manpower cost per year is:$92.5 x 155 sessions = $14291
Total operational costs (per year) is: $57165 + $14291 = $71456
Total material costs (per year) is: $4851 + $71456 = $76307
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Appendix VI
Levels of evidence (SIGN, 2011)
Scottish Intercollegiate Guidelines Network
Key to evidence statements and grades of recommendations
SIGN GRADING SYSTEM 1999-2012
LEVEL OF EVIDENCE
1++ High quality meta-analyses, systematic reviews of RCTs, or RCTs with a very low risk of bias
1+ Well-conducted meta-analyses, systematic reviews, or RCTs with a low risk of bias
1- Meta-analyses, systematic reviews, or RCTs with a high risk of bias
2++ High quality systematic reviews of case control or cohort or studies
High quality case control or cohort studies with a very low risk of confounding or bias and a high probability that the
relationship is causal
2+ Well-conducted case control or cohort studies with a low risk of confounding or bias and a moderate probability that the
relationship is causal
2- Case control or cohort studies with a high risk of confounding or bias and a significant risk that the relationship is not
causal
3 Non-analytic studies, e.g. case reports, case series
4 Expert opinion
GRADES OF RECOMMENDATIONS
At least one meta-analysis, systematic review, or RCT rated as 1++, and directly applicable to the target population; or
A body of evidence consisting principally of studies rated as 1+, directly applicable to the target population, and
demonstrating overall consistency of results
A body of evidence including studies rated as 2++, directly applicable to the target population, and demonstrating
overall consistency of results; or
Extrapolated evidence from studies rated as 1++ or 1+
A body of evidence including studies rated as 2+, directly applicable to the target population and demonstrating overall
consistency of results; or
Extrapolated evidence from studies rated as 2++
Evidence level 3 or 4; or
Extrapolated evidence from studies rated as 2+
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Appendix VII
Timeline for the implementation plan
progress Weeks
0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30
Prepare guideline
and protocol
Recruit implantation
team member
Communicate with
administrator
Communicate with
frontline staff
Staff training
Pilot testing
Pilot test evaluation
Implementation of
innovation
Sustain change of
process
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Appendix VIII
Client Satisfaction Questionnaire
Please tick as appropriate:
Strongly
Agree
Agree Neutral Disagree Strongly
Disagree
1. The training is useful in
managing urinary
incontinence condition.
2. The content of the training is
understandable.
3. The healthcare professionals
are supportive and
knowledge.
4. The environment of the
training room is satisfactory.
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Appendix IX
Healthcare Provider Satisfaction Questionnaire
Please tick as appropriate:
Strongly
Agree
Agree Neutral Disagree Strongly
Disagree
1. The protocol improves
satisfaction of work.
2. The protocol is easy to use
and understand.
3. The training session
provides sufficient
knowledge and skills for
implementing the protocol.
4. It builds confidence in
implementing the protocol
after the training session.