Self-Monitoring for Management of Urinary Incontinence Molly C. Dougherty, PhD, RN Professor Jean Kincade, PhD, RN Research Associate Professor John R.

Self-Monitoring for Self-Monitoring for Management of Urinary Management of Urinary

IncontinenceIncontinenceMolly C. Dougherty, PhD, RNMolly C. Dougherty, PhD, RN

ProfessorProfessor

Jean Kincade, PhD, RNJean Kincade, PhD, RNResearch Associate ProfessorResearch Associate Professor

John R. Carlson, MSJohn R. Carlson, MSAssistant ProfessorAssistant Professor

The University of North Carolina at The University of North Carolina at Chapel HillChapel Hill

Chapel Hill, NC, USAChapel Hill, NC, USA

Goal of PresentationGoal of Presentation

Discuss a single ideaDiscuss a single idea Based on clinical observationBased on clinical observation Idea was tested through researchIdea was tested through research Results: Evidence-based Results: Evidence-based

recommendationsrecommendations For women with urinary For women with urinary

incontinence (UI)incontinence (UI)

A Metaphor for the A Metaphor for the PresentationPresentation A metaphor is a figure of speech A metaphor is a figure of speech

containing an implied containing an implied comparison. comparison.

Here, the development of Here, the development of research in urinary incontinence research in urinary incontinence (UI) is compared to running a (UI) is compared to running a relay.relay.

UI Research As a Relay UI Research As a Relay RaceRaceThink about runners, Think about runners, coaches, handing off the coaches, handing off the baton.baton.

Think about running Think about running towards the finish towards the finish line.line.

The Approach:The Approach:Handing Off the BatonHanding Off the Baton

Chronological over 20 yearsChronological over 20 years SequentialSequential Results buildResults build

Original IdeaOriginal Idea

Among women with UI, simple steps Among women with UI, simple steps result in large improvement for some result in large improvement for some women.women.

UI Studies in the Mid-UI Studies in the Mid-1980s:1980s:Stretching Our MusclesStretching Our Muscles Included simple stepsIncluded simple steps Within other behavioral Within other behavioral

interventionsinterventions ConsequenceConsequence Simple steps contributed to error Simple steps contributed to error

variance and affected the variance and affected the experimental outcomeexperimental outcome

Manage Measurement Manage Measurement Error:Error:Stay on TrackStay on Track Control for simple stepsControl for simple steps Place simple steps first in protocolPlace simple steps first in protocol Measure baseline after simple steps Measure baseline after simple steps

and before randomization into and before randomization into Randomized Controlled Trial (RCT)Randomized Controlled Trial (RCT)

Trust Clinical Trust Clinical ObservationObservation Simple steps are important on their Simple steps are important on their

own.own. Simple steps should be tested in an Simple steps should be tested in an

RCT.RCT.

Both Approaches:Both Approaches:We Have Run It Both WaysWe Have Run It Both Ways

MeritoriousMeritorious Provide important resultsProvide important results

Multiple Studies Mid-Multiple Studies Mid-19801980s:s:More Early WinnersMore Early Winners A whole century ago!A whole century ago! Behavioral management for UI Behavioral management for UI

research growingresearch growing Research funding availableResearch funding available Publications, new knowledgePublications, new knowledge

Several Studies ShowedSeveral Studies Showed

Regardless of behavioral intervention Regardless of behavioral intervention studied, intervention and control studied, intervention and control group improved.group improved.

Keeping a Bladder DiaryKeeping a Bladder Diary

Self-monitoringSelf-monitoring Changed urinary patternsChanged urinary patterns Improved UIImproved UI

Simple Steps:Simple Steps:Runner One Leaves the BlockRunner One Leaves the Block

Dougherty et al., 1993Dougherty et al., 1993

Overview of First StudyOverview of First Study

Pelvic Floor Muscle Exercise (PFME)Pelvic Floor Muscle Exercise (PFME) Intervention for Stress Urinary Intervention for Stress Urinary

Incontinence (SUI)Incontinence (SUI) Results supported use of PFMEResults supported use of PFME

Changes in Urine Loss Variables at Changes in Urine Loss Variables at Baseline, After the Control Period, and Baseline, After the Control Period, and at PME Levels 2 and 4at PME Levels 2 and 4

Primary Outcome Primary Outcome VariableVariable Grams of urine loss in 24 hoursGrams of urine loss in 24 hours Measured by pad testMeasured by pad test

Secondary Outcome Secondary Outcome VariableVariable Episodes of urine loss in 24 hoursEpisodes of urine loss in 24 hours Measured by bladder diaryMeasured by bladder diary Self-report of episodesSelf-report of episodes

Simple StepsSimple Steps

Keep a bladder diaryKeep a bladder diary Maintain fluid intakeMaintain fluid intake Limit caffeine ingestionLimit caffeine ingestion Discuss effect of over-the-counter Discuss effect of over-the-counter

medications on UImedications on UI

Bladder DiaryBladder Diary

Cornerstone of UI researchCornerstone of UI research Episodes of UI – primary variableEpisodes of UI – primary variable Literature support reliability and Literature support reliability and

validityvalidity Clinical observation, logic supportClinical observation, logic support Diligence decreases in many with Diligence decreases in many with

diary keeping over time – during an diary keeping over time – during an interventionintervention

Bladder DiaryBladder Diary

Many formsMany forms One form each 24-hour periodOne form each 24-hour period Hourly time blocksHourly time blocks Simple to complexSimple to complex

Simple Bladder DiariesSimple Bladder Diaries

Hourly time blocksHourly time blocks Woman checks beside hour each Woman checks beside hour each

time she has a urine loss episodetime she has a urine loss episode Needed for elderly and disabled Needed for elderly and disabled

participantsparticipants

Complex Bladder DiariesComplex Bladder Diaries

Hourly time blocksHourly time blocks Woman records:Woman records:

Episodes of urine lossEpisodes of urine loss Amount and type of fluid intakeAmount and type of fluid intake Voluntary voidsVoluntary voids Other informationOther information

Control PeriodControl Period

Careful instruction on keeping bladder Careful instruction on keeping bladder diarydiary

General instructions on fluid intake General instructions on fluid intake and caffeineand caffeine

Review of over-the-counter medicationReview of over-the-counter medication Discussion of their effectDiscussion of their effect No specific instruction about No specific instruction about

medications givenmedications given

Control Period ResultsControl Period Results

Keeping a bladder diary had an effectKeeping a bladder diary had an effect Related toRelated to

Quality of counselingQuality of counseling Learning from bladder diaryLearning from bladder diary

Effect not statistically significantEffect not statistically significant Could be importantCould be important

Controlling errorControlling error As interventionAs intervention

Community-Based, RCT Community-Based, RCT Study:Study:Hand Off the Baton to Runner TwoHand Off the Baton to Runner Two

Dougherty et al., 2002Dougherty et al., 2002

Overview of RCT StudyOverview of RCT Study

Intervention – Behavioral Intervention – Behavioral Management for Continence (BMC)Management for Continence (BMC)

Three phasesThree phases Self-monitoring (simple steps)Self-monitoring (simple steps) Bladder trainingBladder training PFME with biofeedbackPFME with biofeedback

Self-Monitoring:Self-Monitoring:Phase 1, CriteriaPhase 1, Criteria

Caffeine intake: 2+ cups or Caffeine intake: 2+ cups or glasses/dayglasses/day

Fluid intake: <1,500 or >4,000 Fluid intake: <1,500 or >4,000 cc/daycc/day

Excessive voiding interval: average Excessive voiding interval: average 4+ hours4+ hours

Constipation: self-reportedConstipation: self-reported If did not meet any criterion, If did not meet any criterion,

advance to Phase 2advance to Phase 2

Self-Monitoring:Self-Monitoring:Phase 1, GoalsPhase 1, Goals

Reduce caffeine gradually to no more Reduce caffeine gradually to no more than 2 caffeinated beverages/daythan 2 caffeinated beverages/day

Increase (<1,500 cc) or decrease Increase (<1,500 cc) or decrease (>4,000 cc) fluid intake gradually, to (>4,000 cc) fluid intake gradually, to 1,800-2,400 cc/day1,800-2,400 cc/day

Reduce voiding interval to 2-3 hours Reduce voiding interval to 2-3 hours during waking hoursduring waking hours

Increase fiberIncrease fiber

Bladder Training:Bladder Training:Phase 2Phase 2

Protocol – Wyman and Fantl (1991)Protocol – Wyman and Fantl (1991) Guided women to:Guided women to:

Void at scheduled time intervalsVoid at scheduled time intervals Gradually increase the voiding intervalGradually increase the voiding interval

PFME with Biofeedback:PFME with Biofeedback:Phase 3Phase 3

Biofeedback with surface Biofeedback with surface electromyography (EMG)electromyography (EMG)

Observe and modify quality of pelvic Observe and modify quality of pelvic floor muscle contractionsfloor muscle contractions

PFMEPFME Goal: 45 contractions per dayGoal: 45 contractions per day Three times a week for 12 weeksThree times a week for 12 weeks

Outcome MeasuresOutcome Measures

Primary – grams of urine loss in 24 Primary – grams of urine loss in 24 hourshours

Secondary – episodes of urine loss in Secondary – episodes of urine loss in 24 hours24 hours

Analysis PlanAnalysis Plan

Intervention (BMC) evaluated as a Intervention (BMC) evaluated as a wholewhole

Results supported the efficacy of Results supported the efficacy of BMCBMC

Significant reductions in grams of Significant reductions in grams of urine lossurine loss

Also in episodes of urine lossAlso in episodes of urine loss Results sustained over 2 yearsResults sustained over 2 years

Mean Grams Loss per 24 hr at Baseline Mean Grams Loss per 24 hr at Baseline and Four Follow-ups in BMC and and Four Follow-ups in BMC and Control GroupsControl Groups

BMC Group: BMC Group: Looking Inside the InterventionLooking Inside the Intervention

BMC Group: BMC Group: Looking Inside the InterventionLooking Inside the Intervention

BMC Group: BMC Group: Looking Inside the InterventionLooking Inside the Intervention

Tomlinson et al., 1997

Analysis:Analysis:Caffeine IntakeCaffeine Intake

Linear regressionLinear regression Decrease in caffeine intakeDecrease in caffeine intake Decrease in episodes of urine lossDecrease in episodes of urine loss Approached statistical significance Approached statistical significance

((pp = .07) = .07)

Analysis:Analysis:Change in Fluid IntakeChange in Fluid Intake

Increase in fluid intakeIncrease in fluid intake Increase in volume of urine voided Increase in volume of urine voided

((pp = .05) = .05)

Analysis:Analysis:Daytime VoidsDaytime Voids

Fewer daytime voids of intervals Fewer daytime voids of intervals greater than 4 hoursgreater than 4 hours

Increase in volume of urine voided Increase in volume of urine voided ((pp = .04) = .04)

No change in urine lossNo change in urine loss

Results IndicateResults Indicate

Simple steps merit more attentionSimple steps merit more attention Need for RCT on simple stepsNeed for RCT on simple steps

Weakness of Self-Weakness of Self-MonitoringMonitoring Cannot be applied to all women with Cannot be applied to all women with

UIUI One or more criterion does not apply One or more criterion does not apply

to allto all Drink too much or too little, too Drink too much or too little, too

much caffeine, etc.much caffeine, etc.

Design IssuesDesign Issues

Bladder diaryBladder diary Promotes improvement in UIPromotes improvement in UI

Bladder diary aloneBladder diary alone No significant improvementNo significant improvement

Competitive funding not likely Competitive funding not likely

Simple Steps Design Simple Steps Design IssueIssue Caffeine reductionCaffeine reduction Fluid intake modificationFluid intake modification Long voiding intervalLong voiding interval Alleviation of constipationAlleviation of constipation Improvement in UIImprovement in UI

PromisingPromising Not clearly significantNot clearly significant

All women with UI do not need simple All women with UI do not need simple stepssteps

RCT ResearchRCT Research

Participants assigned to a conditionParticipants assigned to a condition Experience that conditionExperience that condition

The Knack:The Knack:Number Three Runs AheadNumber Three Runs Ahead

Miller, Aston-Miller, DeLancey Miller, Aston-Miller, DeLancey (1996)(1996)

What Is The Knack?What Is The Knack?

Precisely timed pelvic floor muscle Precisely timed pelvic floor muscle contraction contraction

Practice in clinic to reinforce learningPractice in clinic to reinforce learning Used before activities that result in Used before activities that result in

urine lossurine loss Significantly reduces urine lossSignificantly reduces urine loss Women with stress urinary Women with stress urinary

incontinenceincontinence

Knack = Knack = Quick KegelQuick Kegel

Simple stepSimple step Appropriate to all women with UIAppropriate to all women with UI Important addition to simple stepsImportant addition to simple steps

Using Quick KegelUsing Quick Kegel

Most women probably use itMost women probably use it Nearly all women can use itNearly all women can use it

RCT on Self-MonitoringRCT on Self-Monitoring: : Runner Four Comes Around the Runner Four Comes Around the BendBend

Kincade, Dougherty & Carlson, Kincade, Dougherty & Carlson, 2000-20062000-2006

Study DesignStudy Design

Random assignmentRandom assignment Self-monitoringSelf-monitoring Wait-list groupWait-list group

Bladder diary and pad testsBladder diary and pad tests BaselineBaseline Follow-upFollow-up

The InterventionThe Intervention

Counseling and instructionCounseling and instruction Simple stepsSimple steps

Caffeine 12 oz or more caffeinated Caffeine 12 oz or more caffeinated beverages/daybeverages/day

Fluid intakeFluid intake 50 oz or less total fluids50 oz or less total fluids 133 oz or more total fluids133 oz or more total fluids

Constipation one or more bowel Constipation one or more bowel symptoms (Kincade et al., 2005)symptoms (Kincade et al., 2005)

Quick Kegel: all participantsQuick Kegel: all participants

Outcome MeasureOutcome Measure

Pad testsPad tests Grams of urine loss in 24 hoursGrams of urine loss in 24 hours

ResultsResults

Conclusions:Conclusions:Simple Steps, Significant Simple Steps, Significant ImprovementImprovement Urine loss (gm)Urine loss (gm) Women with stress and mixed UIWomen with stress and mixed UI

Implications:Implications:The Ideal Training ScheduleThe Ideal Training Schedule

Simple steps should be first stepsSimple steps should be first steps Management of stress and mixed UIManagement of stress and mixed UI Use bladder diaryUse bladder diary Counsel womenCounsel women Follow up on progressFollow up on progress Add Quick Kegel instructionAdd Quick Kegel instruction

SummarySummary

Overall ImplicationsOverall Implications

Women should be screened in all Women should be screened in all clinical settings for bladder control clinical settings for bladder control problems.problems.

Women should be offered evidence-Women should be offered evidence-based counseling.based counseling.

Sampselle et al., 1997Sampselle et al., 1997

ReviewReview

Follow-up on one clinical Follow-up on one clinical observationobservation

Use results from one studyUse results from one study Build rationale for nextBuild rationale for next Support importance of simple stepsSupport importance of simple steps Any nurse can implementAny nurse can implement

Keep Running to the Keep Running to the Finish LineFinish Line

The University of North Carolina at Chapel Hill ~ NC, USAThe University of North Carolina at Chapel Hill ~ NC, USA