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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