Self-Monitoring for Management of Urinary Incontinence

1. Self-Monitoring for Management of Urinary Incontinence Molly C. Dougherty, PhD, RNProfessor Jean Kincade, PhD, RNResearch Associate Professor John R. Carlson, MSAssistant Professor The University of North Carolina at Chapel HillChapel Hill, NC, USA

2. Goal of Presentation • Discuss a single idea • Based on clinical observation • Idea was tested through research • Results: Evidence-based recommendations • For women with urinary incontinence (UI)

3. A Metaphor for the Presentation • A metaphor is a figure of speech containing an implied comparison. • Here, the development of research in urinary incontinence (UI) is compared to running a relay.

4. UI Research As a Relay Race Think about runners, coaches, handing off the baton. Think about running towards the finish line.

5. The Approach:Handing Off the Baton • Chronological over 20 years • Sequential • Results build

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

7. UI Studies in the Mid-1980s:Stretching Our Muscles • Included simple steps • Within other behavioral interventions • Consequence • Simple steps contributed to error variance and affected the experimental outcome

8. Manage Measurement Error:Stay on Track • Control for simple steps • Place simple steps first in protocol • Measure baseline after simple steps and before randomization into Randomized Controlled Trial (RCT)

9. Trust Clinical Observation • Simple steps are important on their own. • Simple steps should be tested in an RCT.

10. Both Approaches:We Have Run It Both Ways • Meritorious • Provide important results

11. Multiple Studies Mid-1980s:More Early Winners • A whole century ago! • Behavioral management for UI research growing • Research funding available • Publications, new knowledge

12. Several Studies Showed Regardless of behavioral intervention studied, intervention and control group improved.

13. Keeping a Bladder Diary • Self-monitoring • Changed urinary patterns • Improved UI

14. Simple Steps:Runner One Leaves the BlockDougherty et al., 1993

15. Overview of First Study • Pelvic Floor Muscle Exercise (PFME) • Intervention for Stress Urinary Incontinence (SUI) • Results supported use of PFME

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

17. Primary Outcome Variable • Grams of urine loss in 24 hours • Measured by pad test

18. Secondary Outcome Variable • Episodes of urine loss in 24 hours • Measured by bladder diary • Self-report of episodes

19. Simple Steps • Keep a bladder diary • Maintain fluid intake • Limit caffeine ingestion • Discuss effect of over-the-counter medications on UI

20. Bladder Diary • Cornerstone of UI research • Episodes of UI – primary variable • Literature support reliability and validity • Clinical observation, logic support • Diligence decreases in many with diary keeping over time – during an intervention

21. Bladder Diary • Many forms • One form each 24-hour period • Hourly time blocks • Simple to complex

22. Simple Bladder Diaries • Hourly time blocks • Woman checks beside hour each time she has a urine loss episode • Needed for elderly and disabled participants

23. Complex Bladder Diaries • Hourly time blocks • Woman records: • Episodes of urine loss • Amount and type of fluid intake • Voluntary voids • Other information

24. Control Period • Careful instruction on keeping bladder diary • General instructions on fluid intake and caffeine • Review of over-the-counter medication • Discussion of their effect • No specific instruction about medications given

25. Control Period Results • Keeping a bladder diary had an effect • Related to • Quality of counseling • Learning from bladder diary • Effect not statistically significant • Could be important • Controlling error • As intervention

26. Community-Based, RCT Study:Hand Off the Baton to Runner TwoDougherty et al., 2002

27. Overview of RCT Study • Intervention – Behavioral Management for Continence (BMC) • Three phases • Self-monitoring (simple steps) • Bladder training • PFME with biofeedback

28. Self-Monitoring:Phase 1, Criteria • Caffeine intake: 2+ cups or glasses/day • Fluid intake: <1,500 or >4,000 cc/day • Excessive voiding interval: average 4+ hours • Constipation: self-reported • If did not meet any criterion, advance to Phase 2

29. Self-Monitoring:Phase 1, Goals • Reduce caffeine gradually to no more than 2 caffeinated beverages/day • Increase (<1,500 cc) or decrease (>4,000 cc) fluid intake gradually, to 1,800-2,400 cc/day • Reduce voiding interval to 2-3 hours during waking hours • Increase fiber

30. Bladder Training:Phase 2 • Protocol – Wyman and Fantl (1991) • Guided women to: • Void at scheduled time intervals • Gradually increase the voiding interval

31. PFME with Biofeedback:Phase 3 • Biofeedback with surface electromyography (EMG) • Observe and modify quality of pelvic floor muscle contractions • PFME • Goal: 45 contractions per day • Three times a week for 12 weeks

32. Outcome Measures • Primary – grams of urine loss in 24 hours • Secondary – episodes of urine loss in 24 hours

33. Analysis Plan • Intervention (BMC) evaluated as a whole • Results supported the efficacy of BMC • Significant reductions in grams of urine loss • Also in episodes of urine loss • Results sustained over 2 years

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

35. BMC Group: Looking Inside the Intervention

36. BMC Group: Looking Inside the Intervention

37. BMC Group: Looking Inside the Intervention Tomlinson et al., 1997

38. Analysis:Caffeine Intake • Linear regression • Decrease in caffeine intake • Decrease in episodes of urine loss • Approached statistical significance (p = .07)

39. Analysis:Change in Fluid Intake • Increase in fluid intake • Increase in volume of urine voided (p = .05)

40. Analysis:Daytime Voids • Fewer daytime voids of intervals greater than 4 hours • Increase in volume of urine voided (p = .04) • No change in urine loss

41. Results Indicate • Simple steps merit more attention • Need for RCT on simple steps

42. Weakness of Self-Monitoring • Cannot be applied to all women with UI • One or more criterion does not apply to all • Drink too much or too little, too much caffeine, etc.

43. Design Issues • Bladder diary • Promotes improvement in UI • Bladder diary alone • No significant improvement • Competitive funding not likely

44. Simple Steps Design Issue • Caffeine reduction • Fluid intake modification • Long voiding interval • Alleviation of constipation • Improvement in UI • Promising • Not clearly significant • All women with UI do not need simple steps

45. RCT Research • Participants assigned to a condition • Experience that condition

46. The Knack:Number Three Runs AheadMiller, Aston-Miller, DeLancey (1996)

47. What Is The Knack? • Precisely timed pelvic floor muscle contraction • Practice in clinic to reinforce learning • Used before activities that result in urine loss • Significantly reduces urine loss • Women with stress urinary incontinence

48. Knack = Quick Kegel • Simple step • Appropriate to all women with UI • Important addition to simple steps

49. Using Quick Kegel • Most women probably use it • Nearly all women can use it

50. RCT on Self-Monitoring: Runner Four Comes Around the BendKincade, Dougherty & Carlson, 2000-2006