1. Self-Monitoring for Management of Urinary Incontinence Molly C. Dougherty, PhD, RN Professor Jean Kincade, PhD, RN Research Associate Professor John R. Carlson, MS Assistant Professor The University of North Carolina at Chapel Hill Chapel Hill, NC, USA

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

3. A Metaphor for the Presentation A metaphor is a figure of speech containing an implied comparison. 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. 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 Chronological over 20 years Sequential Sequential Results build 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 Included simple steps Within other behavioral interventions Within other behavioral interventions Consequence Consequence Simple steps contributed to error variance and affected the experimental outcome Simple steps contributed to error variance and affected the experimental outcome

8. Manage Measurement Error: Stay on Track Control for simple steps Control for simple steps Place simple steps first in protocol Place simple steps first in protocol Measure baseline after simple steps and before randomization into Randomized Controlled Trial (RCT) 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 are important on their own. Simple steps should be tested in an RCT. Simple steps should be tested in an RCT.

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

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

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

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

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

15. Overview of First Study Pelvic Floor Muscle Exercise (PFME) Pelvic Floor Muscle Exercise (PFME) Intervention for Stress Urinary Incontinence (SUI) Intervention for Stress Urinary Incontinence (SUI) Results supported use of PFME 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 Grams of urine loss in 24 hours Measured by pad test Measured by pad test

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

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

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

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

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

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

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

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

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

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

28. Self-Monitoring: Phase 1, Criteria Caffeine intake: 2+ cups or glasses/day Caffeine intake: 2+ cups or glasses/day Fluid intake: 4,000 cc/day Fluid intake: 4,000 cc/day Excessive voiding interval: average 4+ hours Excessive voiding interval: average 4+ hours Constipation: self-reported Constipation: self-reported If did not meet any criterion, advance to Phase 2 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 Reduce caffeine gradually to no more than 2 caffeinated beverages/day Increase ( 4,000 cc) fluid intake gradually, to 1,800-2,400 cc/day Increase ( 4,000 cc) fluid intake gradually, to 1,800-2,400 cc/day Reduce voiding interval to 2-3 hours during waking hours Reduce voiding interval to 2-3 hours during waking hours Increase fiber Increase fiber

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

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

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

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

37. Tomlinson et al., 1997

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

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

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

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

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

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

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

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

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

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

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

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

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

51. Study Design Random assignment Random assignment Self-monitoring Self-monitoring Wait-list group Wait-list group Bladder diary and pad tests Bladder diary and pad tests Baseline Baseline Follow-up Follow-up

52. The Intervention Counseling and instruction Counseling and instruction Simple steps Simple steps Caffeine 12 oz or more caffeinated beverages/day Caffeine 12 oz or more caffeinated beverages/day Fluid intake Fluid intake 50 oz or less total fluids 50 oz or less total fluids 133 oz or more total fluids 133 oz or more total fluids Constipation one or more bowel symptoms (Kincade et al., 2005) Constipation one or more bowel symptoms (Kincade et al., 2005) Quick Kegel: all participants Quick Kegel: all participants

53. Outcome Measure Pad tests Pad tests Grams of urine loss in 24 hours Grams of urine loss in 24 hours

54. Results

55. Conclusions: Simple Steps, Significant Improvement Urine loss (gm) Urine loss (gm) Women with stress and mixed UI Women with stress and mixed UI

56. Implications: The Ideal Training Schedule Simple steps should be first steps Simple steps should be first steps Management of stress and mixed UI Management of stress and mixed UI Use bladder diary Use bladder diary Counsel women Counsel women Follow up on progress Follow up on progress Add Quick Kegel instruction Add Quick Kegel instruction

57. Summary

58. Overall Implications Women should be screened in all clinical settings for bladder control problems. Women should be screened in all clinical settings for bladder control problems. Women should be offered evidence-based counseling. Women should be offered evidence-based counseling. Sampselle et al., 1997 Sampselle et al., 1997

59. Review Follow-up on one clinical observation Follow-up on one clinical observation Use results from one study Use results from one study Build rationale for next Build rationale for next Support importance of simple steps Support importance of simple steps Any nurse can implement Any nurse can implement

60. Keep Running to the Finish Line

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