Clinical trial NCT00506766: Promoting Self Care to Prevent Urinary Incontinence (UI): A Four-Year Follow-up
Official title: Promoting Self Care to Prevent Urinary Incontinence (UI): A Four-Year Follow-up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Urinary Incontinence
Bladder Control
Keywords: Urinary Incontinence
Self efficacy
Pelvic floor muscle training
Bladder training
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2007-07-25
Enrollment: 360
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study examined whether self-efficacy promoted adherence to Pelvic Floor Muscle Training (PFMT) and Bladder Training (BT) in women aged 55 and older.

Detailed description: The study was designed to determine the capacity of self-efficacy to predict maintenance of the practices of PFMT and BT. Women in the treatment arm of the RCT attended a Bladder Health Class (PFMT \& BT) to prevent UI. The class content emphasized self-efficacy. At 3-months post intervention the self-efficacy of participants was measured; these results were collected to analyze for predictive capacity of training adherence. For four years participants in both the treatment and control (no class) arms were followed with both questionnaires and 3-day bladder diaries (2/year) and clinic evaluations of (1/year). In addition, qualitative analyses of the narratives of Bladder Health Class participants identified individual attitudes and strategies that either facilitated or deterred adherence.

Eligibility criteria: Inclusion Criteria:

* Women aged 55 years or older who report 5 or fewer episodes of UI / year, no prior treatment for UI, no neurological disease, no difficulties performing activities of daily living

Exclusion Criteria:

* Less than 55 years old, UI episodes greater that 5 per year, score of less than 24 on Mini Mental Status Examination

Primary outcomes:
measure: Adherence to PMFT and BT (self efficacy) were measured through questionnaires and 3-day voiding diaries.
timeFrame: Every 6 months for 4 years
Secondary outcomes:
measure: Adherence to PMFT and BT (self efficacy) were measured through questionnaires and days of urinary incontinence per 3-day voiding diary
timeFrame: Every 6 months for 4 years
measure: Digital measurement during clinical examination of pelvic muscle function (pressure and displacement).
timeFrame: 1/year for four years
measure: Paper towel bladder test
timeFrame: 1/year for four years
measure: Survey questions (open ended and forced choice) about strategies women use to incorporate PFMT and BT into their lives
timeFrame: 1 time
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan School of Nursing
name: Carolyn M Sampselle, PhD,RNC,FAAN
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan School of Nursing
name: Sandra H Hines, PhD, RNC
role: STUDY_DIRECTOR
References:
citation: Hines SH, Seng JS, Messer KL, Raghunathan TE, Diokno AC, Sampselle CM. Adherence to a behavioral program to prevent incontinence. West J Nurs Res. 2007 Feb;29(1):36-56; discussion 57-64. doi: 10.1177/0193945906293793.
citation: Messer KL, Herzog AR, Seng JS, Sampselle CM, Diokno AC, Raghunathan TE, Hines SH. Evaluation of a mass mailing recruitment strategy to obtain a community sample of women for a clinical trial of an incontinence prevention intervention. Int Urol Nephrol. 2006;38(2):255-61. doi: 10.1007/s11255-006-0018-1.
citation: Sampselle CM, Messer KL, Seng JS, Raghunathan TE, Hines SH, Diokno AC. Learning outcomes of a group behavioral modification program to prevent urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 2005 Nov-Dec;16(6):441-6. doi: 10.1007/s00192-005-1284-7. Epub 2005 Mar 15.
citation: Sampselle CM, Palmer MH, Boyington AR, O'Dell KK, Wooldridge L. Prevention of urinary incontinence in adults: population-based strategies. Nurs Res. 2004 Nov-Dec;53(6 Suppl):S61-7. doi: 10.1097/00006199-200411006-00010.
citation: Sampselle CM. Teaching women to use a voiding diary. Am J Nurs. 2003 Nov;103(11):62-4. doi: 10.1097/00000446-200311000-00031. No abstract available.
citation: Diokno AC, Sampselle CM, Herzog AR, Raghunathan TE, Hines S, Messer K, Karl C, Leite MC. Prevention of urinary incontinence by behavioral modification program: a randomized, controlled trial among older women in the community. J Urol. 2004 Mar;171(3):1165-71. doi: 10.1097/01.ju.0000111503.73803.c2.
citation: Sampselle CM. Behavioral interventions in young and middle-age women: simple interventions to combat a complex problem. Am J Nurs. 2003 Mar;Suppl:9-19. doi: 10.1097/00000446-200303001-00003. No abstract available.
citation: Longworth, J, Davila, Y, Sampselle, CM. (2003) La perdida de orina: Hispanic women's experience of urinary incontinence. Hispanic Health Care International (The official Journal of the National Association of Hispanic Nurses), Vol. 2(1), 13-21.