Promoting Self Care to Prevent Urinary Incontinence (UI): A Four-Year Follow-up

Urinary Incontinence Clinical Trial

Official title:

Promoting Self Care to Prevent Urinary Incontinence (UI): A Four-Year Follow-up

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00506766
• Other study ID #: 5R01NR007618-02
• Status: Completed
• Phase: Phase 3
• First received: July 23, 2007
• Last updated: July 23, 2007
• Start date: September 2000
• Est. completion date: August 2006

Study information

• Verified date: July 2007
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: August 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 55 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bladder Control
• Urinary Incontinence

Intervention

Behavioral:
• Bladder Health Class consisting of 6 weekly group sessions
1 time
• Practice PFMT and BT
As needed for 4 years
• Clinic examination for pelvic muscle function
1/year for 4 years
• Record keeping in 3-day voiding diary
Every 6 months for 4 years

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

References & Publications (8)

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 — View 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. — View 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.

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. 20 — View 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. Epub 2005 Mar 15. — View 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. Review. — View 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. Review. — View Citation

Sampselle CM. Teaching women to use a voiding diary. Am J Nurs. 2003 Nov;103(11):62-4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to PMFT and BT (self efficacy) were measured through questionnaires and 3-day voiding diaries.		Every 6 months for 4 years
Secondary	Adherence to PMFT and BT (self efficacy) were measured through questionnaires and days of urinary incontinence per 3-day voiding diary		Every 6 months for 4 years
Secondary	Digital measurement during clinical examination of pelvic muscle function (pressure and displacement).		1/year for four years
Secondary	Paper towel bladder test		1/year for four years
Secondary	Survey questions (open ended and forced choice) about strategies women use to incorporate PFMT and BT into their lives		1 time