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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00506766
Other study ID # 5R01NR007618-02
Secondary ID
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
Est. primary completion date
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


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
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