Promoting Self Care to Prevent Urinary Incontinence (UI): A Four-Year Follow-up
Primary Purpose
Urinary Incontinence, Bladder Control
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Bladder Health Class consisting of 6 weekly group sessions
Practice PFMT and BT
Clinic examination for pelvic muscle function
Record keeping in 3-day voiding diary
Sponsored by
About this trial
This is an interventional prevention trial for Urinary Incontinence focused on measuring Urinary Incontinence, Self efficacy, Pelvic floor muscle training, Bladder training
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
Sites / Locations
- University of Michigan
Outcomes
Primary Outcome Measures
Adherence to PMFT and BT (self efficacy) were measured through questionnaires and 3-day voiding diaries.
Secondary Outcome Measures
Adherence to PMFT and BT (self efficacy) were measured through questionnaires and days of urinary incontinence per 3-day voiding diary
Digital measurement during clinical examination of pelvic muscle function (pressure and displacement).
Paper towel bladder test
Survey questions (open ended and forced choice) about strategies women use to incorporate PFMT and BT into their lives
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00506766
Brief Title
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
2. Study Status
Record Verification Date
July 2007
Overall Recruitment Status
Completed
Study Start Date
September 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Michigan
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence, Bladder Control
Keywords
Urinary Incontinence, Self efficacy, Pelvic floor muscle training, Bladder training
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
Single
Allocation
Randomized
Enrollment
360 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Bladder Health Class consisting of 6 weekly group sessions
Intervention Description
1 time
Intervention Type
Behavioral
Intervention Name(s)
Practice PFMT and BT
Intervention Description
As needed for 4 years
Intervention Type
Behavioral
Intervention Name(s)
Clinic examination for pelvic muscle function
Intervention Description
1/year for 4 years
Intervention Type
Behavioral
Intervention Name(s)
Record keeping in 3-day voiding diary
Intervention Description
Every 6 months for 4 years
Primary Outcome Measure Information:
Title
Adherence to PMFT and BT (self efficacy) were measured through questionnaires and 3-day voiding diaries.
Time Frame
Every 6 months for 4 years
Secondary Outcome Measure Information:
Title
Adherence to PMFT and BT (self efficacy) were measured through questionnaires and days of urinary incontinence per 3-day voiding diary
Time Frame
Every 6 months for 4 years
Title
Digital measurement during clinical examination of pelvic muscle function (pressure and displacement).
Time Frame
1/year for four years
Title
Paper towel bladder test
Time Frame
1/year for four years
Title
Survey questions (open ended and forced choice) about strategies women use to incorporate PFMT and BT into their lives
Time Frame
1 time
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carolyn M Sampselle, PhD,RNC,FAAN
Organizational Affiliation
University of Michigan School of Nursing
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sandra H Hines, PhD, RNC
Organizational Affiliation
University of Michigan School of Nursing
Official's Role
Study Director
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
17228060
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.
Results Reference
result
PubMed Identifier
16868693
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.
Results Reference
result
PubMed Identifier
16237512
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.
Results Reference
result
PubMed Identifier
15586150
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.
Results Reference
result
PubMed Identifier
14625427
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.
Results Reference
result
PubMed Identifier
14767293
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.
Results Reference
result
PubMed Identifier
12612489
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.
Results Reference
result
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.
Results Reference
result
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Promoting Self Care to Prevent Urinary Incontinence (UI): A Four-Year Follow-up
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