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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00506766
First Posted: July 25, 2007
Last Update Posted: July 25, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Michigan
  Purpose
This study examined whether self-efficacy promoted adherence to Pelvic Floor Muscle Training (PFMT) and Bladder Training (BT) in women aged 55 and older.

Condition Intervention Phase
Urinary Incontinence Bladder Control Behavioral: Bladder Health Class consisting of 6 weekly group sessions Behavioral: Practice PFMT and BT Behavioral: Clinic examination for pelvic muscle function Behavioral: Record keeping in 3-day voiding diary Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Prevention
Official Title: Promoting Self Care to Prevent Urinary Incontinence (UI): A Four-Year Follow-up

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • 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 Measures:
  • 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 ]
  • Digital measurement during clinical examination of pelvic muscle function (pressure and displacement). [ Time Frame: 1/year for four years ]
  • Paper towel bladder test [ Time Frame: 1/year for four years ]
  • Survey questions (open ended and forced choice) about strategies women use to incorporate PFMT and BT into their lives [ Time Frame: 1 time ]

Enrollment: 360
Study Start Date: September 2000
Study Completion Date: August 2006
Intervention Details:
    Behavioral: Bladder Health Class consisting of 6 weekly group sessions
    1 time
    Behavioral: Practice PFMT and BT
    As needed for 4 years
    Behavioral: Clinic examination for pelvic muscle function
    1/year for 4 years
    Behavioral: Record keeping in 3-day voiding diary
    Every 6 months for 4 years
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

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00506766


Locations
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Carolyn M Sampselle, PhD,RNC,FAAN University of Michigan School of Nursing
Study Director: Sandra H Hines, PhD, RNC University of Michigan School of Nursing
  More Information

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

ClinicalTrials.gov Identifier: NCT00506766     History of Changes
Other Study ID Numbers: 5R01NR007618-02 ( U.S. NIH Grant/Contract )
First Submitted: July 23, 2007
First Posted: July 25, 2007
Last Update Posted: July 25, 2007
Last Verified: July 2007

Keywords provided by University of Michigan:
Urinary Incontinence
Self efficacy
Pelvic floor muscle training
Bladder training

Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders


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