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

This study has been completed.
Sponsor:
Information provided by:
University of Michigan
ClinicalTrials.gov Identifier:
NCT00506766
First received: July 23, 2007
Last updated: NA
Last verified: July 2007
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
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

Ages Eligible for Study:   55 Years to 80 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
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: 5 R01 NR07618-02
Study First Received: July 23, 2007
Last Updated: July 23, 2007
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on August 28, 2014