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Completed

NCT Number: NCT00506766

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

This study examined whether self-efficacy promoted adherence to Pelvic Floor Muscle Training (PFMT) and Bladder Training (BT) in women aged 55 and older.

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Key information

Conditions

Urinary Incontinence Bladder Control Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

55 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bladder Health Class consisting of 6 weekly group sessions

Behavioral

1 time

Practice PFMT and BT

Behavioral

As needed for 4 years

Clinic examination for pelvic muscle function

Behavioral

1/year for 4 years

Record keeping in 3-day voiding diary

Behavioral

Every 6 months for 4 years

Primary outcomes

  1. 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 outcomes

  1. 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

  2. Digital measurement during clinical examination of pelvic muscle function (pressure and displacement).

    Time frame: 1/year for four years

  3. Paper towel bladder test

    Time frame: 1/year for four years

  4. Survey questions (open ended and forced choice) about strategies women use to incorporate PFMT and BT into their lives

    Time frame: 1 time

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Important dates

Study start
2000
Study completion
2006
First posted
Jul 25, 2007
Registry last updated
Jul 25, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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