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OpenTrials
Completed

NCT Number: NCT00075114

Prevent Inability To Control Urination

The purpose of this study is to determine the capacity of self-efficacy to predict maintaining a behavior change at four years post urinary control intervention.

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Key information

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

This is a study that will monitor and compare attitudes and strategies that women use to maintain behavior changes that prevent urination problems. Women will complete questionnaires, do muscle strength exercises, and bladder training at 3 months, one year, and 4 years post intervention.

Who can participate

Healthy volunteers accepted: No

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

Inclusion and exclusion criteria

  • Female 55 through 80 years old
  • Post-menopausal-no menstrual cycle for the past 12 months except for women who are on hormone replacement therapy.
  • Continent of urine (using the MESA definition of continence) defined as:
  • No previous incontinence episode except during pregnancy and/or postpartum period.
  • Urine loss less than 6 days during the last 365 days
  • No previous or present incontinence treatment with pharmacological agents, behavioral programs or surgical therapy.
  • No history of bladder cancer, stroke, multiple sclerosis, parkinsonism, epilepsy, spinal cord tumor or trauma.
  • No reported difficulty with activities of daily living, i.e. walking about the house, dressing, getting in/out of bed, getting to/using the toilet, bathing/showering, or eating.

Additional criteria are applied at a physical examination:

  • Mini Mental Status of at least 24
  • Negative for objective urine loss during coughing.

Treatment and study plan

Bladder Health class

Behavioral

A two-hour bladder health class presented by two experts in urinary incontinence and followed by an individual follow-up teaching session with an incontinence nurse specialist.

Primary outcomes

  1. Mean number of incontinence episodes

    Time frame: Baseline, 6-, 12-, 18-, 24-, 32-, 42-, 48-months post baseline

Secondary outcomes

  1. Pelvic floor muscle strength

    Time frame: Baseline, 6-, 12-, 18-, 24-, 32-, 42-, 48-months post baseline

  2. Length of voiding interval

    Time frame: Baseline, 6-, 12-, 18-, 24-, 32-, 42-, 48-months post baseline

  3. Self-efficacy

    Time frame: Baseline, 6-, 12-, 18-, 24-, 32-, 42-, 48-months post baseline

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Official study title

Promoting Self -Care to Prevent Urinary Incontinence

Important dates

Study start
2000
Primary completion
2002
Study completion
2006
First posted
Jan 5, 2004
Registry last updated
Jan 15, 2015

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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