Prevent Inability To Control Urination

University of Michigan

Status and phase: Completed; Phase 3

Conditions: Urinary Incontinence

Treatments: Behavioral: Bladder Health Class

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00075114

1R01NR007618-01

R01NR007618 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 417 patients

Sex: Female

Ages: 55 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion and exclusion criteria

1. Female 55 through 80 years old

2. Post-menopausal-no menstrual cycle for the past 12 months except for women who are on hormone replacement therapy.

3. Continent of urine (using the MESA definition of continence) defined as:

   1. No previous incontinence episode except during pregnancy and/or postpartum period.
   2. Urine loss less than 6 days during the last 365 days
   3. No previous or present incontinence treatment with pharmacological agents, behavioral programs or surgical therapy.

4. No history of bladder cancer, stroke, multiple sclerosis, parkinsonism, epilepsy, spinal cord tumor or trauma.

5. 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:

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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417 participants in 2 patient groups

1 Bladder Health Class

Other group

Description:

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.

Treatment:

Behavioral: Bladder Health Class

2 Control Group

No Intervention group

Description:

Participants randomized to this arm did not receive any interventions.