Prevent Inability To Control Urination

NCT ID: NCT00075114

Last Updated: 2015-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

417 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-09-30

Study Completion Date

2006-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Urinary Incontinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1 Bladder Health Class

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.

Group Type OTHER

Bladder Health Class

Intervention Type 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.

2 Control Group

Participants randomized to this arm did not receive any interventions.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Bladder Health Class

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

55 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Nursing Research (NINR)

NIH

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Carolyn Sampselle

Carolyne K. Davis Professor of Nursing

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Carolyn M Sampselle, PhD, APH

Role: PRINCIPAL_INVESTIGATOR

University of Michigan, School of Nursing, MICHIN Center

Locations

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University of Michigan

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

References

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Funada S, Yoshioka T, Luo Y, Sato A, Akamatsu S, Watanabe N. Bladder training for treating overactive bladder in adults. Cochrane Database Syst Rev. 2023 Oct 9;10(10):CD013571. doi: 10.1002/14651858.CD013571.pub2.

Reference Type DERIVED
PMID: 37811598 (View on PubMed)

Other Identifiers

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R01NR007618

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1R01NR007618-01

Identifier Type: NIH

Identifier Source: org_study_id

View Link

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