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Prevent Inability To Control Urination

Primary Purpose

Urinary Incontinence

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Bladder Health Class
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Incontinence focused on measuring Self Care, Behavior Modification

Eligibility Criteria

55 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Michigan

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

1 Bladder Health Class

2 Control Group

Arm 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.

Participants randomized to this arm did not receive any interventions.

Outcomes

Primary Outcome Measures

Mean number of incontinence episodes

Secondary Outcome Measures

Pelvic floor muscle strength
Length of voiding interval
Self-efficacy

Full Information

First Posted
January 2, 2004
Last Updated
January 14, 2015
Sponsor
University of Michigan
Collaborators
National Institute of Nursing Research (NINR)
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1. Study Identification

Unique Protocol Identification Number
NCT00075114
Brief Title
Prevent Inability To Control Urination
Official Title
Promoting Self -Care to Prevent Urinary Incontinence
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
September 2000 (undefined)
Primary Completion Date
February 2002 (Actual)
Study Completion Date
April 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Institute of Nursing Research (NINR)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence
Keywords
Self Care, Behavior Modification

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
417 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 Bladder Health Class
Arm Type
Other
Arm 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.
Arm Title
2 Control Group
Arm Type
No Intervention
Arm Description
Participants randomized to this arm did not receive any interventions.
Intervention Type
Behavioral
Intervention Name(s)
Bladder Health Class
Intervention 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.
Primary Outcome Measure Information:
Title
Mean number of incontinence episodes
Time Frame
Baseline, 6-, 12-, 18-, 24-, 32-, 42-, 48-months post baseline
Secondary Outcome Measure Information:
Title
Pelvic floor muscle strength
Time Frame
Baseline, 6-, 12-, 18-, 24-, 32-, 42-, 48-months post baseline
Title
Length of voiding interval
Time Frame
Baseline, 6-, 12-, 18-, 24-, 32-, 42-, 48-months post baseline
Title
Self-efficacy
Time Frame
Baseline, 6-, 12-, 18-, 24-, 32-, 42-, 48-months post baseline

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carolyn M Sampselle, PhD, APH
Organizational Affiliation
University of Michigan, School of Nursing, MICHIN Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

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Prevent Inability To Control Urination

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