Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Prevent Inability To Control Urination

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Carolyn Sampselle, University of Michigan
ClinicalTrials.gov Identifier:
NCT00075114
First received: January 2, 2004
Last updated: January 14, 2015
Last verified: January 2015
  Purpose

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.


Condition Intervention Phase
Urinary Incontinence
Behavioral: Bladder Health Class
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Promoting Self -Care to Prevent Urinary Incontinence

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Mean number of incontinence episodes [ Time Frame: Baseline, 6-, 12-, 18-, 24-, 32-, 42-, 48-months post baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pelvic floor muscle strength [ Time Frame: Baseline, 6-, 12-, 18-, 24-, 32-, 42-, 48-months post baseline ] [ Designated as safety issue: No ]
  • Length of voiding interval [ Time Frame: Baseline, 6-, 12-, 18-, 24-, 32-, 42-, 48-months post baseline ] [ Designated as safety issue: No ]
  • Self-efficacy [ Time Frame: Baseline, 6-, 12-, 18-, 24-, 32-, 42-, 48-months post baseline ] [ Designated as safety issue: No ]

Enrollment: 417
Study Start Date: September 2000
Study Completion Date: April 2006
Primary Completion Date: February 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Behavioral: 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.
No Intervention: 2 Control Group
Participants randomized to this arm did not receive any interventions.

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.

  Eligibility

Ages Eligible for Study:   55 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00075114

Locations
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Carolyn M Sampselle, PhD, APH University of Michigan, School of Nursing, MICHIN Center
  More Information

No publications provided

Responsible Party: Carolyn Sampselle, Carolyne K. Davis Professor of Nursing, University of Michigan
ClinicalTrials.gov Identifier: NCT00075114     History of Changes
Other Study ID Numbers: 1-R01-NR007618-01, R01NR007618
Study First Received: January 2, 2004
Last Updated: January 14, 2015
Health Authority: United States: Federal Government

Keywords provided by University of Michigan:
Self Care
Behavior Modification

Additional relevant MeSH terms:
Urinary Incontinence
Lower Urinary Tract Symptoms
Signs and Symptoms
Urination Disorders
Urologic Diseases
Urological Manifestations

ClinicalTrials.gov processed this record on February 27, 2015