Regaining Bladder Control in Postmenopausal Women With Osteoporosis
Primary Purpose
Urinary Incontinence
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Physiotherapy for urinary incontinence
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Incontinence focused on measuring Randomized clinical trial, osteoporosis, urinary incontinence, physiotherapy, education
Eligibility Criteria
Inclusion Criteria: Postmenopausal women osteopenia or osteoporosis and stress urinary incontinence Exclusion Criteria: -
Sites / Locations
- BC Womens' Health Centre
Outcomes
Primary Outcome Measures
Number of Incontinent Episodes (baseline and end of treatment (12 weeks)
Secondary Outcome Measures
Urinary Distress Inventory
Pelvic Floor Muscle Strength
Quality of life: Each participant will complete the Incontinence Impact Questionnaire and the SF-36 at the initial and follow up measurement sessions
Physical Activity (PASE)
24 Hour Pad Test
Voiding Frequency using the bladder diary
Spinal Curvature with a flexicurve ruler
Self-Perceived Efficacy
All at initial and follow up (end) measurement sessions
Full Information
NCT ID
NCT00323245
First Posted
May 8, 2006
Last Updated
April 12, 2011
Sponsor
University of British Columbia
1. Study Identification
Unique Protocol Identification Number
NCT00323245
Brief Title
Regaining Bladder Control in Postmenopausal Women With Osteoporosis
Official Title
Regaining Urinary Continence in Postmenopausal Women With Osteoporosis: A Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of British Columbia
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Conservative management for urinary incontinence has been shown to improve bladder control. We are conducting a study of the effectiveness of conservative management for urinary incontinence in women who also have osteoporosis. We hope to find that treatment for incontinence improves bladder control and thereby allows women to be more active and reduces their risk of falling and breaking bones.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence
Keywords
Randomized clinical trial, osteoporosis, urinary incontinence, physiotherapy, education
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Physiotherapy for urinary incontinence
Intervention Description
See Detailed Description.
Primary Outcome Measure Information:
Title
Number of Incontinent Episodes (baseline and end of treatment (12 weeks)
Secondary Outcome Measure Information:
Title
Urinary Distress Inventory
Title
Pelvic Floor Muscle Strength
Title
Quality of life: Each participant will complete the Incontinence Impact Questionnaire and the SF-36 at the initial and follow up measurement sessions
Title
Physical Activity (PASE)
Title
24 Hour Pad Test
Title
Voiding Frequency using the bladder diary
Title
Spinal Curvature with a flexicurve ruler
Title
Self-Perceived Efficacy
Title
All at initial and follow up (end) measurement sessions
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Postmenopausal women osteopenia or osteoporosis and stress urinary incontinence
Exclusion Criteria:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meena Sran, PT, PhD
Organizational Affiliation
The University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
BC Womens' Health Centre
City
Vancouver
State/Province
British Columbia
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Regaining Bladder Control in Postmenopausal Women With Osteoporosis
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