Regaining Bladder Control in Postmenopausal Women With Osteoporosis

• ClinicalTrials.gov Identifier: NCT00323245
• Recruitment Status: Completed
• First Posted: May 9, 2006
• Last Update Posted: April 14, 2011
• Sponsor: University of British Columbia
• Information provided by: University of British Columbia

Tracking Information

• First Submitted Date: May 8, 2006
• First Posted Date: May 9, 2006
• Last Update Posted Date: April 14, 2011
• Study Start Date: March 2006
• Actual Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: November 20, 2006): Number of Incontinent Episodes (baseline and end of treatment (12 weeks)
• Original Primary Outcome Measures: Not Provided

Current Secondary Outcome Measures (submitted: November 20, 2006)

• 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

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Regaining Bladder Control in Postmenopausal Women With Osteoporosis
• Official Title: Regaining Urinary Continence in Postmenopausal Women With Osteoporosis: A Randomized Controlled Trial.
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment
• Condition: Urinary Incontinence

Intervention

Behavioral: Physiotherapy for urinary incontinence

See Detailed Description.

• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: November 20, 2006): 48
• Original Enrollment (submitted: May 8, 2006): 70
• Actual Study Completion Date: April 2011
• Actual Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

Postmenopausal women osteopenia or osteoporosis and stress urinary incontinence

Exclusion Criteria:

-

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 55 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT00323245
• Other Study ID Numbers: C05-0608; W05-0259
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Dr. Meena Sran, University of British Columbia
• Study Sponsor: University of British Columbia
• Collaborators: Not Provided

Investigators

• Principal Investigator: Meena Sran, PT, PhD; The University of British Columbia

• PRS Account: University of British Columbia
• Verification Date: April 2011