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Regaining Bladder Control in Postmenopausal Women With Osteoporosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00323245
Recruitment Status : Completed
First Posted : May 9, 2006
Last Update Posted : April 14, 2011
Sponsor:
Information provided by:
University of British Columbia

Tracking Information
First Submitted Date  ICMJE May 8, 2006
First Posted Date  ICMJE May 9, 2006
Last Update Posted Date April 14, 2011
Study Start Date  ICMJE March 2006
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 20, 2006)
Number of Incontinent Episodes (baseline and end of treatment (12 weeks)
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Regaining Bladder Control in Postmenopausal Women With Osteoporosis
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Urinary Incontinence
Intervention  ICMJE Behavioral: Physiotherapy for urinary incontinence
See Detailed Description.
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: November 20, 2006)
48
Original Enrollment  ICMJE
 (submitted: May 8, 2006)
70
Actual Study Completion Date  ICMJE April 2011
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Postmenopausal women osteopenia or osteoporosis and stress urinary incontinence

Exclusion Criteria:

-

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 55 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00323245
Other Study ID Numbers  ICMJE C05-0608
W05-0259
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Meena Sran, University of British Columbia
Study Sponsor  ICMJE University of British Columbia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Meena Sran, PT, PhD The University of British Columbia
PRS Account University of British Columbia
Verification Date April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP