Low-Intensity Physical Therapy for Prevention of Pre and Postpartum Urinary Incontinence
Primary Purpose
Urinary Incontinence
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pelvic Floor Muscle exercises
Sponsored by
About this trial
This is an interventional prevention trial for Urinary Incontinence
Eligibility Criteria
Inclusion Criteria: Nulliparous, pregnant women, 18 years or older Less than 20 weeks gestation Able to give consent and who are willing to participate Exclusion Criteria: Multiparous women Women presenting after 20 weeks gestation History of urinary incontinence Mentally impaired women and women who have neurological impairment affecting ability to perform pelvic floor muscle training
Sites / Locations
- University of Rochester
Outcomes
Primary Outcome Measures
Non-intensive physical therapy, 24hr. voiding diary, pad weight, Quality of Life questionnaires
Secondary Outcome Measures
Full Information
NCT ID
NCT00178282
First Posted
September 12, 2005
Last Updated
November 2, 2011
Sponsor
University of Rochester
Collaborators
Watson Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00178282
Brief Title
Low-Intensity Physical Therapy for Prevention of Pre and Postpartum Urinary Incontinence
Official Title
Pilot Study: Low Intensity Physical Therapy for Prevention of Pre and Postpartum Urinary Incontinence
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated early due to poor subject enrollment.
Study Start Date
June 2005 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
October 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Rochester
Collaborators
Watson Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine if pelvic exercises can reduce the occurrence of urinary incontinence (involuntary loss of urine) before and after delivery. We would also like to see if performing pelvic exercises before birth has an effect on labor and/or delivery, and if there are any specific characteristics for developing urinary incontinence during pregnancy and after delivery.
Detailed Description
The studies investigating physiotherapy for prevention of urinary incontinence during and after pregnancy used intensive pelvic floor muscle training. While physical therapy appears to be effective in preventing urinary incontinence, extensive physical therapy is too costly to be implemented as a preventive measure for the general population. Thus, we want to asses if non-intensive pelvic floor therapy decreases the urinary incidence of incontinence during pregnancy and postpartum. We propose a prospective randomized controlled trial to obtain baseline data on the effect of non-intensive pelvic floor muscle training of urinary incontinence in primigravid women.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Pelvic Floor Muscle exercises
Primary Outcome Measure Information:
Title
Non-intensive physical therapy, 24hr. voiding diary, pad weight, Quality of Life questionnaires
Time Frame
During and 3 months after delivery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Nulliparous, pregnant women, 18 years or older
Less than 20 weeks gestation
Able to give consent and who are willing to participate
Exclusion Criteria:
Multiparous women
Women presenting after 20 weeks gestation
History of urinary incontinence
Mentally impaired women and women who have neurological impairment affecting ability to perform pelvic floor muscle training
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gunhilde Buchsbaum, MD
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Low-Intensity Physical Therapy for Prevention of Pre and Postpartum Urinary Incontinence
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