Low-Intensity Physical Therapy for Prevention of Pre and Postpartum Urinary Incontinence

November 2, 2011 updated by: University of Rochester

Pilot Study: Low Intensity Physical Therapy for Prevention of Pre and Postpartum Urinary Incontinence

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Non-intensive physical therapy, 24hr. voiding diary, pad weight, Quality of Life questionnaires
Time Frame: During and 3 months after delivery
During and 3 months after delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

Collaborators

Watson Pharmaceuticals

Investigators

  • Principal Investigator: Gunhilde Buchsbaum, MD, University of Rochester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (Actual)

January 1, 2007

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Estimate)

November 3, 2011

Last Update Submitted That Met QC Criteria

November 2, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11098

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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