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

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ClinicalTrials.gov Identifier: NCT00178282
Recruitment Status : Terminated (The study was terminated early due to poor subject enrollment.)
First Posted : September 15, 2005
Last Update Posted : November 3, 2011
Sponsor:
Collaborator:
Watson Pharmaceuticals
Information provided by:
University of Rochester

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.

Condition or disease Intervention/treatment
Urinary Incontinence Procedure: Pelvic Floor Muscle exercises

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  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Pilot Study: Low Intensity Physical Therapy for Prevention of Pre and Postpartum Urinary Incontinence
Study Start Date : June 2005
Primary Completion Date : January 2007
Study Completion Date : October 2007

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U.S. FDA Resources




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


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00178282


Locations
United States, New York
University of Rochester
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Watson Pharmaceuticals
Investigators
Principal Investigator: Gunhilde Buchsbaum, MD University of Rochester

Responsible Party: Gunhilde Buchsbaum, MD, University of Rochester
ClinicalTrials.gov Identifier: NCT00178282     History of Changes
Other Study ID Numbers: 11098
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: November 3, 2011
Last Verified: November 2011

Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders