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

This study has been terminated.
(The study was terminated early due to poor subject enrollment.)
Sponsor:
Collaborator:
Watson Pharmaceuticals
Information provided by:
University of Rochester
ClinicalTrials.gov Identifier:
NCT00178282
First received: September 12, 2005
Last updated: November 2, 2011
Last verified: November 2011
  Purpose

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 Intervention
Urinary Incontinence
Procedure: Pelvic Floor Muscle exercises

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Pilot Study: Low Intensity Physical Therapy for Prevention of Pre and Postpartum Urinary Incontinence

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Non-intensive physical therapy, 24hr. voiding diary, pad weight, Quality of Life questionnaires [ Time Frame: During and 3 months after delivery ] [ Designated as safety issue: No ]

Enrollment: 23
Study Start Date: June 2005
Study Completion Date: October 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Gunhilde Buchsbaum, MD, University of Rochester
ClinicalTrials.gov Identifier: NCT00178282     History of Changes
Other Study ID Numbers: 11098
Study First Received: September 12, 2005
Last Updated: November 2, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 27, 2014