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

NCT ID: NCT00178282

Last Updated: 2011-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2007-10-31

Brief Summary

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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

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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.

Conditions

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Urinary Incontinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Pelvic Floor Muscle exercises

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Watson Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

University of Rochester

OTHER

Sponsor Role lead

Responsible Party

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University of Rochester

Principal Investigators

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Gunhilde Buchsbaum, MD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

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University of Rochester

Rochester, New York, United States

Site Status

Countries

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United States

Other Identifiers

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11098

Identifier Type: -

Identifier Source: org_study_id