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

Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00178282
• Other study ID #: 11098
• Status: Terminated
• Phase: N/A
• First received: September 12, 2005
• Last updated: November 2, 2011
• Start date: June 2005
• Est. completion date: October 2007

Study information

• Verified date: November 2011
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: October 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Urinary Incontinence

Intervention

Procedure:
• Pelvic Floor Muscle exercises

Locations

Country	Name	City	State
United States	University of Rochester	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	Watson Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non-intensive physical therapy, 24hr. voiding diary, pad weight, Quality of Life questionnaires		During and 3 months after delivery	No