Promoting Effective Recovery From Labor Urinary Incontinence (PERL)

Phase 3

Completed

• Conditions: Urinary Incontinence; Pelvic Organ Prolapse; Perinatal Laceration; Second Stage Labor

• Registration Number: NCT00506116
• Lead Sponsor: University of Michigan

Brief Summary

The purpose of this study is to determine whether pushing during labor that is controlled by the woman results in less birth-related injury and less postpartum urinary incontinence (UI).

Detailed Description

Birth related urinary incontinence (UI) is a predictor of UI in older women. Ways to protect the continence mechanism during delivery may diminish a woman's risk of UI later in life. We propose to study the functional anatomy of the pelvic floor as it relates to UI in women who are having their first baby. We hypothesize non-directed, spontaneous pushing is a protective strategy in decreasing the risk of immediate and long term UI. Longitudinal comparisons of pelvic floor characteristics will be taken at 35 week gestation and 6 weeks, 6 months, and 12 months postpartum. Study participants will be seen first at 20 weeks gestation for documentation of baseline levels of pelvic floor function, specifically voluntary and involuntary muscle strength, urinary continence status, and urethral support. They will be randomly assigned into non-directed, spontaneous (experimental) and directed, sustained pushing (control) groups. Alterations that may occur in urethral support before and after birth will be described through non-invasive urethral ultrasound.

Study Timeline

• Study Start: 1996-07
• Study Completion: 2006-12
• Status Verified: 2007-05
• Study First Submitted: 2007-07-23
• Study First Submitted QC: 2007-07-23
• Study First Posted: 2007-07-25
• Last Update Submitted: 2007-07-30
• Last Update Posted: 2007-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 140

Inclusion Criteria

Women giving birth for the first time who are:

1. Age 18 years or older
2. Less than 20 weeks gestation
3. Expected vaginal birth without use of epidural analgesia
4. Plan to reside in Southeast Michigan for one year following the birth of the infant.

Exclusion Criteria

1. History of genito-urinary or neuro-muscular pathology
2. Previous pregnancy carried beyond 20 weeks gestation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Leakage Index (	20 and 35 weeks gestation, and 6 weeks, 6 months, and 12 months postpartum

Secondary Outcome Measures

Name	Time	Method
Perineal status (Digital, speculum, chart review, ultrasound)	35 week gestation and 6 weeks, 6 months, and 12 months postpartum
Pelvic Organ Prolapse Quantification System (POPQ)	35 weeks gestation and 6 weeks, 6 months, and 12 months postpartum

Trial Locations

Locations (1)

University of Michigan Health System; 🇺🇸 Ann Arbor, Michigan, United States