Research Projects Closed to Enrollment
PERL1+ – Promoting Effective Recovery from Labor 1+
Urinary Incontinence Prevention – Reducing Birthing Risk
Sponsored by the National Institute of Nursing Research R01 NRO4007
The research being performed by the PERL Project is being done to learn about ways to keep the pelvic floor structures strong and healthy during childbirth. The pelvic floor muscles, which can be damaged during vaginal birth, support the uterus and bladder. Weak pelvic floor muscles can cause accidental urine loss (urinary incontinence). Three self-care practices -- pelvic muscle training, prenatal perineal massage and spontaneous pushing during birth -- show promise in preventing birth-induced pelvic floor injury. Our study will evaluate each of the three self-care practices to determine its benefits to the pelvic floor. Our results will potentially change current practices in the delivery room and lead to healthier pelvic floors following delivery and decreased urinary incontinence. This study is now closed for enrollment.
EPI – Establishing the Prevalence of Incontinence
Race Differences in Female UI: Epidemiology and Biology
Sponsored by NICHD R01HD/AG41123
The aims of this research project are to define the prevalence of urinary incontinence in African American and Caucasian women, identify factors associated with urinary incontinence in general and in incontinent subtypes, and to compare the continence control system of African American and Caucasian women. Studying the role of race in continence is important in order to confirm or dispute the present purported differences and further identify risk factors. Once this information is available, research strategies can then be geared towards the development of preventative strategies as well as further refinement of treatment options for those who suffer from urinary incontinence. We will be interviewing 2,500 African American and Caucasian women between the ages of 35 and 64 living in Southeast Michigan. We will also bring in 330 of these women interviewed for a physical examination. Compensation for the interview is $20 and compensation for the clinic exam is $100. IRBMED# 2000-0824. This study is now closed for enrollment.
RUBI – Research Understanding Birth Injury
SCOR Project 1: Pelvic Floor Biomechanics and Birth Injury
Sponsored by NICHD 1P50HD04406
The purpose of this study is to define the normal biomechanics of the pelvic floor and determine how birth and age alter the biomechanics of the pelvic floor. The pelvic floor consists of a series of muscles across the opening of the pelvis, as well as pelvic organs (bladder, uterus, and rectum). We will recruit 90 women 18 years of age or older who have not given birth to a baby and are without pelvic floor injuries. The commitment involves one study visit to the University of Michigan Medical Campus in Ann Arbor, which take approximately one hour. Each participant will be asked to fill out a questionnaire and to undergo a series of clinical bladder tests and a brief pelvic examination. Each woman will receive $100 for the completion of the study. IRBMED# 2002-0637. This study is now closed for enrollment.
ROSE – Research On Stress incontinence Etiology
SCOR Project 2: Which Pelvic Floor Defects Cause Stress Incontinence?
Sponsored by NICHD 1P50HD04406
Stress urinary incontinence is a condition where urine leakage is caused by coughing, sneezing, exercising and/or lifting. We will recruit 300 women for a National Institute of Health study to determine why women have this problem – 150 who have this condition and 150 who have good bladder control. We are studying women 18 years or age and older. The commitment involves two study visits to the University of Michigan Medical Campus in Ann Arbor, which will take approximately one hour each. Each participant will be asked to fill out a questionnaire and to undergo a series of clinical bladder tests, a brief pelvic examination and an MRI. Each woman will receive up to $200 for her time. IRBMED# 2002-0636. This study is now closed for enrollment.
IRIS – Incontinence Research and Intervention Study
SCOR Project 3: Selection criteria for pelvic muscle therapy
in SUI
Sponsored by NICHD 1P50HD04406
Stress urinary incontinence is a condition of urine loss that occurs with coughing, sneezing or exercising. We will recruit 320 women for a National Institute of Health study on the treatment of SUI. We are looking for women 20 years old or older who experience even minor loss of urine with coughing, sneezing or exercise.
The commitment involves two to four study visits to the University of Michigan School of Nursing in Ann Arbor over a one-year period. Each participant will receive an evaluation of the pelvic physical structures that can destabilize and cause incontinence, as well as instruction in self-care practices for treating incontinence. No drugs are used. Each participant will also be asked to fill out brief questionnaires and a three-day diary of toileting and fluid habits before the clinic visit. Each woman will receive $20 for the first visit and $10 for each additional visit required, along with free parking. The first visit involves a commitment of approximately one hour and 30 minutes, with follow-up visits of less than 30 minutes each. IRBMED# 2002-0635.
This study is now closed to enrollment.
EMRLD – Evaluating Maternal Recovery from Labor and Delivery
Maternal Birth-Related Neuromuscular Injury and Recovery
Sponsored by NICHD 1R21HD04981801
The goal of the study is to determine how women physiologically recover from childbirth according to degree of tissue injury. This knowledge may be useful in determining the best prevention and treatment for urinary leakage and pelvic organ prolapse following childbirth.
Initial recruitment will be 20 primiparous women at increased risk for pubococcygeal muscle (or PCM) injury from a delivery at the University of Michigan Women's Hospital. Eligibility criteria includes a delivery that involved forceps or vacuum, third- or fourth-degree perineal tears, or long duration of the second stage of labor. MRI’s will be obtained at two weeks and six months postpartum. Two study visits (six weeks and six months postpartum) will be conducted at the University of Michigan School of Nursing. At the six-month postpartum visit, functional PCM testing will be performed by quantifying PCM strength (instrumented speculum), pelvic organ support (pelvic organ prolapse quantification) and incontinence (standard urodynamic and survey measures). The initial recruitment will generate pilot data aimed at testing the relationship between injury type and pelvic floor function. Our long-term goal is prevention and treatment of incontinence and prolapse, with care based on an improved understanding of the injury responsible for the pathology. IRBMED# 2005-0011.
This study is now closed to enrollment.
