Research Projects

SCOR Project 1 - Biomechanics of Birth-Related Injuries

Sponsored by the National Institutes of Health P50 HD044406

Pregnancy and birth are remarkable times in a woman's life in many positive ways. Unfortunately, for certain women during their reproductive years, changes that occur as a result of vaginal delivery can lead to increased problems later in life. Pelvic floor disorders such as pelvic organ prolapse and urinary incontinence are much more common in women who have given birth than in those who have not. These problems significantly affect women's quality of life and often result in the need for complex surgery that has a high re-operation rate (approximately 30%). If we are to develop preventative strategies that spare at-risk women while not intervening in women who are not at risk for pelvic floor dysfunction, we must know what injuries occur in the pelvic floor that increase women's chance of developing these problems. In addition, we must know what obstetrical factors are associated with the occurrence of these injuries. The previously mysterious pelvic floor changes that allow a 7-½ pound infant to pass out of the body are only now, with the help of advanced technology, being discovered. For the recruitment portion of this project, see PIXIE  

  • PIXIE - Changes in Pelvic Floor During Childbirth

    Pregnant and non-pregnant women are given the option of participating by receiving ultrasounds of their perineums to look at changes in the muscles due to childbirth. The pregnant women are also invited to participate in PIXIE. The objective of the PIXIE project is to create a 3D model of the birthing process by recording the descent of the baby's head during delivery and to determine a normal rate of fetal descent. The recordings are given to biomechanical engineers at the University of Michigan to construct the 3D model. By measuring changes in muscle and tissue structures in the pelvic floor during delivery, the study aims to better understand the muscle changes that occur during the pushing phase of delivery and how the pelvic floor is affected. By monitoring the pelvic floor during delivery, we are able to gain a better understanding of how pelvic floor injuries happen. Study Coordinator:
    Chelsea Low. For further information and/or to enroll, e-mail: rubi@umich.edu

SCOR Project 2 - Maternal Birth-Related Neuromuscular Injury and Recovery: Phase II

Sponsored by the National Institutes of Health P50 HD044406

Preliminary studies using Magnetic Resonance Imagining (MRI) have shown a plausible causal linkage of prolapse and incontinence symptoms to a structural defect in the pubovisceral portion of the levator ani muscle. This defect has not been found in women who have not given birth. This specific muscle defect is found in two to four times as many women who have symptoms of prolapse and incontinence than in those who do not have symptoms. It is also associated with a reduction in muscle strength. Currently, we do not know what kind of injury is responsible for the defect in the PVM muscle. Important questions remain: Is the injury associated with specific events of delivery, or a consequence of pregnancy itself? Do some women become injured but spontaneously recover? How do those women differ from women who don't recover? This study hopes to answer these questions by validating risk factors associated with PVM, and confirming that PVM injuries are caused by birth rather than by pregnancy, by comparing a sample of women who have vaginal births with those who deliver by c-section. This study is only recruiting participants within the University of Michigan. For further information, e-mail: rutab@med.umich.edu

SCOR Project 3 - Mechanisms of Posterior Wall Prolapse

Sponsored by the National Institutes of Health P50 HD044406

This project seeks to clarify the role that birth-related injuries play in causing posterior vaginal prolapse. Competing hypotheses have been proposed relating to the causal role of endopelvic fascia or levator ani muscle failure. However, data to resolve these conflicts are not available and are needed to establish the relative contributions of each type of injury. This study will examine the interaction of these two mechanisms in leading to posterior vaginal prolapse. This study is only recruiting participants within the University of Michigan.

  • APEX - Assessment of Apical Support in subjects with and without Pelvic Organ Prolapse

    The APEX project seeks to learn more about the ligaments that support the uterus. When these ligaments weaken with age, it may result in the uterus falling down (“uterine prolapse”). In this study we will be measuring different positions in clinic to see how these positions affect uterine location and movement in women who have prolapse and women who do not.
    Study coordinator: Nina Dutta. For further information, e-mail: apexstudy@umich.edu

  • OPAL - Organ Prolapse and Levator Ani

    Do Women with Prolapse Have Levator Ani Impairment?
    Mechanisms of Vaginal Wall Support Failure
    Sponsored by the National Institute of Child Health & Human Development R01 HD038665

    Pelvic organ prolapse is a condition where the pelvic organs (the bladder, uterus, vagina and/or rectum) fall downward and bulge out through the opening of the vagina. This study is only recruiting participants within the University of Michigan. For further information, e-mail: OPAL@umich.edu

PALS - Promoting Optimal Healing After Laceration Repair

The objective of the PALS project is to find a process for repairing external perineal tears after birth with minimal pain for the patient. Participants in the study are randomly selected for three different processes: having the perineal laceration repaired with a suture, having the tear aligned without suture, or to line up the tear and use surgical glue to repair it. The project began in January 2014 and is recruiting pregnant women, but only women who suffer a perineal tear during their delivery will be eligible for the project. Participants will follow up 1 day, 2 weeks, 6 weeks and 3 months postpartum. Study Coordinators: Chelsea Low & Katie Luetkens. For further information and/or to enroll, e-mail: PALS-study@umich.edu


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 NR04007

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 the three self-care practices to determine their benefits to the pelvic floor. Our results will potentially change current practices in the delivery room, leading to healthier pelvic floors following delivery and decreased urinary incontinence. This study is now closed to 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 toward the development of preventative strategies as well as the further refinement of treatment options for those who suffer from urinary incontinence. We will be interviewing 2500 African American and Caucasian women between the ages of 35 and 64 living in Southeast Michigan. We will also bring in 330 of the women who have been 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 to enrollment.

RUBI – Research Understanding Birth Injury

SCOR Project 1: Pelvic Floor Biomechanics and Birth Injury
Sponsored by NICHD P50 HD04406

The purpose of this study is to define the normal biomechanics of the pelvic floor and to 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 and are without pelvic floor injuries. The commitment involves one study visit to the University of Michigan Medical Center 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 to enrollment.

ROSE – Research On Stress incontinence Etiology

SCOR Project 2: Which Pelvic Floor Defects Cause Stress Incontinence?
Sponsored by NICHD P50 HD04406

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 Center 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 to enrollment.

IRIS – Incontinence Research and Intervention Study

SCOR Project 3: Selection criteria for pelvic muscle therapy in SUI
Sponsored by NICHD P50 HD04406

Stress urinary incontinence (SUI) 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 a 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 physical pelvic structures that can become destabilized 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 90 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 R21 HD049818

The goal of the EMRLD 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.