Principal Investigator

Jocelyn Fitzgerald, MD

Participants

Women at least 21 years of age scheduled to have surgery for the treatment of Stress Urinary Incontinence using an Ethicon mesh product.

Description

Ethicon Inc. is conducting this registry to look at the long-term performance and safety of several devices used for the treatment of Stress Urinary Incontinence, all of which have been cleared by the FDA for this use. This registry will only collect information on tests or treatments your doctor is already conducting.  The only additional thing that you will be asked to do is to complete questionnaires about your quality of life. You will be asked to complete these questionnaires at various time points before and for a minimum of 5 years, maximum of 10 years after surgery.

For More Information

Contact Lindsey Baranski at 412-641-7894

Principal Investigator

Pamela Moalli, MD, PhD and Lauren Giugale, MD

Participants

Women at least 18 years of age or older who are delivering their first child either via cesarean delivery or a vaginal delivery with certain characteristics at or after 37 weeks of pregnancy. We are specifically interested in women who had a vaginal delivery and pushed for more than 2 hours, had a baby that weighed more than 8lb 13oz, had vacuum or forceps used, or had a 3rd or 4th degree perineal laceration

Description

The purpose of this study is to determine how pregnancy and delivery affect your body, in particular, the support to pelvic organs such as the bladder, uterus, bowel and rectum. The study requires 1-2 visits to Magee-Womens Hospital at 12 weeks and 1 year after your delivery. At the 12-week visit, we will perform a pelvic exam, ultrasound and an MRI (these can also be performed on separate days if needed)

For More Information

Contact Alayna Schwerer at 412-641-7433

Principal Investigator

Christopher Chermansky, MD

Participants

Women at least 18 years of age who have had a prior surgical procedure for stress urinary incontinence (e.g., sling, transvaginal taping procedure, burh procedure) and who continue to have leakage of urine related to activities such as lifting, coughing, or sneezing, may be eligible to participate.

Description

This clinical study is being conducted to evaluate the safety and effectiveness of an investigational cellular product in women with incontinence. If you choose and qualify to participate, you will be asked to have a muscle biopsy from your thigh, from which some of your muscle cells will be taken. Your cells will be processed at a laboratory and then injected into your urethral sphincter to determine if the cells will reestablish control over the retention and release of urine. There are at least 7 study visits, and participants will complete bladder diaries and questionnaires. Lab tests (blood and urine) will also be done.

For More Information

Contact Vickie Polanco-Garcia at 412-641-1364

Principal Investigator

Pamela Moalli, MD, PhD

Participants

Women who are undergoing a procedure to have mesh removed from their pelvis.

Description

Mesh products have been used for more than 20 years in treatments for pelvic organ prolapse and urinary incontinence. More recently, mesh complications have been identified in some women who have had a mesh procedure. Dr. Moalli’s group believes that some of the complications may be related to the product, the tension placed on the mesh at the time is was inserted, and the forces the mesh is subjected to after surgery. In this study, the investigators are looking more closely at the women who have mesh complications and who have opted to have the mesh removed. Women are asked to complete surveys about their symptoms at baseline and again after their surgery. At the time of surgery, the following specimens are collected: 1 tube of blood; vaginal swab for vaginal cells; urine; small vaginal biopsy; mesh. Most specimens are collected after anesthesia is administered and the patient is comfortable. Patients are asked to complete surveys about symptoms 4 times after surgery up to 24 months. The investigators hope this information will help to have a better understanding of what causes mesh problems and what effects these problems have on women.

For more information

Contact Lindsey Baranski at 412-641-7894

Principal Investigator

Pamela Moalli, MD, PhD

Participants

Women who have had a mesh implant and who have not developed problems or complications.

Description

Mesh products have been used for more than 20 years in treatments for pelvic organ prolapse and urinary incontinence. In the prior study we collect information from women who have a complication related to the mesh. In this study, the investigators are looking more closely at the women who DO NOT have a mesh complication. Women are asked to complete surveys about their symptoms at baseline and again at 6, 12, and 24 months after recruitment. The investigators hope this information will help us to have a better understanding of how many women avoid mesh complications.

For more information

Contact Lindsey Baranski at 412-641-7894

Principal Investigator

Pamela Moalli, MD, PhD

Participants

Women over the age of 25 who are having a vaginal surgery for pelvic organ prolapse are being asked to participate. A subgroup of women having surgery but who do not have pelvic organ prolapse are also being asked to participate.

Description

The investigators in this study hope to determine differences in the tissue make-up in women with pelvic organ prolapse and those without pelvic organ prolapse. Specifically, the study is looking at structural proteins that confer the properties of strength (collagen) and resilience (elastin) as well as the enzymes that regulate their synthesis and breakdown. Women in the study consent to having specimens collected at the time of surgery (in the operating room after anesthesia). These specimens include: biopsy, vaginal swabsand urine.

For more information

Contact Lindsey Baranski at 412-641-7894

RELIEF

sIRB reduced-dose onabotuLinumtoxinA for urgency urinary Incontinence among elder females: a mixed methods randomized controlled trial – the RELIEF trial.

Participants

Women aged 70 and older with overactive bladder (OAB) symptoms of urinary urgency and frequency leading to leakage of urine (loss of bladder control).

Description

OAB and urgency urinary incontinence (UUI) are common among older women, ages 70 and older. Botox medication is an effective and safe treatment. However, a minority of women who receive standard dose treatment have undesirable side effects. The goal of this research is to study the effectiveness and side effects of two doses of Botox treatment for UUI in older women. Some women will receive the standard dosage and others a lower dosage. Information gained in this study will tell us more about the safety and effectiveness of the lower dose of Botox in older women.

For More Information

Contact Lindsey Baranski, MS, at 412-641-7894.

PREMIER

sIRB patient-centered outcomes of sacrocolpopexy versus uterosacral ligament suspension for the treatment of uterovaginal prolapse

Participants

Women planning surgery for Uterine and Vaginal Prolapse (UVP) with a physician in the Women’s Center for Bladder and Pelvic Health may be eligible for this study.

Description

Uterovaginal Prolapse (UVP) affects many women. The purpose of this study is to compare the two most common corrective surgeries in the U.S. for uterovaginal prolapse (UVP). Uterine prolapse surgery most often includes removal of the uterus (hysterectomy) and suspension of the vagina. This can be achieved through vaginal incisions using the patient’s own tissue or through small abdominal incisions (most often laparoscopically or robotically). No high-quality data exists to help guide patients and surgeons on the best individualized surgical plan. The goal of the study is to determine which surgery works best from a patient’s perspective and which has the fewest complications. Both types of surgery are performed regularly and are considered the standard of care.

For More Information

Contact Lindsey Baranski at 412-641-7894