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 Judy Gruss, RN, at 412-641-5388

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 Judy Gruss, RN, at 412-641-5388

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 Judy Gruss, RN, at 412-641-5388

Principal Investigator

Mary Ackenbom, MD

Participants

Women who are at least 60 years old and who are scheduled to undergo surgical repair of pelvic organ prolapse will be enrolled in this study.

Description

This is a research study to determine the incidence of postoperative cognitive impairment, in the forms of postoperative cognitive dysfunction and delirium, for older women undergoing pelvic organ prolapse (POP) surgery. Cognitive dysfunction in the postoperative setting can have a role in loss of independence, socioeconomic burden, and decreased quality of life. This study will help to determine how often this is happening in the population of older women undergoing POP surgery.

For more information

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

REDUCTION

A randomized pilot and feasibility study of a culture-directed approach to urinary tract Infection symptoms in older women: a mixed methods evaluation – the REDUCTION trial.

Participants

Women aged 65 or older who have had prior, recent urinary tract infections, and who currently have symptoms of a urinary tract infection (painful urination, urinary urgency and/or frequency, suprapubic pain) may be eligible to participate.

Description

Urinary Tract Infections (UTIs) in women are common, occurring in 60% of women over a lifetime. This is also the second most common reason for antibiotic use in women. Some women are prescribed antibiotics at the onset of symptoms (empiric) while others are only prescribed an antibiotic after a urine culture has indicated that an antibiotic is necessary (Culture-proven). This study will look closely at when antibiotics are prescribed for women who have symptoms of a UTI and compare the outcomes for women who are treated empirically to those who are treated only after culture is done and indicates infection.

For More Information

Contact Judy Gruss, RN, at 412-641-5388 or 412-641-6881.

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.

TAPER

Techniques of Applying Vaginal Estrogen for Prevention of Recurrent Urinary Tract Infections (TAPER) Randomized Controlled Trial: Periurethral vs Intravaginal Estrogen for Prevention of Recurrent Urinary Tract Infections.

Participants

Postmenopausal women who have experienced at least two UTI’s in the past six months or at least three in the past 12 months may be eligible to participate.

Description

Many women experience frequent or recurrent Urinary Tract Infections (UTI’s), which can be a very frustrating experience. There is strong evidence that vaginal estrogen cream use in menopausal women with recurrent UTI’s reduces the risk for recurrent infections by helping to restore healthy bacteria in the vagina. In this research study, two methods of cream application will be compared for effectiveness. Participating women will be randomly assigned to periurethral application (around the urethra or opening to the bladder) or vaginal applicator insertion of the cream. Investigators seek to learn if easier finger application and overall smaller amount of estrogen cream use will be as beneficial as the traditional applicator approach.

For More Information

Contact Alayna Schwerer, BS, at 412-641-7433.

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 Judy Gruss, RN, 412-641-5388

Participants

Women who suffer from chronic pelvic / bladder pain may be eligible to participate.

Description

Some women experience pelvic and bladder pain that is not easily explained or treated, and this can be very frustrating for these women. This research is being done to determine if women with chronic pelvic and bladder pain improve with a multi-modal versus stepwise approach to treatment. Multi- modal means that patients are offered multiple drugs and treatments with several ways of working all given at the same time, whereas stepwise is trying different drugs or treatments at different times, depending on the patient’s response. All the treatments available are available to all patients in this study. In the study we will compare giving them all at once versus having your physician decide which ones you have in a stepwise decision-making process. The study is not testing any particular drug or treatment, it is looking at whether the timing of treatments, all at once or stepwise, is better.

For More Information

Contact Alayna Schwerer, BS, at 412-641-7433