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Cook Myosite Study: a Female Stress Urinary Incontinence Clinical Research Study
Principal Investigator
Christopher Chermansky, MD
Participants
Women at least 18 years of age who have symptoms of stress urinary incontinence, including 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 Anne Wecht at 412-647-5907
Mesh Biorepository Study: Insight Into the Pathogenesis of Mesh Complications
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 at 412-641-5388
MESH Control Study
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 at 412-641-5388
Pelvic Floor Tissue Study: a Comparison of Pelvic Floor Connective Tissue Remodeling in Premenopausal and Postmenopausal Women
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 at 412-641-5388
Estrogen and Pelvic Floor Physical Therapy in Women With Symptomatic Pelvic Organ Prolapse
Principal Investigator
Pamela Moalli, MD, PhD
Participants
Women aged 40-80 with mild, symptomatic pelvic organ prolapse
Description
Pelvic Floor Physical Therapy has been shown to be helpful in women with mild pelvic organ prolapse. Some doctors are also using vaginal estrogen to help with these symptoms in the early stages. In this study, women are randomly assigned to receive either vaginal estrogen or placebo, and then initiate a 6 month pelvic floor physical therapy program. Baseline and 6 months visits are required; visit activities include completion of questionnaires and a pelvic exam. The study cream and physical therapy co-payment is provided to patients.
This study is supported by a research grant from the PFD Research Foundation of the American Urogynecologic Society.
For more information
Contact Judy Gruss at 412-641-5388
Postoperative Cognitive Impairment in Older Women Undergoing Pelvic Organ Prolapse Surgery
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 at 412-641-7894
Neuromodulation for Accidental Bowel Leakage (NOTABLE)
Principal Investigator
Halina Zyczynski, MD
Participants
Women who experience accidental bowel leakage, are 18 or older, have had symptoms for more than 3 months and are not responsive to other treatments such as Pelvic floor muscle therapy and medication.
Description
The purpose of this study is to evaluate a new treatment for accidental bowel leakage called percutaneous tibial nerve stimulation or (PTNS). PTNS uses mild electrical pulses to stimulate a nerve at the ankle (the tibial nerve). During PTNS a very thin needle is placed in to the skin above the ankle and mild electrical pulses are sent to the tibial nerve for about 30 minutes. This treatment will take place weekly over the course of 12 weeks. Small studies have shown that PTNS reduces accidental bowel leakage. Participants will also be asked to complete a bowel diary and will be compensated for their participation. Through this research investigators are seeking further evidence to support the use of PTNS as a treatment for accidental bowel leakage.
For more information
Contact Jacqueline Noel at 412-641-6679
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