The goal of this application is to competitively identify clinical sites to conduct clinical trials for female pelvic floor disorders. This application from the University of Pennsylvania with Lily Arya MD, MS (Epidemiology) as Principal Investigator demonstrates our research plan for a new treatment for urge urinary incontinence, myofascial physical therapy. This potentially effective and safe method will greatly enhance treatment choice and improve the quality of life of women with urge urinary incontinence. This application outlines our extensive experience with similar large multi-center clinical trials. We highlight our ability to recruit and maintain subjects in female pelvic floor disorder clinical trials, noting we have been one of the leading recruitment centers in the nation for similar trials. We have often been able to recruit a greater number of subjects than our original estimates. The facilities at the University of Pennsylvania are supportive and outstanding. Our existing research unit and personnel has continuously demonstrated highly successful management of large clinical trials with outstanding organization, attention to detail and compliance with Good Clinical Practice, federal regulations and local Institutional Review Boards. Dr. Arya is an active researcher in the field of health measurement for pelvic floor disorders and she has successfully conducted a number of clinical trials in women's health. Specifically, she and her team of co- investigators and staff have been actively involved in surgical and non-surgical trials for urinary incontinence. She will bring significant expertise regarding study design and health measurement research to the Pelvic Floor Disorders Network. She leads a team of co-investigators who have a track record of collaborative clinical and translational research. We feel that the combination of a high quality personnel, experience in the research area, ability to recruit, and outstanding management and organization will contribute to a high likelihood of successful completion of this and future trials of treatment methods of pelvic floor disorders.

Public Health Relevance

The University of Pennsylvania has the expertise, infrastructure and experience to be a significant contributor to the Pelvic Floor Disorders Network. The proposed study, to investigate the efficacy of a new treatment for urge urinary incontinance, will improve quality of life of women with urge incontinence and result in considerable savings of health care resources.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
5U10HD069010-04
Application #
8699236
Study Section
Special Emphasis Panel (ZHD1-DSR-N (02))
Program Officer
Parrott, Estella C
Project Start
2011-08-01
Project End
2016-06-30
Budget Start
2014-07-01
Budget End
2015-06-30
Support Year
4
Fiscal Year
2014
Total Cost
$342,157
Indirect Cost
$128,309
Name
University of Pennsylvania
Department
Obstetrics & Gynecology
Type
Schools of Medicine
DUNS #
042250712
City
Philadelphia
State
PA
Country
United States
Zip Code
19104
Markland, Alayne D; Jelovsek, J Eric; Rahn, David D et al. (2017) Irritable Bowel Syndrome and Quality of Life in Women With Fecal Incontinence. Female Pelvic Med Reconstr Surg 23:179-183
Arya, Lily A (2017) Rationale for Investigating Stool Metabolites and Microbiota in Women With Fecal Incontinence. Dis Colon Rectum 60:249-252
Arya, Lily A; Richter, Holly E; Jelovsek, Eric et al. (2017) Metabolites and microbial composition of stool of women with fecal incontinence: Study design and methods. Neurourol Urodyn :
Komesu, Yuko M; Richter, Holly E; Dinwiddie, Darrell L et al. (2017) Methodology for a vaginal and urinary microbiome study in women with mixed urinary incontinence. Int Urogynecol J 28:711-720
Richter, Holly E; Moalli, Pamela; Amundsen, Cindy L et al. (2017) Urinary Biomarkers in Women with Refractory Urgency Urinary Incontinence Randomized to Sacral Neuromodulation versus OnabotulinumtoxinA Compared to Controls. J Urol 197:1487-1495
Markland, A D; Jelovsek, J E; Whitehead, W E et al. (2017) Improving biofeedback for the treatment of fecal incontinence in women: implementation of a standardized multi-site manometric biofeedback protocol. Neurogastroenterol Motil 29:
Amundsen, Cindy L; Richter, Holly E; Wallace, Dennis et al. (2017) OnabotulinumtoxinA vs Sacral Neuromodulation for Urgency Incontinence-Reply. JAMA 317:535-536
Weissbart, Steven J; Lewis, Rusell; Smith, Ariana L et al. (2016) Impact of Dry Mouth on Fluid Intake and Overactive Bladder Symptoms in Women taking Fesoterodine. J Urol 195:1517-22
Visco, Anthony G; Zyczynski, Halina; Brubaker, Linda et al. (2016) Cost-Effectiveness Analysis of Anticholinergics Versus Botox for Urgency Urinary Incontinence: Results From the Anticholinergic Versus Botox Comparison Randomized Trial. Female Pelvic Med Reconstr Surg 22:311-6
Nager, Charles W; Zyczynski, Halina; Rogers, Rebecca G et al. (2016) The Design of a Randomized Trial of Vaginal Surgery for Uterovaginal Prolapse: Vaginal Hysterectomy With Native Tissue Vault Suspension Versus Mesh Hysteropexy Suspension (The Study of Uterine Prolapse Procedures Randomized Trial). Female Pelvic Med Reconstr Surg 22:182-9

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