Pelvic Floor Disorders Network Clinical Sites (UG1)

NIH RePORTER · NIH · UG1 · $262,702 · view on reporter.nih.gov ↗

Abstract

Project Summary This application demonstrates the achievements and capabilities of the Pelvic Floor Disorders Unity (PFDU) of the University of Pennsylvania as a clinical site for the Pelvic Floor Disorders Network. We detail our unique strengths that have allowed us to make significant academic, clinical and administrative contributions to the Network in our first cycle of participation. Our core team of five academic investigators is part of a team of twelve pelvic floor specialists at the University of Pennsylvania and includes three fellowship-trained urogynecologists, one fellowship-trained urologist and a behavioral nurse practitioner who provide diverse and complementary expertise in multi-center trials of pelvic floor disorders. Our investigators have contributed to all areas of clinical trial design and development, recruitment and retention and scientific reporting in the Network. Specifically, Penn investigators are leading several active research protocols including 1) clinical and translational research in defecatory dysfunction (SMM-CAPABLe, Arya) 2) development of behavioral intervention for mixed urinary incontinence for ESTEEM (Newman), and 3) cost-effectiveness analyses for all four trials (Harvie). Our recruitment and retention in multi-center trials is outstanding and the result of an exceptional research infrastructure and culture of research that permeates all our clinical activities. Our unique geographical location allows us to recruit a large and ethnically diverse patient population from three states (Pennsylvania, New Jersey and Delaware).We are in the top three recruiting sites for two of the four randomized trials conducted in this cycle and 37% of our enrolled subjects are minorities (highest recruitment of minority subjects from all sites). Additional unique strengths of the Penn site include 1) strong collaboration with Urology co-investigators which includes our alternate PI (Smith) 2) a dedicated clinical research unit in the Department of OB/GYN that provides direct financial, logistical and personnel support beyond the PFDN budget 2) translational research experts that are allowing Penn PFDU investigators to develop innovative treatments for pelvic floor disorders including fecal gut transplantation for fecal incontinence 3) the Penn Clinical and Translational Research Center (CTRC) that provides PFDN investigators low cost access to all state-of-the art technologies specified in the RFA. Ultimately, the team of investigators, available population, our cost-effective and efficient approach to clinical trials and outstanding university resources make the Penn PFDU an ideal site to advance the scientific productivity of the Pelvic Floor Disorders Network.

Key facts

NIH application ID
9979654
Project number
5UG1HD069010-10
Recipient
UNIVERSITY OF PENNSYLVANIA
Principal Investigator
Heidi S Harvie
Activity code
UG1
Funding institute
NIH
Fiscal year
2020
Award amount
$262,702
Award type
5
Project period
2011-08-01 → 2022-06-30