Pelvic Floor Disorders Network Clinical Sites (UG1)

NIH RePORTER · NIH · UG1 · $265,150 · view on reporter.nih.gov ↗

Abstract

Project Summary/Abstract (30 lines of text) This application demonstrates the achievements and capabilities of the Pelvic Floor Disorders Unit (PFDU) of the University of Pennsylvania as a clinical site for the Pelvic Floor Disorders Network (PFDN). We detail our unique strengths that have allowed us to make significant academic, clinical and administrative contributions to the Network. We have a well-established research and multi-disciplinary clinical infrastructure including long-standing clinical and research relationships with urology, colorectal surgery, gastroenterology, advanced practice nursing, geriatrics, behavioral medicine, radiology, basic sciences and epidemiology and extensive experience in performing relevant clinical trials and observational studies both within and outside the PFDN Network. Our investigators have substantially contributed to all areas of clinical trial design and development, implementation, recruitment and retention and scientific reporting in the Network and presented outcomes of this research at national scientific meetings. We have an excellent track record of facilitation and cooperation with other network sites, the Data Coordinating Center, Advisory and Data Safety Monitoring Boards and participation as Chair of various committees. Specifically, Penn investigators are leading several active research protocols including 1) Treatment for Mixed Urinary Incontinence: Mid-urethral Sling vs. Botox A (MUSA, Harvie), 2) accidental bowel leakage severity association with dietary intake (NOTABLe Dietary Screener, Andy), 3) clinical and translational research in defecatory dysfunction (SMM-CAPABLe, Arya), and 4) cost-effectiveness analyses for all 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). Additional unique strengths of the Penn site include 1) strong collaboration with Urology 2) a dedicated clinical research unit in the Department of OB/GYN that provides direct financial, logistical and personnel support beyond the PFDN budget 3) the Penn Clinical and Translational Research Center (CTRC) that provides PFDN investigators low cost access to all state-of-the art technologies. 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 and we are committed to continuing these activities in this Administrative Supplemental bridge year.

Key facts

NIH application ID
10405907
Project number
3UG1HD069010-10S1
Recipient
UNIVERSITY OF PENNSYLVANIA
Principal Investigator
Heidi S Harvie
Activity code
UG1
Funding institute
NIH
Fiscal year
2021
Award amount
$265,150
Award type
3
Project period
2011-08-01 → 2022-06-30