# Pelvic Floor Disorders Network Clinical Sites (UG1)

> **NIH NIH UG1** · UNIVERSITY OF PENNSYLVANIA · 2020 · $262,702

## 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 organization:** UNIVERSITY OF PENNSYLVANIA
- **Principal Investigator:** Heidi S Harvie
- **Activity code:** UG1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $262,702
- **Award type:** 5
- **Project period:** 2011-08-01 → 2022-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9979654

## Citation

> US National Institutes of Health, RePORTER application 9979654, Pelvic Floor Disorders Network Clinical Sites (UG1) (5UG1HD069010-10). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/9979654. Licensed CC0.

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