# Pelvic Floor Disorders Network

> **NIH NIH UG1** · UNIVERSITY OF PENNSYLVANIA · 2024 · $276,250

## Abstract

Project Summary/Abstract
In this application, we present the unique strengths of the University of Pennsylvania clinical site that have
allowed us to make significant academic, clinical, and administrative contributions to the Pelvic Floor Disorders
Network (PFDN) in our two cycles of participation. Our core team of five academic investigators is part of a
team of twenty pelvic floor specialists 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) surgical trial of mixed urinary
incontinence (Harvie) 2) gut microbiome and metabolome in fecal incontinence (Arya) 3) behavioral
interventions for urinary and fecal incontinence (Newman) 4) cost-effectiveness analyses for all seven trials
(Harvie) and 5) use of Penn Clinical and Translational Science Award (CTSA) to validate a fecal transplant
protocol for potential application in the PFDN (Andy). 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 consistently rank in top
half of recruiting sites for all seven randomized trials conducted in our two cycles of participation and 32% of
our enrolled subjects are minorities (highest recruitment of Black/African-American subjects from all sites).
Additional unique strengths of the Penn site include 1) strong collaboration with Urology co-investigator (Smith)
that placed us in top three recruiting sites for two trials 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 CTSA funded Institute for Translational Medicine and Therapeutics (ITMAT) that provides PFDN
investigators low cost access to all state-of-the art technologies specified in the RFA including fecal transplant
4) a Health Care Innovation Center that is supporting a patient-centered texting platform for urinary
incontinence in our concept proposal and 5) Administratively, Penn holds the IND for botulinum toxin A (mixed
urinary incontinence) and fecal transplant (fecal incontinence). Ultimately, the team of investigators, available
population, our cost-effective and efficient approach to recruitment and outstanding university resources make
the University of Pennsylvania an ideal site to advance the productivity of the Pelvic Floor Disorders Network.

## Key facts

- **NIH application ID:** 10873962
- **Project number:** 5UG1HD069010-13
- **Recipient organization:** UNIVERSITY OF PENNSYLVANIA
- **Principal Investigator:** Heidi S Harvie
- **Activity code:** UG1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $276,250
- **Award type:** 5
- **Project period:** 2011-08-01 → 2027-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10873962

## Citation

> US National Institutes of Health, RePORTER application 10873962, Pelvic Floor Disorders Network (5UG1HD069010-13). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10873962. Licensed CC0.

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