# Duke University Medical Center (DUMC) Pelvic Floor Disorders Network (PFDN) Clinical Site

> **NIH NIH UG1** · DUKE UNIVERSITY · 2020 · $241,707

## Abstract

Duke University Medical Center (DUMC) is dedicated to continued active participation in the NICHD Pelvic
Floor Disorders Network (PFDN) by using our growing patient volume, sophisticated research structure,
extensive quality improvement systems, and successful track record of high recruitment in clinical and
translational research. DUMC has a rich tradition of excellence in clinical care, training and research in pelvic
floor disorders offering detailed evaluation and treatment in a high-volume, multidisciplinary setting and serving
as a tertiary southeastern US referral center. Our seven fellowship-trained and board certified urogynecology
(5) and urology (2) investigators have expertise in both surgical and non-surgical management of urinary (UI)
and fecal incontinence, and pelvic organ prolapse (POP) including vaginal native tissue repair, vaginal mesh
placement and robotic sacrocolpopexy. Last year, our Urogynecology Division cared for 2087 new patients and
performed more than 252 surgical procedures for UI and 465 for POP. Our diverse patient population is 82%
Caucasian, 14% African American, 1% Asian and 2% Hispanic, from suburban and rural communities with
stable care and follow-up patterns. DUMC is the hub of a multidisciplinary team of outstanding collaborators
from urogynecology, urology, colorectal surgery, gastroenterology, radiology, epidemiology and physical
therapy. DUMC provides comprehensive diagnostic evaluation including multi-channel urodynamic testing,
video urodynamics, cystoscopy, defecography, pelvic MRI, and endoanal ultrasound. We have expertise in
study design, recruitment, retention, adverse event reporting, and data and cost-effectiveness analysis. Our
substantial basic science and translational capabilities, including a robust divisional biorepository, are
supported by experts in bladder physiology and epigenetics. Committed to data quality, we built robust
systems for the prevention, early detection, and correction of errors, and have shared these with the PFDN to
enhance data quality. We are harnessing our sophisticated electronic health record to integrate source
documentation with research data, minimize paper case report forms, maximize electronic data collection, and
include quality checks at multiple levels to improve both efficiency and data integrity. DUMC has consistently
been a high recruitment site across a wide range of research studies. During the current cycle, the PFDN
completed two DUMC-initiated RCTs: Anticholinergic vs Botox (ABC, Dr. Visco, PI) and Interstim vs Botox
(ROSETTA, Dr. Amundsen, PI). The DUMC clinical site actively participated in all other trials with outstanding
recruitment in SUPER (native tissue vs vaginal mesh for uterine prolapse). Our proven ability to enroll for
SUPER strongly suggests equally high performance in the upcoming ASPIRE trial (3-arm RCT: vaginal native
tissue vs vaginal mesh vs sacrocolpopexy). As we have proven our ability to successfully complete large-scale,
mul...

## Key facts

- **NIH application ID:** 9987340
- **Project number:** 5UG1HD041267-21
- **Recipient organization:** DUKE UNIVERSITY
- **Principal Investigator:** ANTHONY G VISCO
- **Activity code:** UG1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $241,707
- **Award type:** 5
- **Project period:** 2001-09-01 → 2022-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9987340

## Citation

> US National Institutes of Health, RePORTER application 9987340, Duke University Medical Center (DUMC) Pelvic Floor Disorders Network (PFDN) Clinical Site (5UG1HD041267-21). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/9987340. Licensed CC0.

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