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

NIH RePORTER · NIH · UG1 · $245,952 · view on reporter.nih.gov ↗

Abstract

Project Summary/Abstract Project Summary: Pelvic floor disorders research at Duke University Medical Center (DUMC) is sophisticated and comprehensive with committed investigators addressing issues of great importance to women. DUMC has a tradition of excellence in clinical care, training and research in pelvic floor disorders and includes one of the nation's first accredited fellowship programs in the field. DUMC offers detailed evaluation and treatment in a high-volume, multidisciplinary setting that serves as a tertiary referral center for women across the southeast US. Each of the seven Duke urogynecology investigators is fellowship-trained with expertise in both surgical and non-surgical management of urinary incontinence (Ul), pelvic organ prolapse (POP), fecal incontinence, and defecatory dysfunction. Last year, our Division cared for more than 2732 new patients and performed more than 513 surgical procedures for Ul and POP. Our patient population is 80% Caucasian, 15% African American, 2% Asian and 2% Hispanic, from both suburban and rural communities with stable care and follow-up patterns. DUMC Is the hub of a multidisciplinary team of outstanding collaborative investigators in urogynecology, urology, colorectal surgery, gastroenterology, maternal-fetal medicine, physical therapy and epidemiology. DUMC offers a wide range of diagnostic resources: multi-channel urodynamic testing, video urodynamics, cystoscopy, defecography, pelvic MRI, endoanal ultrasound, and needle electromyography. During the current PFDN cycle, DUMC completed two DUMC-initiated RCTs: Anticholinergic vs Botox RCT (ABC, Dr. Visco) and Interstim vs Botox RCT (ROSETTA, Dr. Amundsen), as well as a RCT evaluating transvaginal mesh hysteropexy (SUPER) and a 3-arm RCT comparing vaginal native tissue, vaginal mesh repair and sacrocolpopexy (ASPIRE) for prolapse repair. We are actively enrolling in a RCT comparing midurethral sling to Botox as initial treatment for patients with bothersome mixed urinary incontinence. DUMC has consistently been a high recruitment site across a wide range of non-surgical and surgical studies with unparalleled retention rates. We have proven our ability to support and successfully complete large-scale, multi-centered investigations through our robust clinical practice and exceptional research infrastructure. This one-year supplement will allow DUMC, to complete enrollment in the MUSA randomized trial, complete follow-up of the SUPER and ASPIRE RCTs and complete data analysis, reporting and dissemination of our important research findings.

Key facts

NIH application ID
10405723
Project number
3UG1HD041267-21S1
Recipient
DUKE UNIVERSITY
Principal Investigator
ANTHONY G VISCO
Activity code
UG1
Funding institute
NIH
Fiscal year
2021
Award amount
$245,952
Award type
3
Project period
2001-09-01 → 2022-06-30