Premium
Challenges of conducting multi‐center, multi‐disciplinary urinary incontinence clinical trials: Experience of the urinary incontinence Treatment Network
Author(s) -
Steers William,
Richter Holly,
Nyberg Leroy,
Kusek John,
Kraus Stephen,
Dandreo Kimberly,
Chai Toby,
Brubaker Linda
Publication year - 2009
Publication title -
neurourology and urodynamics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.918
H-Index - 90
eISSN - 1520-6777
pISSN - 0733-2467
DOI - 10.1002/nau.20653
Subject(s) - medicine , urinary incontinence , clinical trial , randomized controlled trial , physical therapy , stress incontinence , urinary system , urology
Aims The U rinary I ncontinence T reatment N etwork (UITN) was established in 2000 as a multi‐disciplinary, multi‐institutional network by the National Institute for Diabetes, Digestive, and Kidney Diseases (NIDDK) to investigate treatments for urinary incontinence in women. Methods Over 8 years this network composed of urologists, urogynecologists, geriatricians, behavioral psychologists, physical therapists, nurses, epidemiologists, social scientists and statisticians from nine academic sites and a Data Coordinating Center has been effective in designing and completing prospective randomized clinical trials for treatments of urinary incontinence in women. Results Two major clinical trials have been completed and a third has completed recruitment. The focus of the completed trials was a comparison of surgical methods to treat stress urinary incontinence whereas the third examined the potential benefit of combined behavioral intervention and antimuscarinic drug therapy to eliminate the need for long‐term use of drug therapy alone to manage urge urinary incontinence. The scientific output of the network measured by abstracts, original papers and presentations demonstrates the productivity of the network. Conclusions Many unique challenges are posed by a multi‐disciplinary team located at sites across the United States undertaking several clinical trials. This review presents some of the logistics, barriers, tactics, and strategies used to create this successful clinical trials network focused on urinary incontinence. Neurourol. Urodynam. 28:170–176, 2009. © 2008 Wiley‐Liss, Inc.