Challenges of conducting multi-center, multi-disciplinary urinary incontinence clinical trials: experience of the urinary incontinence treatment network.
OBJECTIVE
The Urinary Incontinence Treatment Network (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.
Steers
William
W
Department of Urology, University of Virginia, Charlottesville, VA, USA. wds6t@virginia.edu
Richter
Holly
H
Nyberg
Leroy
L
Kusek
John
J
Kraus
Stephen
S
Dandreo
Kimberly
K
Chai
Toby
T
Brubaker
Linda
L
D002986:Clinical Trials as Topic; D005260:Female; D019981:Health Care Sector; D006801:Humans; D015337:Multicenter Studies as Topic; D017773:Pelvic Floor / Q000473:pathology; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D014549:Urinary Incontinence / Q000145:classification / Q000150:complications / Q000628:therapy*; D013520:Urologic Surgical Procedures / Q000193:education / Q000592:standards; D014572:Urology / Q000193:education / Q000592:standards