Challenges of conducting multi-center, multi-disciplinary urinary incontinence clinical trials: experience of the urinary incontinence treatment network.

AIMS: 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.

The contribution of common medical conditions and drug exposures to erectile dysfunction in adult males.

PURPOSE: We examined the association of prevalent erectile dysfunction and coexisting medical conditions in United States men taking into account age and drug exposures. MATERIALS AND METHODS: Men older than 40 years who participated in the 2001 to 2002 National Health and Nutrition Examination Survey were asked to report on erectile function. Men who were never able to achieve an erection sufficient for intercourse were defined as having complete erectile dysfunction. Adjusted odds ratios for complete erectile dysfunction prevalence in men with a coexisting condition compared to those without the condition were calculated. Age, race/ethnicity, urinary symptoms, cardiovascular disease, diabetes, hypertension with and without selected antihypertensive therapy (mainly beta blockers and thiazide diuretics), selected antidepressant therapy (mainly, tricyclics and selective serotonin reuptake inhibitors), smoking and alcohol were included in all statistical models. RESULTS: Of United States men 8% (95% CI 6.0-10.2) reported complete erectile dysfunction. In multivariate analyses, obstructive urinary symptoms (OR 2.0, 95% CI 1.2-3.4), diabetes (OR 2.6, 95% CI 1.3-5.2), hypertension with selected antihypertensive therapy (OR 3.0, 95% CI 1.6-5.9), and selected antidepressant therapy (OR 5.2, 95% CI 1.7-15.9), increased the odds of complete erectile dysfunction prevalence, whereas presence of cardiovascular disease, urinary incontinence and hypertension without selected antihypertensive therapy did not. CONCLUSIONS: Obstructive urinary symptoms, diabetes, hypertension treated with selected medications, and selected antidepressant drug use are independently associated with increased erectile dysfunction risk in United States men. Physicians should carefully consider the potential impact of these medications and comorbid conditions when discussing sexual function with their male patients.

Proceedings of the National Institute of Diabetes and Digestive and Kidney Diseases International Symposium on Epidemiologic Issues in Urinary Incontinence in Women.

The Epidemiologic Issues in Urinary Incontinence: Current Databases and Future Collaborations Symposium included an international group of 29 investigators from 10 countries. The purpose of the symposium was to discuss the current understanding and knowledge gaps of prevalence, incidence, associated risk factors, and treatment outcomes for incontinence in women. During the symposium, investigators identified existing large databases and ongoing studies that provide substantive information on specific incontinence research questions. The investigators were able to form an international collaborative research working group and identify potential collaborative projects to further research on the epidemiology of urinary incontinence and bladder dysfunction.