Urinary Incontinence Treatment Network (UITN) Continence Treatment Centers

• Ancillary Study Policies
• Background: Urinary Incontinence
• UITN Description
• Recruiting patients: see www.clinicaltrials.gov (Key Word: UITN)

Background

Urinary incontinence is a complex condition that affects females and males of all ages; however, prevalence of the condition is significantly higher in women than in men. Factors that influence a patient's decision to seek care are not well-described and the criteria by which a clinician selects therapy are not uniform. Diagnostic criteria that delineate the various categories and subcategories of urinary incontinence are neither well defined nor used by many physicians. In addition, factors that may predict a successful outcome of treatment have not been examined systematically. Numerous options are available for treating urinary incontinence, including surgery, pharmaceuticals, behavioral modification, and prostheses. These therapies are frequently combined. Much of the literature pertaining to surgical intervention suggests that continence markedly improves during the immediate and short-term post-operative period.

However, very few well-designed, clinical trials have been conducted to document the outcomes of invasive interventions over a longer period of follow-up. The clinical trials reported to date suffer from a number of methodological shortcomings, including short follow-up period, inadequate sample size (and thus, low statistical power), uncertain diagnostic criteria for patient selection, inadequate measurement of quality of life, uncertainty about the relevance of reported clinical and patient-related outcomes, absence of documentation of post-operative complications, and high rates of patients lost to follow-up (thus introducing possible bias into results). Despite the frequent use of surgery for urinary incontinence, consensus is lacking on which procedure(s) offers the optimal long-term improvement and greatest patient satisfaction. No rigorously conducted long-term studies using accepted outcomes measures that evaluate the most commonly performed surgical procedures have been performed to date. In addition, although the use of pharmacological therapy and behavioral interventions before and after surgery for urinary incontinence is common, these adjunctive interventions have not been evaluated in a standardized fashion. The UITN seeks to address these shortcomings in the literature in order to improve the care of all patients with urinary incontinence.

Urinary Incontinence Treatment Network

The Urinary Incontinence Treatment Network (UITN) was established in 1999 as a result of a 1998 workshop on urinary incontinence sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) in collaboration with the National Institute of Child Health and Human Development (NICH). Workshop participants focused on current knowledge of urinary incontinence, including epidemiology, clinical treatment strategies, prognosis, and outcomes. They concluded that urinary incontinence is a significant health care burden for the entire U.S. population and a major burden for the adult female population. Participants also concluded that there were few well-designed studies upon which physicians could base their decisions on treating patients with urinary incontinence.

The purpose of the network is to establish a group of collaborating investigators who will conduct long-term studies, including clinical trials, of the most commonly used surgical, pharmacological, and behavioral approaches to the management of urinary incontinence in women diagnosed with stress and mixed incontinence.

The UITN clinical centers are located at the following institutions: University of California, San Diego; University of Pittsburgh; University of Texas, Southwestern; University of Maryland; University of Utah; University of Texas, San Antonio; William Beaumont Hospital, Royal Oak, Michigan and Oakwood Hospital, Dearborn, Michigan ; Loyola University, Maywood, Illinois; and the University of Alabama at Birmingham. The biostatistical center is located at the New England Research Institute in Watertown, Massachusetts.

The UITN has completed recruitment for its first clinical trial, Stress Incontinence Surgical Treatment Efficacy Results (SISTEr), a randomized controlled clinical trial comparing two surgical procedures commonly used to treat women with stress urinary incontinence; the procedures are the autologous rectus fascial sling procedure and the Burch urethropexy.

The UITN is now recruiting for a second clinical trial, the Behavior Enhances Drug Reduction of Incontinence (BE-DRI). This trial will compare effects of two interventions, drug therapy alone and combination drug therapy and behavioral treatment, on the frequency of urinary incontinence and success in withdrawing patients from drug therapy. Women with pure or predominant urge incontinence interested in participating in this trial should go to www.clinicaltrials.gov and enter the key word urinary incontinence.

Program Officer: Leroy Nyberg, M.D., Ph.D., 301-594-7717