RTI International will continue supporting research efforts to improve clinical care for women with pelvic floor disorders as part of the Pelvic Floor Disorders Network.
The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which funds the network, awarded RTI a five-year cooperative agreement grant, worth approximately $16 million, to continue serving as the data coordinating center for the network. The award extends the work that RTI has conducted since 2011, providing statistical leadership, data management and logistical support for the network.
The Pelvic Floor Disorders Network was established in 2001 to conduct multi-center clinical trials and other collaborative research on pelvic floor disorders such as urge and stress urinary incontinence, fecal incontinence, and pelvic organ prolapse. The network includes a cooperative group of seven U.S. hospitals that conduct clinical research to answer questions regarding the safety and efficacy of treatment strategies for these disorders.
As the data coordinating center, RTI investigators have led the statistical design for all ongoing and planned network trials from inception through implementation. RTI also assists in the development of study materials, programs data collection systems, provides data management, and conducts quality control and quality assurance activities to ensure high quality study data.
"It is estimated that a quarter of the women in the U.S. experience one or more pelvic floor disorders during their lifetime, and the studies conducted by the Pelvic Floor Disorders Network provide crucial information for women and their physicians to inform decisions about treatment options," said Marie Gantz, Ph.D., a biostatistician at RTI and the principal investigator for the network data coordinating center.
Studies analyzed by RTI for the network have found:
Sacrospinous ligament fixation and uterosacral ligament suspension for treating apical pelvic organ prolapse provide comparable anatomic, functional, and safety outcomes, and behavioral therapy with pelvic floor muscle training did not improve pelvic organ prolapse or urinary incontinence symptoms
Anticholinergic medications and onabotulinumtoxinA (Botox A®) achieved similar reductions in the frequency of urge urinary incontinence episodes and improvement of critical quality of life measures in women with moderate to severe urge urinary incontinence
Over a six month assessment period, a single injection of 200 units of Botox A® provided a greater reduction in urgency urinary incontinence episodes than sacral neuromodulation (InterStim®) therapy among women with refractory urge urinary incontinence, and use of Botox A® resulted in a higher risk for urinary tract infections compared to InterStim®
A recently completed clinical trial currently being analyzed evaluated loperamide compared to oral placebo, and anal sphincter exercise training with biofeedback compared to usual care, to treat fecal incontinence. Ongoing studies in the network include a randomized clinical trial of midurethral sling surgery combined with behavioral pelvic floor therapy compared to surgery alone to treat women with both urge and stress urinary incontinence, and two randomized trials assessing the safety and efficacy of various surgical methods for repairing pelvic organ prolapse.
"These studies address critical knowledge gaps in the clinical care of women with pelvic floor disorders," said John Heinrich, vice president of RTI's Biostatistics and Epidemiology Division. "With this award, RTI has the opportunity to continue to work with clinical experts in the network to design innovative yet practical trials to provide evidence regarding the safest and most efficacious treatments for conditions that greatly impact women's quality of life."