DHMC researchers approved for $6.6 million for study on nonsurgical treatment options for urinary incontinence | News & Stories

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DHMC researchers approved for $6.6 million for study on nonsurgical treatment options for urinary incontinence | News & Stories


A research team at Dartmouth Hitchcock Medical Center (DHMC), the flagship academic medical center of Dartmouth Health, has been approved for a $6.6 million funding award by the Patient-Centered Outcomes Research Institute (PCORI) to study treatment of urinary urgency incontinence, a common, bothersome condition of losing control of urine, associated with a feeling of urgency among older women. The study, “Reduced-dose onabotulinumtoxinA for urgency Incontinence among Elder Females (RELIEF): A mixed methods randomized controlled trial,” is headed by Anne C. Cooper, MD, MA, a urogynecologist at DHMC, and E. Ann Gormley, MD, a urologist at DHMC.

Urgency incontinence is associated with shame, discomfort, falls, expense, nursing home admission and even increased risk of death. There are several effective treatments, but most of them are not well suited to for use among older women. However, treatment with onabotulinumtoxinA, better known by its brand name Botox©, shows promise as a treatment for older women.

“Overactive bladder is very common in older women and is historically treated in a step-wise fashion: behavioral therapy, pharmacologic treatment and then procedural treatments,” Gormley said. “Many older women can’t or won’t do behavioral therapy or take the drugs. Botox injection into the bladder muscle is a well-tolerated office procedure but has been used cautiously in older women due to a theoretical risk of difficulties with bladder emptying post procedure. The RELIEF study, which will randomize patients to the standard dose and a lower dose, will allow us to evaluate the outcomes of the two doses. The study will also allow us to better characterize multiple aspects of the patients’ symptoms and the impact that incontinence and its treatment has on their lives.”

“Many older women with urgency incontinence suffer in silence, partially due to having fewer treatment options and less targeted research,” Cooper said. “We are thrilled to partner with PCORI and a robust group of investigators across the country to focus on effectiveness and acceptability of bladder Botox treatment for women ages 70 and older. We already know that this treatment works well for younger women, and anticipate that it can be tailored to the needs of older women as well.”

Cooper and Gormley’s study was selected for funding through a PCORI funding announcement specifically focused on comparing the effectiveness of nonsurgical treatment options for urinary incontinence for non-pregnant women.

“This study was selected for PCORI funding for its potential to fill an important gap in our understanding of how best to treat a health condition common among women,” said PCORI Executive Director Nakela L. Cook, MD, MPH. “Although the efficacy of many nonsurgical interventions for urinary incontinence are soundly substantiated, evidence gaps remain, particularly related to direct comparisons of the options. We look forward to following the study’s progress and working with DHMC and the other study sites to share the results.” 

Cooper and Gormley’s award has been approved pending completion of a business and programmatic review by PCORI staff and issuance of a formal award contract.

PCORI is an independent, nonprofit organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers, and clinicians with the evidence-based information needed to make better-informed healthcare decisions. For more information about PCORI’s funding, visit www.pcori.org.  



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