The Patient-Centered Outcomes Research Institute (PCORI) Board of Governors recently awarded more than $2.7 million in contracted funding to Katina Robison, MD, a gynecologic oncologist with the Program in Women's Oncology at Women & Infants Hospital of Rhode Island, a Care New England hospital, for the study "Cancer of the Uterus and Treatment of Stress Incontinence (CUTI)."
The study, which will also include a recruitment site at the University of Alabama, is focused on improving the quality of life for women who undergo surgery for endometrial cancer by screening for and offering treatment of existing stress urinary incontinence (SUI) at the same time as their cancer surgery. This step should also decrease costs for patients and the health care system by combining two surgeries into one.
"We believe that concurrent treatment of endometrial cancer and stress urinary incontinence may improve quality of life, as well as emotional and physical health for women," Robison explains, who adds that the research team also includes Drs. Kyle Wohlrab, Vivian Sung and Paul DiSilvestro from Women & Infants, and Drs. Melissa Clark and Chanelle Howe from Brown University.
SUI often exists among women with endometrial cancer, which is the fourth most common cancer among American women. While SUI is very common, about 40 percent of women with it have not discussed their symptoms with a health care provider, and only 25 percent have sought care. This, Robinson says, is unfortunate because SUI can severely decrease a woman's quality of life, sexual function and is often a considerable financial burden.
"It's something of a domino effect. A woman with stress urinary incontinence experiences leakage when she laughs, coughs or sneezes. Because of her embarrassment over this, it can easily affect her sexual activity, which then can increase any chance of depression and reduce her overall quality of life," she notes.
In addition to impacting a woman's sexual activity, research has shown that endometrial cancer survivors with increased levels of physical activity report feeling better physically and emotionally. However, if the survivor experiences SUI, a fear of leakage can limit how much she exercises, Robison says.
She and the research team believe that asking basic questions about incontinence before any cancer surgery and then offering treatment of SUI at the time of cancer surgery can help.
"We want to see if treating SUI at the same time as we remove the endometrial cancer will improve a woman's quality of life in survivorship," Robison says. "We know that quality of life improves for women after treatment for pelvic floor symptoms causing SUI. We now want to promote screening of SUI among women with endometrial cancer and see if that improves their quality of life after surgery."
The study will measure the quality of life reported by women who have both surgeries at the same time, versus those who do not.
Robison was one of 13.18 percent of applicants chosen for the prestigious research funding. Her proposal was one of 46 that PCORI approved for funding to advance the field of comparative clinical effectiveness research and provide patients, health care providers, and other clinical decision makers with information that will help them make better informed choices. The award has been approved pending completion of a business and programmatic review by PCORI staff and issuance of a formal award contract to Women & Infants.
"The project was selected for PCORI funding not only for its scientific merit and commitment to engaging patients and other stakeholders, but also for its potential to fill and important gap in our health knowledge and give people information to help them weigh the effectiveness of their care options," says PCORI Executive Director Joe Selby, MD, MPH. "We look forward to following the study's progress and working with Women & Infants to share the results."
Robison's study and the other projects approved for PCORI funding were selected through a highly competitive review process in which patients, clinicians and other stakeholders joined clinical scientists to evaluate the proposals. Applications were assessed for scientific merit, how well they will engage patients and other stakeholders, and their methodological rigor among other criteria.
The study will begin enrolling participants in 2016 and will be promoted on http://www.
About Women & Infants HospitalWomen & Infants Hospital of Rhode Island, a Care New England hospital, is one of the nation's leading specialty hospitals for women and newborns. A major teaching affiliate of The Warren Alpert Medical School of Brown University for obstetrics, gynecology and newborn pediatrics, as well as a number of specialized programs in women's medicine, Women & Infants is the 11th largest stand-alone obstetrical service in the country with approximately 8,400 deliveries per year. A U.S.News & World Report 2014-15 Best Children's Hospital in Neonatology and a 2014 Leapfrog Top Hospital, in 2009 Women & Infants opened what was at the time the country's largest, single-family room neonatal intensive care unit.
Women & Infants and Brown offer fellowship programs in gynecologic oncology, maternal-fetal medicine, urogynecology and reconstructive pelvic surgery, neonatal-perinatal medicine, pediatric and perinatal pathology, gynecologic pathology and cytopathology, and reproductive endocrinology and infertility. It is home to the nation's only mother-baby perinatal psychiatric partial hospital, as well as the nation's only fellowship program in obstetric medicine.
Women & Infants has been designated as a Breast Center of Excellence by the American College of Radiography; a Center of Excellence in Minimally Invasive Gynecology; a Center for In Vitro Maturation Excellence by SAGE In Vitro Fertilization; a Center of Biomedical Research Excellence by the National Institutes of Health (NIH); and a Neonatal Resource Services Center of Excellence. It is one of the largest and most prestigious research facilities in high risk and normal obstetrics, gynecology and newborn pediatrics in the nation, and is a member of the National Cancer Institute's Gynecologic Oncology Group and the Pelvic Floor Disorders Network.
About PCORIPCORI is an independent, non-profit organization authorized by Congress in 2010 to fund comparative clinical effectiveness research that will provide patients, their caregivers, and clinicians with the evidence-based information needed to make better informed health and health care decisions. PCORI is committed to seeking input from a broad range of stakeholders to guide its work.
PCORI has approved $854 million to support 399 research studies and initiatives since it began funding research in 2012. For more information about PCORI funding, go to pcori.org.