9/17/2019
PITTSBURGH – According to new data from a nationwide consortium involving researchers at Magee-Womens Research Institute and patients at UPMC Magee-Womens Hospital, women had comparable clinical outcomes three years after pelvic organ prolapse surgery — regardless of whether the surgeon used mesh to suspend the uterus or removed the uterus entirely.
The results of this randomized, blinded clinical trial will publish today in JAMA.
“The findings of this study refute to a great degree the negative associations with vaginal mesh and challenge the traditional dictum that the uterus needs to be removed,” said principal investigator of the Pittsburgh site, Halina Zyczynski, M.D., professor of obstetrics, gynecology & reproductive sciences at the University of Pittsburgh School of Medicine, and medical director of Magee-Womens Specialty Services at UPMC Hamot.
Pelvic organ prolapse occurs when one or more of the pelvic organs drop from their normal position and bulge into the vagina or protrude beyond the opening of the vagina. This condition is common following childbirth and in old age and can cause intimate discomfort, problems urinating, as well as pain. Approximately 13% of women in the United States will undergo a procedure for vaginal prolapse by the age of 80.
To rigorously determine how the clinical outcomes compare between surgeries involving uterine suspension with mesh versus hysterectomy, the Study of Uterine Prolapse Procedures - Randomized Trial (SUPeR) recruited 183 postmenopausal women at nine centers across the nation. Ninety-three women were randomized to mesh surgery and 90 were randomized to hysterectomy. The women were not told which procedure they would receive.
“For three years, 75% of the women did not know if they had a uterus or not. It shows how much they wanted to support scientific research and improve their quality of life,” said Charles Nager, M.D., lead author of the study and chair of obstetrics, gynecology and reproductive sciences at UC San Diego School of Medicine. “Our team is so grateful for their cooperation. They helped us conduct a high-quality study for the future of health care.”
Over the three-year study period, the mesh support surgery had a 12% lower failure rate than hysterectomy, and the researchers will continue to follow these patients for a total of ten years to better understand whether one procedure is truly more effective than the other.
Additionally, a post-surgery survey found 90% of patients in both groups reported “much better” or “very much better” improvement. There also were no differences in patient-reported surgical or pelvic pain and both groups reported improvements in sexual function and lower incidence of painful sex.
While this paper was being prepared, the U.S. Food and Drug Administration (FDA) halted the sale and distribution of mesh kits used for this type of surgery, citing insufficient evidence from the manufacturers to reasonably demonstrate safety and efficacy.
“At this time, we are unable to offer our patients the option of the uterine suspension procedure studied in the SUPeR trial, though we expect that the FDA will consider our study findings when they revisit their decision in the next few years,” Zyczynski said. “There is no better, cleaner, higher-quality data than that which is generated by randomized clinical trials.”
Co-authors include Anthony Visco, M.D., of Duke University Medical Center; Holly Richter, Ph.D., M.D., of University of Alabama; Charles Rardin, M.D., of Alpert Medical School of Brown University; Rebecca Rogers, M.D., of University of New Mexico and Dell Medical School, University of Texas; Heidi Harvie, M.D., M.S.C.E., M.B.A., of University of Pennsylvania; Marie Fidela Paraiso, M.D., of Cleveland Clinic; Donna Mazloomdoost, M.D., of Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health; and Scott Grey, Ph.D., Amaanti Sridhar, M.S., and Dennis Wallace, Ph.D., of Research Triangle International.
Funding for this research came, in part, from the National Institutes of Health and the NICHD Pelvic Floor Disorders Network (grant numbers U10 HD054214, U10 HD041267, U10 HD041261, U10 HD069013, U10 HD069025, U10 HD069010, U10 HD069006, U10 HD054215, U01 HD069031).