Global medical technology company Boston Scientific provided a research and education grant of more than $1 million to the Pelvic Floor Disorders Network (PFDN) for the SUPeR clinical trial. The SUPeR study will evaluate treatment outcomes of two different surgical options for women with uterine prolapse, a form of pelvic organ prolapse. PFDN is funded by the NIH.
An estimated 28 million women in the U.S. live with at least one pelvic floor disorder. The two most common conditions are urinary incontinence, which is the inability to hold urine, and pelvic organ prolapse, a medical condition that occurs when the tissue and muscles of the pelvic floor no longer support the pelvic organs, resulting in "sagging" or dropping of organs such as the bladder, uterus or rectum.
The SUPeR study anticipated enrollment of 180 women who are considering surgery for their uterine prolapse and do not plan to have additional children. They will be randomly assigned to either a uterine-preserving transvaginal mesh repair using the Boston Scientific Uphold LITE Vaginal Support System or traditional surgery that will include a vaginal hysterectomy.
"The data for this study will give physicians reliable evidence from a randomized trial on surgical treatment for women with uterine prolapse," said Charles Nager, M.D., director of the Urogynecology and Reconstructive Pelvic Surgery Division at UC San Diego School of Medicine. "That evidence will help inform clinicians as they make decisions in an effort to provide the best patient care possible."
After surgery, patients will be evaluated every six months for up to five years to determine surgical success, patient safety, cost-effectiveness, quality of life and body image. Data are expected to be available in 2017 and the final results to follow approximately one year later.