Visco, Colleagues Publish SUPER Trial 10-year Outcome Data

Congratulations to urogynecologist Anthony Visco, MD, and colleagues on the publication of Sacrospinous Hysteropexy with Mesh vs Vaginal Hysterectomy for Treatment of Uterovaginal Prolapse — 10-Year Results of a Randomized Clinical Trial in the Journal of the American Medical Association Network (JAMA Surgery, June 24). 

“This study offers valuable insights into the long-term outcomes of uterine-sparing prolapse surgery. To our knowledge, this was the first randomized clinical trial of prolapse surgery with 10-year follow-up, making it a significant contribution to the field of urogynecology and reconstructive pelvic surgery,” said Dr. Visco.

In 2021, researchers reported the five-year results of the Pelvic Floor Disorders Network (PFDN) Study of Uterine Prolapse Procedures — Randomized Trial (SUPER) comparing transvaginal mesh augmented hysteropexy and traditional vaginal hysterectomy with suture apical suspension. Patients’ expectations of durable surgical benefit provided compelling need for long-term anatomic, subjective and safety outcomes to inform pre-operative counseling, according to the study. 

The recent publication reports 10-year outcome data for the randomized trial that Duke was a part of from conception, recruitment, analysis and long-term follow-up, notes Dr. Visco. 

The study’s goals were to compare the efficacy and adverse events of the two procedures over 10 years — outcomes for which are rarely reported. Study results show that vaginal mesh hysteropexy continued to have a lower composite failure rate through 10 years than vaginal hysterectomy, and that both procedures are reasonable options for patients. If available, hysteropexy with mesh augmentation for patients who desire uterine preservation is a low-risk and effective option.

Duke University is one of seven clinical centers and one data coordinating center that comprise the PFDN, a research network created to study pelvic floor disorders and provide evidence-based answers for women and health care providers about treatment options for these conditions. The PFDN started in 2001 and is funded by the National Institutes of Health, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).

NICHD established the PFDN in 2001 to encourage collaborative research on pelvic floor disorders (PFDs) and to improve patient care. PFDs include pelvic organ prolapse, urinary and fecal incontinence and other sensory and emptying abnormalities of the lower urinary tract and the gastrointestinal tract. As many as one in five women report at least one pelvic floor disorder in her life.

The study was supported by NICHD–sponsored PFDN grants.

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