UPMC Magee-Led Trial Provides Reassuring Results to Women with Prolapse
By: Allison Hydzik
The National Institutes of Health (NIH) recently featured a study led by UPMC Magee-Womens Hospital physician-scientists that provides reassuring results to women experiencing pelvic organ prolapse, a condition in which pelvic floor muscles and ligaments become too weak to support the uterus.
The Study of Uterine Prolapse Procedures – Randomized Trial (SUPeR) randomly assigned 183 postmenopausal women with uterovaginal prolapse to have either a type of mesh placed through a hysteropexy operation to support the pelvic organs or to have the more traditional treatment involving a hysterectomy coupled with a procedure to restore ligament support of the remaining organs. The trial previously found that women who received the mesh treatment had more successful outcomes.
To learn more about outcomes among the 91 women who received the mesh treatment, researchers followed them for five years and reported in the International Urogynecology Journal that mesh treatment had failed in about 1 in 3 women. While most of those women did not have severe enough symptoms to prompt them to seek a reoperation after the mesh failed, the seven who did had earlier and more severe failure and the majority of them chose a hysterectomy.
Dr. G. Sarah Napoe (left), Dr. Halina Zyczynski (right)
Uterovaginal prolapse affects women of all ages. Treatment choice is not based only on the scientific evidence currently available but is also individualized to each woman’s preference and lifestyle.
Interest in uterine-sparing procedures has been gaining traction in recent years. Unfortunately, due to insufficient data on long-term outcomes and safety concerns, the mesh products used for transvaginal hysteropexy were removed from the U.S. market by the U.S. Food and Drug Administration (FDA) pending further research.
Beginning in 2013, urogynecologists at UPMC and their patients have participated in a multicenter NIH-funded comparative effectiveness trial of hysterectomy and mesh hysteropexy for uterovaginal prolapse. The five-year follow-up of the SUPeR Trial found the mesh hysteropexy group had 18% better overall success, defined as a composite of retreatment, recurrence of prolapse and prolapse symptoms.
Our current analysis addresses many gaps in knowledge identified by the FDA about longer-term outcomes of mesh-augmented hysteropexy. For women who experienced a recurrence of pelvic organ prolapse after mesh hysteropexy, fewer than 8% pursued additional surgery. All of them experienced symptom recurrence early (most within 12 months after their initial surgery). Reassuringly, they remained symptom-free over the three years after their second procedure. Understanding what causes recurrence and how women chose to manage their symptoms can help physicians offer personalized care and counseling.
Did the findings surprise you?
Every surgery is associated with risks of complications, including recurrence of prolapse or new unintended consequences. It was surprising that so few women underwent repeat surgery after mesh hysteropexy. It was also reassuring that none of the women who chose to have reoperation did so because of a mesh-specific complication. This provides overall reassurance about the safety of mesh for reconstructive pelvic surgery when performed by trained urogynecologists.
What do you want your patients to know about these findings and does it change how you counsel patients with pelvic organ prolapse?
Only a small number (fewer than 8%) of women sought reoperation after mesh hysteropexy. Those who did were safely and successfully treated with a second surgical procedure. There is no single best operation for women with prolapse. Lifestyle, sexual function and general health all contribute to an individualized surgical plan. Importantly, we learned from SUPeR Trial participants that there were no group differences in pelvic floor symptoms, quality of life and pelvic pain, which further supports that both vaginal hysterectomy and transvaginal hysteropexy are good treatment options.
Should vaginal mesh products become available again on the market, this study will empower surgeons to counsel women about mesh hysteropexy success rates and the low likelihood of needing reoperation.
Is there anything particularly important that you want to add?
While the FDA suspension of vaginal mesh kit sales is ongoing, the FDA does not prevent surgeons from using mesh for prolapse repair. To learn about treatment options, women with pelvic organ prolapse and other pelvic floor disorders can access the expertise of physicians from the Division of Urogynecology and Pelvic Reconstructive Surgery at one of the 14 community offices within UPMC. Our program is committed to offering evidence-based care to our patients.
