Results from a randomized clinical trial evaluating three common surgeries to repair pelvic organ prolapse indicate that all three are generally comparable and safe three years later. This work provides healthcare providers and patients with clinical evidence to discuss the pros and cons of available surgeries and decide upon the most appropriate treatment for an individual.
Background
The “pelvic floor” describes the group of muscles and tissues that support the pelvic and abdominal organs, such as the bladder, urethra, intestines, rectum, and uterus. Pelvic floor disorders occur when the pelvic floor is weakened or injured, causing organs to move or fall out of place or not function properly. Pelvic organ prolapse occurs when organs sag into and sometimes through the vaginal canal. Treatments include pelvic floor exercises, the use of a supportive device called a pessary, or surgery.
The current clinical trial compares prolapse surgery that uses a patient’s own tissues, called native tissue repair, to two procedures that involve the use of surgical mesh, called sacrocolpopexy and transvaginal mesh.
Results
The study treated 360 participants between 2016-2019 at nine U.S. centers that are part of NICHD’s Pelvic Floor Disorders Network. Participants were randomized to one of the three procedures (123 for native tissue repair, 121 for sacrocolpopexy, and 116 for transvaginal mesh) and were made unaware (i.e., blinded) to their procedure until after surgery. Study personnel who evaluated participants after surgery were also blinded to the procedure performed.
Failure rates—based on the occurrence of symptoms, anatomic measurements performed by a provider, or the need to re-treat the prolapse—at three years after surgery was 28% for sacrocolpopexy, 29% for transvaginal mesh, and 43% for native tissue repair. Statistically, sacrocolpopexy was better than native tissue repair, but transvaginal mesh was similar to native tissue repair.
The study is ongoing, and the team will evaluate five-year outcomes, which will help determine if mesh-based repairs perform better over time, as well as monitor the long-term safety of all procedures.
Significance
This clinical trial is the first and largest to directly compare three common prolapse surgeries. Importantly, all three approaches had high participant-reported treatment satisfaction, improved symptoms and quality of life, improved sexual function, and low rates of adverse events.
Reference
Menefee, SA et al., Apical suspension repair for vaginal vault prolapse in a three-arm randomised superiority and noninferiority trial (ASPIRe). JAMA Surgery DOI: 10.1001/jamasurg.2024.1206 (2024)
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