Kahn BS, et al. Obstet Gynecol. 2022;doi:10.1097/AOG.0000000000004794.
Kahn BS, et al. Obstet Gynecol. 2022;doi:10.1097/AOG.0000000000004794.
Transvaginal mesh was noninferior to native tissue repair in women with pelvic organ prolapse at 36 months, according to a prospective, nonrandomized study published in Obstetrics & Gynecology.
“This study was conducted in response to an FDA order to investigate concerns over the use and safety of polypropylene mesh placed vaginally for treatment of pelvic organ prolapse (POP) in women,” Bruce S. Kahn, MD, FACOG, an OB/GYN at Scripps Clinic in San Diego, told Healio.
According to the researchers, these concerns originally arose in 2011. In 2019, the FDA ordered two manufacturers — including the funder of the present study, Boston Scientific — to stop selling mesh for the transvaginal repair of POP.
“While this study showed that vaginal mesh was not inferior to native tissue for the treatment of POP, it did not demonstrate superiority of mesh,” Kahn said. “However, the primary study composite outcome was determined by the FDA. The investigators believe the primary anatomic outcome measure is flawed and added a secondary measure. Using this measure, vaginal mesh was superior to native tissue at 3 years.”
Between Oct. 10, 2013, and Dec. 31, 2016, Kahn and colleagues assigned 225 women to receive POP treatment using transvaginal mesh (Uphold LITE, Boston Scientific) and 64 women to treatment with native tissue repair (NTR). They also included 421 patients from the American Urogynecologic Society’s Pelvic Floor Disorders Registry, creating an NTR group of 485 patients.
To assess noninferiority, the researchers evaluated composite success at 36 months, which included anatomical and subjective success, retreatment measures and adverse events. They accounted for different definitions of anatomical success by outlining a primary and secondary endpoint. The first, which was mandated by the FDA, defined anatomical success as POP quantification (POP-Q) scores of no greater than zero for anterior (point Ba) and apical (point C) compartment prolapse. For the secondary endpoint, the researchers defined anatomical success as POP-Q less than zero for points Ba and C.
The primary composite endpoint was achieved in 89.3% of women who received transvaginal mesh (TVM) and 80.2% of women who received NTR (propensity score-adjusted treatment difference, 6.5%; 90% CI, –0.2% to 13.2%). Because the noninferiority margin for this endpoint was 12%, TVM was considered noninferior to NTR.
For the secondary composite endpoint, TVM was superior to NTR (83.6% vs. 72.7%; propensity score-adjusted treatment difference, 10.6%; 90% CI, 3.3%-17.9%).
The subjective success rate for both endpoints was 92.4% with TVM and 92.8% for NTR, with a propensity score-adjusted difference of –4.3% (95% CI, –12.3% to 3.8%). For both endpoints, retreatment was not needed in 97.3% of women who received TVM and 95.5% of women who received NTR.
Overall, adverse events occurred in 35.1% of the TVM group and 46.4% of the NTR group, with serious adverse events occurring in 3.1% and 2.7%, respectively. Of note, the mesh exposure rate was 4.9% in the TVM group, with 13 exposures among 11 patients.
“This is lower than that the 11% to 20% reported in earlier studies,” Kahn said. “Most (9/13) required no treatment or a simple office procedure. The others were treated on an outpatient basis.”
Taken together with findings from previous studies, Kahn said “that transvaginal mesh is as safe and probably a superior treatment for POP” compared with NTR.
Kahn suggested that more research on TVM could help show which women with POP would most likely benefit from it.
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