Prospective comparative data on transvaginal mesh repair (TVM) is lacking. The objective was to compare safety of TVM to native tissue repair (NTR) in women surgically treated for anterior and/or apical pelvic organ prolapse with the Uphold LITE.

In this prospective, parallel cohort, multi-center trial, subjects received TVM (n=225) or NTR (n=485).The  primary endpoint was to compare rates of serious device or serious procedure-related adverse events (SAE). Secondary endpoints included evaluation of mesh- and procedure-related complications between baseline and 36 months. A propensity score (PS) stratification method was used to account for non-randomization. All analyses were performed using SAS (v9.4). Non-inferiority (NI) was specified with a pre-specified NI margin of 10%.

At 36 months, rates of SAEs were similar between TVM and NTR (3.1% vs. 2.7%, -0.4%, 95% confidence interval (CI): -3.1%, 2.3%). Overall rates of adverse events were similar between arms: 35.1% (79/225) in TVM subjects and 46.4% (225/485) in NTR subjects (-15.7%, 95% CI [-24.0%, -7.5%]), with the majority of SAEs occurring within 6 months (Table 1). Incidence of mesh erosion was 0% and mesh exposure was 1.3% at 6 months, 2.2% at 12 months, and 4.9 (11/225)% at 36 months. 5 of the mesh exposure patients underwent surgical intervention, 3 had office procedures, and 3 had no intervention. The rate of office-based intervention for complications was similar between TVM (5.8%, 13/225) and NTR (8.2%, 40/485) (-3.1%, 95% CI: -6.5, 0.4%). In the office, 7 NTR patients had intervention for suture exposure, 4 TVM patients had treatment of mesh exposure and 3 patients (2 TVM, 1 NTR) had pudendal nerve block for neuralgia. Surgical intervention rate for complications was 8.9%(20/225) for TVM vs. 7.0% (34/485) for NTR (0.3%, 95% CI: -4.0%, 4.6%).

Transvaginal mesh is no longer approved for use in pelvic organ prolapse surgery despite the fact that few prospective studies exist comparing outcomes to NTR. In this study, the rate of mesh erosion at 36 months was low at 4.9%. Altman et al. also conducted a prospective study comparing transvaginal anterior mesh study to NTR. Rates of mesh extrusion were very similar at 3.2%. However, in contrast to our study, surgical intervention rates were lower in the NTR arms. We found that the rate of surgical intervention for complications was similar between groups and that the rate for office intervention was also similar between the mesh and NTR arms. Altman et al.’s study did not comment on office interventions. Strengths of our study include large numbers of patients and attention to detail for complications.

In this prospective comparative study, rates of complications and SAEs were similar between patients who underwent TVM repair and NTR, demonstrating a similar safety profile for both procedures. Before permanently removing transvaginal mesh from the armamentarium for pelvic organ prolapse surgery, more comparative studies are needed.

Altman D, Vayrynen T, Engh ME, Axelsen S, Falconer C, Nordic Transvaginal Mesh Group. Anterior colporrhaphy versus transvaginal mesh for pelvic organ prolapse. N Eng J Med. 2011;364(19):1826–36.