Results
The Consolidated Standards of Reporting Trials (CONSORT) flow diagram covering all patients is shown in Figure 1. From 192 eligible patients, a total of 168 patients (87.5%) were randomized into SIS (n=84) and TOT groups (n=84). Finally, 66 patients (78.6%) in the SIS group and 64 patients (76.2%) in the TOT group completed the 5-year follow-up.
There were no significant differences in age, body mass index, parity, or pre-operative quality of life assessment between both comparative study groups (Table 1). Objective and patient-reported outcomes four years after surgery are detailed in Table 2. The SIS surgery was non-inferior to standard TOT procedure in terms of objective (86.4% vs. 83.1%; 95% CI 0.30-2.02; p=0.635) and subjective cure rates (83.3% vs. 80.0%; 95% CI 0.33-1.94; p=0.657). Furthermore, the comparison of urgency incontinence incidence and quality of life investigation between TOT and SIS groups didn’t indicate statistically significant differences. Mean change in ICIQ-SF scores before and after surgery was 11.6±3.0 in the SIS group and 11.4±3.2 in the SIS group.
Table 3 notes intraoperative and postoperative complications and need of re-intervention in both groups. No severe intraoperative complications occurred in either group. Five patients had early postoperative urine retention (4BbT2S3), and two of them successfully recovered after temporary 24-hour catheterization. Another three (2x SIS, 1x TOT) finally required mesh surgical loosening the second or third day after surgery (4BeT2S3). Three patients out of 130 (2.3%) were identified with mesh exposure/extrusion. The mesh exposure rate in all cases (1x SIS, 2x TOT) was ≤ 1 cm and had been diagnosed later than 12 months after surgery, always in the vaginal area of suture line (2AaT4S1). Women were successfully managed conservatively with topical estrogen therapy excepting one case in TOT group. That patient underwent surgical overlap of exposure by vaginal mucosa without the need for tape excision. During the 5-year follow-up, nine out of 130 women (6.9%) in both study groups (5x SIS, 4x TOT) required further surgical treatment owing to recurrent SUI. In all patients a retropubic sling was placed successfully during the third or fourth year of follow-up.