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.