Hypothesis / aims of study
The treatment of female stress urinary incontinence (SUI) has undergone a revolution in recent years due to controversy regarding the use of suburethral slings and prosthetic material via the vaginal route.
The objective of this study is to compare two surgical techniques for the treatment of SUI: the transobturator suburethral sling (TOT-Monarc™) and the single-incision suburethral sling (SIU-MiniArc®), both of which are no available on the market.
Study design, materials and methods
A prospective randomized study was conducted from June 2007 to February 2013, including 502 women treated at our hospital: 293 underwent TOT, and 209 underwent SIU. Follow-up was discontinued in 2024.
Results
A total of 502 patients were included, with an average age of 52.7 years and a median follow-up of 166 months (14 years). Among them, 293 were treated with TOT and 209 with SIU.
Regarding patient characteristics, the average age was 57.86 years in the TOT group and 59.08 years in the SIU group, with no statistically significant difference. The median parity was two births in both groups. The presence of urgency urinary incontinence (UUI) was observed in 23.5% of TOT patients and 27.75% of SIU patients, showing a significant difference.
In terms of surgical outcomes, the average hospital stay was longer in the TOT group (3.47 days) compared to the SIU group (2.15 days). The surgical time was also longer for TOT, averaging 27.34 minutes, compared to 18.43 minutes for SIU. The median follow-up period was significantly longer in the TOT group (177 months) than in the SIU group (154 months). A higher percentage of patients in the SIU group had a history of pelvic organ prolapse surgery and previous SUI surgery compared to the TOT group.
COMPLICATIONS
Early complications included acute urinary retention, which was more frequent in the TOT group (9.89%) compared to the SIU group (3.39%). Urinary tract infections and hematomas were rare in both groups. Bladder perforation occurred only in the SIU group (1.43%).
Among late complications, symptomatic vaginal erosion requiring mesh removal was observed in 1.02% of TOT patients and 3.34% of SIU patients. Persistent SUI was significantly more frequent in the SIU group (23.4%) compared to the TOT group (4.77%). The rate of "de novo" UUI was similar in both groups, while persistent UUI was higher in the TOT group (10.92%) compared to the SIU group (4.3%). The need for urethrolysis due to high post-void residual volumes was similar in both groups.
SUCCESS RATE
The objective success rate was significantly higher in the TOT group, with 85.66% of patients achieving continence, compared to 67.94% in the SIU group. The need for reintervention due to recurrent SUI was higher in the SIU group (14.35%) than in the TOT group (5.8%). Patient satisfaction, measured by the PGI scale (scores 1 and 2), was also higher in the TOT group (81.9%) compared to the SIU group (73.2%).
Surgical success was defined as the absence of urine leakage during a Valsalva maneuver in a physical examination with a full bladder, the absence of "de novo" urgency urinary incontinence, and the absence of the need for intermittent catheterization due to urinary retention, with a minimum follow-up of two years.
The percentages were adjusted for losses during follow-up. The mortality rate was the same in both groups, with 18 patients lost in each.
Interpretation of results
Autologous and synthetic slings presented comparable success rates, however BOO was more common among patients treated by autologous slings