Single-incision (Altis and Solyx) and modified trans-obturator (TVT Abbrevo) sling for stress urinary incontinence-Medium-term clinical efficacy and safety.

Abstract

Objective: Single-Incision Slings (SIS) are the newest generation midurethral slings (MUS) used to treat female stress urinary incontinence (SUI). We aim to evaluate the efficacy and safety of two types of SIS (Altis and Solyx), and compare this with trans-obturator (TVT Abbrevo) historical controls over medium term follow-up. Method(s): We conducted an ambispective cohort study of women with SUI having failed conservative therapy and offered a SIS. Exclusions included intrinsic sphincter deficiency (ISD) and previous sling. Data collected >12 months included examination, cough stress test (CST), patient reported outcome questionnaires, and adverse events. Institutional ethics approval was obtained. Secondary analysis was to matched TVT Abbrevo historical controls from another RCT. Cure was defined as negative response to ICIQ-Urinary Incontinence SF (ICIQ-UI SF, leakage during coughing/sneezing/activity). Objective cure was defined as a negative CST. Result(s): Between 01/2012 and 01/2017, 101 women received one of 2 SIS surgeries (Altis n=57, Solyx n=44). Mean follow-up was 32 months (21.6 vs 47; P>0.05) for Altis and Solyx respectively. Baseline characteristics were comparable. There was no statistically significant difference in the subjective (71.4% vs 72.5%; P: 1.00) or objective (94.1% vs 87.5%; P: 0.29) SUI cure rates between Altis and Solyx and no differences in functional outcomes (PGI-Improvement score, ICIQ-UI SF, or treatment for urgency). The mean change in APFQ bladder score in both groups was clinically meaningful (approximately 2x MID), with no difference between the groups (Table 1). Mesh adverse events were low with no difference seen in exposure, excision, sling loosening, or repeat sling for failure. 3 cases developed groin pain up to 12 months which resolved. Secondary analysis pooling SIS to matched TVT Abbrevo historical controls (n=91) shows no difference in subjective (71.9% vs 75.6%; P: 0.62) or objective (91.2% vs 96.7%; P: 0.21) cure or functional outcomes. Conclusion(s): Altis and Solyx SIS appear comparable to each other and trans-obturator (TVT Abbrevo) historical controls for treating SUI over medium-term follow-up, with a low rate of complications.