Long Term Safety and Efficacy of Single-Incision Sling versus
Mid-Urethral Sling in the Treatment of Stress Urinary Incontinence
Abstract
Objective: To compare long term efficacy and safety of an innovative
single incision sling (SIS) with the inside-out trans-obturator sling
(TOT) in the treatment of female stress urinary incontinence (SUI).
Design: randomized controlled trial. Setting: single tertiary referral
urogynecology center. Population: women with pure urodynamic SUI.
Methods: randomized to either an SIS or TOT and followed-up for four
years. Main Outcome Measures: The primary outcomes were objective cures
defined with a negative cough stress test and subjective cure reported
via patient’s satisfaction scale. Secondary outcomes involved surgery
complications including re-operations, postoperative de-novo urgency,
and impact on patient quality of life. Results: The 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) were similar with the
SIS and TOT groups. Both procedures were associated with low
complication rates. Repeated surgery rates owing to recurrent SUI were
7.6% in SIS and 6.3% in TOT groups, respectively. Overall mesh
exposure rate was 2.3% for both groups. Incidence of de-novo urgency
didn’t vary between TOT and SIS patients. Both groups registered a
significant quality of life improvement. Conclusions: Following long
term follow-up, anti-incontinence SIS surgery proved non-inferior to
inside-out TOT procedure in terms of objective and subjective cure
rates. Funding: supported by Czech Republic Ministry of Health, No.
FNBr65269705 Keywords: Stress urinary incontinence; mid-urethral sling;
single incision sling; efficacy; patient-reported outcomes; randomized
controlled trial Clinical Trial Registration: ClinicalTrials.gov,
NCT02506309