Long Term Safety and Efficacy of Single-Incision Sling versus Mid-Urethral Sling in the Treatment of Stress Urinary Incontinence
Martin Huser MD, PhD (1, 2), Robert Hudecek MD, PhD (1, 2), Ivan Belkov MD (1, 2), Ivan Horvath (2), Jiri Jarkovsky MA (3), Samuel Tvarozek MD (1)
  1. Brno University Hospital, Department of Obstetrics and Gynecology, Jihlavska 20, 625 00 Brno, Czech Republic
  2. Masaryk University Medical School, Department of Obstetrics and Gynecology, Kamenice 753/5, 625 00 Brno, Czech Republic
  3. Institute of Biostatistics and Analyses, Masaryk University Medical School, Kamenice 126/3, 625 00 Brno, Czech Republic
Corresponding author:
Robert Hudecek, MD, PhD Brno University Hospital, Department of Obstetrics and Gynecology, Jihlavska 20, 625 00 Brno, Czech Republic, tel. +420 605 580 606,185124@mail.muni.cz
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Innovations in stress urinary incontinence therapy
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Following long term follow-up, anti-incontinence SIS surgery proved non-inferior to inside-out TOT procedure.
Abstract (230 words, 250 max.)
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