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)
- Brno University Hospital, Department of Obstetrics and Gynecology,
Jihlavska 20, 625 00 Brno, Czech Republic
- Masaryk University Medical School, Department of Obstetrics and
Gynecology, Kamenice 753/5, 625 00 Brno, Czech Republic
- 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