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Long Term Safety and Efficacy of Single-Incision Sling versus Mid-Urethral Sling in the Treatment of Stress Urinary Incontinence
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  • Martin Huser,
  • Robert Hudecek,
  • Ivan Belkov,
  • Ivan Horvath,
  • Jíři Jarkovský,
  • Samuel Tvarozek
Martin Huser
Brno University Hospital and Masaryk University Medical School, Department of Obstetrics and Gynecology
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Robert Hudecek
Brno University Hospital and Masaryk University Medical School, Department of Obstetrics and Gynecology
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Ivan Belkov
Brno University Hospital and Masaryk University Medical School, Department of Obstetrics and Gynecology
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Ivan Horvath
Masaryk University Medical School, Department of Obstetrics and Gynecology
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Jíři Jarkovský
Institute of Biostatistics and Analyses, Masaryk University Medical School
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Samuel Tvarozek
Brno University Hospital and Masaryk University Medical School, Department of Obstetrics and Gynecology
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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

Peer review status:UNDER REVIEW

12 Mar 2020Submitted to BJOG: An International Journal of Obstetrics and Gynaecology
13 Mar 2020Submission Checks Completed
13 Mar 2020Assigned to Editor
22 Mar 2020Reviewer(s) Assigned
10 Apr 2020Review(s) Completed, Editorial Evaluation Pending
29 Apr 2020Editorial Decision: Revise Major
08 May 20201st Revision Received
12 May 2020Assigned to Editor
12 May 2020Submission Checks Completed
25 May 2020Reviewer(s) Assigned
29 May 2020Review(s) Completed, Editorial Evaluation Pending
07 Jul 2020Editorial Decision: Revise Major
10 Aug 20202nd Revision Received
11 Aug 2020Assigned to Editor
11 Aug 2020Submission Checks Completed
14 Aug 2020Reviewer(s) Assigned
31 Aug 2020Review(s) Completed, Editorial Evaluation Pending