Prospective randomized comparison of the transobturator mid-urethral sling with the single-incision sling among women with stress urinary incontinence: 1-year follow-up study. Issue 5 (May 2016)

• Record Type: Journal Article
• Authors: Jurakova, Michaela; Huser, Martin; Belkov, Ivan; Janku, Petr; Hudecek, Robert; Stourac, Petr; Jarkovsky, Jiri; Ventruba, Pavel
• Is Part Of: International urogynecology journal. Volume 27:Issue 5(2016)
• Page Start: 791
• Page End: 796
• Publication Date: 2016-05
• Subjects: Stress urinary incontinence -- Mid-urethral sling -- Single-incision sling -- Efficacy -- Patient-reported outcomes -- Randomized controlled trial; Urogynecology -- Periodicals; Generative organs, Female -- Diseases -- Periodicals; 616.60082
• DOI: 10.1007/s00192-015-2895-2
• Languages: English
• ISSNs: 0937-3462

Abstract

Abstract Introduction and hypothesis The objective was to compare the efficacy and safety of an innovative single-incision sling (SIS) with the inside-out transobturator sling (TOT) in the treatment of female stress urinary incontinence (SUI). Methods A prospective randomized trial was performed in a tertiary referral urogynecology center from January 2012 to December 2013. The study included women with pure urodynamic SUI. Patients were randomized to either the SIS or the TOT anti-incontinence procedure. Surgery duration, blood loss, and groin pain scores were recorded for each patient. The 1-year follow-up visit included objective and subjective cure parameters, postoperative de novo urgency, complications, and the impact on the patient's life quality. Results Of 285 patients assessed for eligibility, a total of 93 patients (32.6 %) were randomized into TOT (n = 48) and SIS groups (n = 45). There were no significant differences in either operating time or blood loss. A statistically significant difference between the two groups was found in pain scores three (5.6 ± 1.8 vs 3.1 ± 2.1, p < 0.001) and 12 h postoperatively (3.8 ± 1.7 vs 2.1 ± 1.7, p < 0.001). After 1 year, there were no significant differences between the TOT and SIS groups in objective cure rates (87.0 % vs 90.9 %;p = 0.399) or patient-reported success rates (91.3 % vs 93.2 %;p = 0.999). Incidence of postoperative de novo urgency did not differ between TOT and SIS patients. Both groups registered a significant improvement in quality of life. Conclusions The Ophira SIS procedure has 1-year success rates comparable to standard TOT with significantly less groin pain in the early postoperative period. Both methods were safe and effective in terms of postoperative urgency and life quality improvement.