Importance This study compares the long-term efficacy and safety of an innovative single-incision sling (SIS) with the inside-out transobturator tape (TOT) sling in the treatment of female stress urinary incontinence. Objectives Women with urodynamic stress urinary incontinence were randomized to either SIS or TOT groups and followed up for 4 years. The primary outcome was objective cure defined with a negative cough stress test result. Secondary outcomes involved subjective cure reported via patient's satisfaction scale, surgery complications, postoperative de novo urgency, and patient's life quality. Study Design This is a randomized noninferiority controlled trial. Results A total of 168 women were randomized (84 in both groups). After 4-year follow-up, 130 patients were analyzed (66 in the SIS group and 64 in the TOT group). The objective (86.4% vs 84.4%; risk difference [95% confidence interval], 0.020 [−0.101 to 0.141]; P = 0.807) and subjective cure rates (83.3% vs 81.3%; risk difference [95% confidence interval], 0. 020 [−0.111 to 0.151]; P = 0.821) were similar with the SIS and TOT groups. Both procedures were associated with low complication rates. Repeated surgery rates were 7.6% in the SIS group and 6.3% in the TOT groups. The mesh exposure rate was 1.5% for the SIS group and 3.1% for the TOT group. Incidence of de novo urgency did not vary between TOT and SIS patients. Both groups registered significant life quality improvement. Conclusion After long-term follow-up, anti-incontinence SIS surgery proved noninferior to the inside-out TOT procedure in terms of objective and subjective cure rates.
Objective: To compare long term 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). 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 noninferior to inside-out TOT procedure in terms of objective and subjective cure rates.
The midurethral sling (MUS) is the criterion standard for SUI treatment in women, with a third-generation MUS utilizing a single vaginal incision (single-incision sling [SIS]) becoming a means for preventing postoperative groin pain associated (rarely) with transobturator sling. However, SIS requires additional long-term evidence of effectiveness through randomized trials comparing their use with MUS. The goal of this study was an evaluation of safety and efficacy of the use of Ophira SIS as compared with inside-out full-length transobturator tape (TOT) sling (MUS) use over long-term follow-up. Primary randomized controlled trial outcomes included SUI objective cure rate evaluations 4 years after MUS operation. Secondary study end points included quality of life, early and late operative complications, subjective cure, recurrent surgery need, and urgency incontinence occurrence.This study, which took place at the Czech tertiary referral Brno University Hospital Urogynecology Center, was a randomized noninferiority controlled trial held from January 2015 through December 2019. Women with urodynamic SUI, as confirmed via positive cough test during cystometry, were included in this nonblinded study. Exclusion criteria were as follows: urgency or predominant urgency incontinence, pelvic organ prolapse stage 2 or greater, intrinsic sphincter deficiency, previous SUI surgery, previous pelvic organ prolapse surgery, and presence of additional organ pathology. The International Consultation on Incontinence Questionnaire—Short Form was completed to assess symptom impact on patient quality of life. Baseline patient characteristics including body mass index, age, and parity were recorded, and written informed consent for enrollment in the study was collected from all patients.Randomization occurred via the envelope technique (sequentially numbered opaque envelopes distributed at the time of surgery) to assign patients to an SIS anti-incontinence procedure or MUS. The SIS procedures used Ophira (Promedon) surgical kits, and the MUS procedure used the inside-out Gynecare TVT Obturator System (Ethicon). Senior surgeons with more than 200 previous MUS or SIS procedures performed the operations. The authors assumed a minimum sample size of 64 patients in each group was needed to identify noninferiority.An independent clinician performed follow-up visits at 4 years postoperation, including an evaluation of objective cure (absence of urinary leakage) as primary study outcome. Subjective cure included the International Consultation on Incontinence Questionnaire—Short Form tiers of 1 (“very much improved),” 2 (“much improved),” or 3 (“improved).” A total of 192 eligible patients participated, with 24 declining randomization for a total of 168 patients (87.5%) being randomized into SIS (n = 84) and MUS groups (n = 84). From these, full completion of the 4-year follow-up took place for 66 SIS patients (78.6%) and 64 MUS patients (76.2%). The results of the analysis indicated that the MUS and SIS groups demonstrated no statistic...
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