Safety and Efficacy of Single Incision Sling Versus Midurethral Sling in the Treatment of Stress Urinary Incontinence: A Randomized Controlled Trial.

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.

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.

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.

Pregnancy and delivery following midurethral sling surgery for stress urinary incontinence.

OBJECTIVE: To analyze the available clinical evidence on the continued effectiveness of midurethral sling (MUS) surgery for stress urinary incontinence (SUI) in women who become pregnant and undergo delivery, and then to determine the optimal mode of delivery for such women. METHODS: An online search was carried out to retrieve the available evidence regarding the risk of SUI recurrence during pregnancy and after delivery following a successful MUS treatment. Appropriate keywords were used to identify all relevant reports published from 1996 through 2011. Basic patient characteristics, mode of delivery, and presence of SUI during pregnancy and the postpartum were analyzed. RESULTS: No more than 36 relevant cases were found. The overall urinary continence rates were 91.7% during pregnancy and 80.6% during the postpartum. Most (58.3%) of the women were delivered vaginally. CONCLUSION: The evidence indicates that the risk of SUI recurrence is not significantly different after a vaginal or a cesarean delivery. In women successfully treated with a MUS, pregnancy care and delivery mode therefore need to be considered case by case, according to factors other than the risk of recurrence.