Transobturator hybrid tape versus synthetic tape in treatment of female stress urinary incontinence: A prospective randomized clinical study.

Abstract

Objective: To compare the clinical and operative outcomes of transobturator hybrid tape versus synthetic tapes during mid-urethral sling in treating female stress urinary incontinence (SUI).

Patients and methods: This prospective randomized study included 63 women with SUI. Patients were categorized into two groups: Group I included 32 patients who underwent midurethral sling procedure using hybrid tape; and Group II included 31 patients that had synthetic sling, using transobturator tape approach (TOT) in both groups. Two patients in group I lost to follow up and one patient in group II lost to follow up. The primary endpoint was the safety of sling erosion and major complications. The 2ry endpoint was the efficacy that was assessed objectively by the Cough stress test and subjectively by International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI-SF) and this was assessed at 1, 6, and 12 months. The following variables were compared: operative time, post-operative pain scores, duration of indwelling urethral catheter, hospital stay, and quality of life (QoL) assessment (International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form [ICIQ-UI-SF]) assessing the continence status before and after discharge from hospital.

Results: Patients among the two groups were normally distributed with no statistical significant difference in patient's demographic data and comorbidities. The hybrid tape procedure had a longer mean (SD) operative time of 45.3 ± 3.6 min, which was longer than that of synthetic tape procedure, at a mean (SD) of 29.5 ± (3.5) min. This increase was statistically significant (p < 0.001). The mean time to return to normal activity was significantly shorter in Group II patients compared to those in Group I. Overall cure rate (defined as no more episodes of SUI or pad use) was statistically insignificant in both groups being 86.7% and 83.3% respectively. No bladder, vascular, nervous or intestinal injuries were encountered in either group. Pain was significantly higher in hybrid tape (Group I). Post operative urgency, and urge incontinence rates were not significantly different between in both groups. Two cases in group 1 and one case in the other group, and these cases were managed by medical treatment. Vaginal sling erosion was encountered in one case in group II which was managed by sling removal.

Conclusion: Hybrid tape may be considered as a treatment option during TOT for female SUI with comparable efficacy and safety to synthetic tape. Long term follow up should be considered.