The clinical effectiveness of retropubic (IVS-02) and transobturator (IVS-04) midurethral slings: randomized trial

Abstract

Background: Few series comparing the clinical efficacy of retropubic slings versus transobturator slings for the treatment of female stress urinary incontinence (SUI) are available.

Objective: To compare clinical efficacy of retropubic tape operations and transobturator suburethral tape operations for the surgical treatment of female SUI.

Design, setting, and participants: From January 2003 to December 2005, 611 patients underwent clinical and urodynamic evaluation before surgical treatment for SUI. Patients with advanced urogenital prolapse (pelvic organ prolapse-quantification scale [POP-Q] scale grade >1) were excluded, and 537 patients were included in this study. After 18 mo, 398 women were available for follow-up efficacy evaluation at a tertiary academic center.

Intervention: All patients underwent either a retropubic sling procedure or a transobturator sling procedure. Patients were randomly allocated into two study groups at a ratio of 1:1.

Measurements: After 18 mo all enrolled patients were clinically checked for clinical efficacy of both procedures.

Results and limitations: Demographic and urodynamic parameters of patients were similar in both groups. No bladder injury occurred in the transobturator sling group (IVS-04), whereas 13 intraoperational bladder perforations (6.5%) occurred in the retropubic sling group (IVS-02) (p<0.001). The tape erosion rate was <2.5% in both groups (p=0.7). After 18 mo, 398 patients (201 in the IVS-02 group and 197 in the IVS-04 group) were evaluated in terms of clinical efficacy of the procedures. We found out that there was no statistically significant difference in clinical efficacy between these two procedures (chi(2)=1.88, p=0.39). In the IVS-02 group, 75.1% of patients (n=151) remained dry (cured), 16.9% of patients (n=34) reported significant improvement, and 8.0% of patients (n=16) were considered as failures. In the IVS-04 group, 74.1% of patients (n=146) remained dry, 14.2% of patients (n=28) reported significant improvement, and 11.7% (n=23) were considered as failures.

Conclusions: Based on an 18-mo follow-up, the efficacies of both techniques are comparable; however, the retropubic route appears to be more efficient in the intrinsic sphincter deficiency (ISD) group.