We analyzed the results of a prospective, observational trial designed to assess the safety and efficacy of the TVT-O procedure for female SUI.
Preoperative and postoperative evaluations included physical examination, and urinary symptom and quality of life scale questionnaires.
Between March 2003 and December 2004, 253 patients with clinical and urodynamic diagnoses of SUI who fulfilled inclusion and exclusion criteria were enrolled in the trial and underwent the TVT-O procedure. No significant intraoperative complications were observed. One-year minimum followup was available on 99 of the initial 102 patients, of whom 16 had undergone concomitant pelvic organ prolapse surgical treatment. The SUI complete cure rate was 91%. No patient had vaginal or urethral erosion. Four patients required tape release or section. Frequency and urge symptoms improved after the operation (p <0.001). The severity of obstructive symptoms slightly increased postoperatively in the group of patients who did not undergo associated pelvic organ prolapse treatment (p <0.05), while maximum flow rates somewhat decreased (p <0.001) and post-void residual urine volumes somewhat increased (p <0.005). Most patients reported a significant decrease in incontinence severity and improvement in quality of life (p <0.0001).
The results of this study, which suggest that the TVT-O procedure is a safe and efficient surgical treatment for female SUI, warrant further comparative evaluation of this procedure with retropubic and outside in transobturator approaches in appropriately designed, prospective, randomized trials.