Tension-free vaginal tape-obturator for the treatment of stress urinary incontinence: a 12-year prospective follow-up.

OBJECTIVE: To evaluate the long-term safety and effectiveness of inside-out transobturator tape (tension-free vaginal tape-obturator, TVT-O) for the treatment of stress urinary incontinence (SUI). PATIENTS AND METHODS: Between August 2004 and August 2006, 87 consecutive patients with SUI who underwent TVT-O were enrolled in this prospective cohort study. Patients with mixed UI, or pelvic organ prolapse requiring surgery, were excluded. Data relating to long-term postoperative complications, subjective satisfaction rate (Patient Global Impression of Improvement), objective cure rate (stress test), quality of life (QoL), and sexual function, were collected during follow-up. The Incontinence Impact Questionnaire (IIQ-7) and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) were used to assess QoL and sexual function, respectively. Statistical analyses were performed using paired-sample t-tests. RESULTS: At the 12-year follow-up, 73 patients (84%) were available for evaluation. Overall, the long-term complication rate was 45.2%. De novo overactive bladder was observed in 12.3% of patients. None of the patients reported severe voiding dysfunction that required treatment by tape removal or catheterisation. However, 16 patients (16/73, 21.9%) had voiding changes compared with their preoperative status. Persistent groin pain was reported in 1.4% of the patients, and tape exposure occurred in 5.5%. The subjective satisfaction rate and objective cure rate were 80.8% and 82.2%, respectively. Compared with preoperative scores, the IIQ-7 score decreased significantly (P < 0.05), whilst there was no significant difference in the PISQ-12 score (P = 0.893). CONCLUSIONS: This 12-year follow-up study showed that TVT-O is a highly effective procedure for the treatment of SUI. The long-term complication rate appears to be slightly high, which should raise concern.