Tension-free vaginal tape for the treatment of stress urinary incontinence: a 13-year prospective follow-up.

OBJECTIVE: To evaluate the long-term safety and efficacy of tension-free vaginal tape (TVT).

DESIGN: Prospective observational study (Canadian Task Force Classification II-2).

SETTING: Tertiary referral center in China.

PATIENTS: Between January 2004 and December 2005, 85 consecutive patients who underwent TVT procedure were included. Patients with mixed incontinence or pelvic organ prolapse requiring surgery were excluded.

INTERVENTIONS: TVT procedure.

MEASUREMENTS AND MAIN RESULTS: The primary outcomes were long-term postoperative complications. The secondary outcomes included long-term subjective satisfaction (Patient Global Impression of Improvement), objective cure rate (stress test), quality of life and sexual function. At the13-year follow-up, 70 patients (82%) were available for evaluation. De novo overactive bladder was observed in 15.7% of patients, and voiding symptoms were found in 17.1% of patients. None of the patients reported voiding dysfunction that needed treatment with tape removal or catheterization. Tape exposure occurred in 2.9% of patients. The subjective satisfaction rate and objective cure rate were 78.6% and 81.4%, respectively.

CONCLUSION: TVT is a safe and effective treatment for stress urinary incontinence, even at the 13-year follow-up. The prevalence rates of overactive bladder and voiding symptoms are increased with advancing age and should not be considered long-term postoperative complications.