What Determines a Successful Tension-Free Vaginal Tape? A Prospective Multicenter Cohort Study: Results from The Netherlands TVT Database

Abstract

To identify the preoperative and intraoperative factors that might affect the outcome from a tension-free vaginal tape (TVT) procedure for the treatment of stress urinary incontinence (SUI), 809 participants were recruited from women scheduled to undergo TVT between March 2000 and September 2001. Patients with recurrent urinary tract infections, symptoms of urge incontinence greater than those of SUI, detrusor overactivity, postvoiding bladder retention, bladder capacity less than 200 mL, or physical/mental impairment were not included. All patients were examined before TVT and 2, 6, 12, and 24 months after the procedure. The short version of the Urogenital Distress Inventory was used to evaluate quality-of-life measures. All participating gynecologists and urologists underwent a short training in the TVT procedure. Each surgeon’s cases were identified as taking place in the first 10 procedures, from 11th to 20th, or after 20 procedures had been performed. The TVT procedure was considered successful if, at the 2-year follow up on the Urogenital Distress Inventory completed privately and anonymously, the patient answered “no” to this question: “Do you experience urinary leakage during physical activity, coughing, or sneezing?” A secondary measure was the answer to the same question when asked directly by the doctor. The 809 subjects underwent TVT in 41 different hospitals. Fifty-four gynecologists and urologists performed the procedures. Mean operating time was 32.4 minutes for the TVT procedure only. Fifty-nine patients underwent simultaneous prolapse surgery and 63 had other nonurogynecologic procedures. General anesthesia was used for patients with combined procedures (7.8%). Local anesthesia was used in 80% of patients and 8.3% had a spinal. Seventy-nine percent of the patients completed the 2-year follow up. At this time, 66% of the patients were considered a success. The success rate was significantly higher (72.4%) among patients from the third group of the surgeon’s experience (more than 20 procedures) (P = .003 after multivariate analysis). In the secondary outcome measure, the overall success rate was 78%; it increased to 83.3% in patients who were treated after the surgeon had performed more than 20 TVT procedures (P = .035 after multivariate analysis). The success rate was significantly lower (68.1%) among patients who had general anesthesia (P = .032 after multivariate analysis). No other factors, including demographic information, symptoms, preoperative urodynamic studies, and surgical details, were statistically significantly related to outcome.