A multicenter study of tension-free vaginal tape (TVT) for surgical treatment of stress urinary incontinence

The aim of the study was to evaluate the safety and efficacy of TVT (tension-free vaginal tape) for the surgical treatment of stress urinary incontinence. The design was a prospective open multicenter study including six centers, each operating an approximately 20 patients. In total 131 patients suffering from genuine stress incontinence were included. They were followed for at least 1 year using a specific protocol for objective and subjective evaluation of the outcome. All patients underwent the operation under local anesthesia. Mean operation time was 28 minutes (range 19–41 minutes); 119 (91%) of the patients were cured according to the protocol and another 9 (7%) were significantly improved. There were 3 (2%) failures. The majority of the patients (about 90%) were operated upon on a day-care basis, which implied that they were released from the hospital within 24 hours, with no postoperative catheterization. No defect healing and no tape rejection occurred. Three patients needed an indwelling catheter for 3 days. In 1 patient catheterization was necessary for more than 10 days. Two uncomplicated hematomas and one uncomplicated bladder perforation occurred. Based on the results, we conclude that TVT is a safe and effective ambulatory procedure for surgical treatment of genuine stress urinary incontinence.Editorial Comment: This is the first prospective study of a relatively new and minimally invasive surgical procedure for stress urinary incontinence. The authors are to be complimented on the fact that they went out into the community hospitals in their area to see if their results could be reproduced by the average practicing gynecologist. Also, it is good to see that the investigators used a validated quality of life assessment to provide very important follow-up information on the improvement in the patient's quality of life, as this should be the basic tenet of all therapies for urinary incontinence. However, many questions remain regarding the diagnostic criteria they used in selecting their patients, as well as the degree of testing performed postoperatively. Further study is needed to confirm the results found here with a very new and interesting technique in the surgical treatment of stress incontinence.