Peri-operative morbidity and early results of a randomised trial comparing TVT and TVT-O: response to comment by Minassian and colleagues

Abstract

We really appreciate the comments of Dr. Minassian and co-workers on our study regarding the comparison between tension-free vaginal tape (TVT) and tension-free vaginal tape obturator (TVT-O) in the treatment of urodynamic stress incontinence [1] and we hope to answer all the questions and remarks they raised. We did not describe both surgical techniques in the article as they were reproduced exactly as the promoting authors, Prof. Ulmsten [2] and Prof. deLeval [3], suggested, except for using different types of anaesthesia in patients undergoing TVT. Therefore, we believed that a full description of the techniques was unnecessary for most of the readers. The procedure time was different, and we agree that 9 min difference has poor clinical and economic relevance, but this was not one of our outcome measures and probably is related to the fact that cystoscopy was performed only in half of the patients undergoing TVT-O. Unfortunately, the original study protocol shared by all participants included cystoscopy for both procedures; but collecting data for the analysis, we realized that some centres did not perform it in all the patients. Most of the patients, 75 (65%) in TVT group and 70 (60%) in TVT-O group, underwent surgery under locoregional anaesthesia; therefore, patients who received general anaesthesia are a small part of the entire sample: six (5%) and 23 (19%). This difference could be explained by the fact that an intraoperative cough test was performed in 62% of the cases in TVT group compared with 15% in TVT-O group. We remind you that the original procedure included the cough test for TVT but not necessarily for TVT-O. Nevertheless, despite this different behaviour, the success rate was similar between the procedures. Time for surgery was calculated at the beginning of the procedure once the patient was ready to be operated on and timerequiredfor anaesthesia was not taken intoconsideration. On the other hand, we agree that time to perform cystoscopy could be responsible for longer time in TVT group. In the original description of the TVT-O procedure, cystoscopy was not considered mandatory but, nevertheless, we included it in our study protocol. As we said before, despite this, the adherence to the study protocol was not complete, and some surgeons did not perform it as suggested. We believe that there were no bladder or urethral perforations as no patient came back either reporting irritative bladder symptoms or micturition disorders; moreover, at physical examination, no fistula or erosion was observed.