Three- and twelve-month follow-up outcomes of TVT-EXACT and TVT-ABBREVO for treatment of female stress urinary incontinence: a randomized clinical trial.

Objective: To compare the efficacy, safety, postoperative complications and discomforts between TVT-EXACT (TVT-E) and TVT-ABBREVO (TVT-A) for treatment of female stress urinary incontinence.

Methods: Recruited patients were randomized into either TVT-E or TVT-A group using SPSS software. Follow-up measures were performed at day 1 before surgery and both 3 and 12 months after the surgery. The measurement outcomes were the scores of involved six questionnaires on quality of life, symptom severity and patient satisfaction. Sixty patients in each arm were planned to be powerful enough to draw a valid conclusion. All statistical analyses were done with t test, Chi square, Mann-Whitney U test and ANOVA as appropriate.

Results: The final sample sizes were 63 (TVT-E) versus 62 (TVT-A). TVT-E took more time but caused less postoperative pain than TVT-A. The number of patients who did not suffer from peri-operational complications or discomforts in each group was similar. The rate of urine leakage in TVT-A group was higher than that in TVT-E, but the difference was not statistical significant in 12 months. At both 3- and 12-month time points, the TVT-E group showed the higher score in I-QOL and the lower scores in both ICIQ-SF and PFIQ-7 scales, which might imply better effectiveness and quality of life. The two groups demonstrated comparable objective cure rates by cough stress test in both 3 and 12 months. The subjective cure rate of TVT-E was better than that of TVT-A in 3 months, but was similar between two groups in 12 months.

Conclusions: The present study provided evidences showing that although TVT-E might provide the better subjective cure rate and the fewer troublesome discomforts at 3 months comparing to TVT-A, the long-term results between these two treatments showed no significant difference.