Randomized controlled study of MONARC® vs. tension-free vaginal tape obturator (TVT-O®) in the treatment of female urinary incontinence: comparison of 3-year cure rates.

PURPOSE: Transobturator approaches to midurethral sling surgery are one of the most commonly performed operations for female stress urinary incontinence throughout the world. However, very few results of randomized clinical trials of transobturator midurethral sling surgery (MONARC vs. TVT-O) for the treatment of female urinary incontinence have been reported. In this study, we compared the 3-year follow-up cure rates of these two procedures.
MATERIALS AND METHODS: From July 2006 to June 2008, 74 patients who had undergone MONARC (35 patients) or TVT-O (39 patients) were included in the study and were analyzed prospectively. The mean follow-up duration of both groups was 39.2 months. Preoperative and postoperative evaluations included physical examination, uroflowmetry and postvoid residual measurement, involuntary urine loss with physical activity, and urinary symptoms. Cure of female urinary incontinence was defined as patient report of no loss of urine upon physical activity. The patients' satisfaction after treatment was rated as very satisfied, satisfied, equivocal, and unsatisfied. Very satisfied and satisfied were considered as the satisfied rate.
RESULTS: There were no significant differences in preoperative patient characteristics, postoperative complications, or success rate between the two groups. The cure rate of the MONARC and TVT-O groups was 85.7% and 84.6%, respectively. The patient satisfaction (very satisfied, satisfied) rate of the MONARC and TVT-O groups was 82.8% and 82.1%, respectively.
CONCLUSIONS: The MONARC and TVT-O procedures were equally efficient for the treatment of female urinary incontinence, with maintenance of high cure rates for 3 years. Longer follow-up is needed to confirm these results.

RCT Entities:   Population Interventions Outcomes