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

Abstract

PurposeTransobturator 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 MethodsFrom 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.ResultsThere 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.ConclusionsThe 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.

Medium-term and long-term outcomes following placement of midurethral slings for stress urinary incontinence: a systematic review and metaanalysis

“…There were 11 RCTs [14][15][16][17][18][19][20][21][22][23][24] and 38 nonrandomized studies, including prospective, retrospective, and cohort studies with a total of 6,406 patients (1,200 in RCTs and 5, 206 in nonrandomized studies) aged 19 -89 years. The sample size ranged from 15 to 563 patients evaluated at the last follow-up.…”

“…All RCTs showed a Jadad score of ≥3, with the exception of two studies [20,24] (Table in Electronic supplementary material). A power calculation was reported in six studies (54.5 %).…”

“…Among the non-RCT studies, SUI was clinically diagnosed in eight (no urodynamic studies performed) [26,34,36,41,48,51,53,60] and a blinded assessment was performed in only three [40,50,51] (Figure in Electronic supplementary material). Outcome was assessed as a composite measure of cure (objective and subjective definition of cure met) [20,24,30,31,35,59], subjective [14,19,21,26,34,36,38,39,42,44,48], objective outcome [15,16,22,50] or both [17, 18, 23, 25, 27-29, 32, 33, 37, 40, 41, 43, 45-47, 49, 51-58, 60-62]. The follow-up was described in each study with a minimum of 36 months and a maximum of 17 years.…”

Updated Systematic Review and Meta-Analysis of the Comparative Data on Colposuspensions, Pubovaginal Slings, and Midurethral Tapes in the Surgical Treatment of Female Stress Urinary Incontinence

“…The available RCTs have reported just a few cases of de novo dyspareunia [32,44]. However, the available literature seems to suggest improvements in sexual function for the sexually active patients treated with MUS for SUI [50][51].…”

Patients lost to follow-up after midurethral sling surgery: How are they?

“…The operative technique was modified from DeLorme et al (18,19). The patients were put in lithotomy position.…”