Modified transobturator (TVT Abbrevo) and single incision (MiniArc) suburethral sling in women with stress urinary incontinence-A randomised controlled trial: 3 year follow up.

Abstract

Objective: To evaluate 3-year objective and subjective outcomes of single incision and modified transobturator sling in women with stress urinary incontinence. Method(s): Women assessed for stress urinary incontinence surgery were eligible to participate. Exclusion criteria included intrinsic sphincter deficiency, previous failed midurethral or fascial sling, untreated detrusor overactivity or significant voiding dysfunction. Randomization was performed with computer-generated blocks of 4-8, with concealed allocation. Assuming an objective cure rate of 90% for TVT Abbrevo with a power of 80%, a sample size of 79 in each arm was required to detect a clinical difference of 15%, using a 1-sided alpha of 0.05. Allowing for 15% attrition rate, target recruitment was 220. Institution ethics approval (11261B) was obtained. Three year follow up consisted of patient-reported outcome measures utilizing ICIQ UI SF, ICIQ OAB, IIQ7, PISQ12 & PGII and objective outcomes included POP-Q, cough stress test, assessment of mesh complications and uroflowmetry. Objective cure was defined as a negative cough stress test with a comfortably full bladder. Subjective cure was defined as "no" leakage on section 3 and 5 of ICIQ UI SF Question 6. Result(s): At 3 years data was available for 207 women (MiniArc: 100 and TVT Abbrevo:107) from the original 246 women. Those who were excluded after randomization were described in the 12 month follow up publication. Baseline characteristics of the two groups were comparable. There was no statistically significant difference in subjective (59% vs 69.5%; P: 0.14) or objective (92.6% vs 98.7%; P: 0.12) cure rates between MiniArc and TVT Abbrevo at 3 years, respectively. A sensitivity analysis taking into account all missing data also showed this. No statistically significant differences were found in functional outcomes and incontinence impact scores significantly improved and were greater than the minimally important difference in both groups. Conclusion(s): There are no statistically significant differences in subjective and objective cure rates and a low rate of complications at 3 years between the single incision and modified transobturator sling.