abstract134 - MINIARC MONARC SUBURETHRAL SLING IN WOMEN WITH STRESS URINARY INCONTINENCE - AN RCT - 60M FOLLOW UP
MINIARC MONARC SUBURETHRAL SLING INWOMEN WITH STRESS URINARY INCONTINENCE - AN RCT - 60M FOLLOW UP
J. K. LEE1, A.ROSAMILIA 2, Y. N. LIM 3, E. A. THOMAS 4,C. J. MURRAY 5, A. LEITCH 6, P. L. DWYER 7;
1Mercy Hosp. for Women, Armadale, Australia, 2MonashHlth., Monash Univ. & Cabrini Hospita, melbourne, Australia,3Mercy Hosp. for Women, Heidelberg, Australia,4Urogynaecology, Mercy Hosp. for Women, Victoria,Australia, 5Urogynaecology, Mercy Hosp. for Women,Melbourne, Australia, 6Monash Hlth., East Bentleigh,Australia, 7Mercy Hopsital for Women, Melbourne,Australia.
Introduction: Single incisionmidurethral slings, such as Miniarc, were introduced to reducepostoperative pain, and improve recovery.
Objective: tocompare objective, subjective and functional outcomes after Miniarcor Monarc midurethral sling in women with stress urinary incontinence(SUI) at 60m
Methods: Women who had SUI or urodynamicstress incontinence (USI) were randomised, to receive either Miniarcor Monarc equally. Women with intrinsic sphincter deficiency,previous MUS, untreated detrusor overactivity or significant voidingdysfunctions were excluded. A sample size of 220 was based upon anassumption of objective cure of 85% for Monarc, power of 80% for aclinical difference and attrition of 15% each, using a one sided αof 0.05. Computer generated random allocation was concealed andstratified to centre. Surgeons or patients were not blinded onceallocation was revealed. Patients were seen at 6m, then yearly to 60mwith a clinical examination. Standardised proformas together withvalidated tools, including ICIQ UI SF, ICIQ OAB, PISQ12, IIQ7, PGIIand 24 pad weigh (6m), were used to facilitate prospective collectionof data to evaluate objective, subjective and functional outcomesfollowing surgery. Objective cure was defined as negative USI orcough stress test (CST) at follow up. Subjective cure was defined asabsence of patient reported SUI at follow up. Surgeries wereperformed, according to manufacturer’s instructions, by surgeonswho had performed at least 10 Miniarc, which was tensioned to snug.Urodynamic studies were performed pre operatively and 6m postoperatively. Definitions, outcome measures and reporting adhered toIUGA terminology, IUGA & CONSORT guidelines. Institution ethicsapproval was obtained together w registration at trial registry.Outcomes were compared with exact binomial tests for categorical dataand Student t test or exact versions of Wilcoxon test fornumerical data as appropriate.
Results: 282 women wereassessed for eligibility, of which 42 declined participation, 2indicated a preference to Miniarc, and 14 were excluded postrandomisation (3 did not meet criteria, 10 withdrawn from surgery, 1unfit). 235 women aged 31-80 (51.6±9.71) received Miniarc (112) orMonarc (113). Median parity was 2 (0-7), mean BMI 27.5±5.6 (15 -47). Baseline characteristics were balanced, with no statisticallysignificant difference between two treatment arms for knownconfounders, including age, parity, BMI, prior medical history,baseline symptom severity (excluding PGI-S), urodynamic diagnosis,vaginal topography and types of concomitant prolapse surgeries. Table1 demonstrated no statistically significant difference in thesubjective (absence of SUI) or objective (absence of USI or CST) curerates between Miniarc and Monarc at all 6 time points. Withinboth Miniarc and Monarc groups, there was a statistically significantimprovement from baseline to all 6 time points for ICIQ UI, ICIQ OAB,PISQ12, IIQ7, PGII scores and 24h pad weigh (6m). The ICIQ UI SFscore was lower in the Monarc group at 36m, 48m and 60m but thedifference was less than the minimally important difference of 5 andnot statistically significant. At 12m the Miniarc arm has a lowerproportion using antimuscarinics, which was not statisticallydifferent at subsequent time points. At 60m 5 in Miniarc and 4 inMonarc group underwent repeat surgery for SUI (TVT). Two women hadrepeat surgery 6m after their Miniarc operation, two at 12m and oneat 39m. In contrast, two women had repeat surgery 12m after theirMonarc operation, one at 24m and one at 36m. There were no slingdivisions or excision in both arms. There were two cases of meshexposure on each arm, one in a patient who underwent concurrentanterior vaginal mesh repair, another in a patient who underwentMonarc sling.
Conclusions: Although a reduction insubjective cure rate was observed in both arms across all time pointsto 60 months, mid to long term results suggest comparable cure ratesand functional outcomes between Miniarc and Monarc.