MiniArc vs TVT Abbrevo MIDURETHRALSLING IN WOMEN WITH STRESS URINARY INCONTINENCE. AN RCT 6 AND 12MONTHFOLLOW UP
J. MELENDEZ MUNOZ1,M. BRAVERMAN 2, A. ROSAMILIA 1, N. R. YOUNG 1,A. LEITCH 1, J. K. LEE 1;
1PelvicFloor Unit., Monash Hlth., Bentleigh East, Australia, 2O&G,Haemek Hosp., moledet, Israel.
Introduction: Single incisionslings (SIS) were introduced in an attempt to decrease thecomplications associated with retropubic and transobturator slings.The FDA has requested ongoing studies to determine the efficacy ofsingle incision slings. The TVT Abbrevo is a modification of theTVT-O with a reduced length and less immediate postoperative pain1.The Miniarc SIS has been shown to be equivalent to outside-intransobturator sling, Monarc at 12 month follow-up2
Objective:To evaluate objective and subjective outcomes of MiniArc SIS and TVTAbbrevo midurethral sling (MUS) in women with stress urinaryincontinence
Methods: Female subjects who were assessed andreferred for stress urinary incontinence surgery were eligible toparticipate in this study. Women with intrinsic sphincterdeficiency (maximum urethral closure pressure (MUCP) of 20 cmH2Oor less and/or abdominal leak point of 60 cm H2O or less),previous failed midurethral or fascial sling, untreated detrusoroveractivity or significant voiding dysfunction (maximum flow rate <15 mL/s or < 10% Liverpool nomogram and/or postvoidresidual > 100 mL) were excluded. Patients had equalprobability of allocation to TVT Abbrevo or MiniArc sling;randomisation was performed with computer-generated blocks of 4-8,with concealed allocation. Surgeons or patients were not blinded onceallocation was revealed. Assuming an objective cure rate of 90% forTVT AbbrevoTM with a power of 80%, a sample size of 79 iineach arm was required to detect a clinical difference of 15%, using aone sided α of 0.05. The target recruitment number was 220allowing for an attrition rate of 15%. Institution ethics approval(11261B) was obtained and the trial was registered with the nationalclinical trial registry. Routine preoperative assessment (symptomevaluation, clinical examination, urodynamics and perinealultrasound, urinary diary) was conducted for objective data, whilstpatient reported outcome tools (PRO) were utilised for subjectiveoutcomes. These include ICIQ UI SF, ICIQ OAB, IIQ7, EQ5D, PISQ12,PGIs & PGII.TVT AbbrevoTM or MiniarcTM wereperformed in a standardized fashion, together with any concomitantprolapse surgery, followed by routine post operative care includingvoiding trial and assessment of post operative pain. Review wasconducted at 6 weeks and at 6 and 12 months at which time,uroflowmetry, a clinical cough stress test and examination wereperformed in addition to symptom and quality of life questionnaires.Objective cure was defined as a negative cough stress test with acomfortably full bladder. Subjective cure was defined as no report ofleakage with physical exertion. All Data was collected on astandardized proforma including patient characteristics. Outcomeswere compared with exact binomial tests (eg, Fisher exact test fordichotomous data) for categorical data and Student t test orexact versions of Wilcoxon tests for numerical data asappropriate.
Results: Between 2011 and December 2015,a total of 241 women were randomized to receive MiniArc (119) or TVTAbbrevo (123) with 24 withdrawals over the first 12 months. Baselinecharacteristics were clinically balanced in both groups. At thecurrent time-point, 170 women were assessed. There were significantdifferences in subjective cure at 12 month though no significantdifferences on objective cure rates and patient reported outcomes, asshown in Table 1. There were two tape exposures, one requiringexcision which caused recurrence of SUI. One TVT abbrevo had to beloosened. Sixty patients (44 Abbrevo vs 16 MiniArc) complained oftransient groin pain varying between 1 to 6 weeks. All selfresolved.
Conclusions: There was no significant differencein objective cure rates at 6 and 12m between MiniArc and TVT Abbrevo.Subjective cure rate was significantly higher for TVT Abbrevocompared with MiniArc at 12months but not at 6 months.
Shaw JS,Jeppson PC, Rardin CR. Decreasing transobturator sling groin painwithout decreasing efficacy using TVT-Abbrevo. Int Urogynecol J.2015 Sep;26(9):1369-72.
Lee JK-S,Rosamilia A, Dwyer PL, et al. Randomizes trial of a single incisionversus an outside-in obturator midurethral sling in women withstress urinary incontinence: 12 months results. Am J Obstet Gynecol2015;213:35.e1-9