| ContextMidurethral slings have been thought to be the first-line treatment in surgery of femalestress urinary incontinence (SUI). Recently，a new type of single-incision mini-sling,named AjustTM, is introduced to clinical doctors and patients because of its severalsuperiorities. However, no certain evidences have previously assessed this relativelynew product.ObjectTo assess the current evidence of clinical efficacy, safety, and cost effectiveness ofAjustTMsling in the management of female SUI.MethodsWe conducted a literature search between January2008and February2014, fromdatabase such as Pubmed, Medline, EBSCO, EMBASE, Conchrane Library, Science,CNKI and abstracts of several annual meeting. All randomized controlled trials (RCTs)and controlled clinical trials (CCTs) comparing Ajust versus TVT-O or TOT were performed with Meta-analysis, using the RevMan5.2. Evidence from other researchdesigns were analyzed with case summary descriptive analysis and narrative synthesis,using the Microsoft Excel2010. Outcomes include subject and objective cure rates,operative data, perioperative complications and quality of life changes.Result1. A total of625women (332in Ajust group vs293in TVT-O/TOT group) in fiveRCTs or CCTs were included to our Meta-analysis. The Meta-analysis showed that noevidence of significant differences between Ajust and TVT-O/TOT in object cure rate(risk ratio [RR]:1.03;95%confidence interval [CI](0.94,1.130)), subjective cure rates(RR:1.02;95%CI (0.94,1.11)), operating time (means difference [MD]:-2.86;95%CI(-5.62,-0.09)), lower urinary tract or vaginal injury rate (RR:2.80;95%CI:(0.14,57.14)) and de novo lower urinary tract symptom occurrence rate (RR:0.64,95%CI(0.28,1.45)). However, Ajust group had significantly lower postoperative pain scores(VAS scores) than TVT-O/TOT group in one-day (MD:2.26,95%CI (-2.88,-1.65)) andfour-day (MD:-1.09,95%CI (-1.67,-0.51)) after operation, as well as lower groin painin3weeks (RR=0.45,95%CI (0.28,0.72)) after operation.2. Eleven articles were include to our case summary descriptive analysis, including637cases. The baseline characteristics of the patients included were about consistent.The result from the analysis showed that the object cure rate in1-month,6-month and12-month after surgery was86.96%(n=391),85.71%(n=259),85.71%(n=216); subjectcure rate in1-month,6-month and12-month was90.44%(n=293),87.74%(n=261),83.90%(n=267). The mean operating time was17.45±6.87min (n=552) and lowerurinary tract or vaginal injury rate was0.67%(n=593).The mean VAS scores one dayafter operation was2.14±3.51(n=286) while the1-day after operation serious painoccurrence rate was2.70%(n=259).4.71%(n=594) of the patients reportedpostoperative voiding difficulties while9.41%(n=340) reported de novo OAB. Theurinary tract infection rate was3.85%(n=441), the tape erosion rate was0.12%(n=268)as well as the tape reset rate was2.70%(n=445). The mean hospital stay days were2.51 ±1.71and0.81%(n=246) patients who had surgery complained their sexual symptomsafter they back to normal life.ConclusionThe evidences available indicate that AjustTMsingle-incision mini-sling is an effectiveand safe procedure in the surgical management of female stress urinary incontinence.But further studies are still needed to verify its long-term efficacy and complications. |
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