Medium-term clinical efficacy and safety of single incision and modified trans-obturator mid-urethral slings for female stress urinary incontinence
摘要Aims:To evaluate the medium term efficacy and safety of Altis and Solyx single incision slings(SIS)compared with tension-free vaginal tape(TVT)Abbrevo trans-obturator sling.We hypothesize that both SIS show little difference in efficacy and safety and perform similarly to TVT Abbrevo.Methods:We conducted an ambispective comparative cohort study of women with stress urinary incontinence who received a SIS in comparison to matched TVT Abbrevo subjects from a concurrent randomized controlled trial(RCT).Subjects were identified retrospectively,and prospectively invited for examination and ques-tionnaires>12 months post-operatively.Exclusions included intrinsic sphincter deficiency,previous sling surgery,and others.Primary outcome was subjective cure[negative response to International Consultation Incontinence Questionnaire-Urinary Incontinence Short Form(ICIQ-UI SF)question 6,leakage during coughing/activity].Secondary outcomes include objective cure(negative cough stress test),functional outcomes,and adverse events.Results:Between 2012 and 2018,a total of 113 women received one of two SIS surgeries;Solyx(n=50)followed by the Altis(n=63);104 were available for final efficacy analysis.Mean follow-up was 21.7(Altis),46.0(Solyx),and 29.0(Abbrevo)months.Baseline characteristics were comparable between the groups.There was no sig-nificant differences in the subjective or objective cure rates between the groups,and no differences in functional outcomes such as patient global impression of improvement,and post-operative ICIQ-UI SF score.There was a low rate of mesh related complications and no differences seen between the groups.Conclusions:Despite being an underpowered study,Altis and Solyx SIS have favourable efficacy and safety profiles which are comparable to an established trans-obturator mid-urethral slings(MUS).
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