<strong>Objectives</strong>: <span style="font-family:;" "=""><span>The aim of this thesis is to determine the clinical effectiveness, safety and cost-effectiveness of ...<strong>Objectives</strong>: <span style="font-family:;" "=""><span>The aim of this thesis is to determine the clinical effectiveness, safety and cost-effectiveness of Single Incision needleless Mini-Slings compared with tension-free Standard Mid-urethral Sling in the surgical management of female stress urinary incontinence, but with less side effects. </span><b><span>Methods:</span></b><span> The study will be conducted in Zagazig University Hospitals. From 2018 to Sept. 2019, 40 cases were enrolled in the study and were randomized by envelope technique at the time of surgery to either a trans-obturator vaginal tape (TOT) or Needleless anti-incontinence procedure. The patients will be divided into 2 groups: Group 1 patient treated by standard sling (TOT). Group 2 those treated by mini-sling. Parameters in perioperative period such as operating time, intraoperative hemorrhage volume, length of stay in hospital, intraoperative complications, and postoperative pain of each patient were recorded. The sample size was calculated to be 40 cases (20 cases will be treated by standard slings, 20 case will be treated by mini-sling). </span><b><span>Results: </span></b><span>A total of 40 patients assessed for eligibility were randomized into Needleless groups. There were no significant differences in age, body mass index, process, parity, pad test or the assessment of preoperative quality of life between the two groups. In the perioperative period, statistically significant differences between the two groups were found in operating time, intraoperative hemorrhage volume, groin pain scores at 24 h after operation and length of stay in hospital (P < 0.001). After two weeks of follow-up, a statistically significant difference between the two groups was found in groin pain/femori-bus internus pain scores, but there were no significant differences in cure rates, pad test, complications or ICIQ-SF. After 1 year, there were no significant differences between the Needleless and TOT groups in cure rates, pad test, groin pain or ICIQ-SF (P > 0.05). Both groups registered a significant improvement in the quality of life (P < 0.001), but there were no significant differences between the two groups (P > 0.05). </span><b><span>Conclusion: </span></b><span>We conclude that compared with the TOT surgery, single-incision Needleless sling in the treatment of female stress urinary incontinence is simpler and quicker and has less hemorrhage during surgery as well as faster recovery and it also can obviously reduce the inguinal region pains after operation and shorten hospital stays. In summary, single-incision Needleless sling is a kind of convenient, safe and effective minimally invasive surgery for urinary incontinence.</span></span>展开更多
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 dif...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 questionnaires>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 significant 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).展开更多
文摘<strong>Objectives</strong>: <span style="font-family:;" "=""><span>The aim of this thesis is to determine the clinical effectiveness, safety and cost-effectiveness of Single Incision needleless Mini-Slings compared with tension-free Standard Mid-urethral Sling in the surgical management of female stress urinary incontinence, but with less side effects. </span><b><span>Methods:</span></b><span> The study will be conducted in Zagazig University Hospitals. From 2018 to Sept. 2019, 40 cases were enrolled in the study and were randomized by envelope technique at the time of surgery to either a trans-obturator vaginal tape (TOT) or Needleless anti-incontinence procedure. The patients will be divided into 2 groups: Group 1 patient treated by standard sling (TOT). Group 2 those treated by mini-sling. Parameters in perioperative period such as operating time, intraoperative hemorrhage volume, length of stay in hospital, intraoperative complications, and postoperative pain of each patient were recorded. The sample size was calculated to be 40 cases (20 cases will be treated by standard slings, 20 case will be treated by mini-sling). </span><b><span>Results: </span></b><span>A total of 40 patients assessed for eligibility were randomized into Needleless groups. There were no significant differences in age, body mass index, process, parity, pad test or the assessment of preoperative quality of life between the two groups. In the perioperative period, statistically significant differences between the two groups were found in operating time, intraoperative hemorrhage volume, groin pain scores at 24 h after operation and length of stay in hospital (P < 0.001). After two weeks of follow-up, a statistically significant difference between the two groups was found in groin pain/femori-bus internus pain scores, but there were no significant differences in cure rates, pad test, complications or ICIQ-SF. After 1 year, there were no significant differences between the Needleless and TOT groups in cure rates, pad test, groin pain or ICIQ-SF (P > 0.05). Both groups registered a significant improvement in the quality of life (P < 0.001), but there were no significant differences between the two groups (P > 0.05). </span><b><span>Conclusion: </span></b><span>We conclude that compared with the TOT surgery, single-incision Needleless sling in the treatment of female stress urinary incontinence is simpler and quicker and has less hemorrhage during surgery as well as faster recovery and it also can obviously reduce the inguinal region pains after operation and shorten hospital stays. In summary, single-incision Needleless sling is a kind of convenient, safe and effective minimally invasive surgery for urinary incontinence.</span></span>
文摘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 questionnaires>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 significant 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).
