Single-incision Mini-slings Research Articles

Use of the Martius Flap for Tethered Vagina Syndrome After a Single-Incision Mini-Sling Procedure.

Tethered vagina syndrome is an iatrogenic, but poorly defined condition that usually develops after surgical procedures performed on the anterior vaginal wall. Loss of elasticity as a result of scarring in the bladder neck-urethra is blamed for its pathogenesis. Patients often present with typical, massive uncontrollable urine loss and have specific examination findings. Having awareness about the diagnosis is important for its management. Surgical restoration and maintenance of bladder neck elasticity are essential for treatment. In our case, we presented the surgical approach we applied to tethered vagina syndrome that developed after the single-incision mini-sling operation. We demonstrated the surgical technique of Martius flap transposition and showed that this flap can be used to maintain the elasticity of the bladder neck area of the vagina.

Management of female stress urinary incontinence with single-incision mini-sling (Altis®): 36 month multicenter outcomes.

To assess noninferiority of the safety and effectiveness of the Altis® Single Incision Sling (SIS) with standard midurethral transobturator and/or retropubic slings through 36 months in a prospective, longitudinal, nonrandomized USFood and Drug Administration (FDA) 522 cohort study. Adult females with confirmed predominant stress urinary incontinence (UI) through cough stress test (CST) or urodynamics and failed two noninvasive incontinence therapies. Effectiveness endpoints included objective dryness, negative CST, adverse events, and revision/resurgery through 36 months. The primary effectiveness endpoint was reduction from baseline in 24-h pad weight of ≥50% at 6 months, as requested by the FDA, and is included as a study point in this paper. Primary safety endpoint was rate of related serious adverse events (SAE) through 36 months. Noninferiority margins of 15% and 10% were prespecified for the effectiveness and safety endpoints. Due to the observational nature of the cohort study, a propensity methodology was conducted to assess the effect of potential confounding variables on the primary endpoints between groups. Three hundred fifty-fivewomen underwent the sling procedure (n = 184 Altis; n = 171 Comparator). One hundred fourty(76%) Altis subjects and 101 (59%) Comparator subjects completed follow-up through 36 months. At 36 months, for the effectiveness endpoint, the difference in proportions of -0.005 for Altis versus Comparator (95% confidence interval [CI]: -0.102 to 0.092) was statistically significant (p = 0.002), supporting the hypothesis that Altis is noninferior to Comparator. Furthermore, both groups demonstrated high objective efficacy; in the Altis arm n = 99 (81.8%) subjects were a success, and in the Comparator arm, n = 79 (82.3%) subjects were a success. Additionally, regarding the CST, Altis was found to be noninferior to the Comparator at every study visit, and the rate of negative CST remained above 80% for both groups (p < 0.001). At 36 months, Altis (n = 2; 1.1%) and Comparator (n = 4; 2.3%) subjects experienced a device and/or procedure-related SAE. The difference in proportions of 0.013 for Altis versus Comparator (95%CI: -0.023 to 0.048) was statistically significant (p < 0.001), demonstrating that Altis is noninferior to Comparator with respect to the primary safety endpoint throughout the study. There were 62 (36.3%) retropubic midurethral slings (RMUS), 96 (56.1%) transobturator midurethral slings (TMUS), and 13 (7.6%) SIS slings in the Comparator group. For the 36 month effectiveness endpoint, assessing the noninferiority of Altis versus RMUS and Altis versus TMUS, 99 (81.8%) Altis and 37 (90.2%) RMUS were a success, trending toward statistical significance, however, it cannot be determined to be noninferior (p = 0.092). Ninty-nine(81.8%) Altis and 33 (71.7%) TMUS were a success; this was statistically significant (p < 0.001), demonstrating Altis was noninferior to TMUS. Rates of negative CST were 122 (87.1%) Altis, 40 (93.0%) RMUS (p < 0.001), and 44 (91.7%) TMUS (p < 0.001). CST demonstrated that Altis was noninferior to RMUS and Altis was noninferior to TMUS at 36 months. Altis single-incision sling was noninferior to standard midurethral sling for treatment of stress UI, throughout the study and at 36 months. Furthermore, adverse event rates were low.

The Efficacy and Safety of Single-Incision Mini-Slings for Stress Urinary Incontinence: A Network Meta-Analysis.

To evaluate the efficacy and safety of single-incision mini-sling for stress urinary incontinence based on network Meta-analysis. We searched PubMed, Embase, and Cochrane libraries from August 2008 to August 2019. Randomized controlled trials comparing two or more indicators of Miniarc (Single Incision Mini-slings), Ajust (Adjustable Single-Incision Sling), C-NDL (Contasure-Needleless), TFS (Tissue Fixation System), Ophria (Transobturator Vaginal Tap), TVT-O (Transobturator Vaginal Tape), and TOT (Trans-obturatortape) in treating female stress urinary incontinence were collected. Totally, 3,428 patients from 21 studies were included. Ajust had the highest subjective cure rate (Rank=0.52), while Ophira had the worst (Rank=0.67). TFS had the highest objective cure rate, and the worst was found in Ophira. TFS required the shortest operating time (Rank=0.40), while TVT-O required the longest operating time (Rank=0.47). Miniarc had the least bleeding (Rank=0.47), while TVT-O had the most bleeding (Rank=0.37). C-NDL had the shortest postoperative hospital stay (Rank=0.77), while Ajust had the longest postoperative hospital stay (Rank=0.36). For postoperative complications, TFS performed best in groin pain (Rank=0.84), urinary retention (Rank=0.78), and repeat surgery (Rank=0.45). TVT-O performed worst in groin pain (Rank=0.36), and urinary retention (Rank=0.58). Miniarc had the highest repeat surgery rate (Rank=0.35). Ajust had the lowest probability of tap erosion (Rank=0.30), while Ophira had the highest tap erosion level (Rank=0.45). Miniarc showed the greatest advantage in urinary tract infections (Rank=0.84) and de novo urgency (Rank=0.60), while C-NDL had the highest incidence of urethral infections (Rank=0.51). Ophira performed worst in de novo urgency (Rank=0.60). C-NDL performed the best in sexual intercourse pain (Rank=0.79) while Ajust was the worst (Rank=0.49). In view of comprehensive efficacy and safety, we recommend that TFS or Ajust should be selected first for single-incision sling and the application of Ophria should be minimized.

Single Incision Mini-Sling Versus Mid-Urethral Sling (Transobturator/Retropubic) in Females With Stress Urinary Incontinence: A Systematic Review and Meta-Analysis.

Stress urine incontinence (SUI) is most common in middle-aged women and the second most common in those over 75. SUI causes significant discomfort and suffering for patients and has a considerable financial impact on the healthcare system. Conservative approaches are recommended as the first step in treatment. However, surgery is often necessary to improve a patient's quality of life due to the high failure rate of conservative treatments. A thorough literature review of studies published before March 2023 was conducted on the safety and effectiveness of single-incision mini slings (SIMS) and standard mid-urethral slings (MUS). PubMed, Embase, Cochrane Library, and Elsevier's ScienceDirect were used to retrieve the studies. Two reviewers independently searched and evaluated the data based on inclusion and exclusion criteria. Review Manager 5.4 software was used for meta-analysis. Included were seventeen studies involving 3,503 female SUI patients without intrinsic sphincter deficiency (ISD) or mixed urinary incontinence. According to the results of our meta-analysis, the clinical efficacy of SIMS is comparable to that of MUS in terms of objective cure rate (RR: 0.99; 95% CI: 0.95 to 1.03, p: 0.66, I2: 29%). In contrast, it increases the post-procedure International Consultation on Incontinence Questionnaire (ICIQ) score (WMD: 0.08; 95% CI: -0.08 to 0.08). CI: -0.02 to 0.18, p: 0.11, I2: 55%) and improves the PGI-I score to a greater extent (RR: 1.04; 95% CI: 0.96 to 1.08, p: 0.36, I2: 76%). In contrast, there is no difference between the two groups regarding patient satisfaction (RR: 0.96; 95% CI: 0.92 to 1.01, p: 0.16, I2: 0%) and Sandvik score reduction (RR: 0.98; 95% CI: 0.94 to 1.02, p: 0.35, I2: 0%). In conclusion, single-incision mid-urethral slings (SIMS) are as effective as mid-urethral slings (MUS) for treating pure stress urinary incontinence (SUI) without intrinsic sphincter deficiency (ISD), with a shorter operation time. However, the SIMS procedure has a higher incidence of dyspareunia. At the same time, bladder perforation, mesh-related complications, pelvic/groin pain, urinary tract infection (UTI), worsening urgency, dysuria, and pain score are less likely to occur with SIMS. Only the decrease in pelvic/groin pain was statistically significant.

Adjustable slings versus other surgical methods in female stress urinary incontinence: a systematic review and meta-analysis.

The objective of this study was to evaluate the efficacy and safety of different adjustable slings compared to other surgical methods for the treatment of stress urinary incontinence (SUI) among women. The inclusion criteria were as follows: randomized controlled trials (RCTs) and non-RCTs assessing adult women with SUI. The exclusion criteria were as follows: other types of urinary incontinence, studies that combined conservative interventions and pharmacological treatment, pregnant and lactating patients. Databases were searched up to November 2022 to identify articles evaluating the effectiveness and safety of different adjustable slings compared to other surgical methods for the treatment of SUI among women. The systematic review was conducted in accordance with the PRISMA 2020 checklist and registered in PROSPERO. Risk-of-bias assessment tools recommended by the Cochrane Society were used to evaluate the risk of bias in the included studies. Eighteen clinical trials were included in this systematic review, and 11 studies were included in the meta-analysis. Fourteen studies were RCTs, and four were retrospective studies. Only RCTs were included in the meta-analyses. There was no statistically significant difference in the objective cure rate, subjective cure rate, or long-term postoperative complication rate between Ajust single-incision mini-slings (SIMS) and standard mid-urethral slings (SMUS) or MiniArc SIMS. However, the operation time in the adjustable SIMS group was significantly shorter (RR = -4.20, 95% CI: [-7.51, -0.89], p = 0.01). This systematic review and meta-analysis revealed that adjustable SIMS is equally effective when compared with SMUS for the treatment of SUI among women. Moreover, the operation time for the adjustable SIMS was shorter. However, additional well-designed studies with standard outcome measures and complete follow-up periods will help to increase confidence in the choice of different options for treating SUI among women.

The “Aberdeen Home Continence Stress Test”: a novel objective assessment tool for female stress urinary incontinence

Introduction and hypothesisClinical trials for stress urinary incontinence (SUI) require a robust, reliable, and responsive tool for objective assessment of SUI post-intervention. The Aberdeen Home Continence Stress Test (HCST) is a novel patient-reported objective assessment tool, aimed to be patient-friendly and reduce attrition rates by avoiding hospital appointments and prolonged pad-wearing. We aim to describe the HCST for the first time and evaluate its reliability, diagnostic accuracy, and response to change.MethodsA secondary analysis of the Single-Incision Mini-Slings (SIMS) study (a prospective multicentre randomised control trial (RCT) comparing two surgical treatments of SUI was performed. In SIMS (n = 600 women), the objective outcome was assessed by the 24-h pad test, while the patient-reported success rates were assessed using the Patient Global Impression of Improvement (PGI-I) at 15 months, 2 years and 3 years post-randomisation. Participants were instructed to perform the HCST before and after the 24-h pad test. The HCST was analysed in relation to reliability, validity, and the relationship between the 24-h pad test and HCST results and finally with regard to its responsiveness to change in PGI-I. (Trial registration-number ISRCTN93264234, registration date 14/01/2014).ResultsCompared to the 24-h pad test, the sensitivity of the HCST ranged from 0.81–0.95, specificity was 0.76–0.79, negative predictive value was 0.96–0.99 and positive predictive value was 0.32–0.43. Reliability was indicated by high-performing Cronbach’s alpha value (> 0.7). An improvement of ≥ 2 leakage groups on the HCST (for example from Large at baseline to Small leakage at follow-up) was strongly associated with patient-reported success on PGI-I (OR 4.38, 95% CI 2.31, 8.31).ConclusionsThe HCST is a valid and reliable patient-reported objective assessment tool that can be used for assessing SUI in surgical trials with good specificity, sensitivity, and consistency.

MP37-04 SINGLE-INCISION MINISLINGS IN 2022: A META ANALYSIS

You have accessJournal of UrologyCME1 Apr 2023MP37-04 SINGLE-INCISION MINISLINGS IN 2022: A META ANALYSIS Ann C. Stolzle, Harrison Torres, Clifton F. Frilot, and Alex Gomelsky Ann C. StolzleAnn C. Stolzle More articles by this author , Harrison TorresHarrison Torres More articles by this author , Clifton F. FrilotClifton F. Frilot More articles by this author , and Alex GomelskyAlex Gomelsky More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003275.04AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The TVT-Secur, which comprised many of the randomized controlled trials (RCTs) in the 2017 Cochrane Review of single-incision minislings (SIMS), has since been withdrawn from the market. Our purpose is to review the emerging RCTs in which SIMS comprises at least one of the trial arms. METHODS: A comprehensive PubMed search was performed, and several reviewers independently assessed the quality of the studies and extracted data. Study exclusion criteria included: abstract only, non-English language publication, minimum follow-up <6 months, and TVT-Secur as the sole other trial arm. A meta-analysis of surgical outcomes and adverse postoperative sequelae was performed. RESULTS: Literature search yielded 31 unique data sets (research groups) and 43 RCTs. SIMS comprising at least one arm included: Ajust, Altis, Contasure Needleless, EFA, MiniArc, Ophira, TFS, and TVT-Abbrevo. While all studies were randomized, there was significant variation in study design, allocation concealment, blinding of outcome assessment, and handling of incomplete data sets. There was also significant variation in inclusion/exclusion criteria, outcome criteria, and adverse event reporting. In all, 2844 women had a SIMS in at least one study arm. Six studies either had a combination of two SIMS or two MUS in a trial arm, or two separate SIMS individually compared to one MUS. Objective and subjective outcomes stratified by length of follow-up and comparison device are summarized in the Table 1. Only one study reported outcomes at >48 months. Most of the comparisons were SIMS vs. transobturator midurethral slings (MUS), with only four data sets comparing SIMS and retropubic MUS. Overall, SIMS were non inferior to other MUS procedures and no one SIMS was associated with significantly better outcomes. Rates of de novo urgency and urgency incontinence, long-term pain, vaginal mesh exposure, and repeat surgery were low and were not significantly different between groups. CONCLUSIONS: Short- and medium-term results from RCTs suggest that SIMS are safe and non-inferior to other MUS. The majority of the comparisons are between SIMS and transobturator MUS and significant variations in study design make grouping of outcomes challenging. Source of Funding: None © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e514 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Ann C. Stolzle More articles by this author Harrison Torres More articles by this author Clifton F. Frilot More articles by this author Alex Gomelsky More articles by this author Expand All Advertisement PDF downloadLoading ...

Re: Single-incision Mini-slings for Stress Urinary Incontinence in Women

Re: Single-incision Mini-slings for Stress Urinary Incontinence in Women

Single-incision mini-slings versus standard mid-urethral slings in the surgical management of female stress urinary incontinence: An updated systematic review and meta-analysis

Single-incision mini-slings versus standard mid-urethral slings in the surgical management of female stress urinary incontinence: An updated systematic review and meta-analysis

Re: Single-incision Mini-slings for Stress Urinary Incontinence in Women

Re: Single-incision Mini-slings for Stress Urinary Incontinence in Women

A new promising approach to urodynamic stress urinary incontinence care can help menopausal women.

The goal of this study is to evaluate the effectiveness of single-incision mini-sling in the surgical treatment of postmenopausal urodynamic stress urinary incontinence (SUI) compared to the standard trans-obturator mid-urethral sling. This prospective study was carried out in two tertiary centres; Al-Azhar University Maternity & Urology Hospitals. A total of 120 postmenopausal women with urodynamic SUI were randomized to undergo either single-incision mini-sling (n = 60) or standard trans-obturator mid-urethral sling procedure (n = 60) from May 2019 until Oct 2021. Main outcome measures: efficacy was evaluated utilizing objective cure rate (cough stress test) and subjective cure rate (Sandvik incontinence severity index and International Consultations on Incontinence Questionnaire - Short Form), intraoperative and postoperative complications, and postoperative pain (using a visual analogue scale). The single-incision mini-sling (SIMS) and transobturator tape (TOT) groups had no statistically significant difference in subjective and objective cure rates (p > 0.05). Compared with the transvaginal tape O group, patients in the SIMS group had significantly less postoperative pain, shorter operative duration, and less intraoperative blood loss (all p-values < 0.05). No significant difference in perioperative complications was observed between both groups. Single-incision mini-sling was superior to TOT in postmenopausal as SIMS is of similar effectiveness, more safe and minimally invasive with earlier ambulance.

Comparison of adjustable and nonadjustable single-incision mini-slings in the treatment of female stress urinary incontinence: An initial experience with 30 cases

ObjectiveSeveral single-incision mini-slings (SIMSs) have been developed to minimize the potential complications associated with retropubic or transobturator mid-urethral slings. However, few studies compared the efficacy of different types of SIMS. This study compared the outcomes of an adjustable SIMS (Ajust) with a nonadjustable SIMS (Solyx) in the treatment of urodynamic stress incontinence (USI) over postoperative follow-up of 12 months. Materials and methodsIn this study, the surgical outcomes of the first 30 patients receiving Ajust and the first 30 patients undergoing Solyx at a university hospital were reviewed retrospectively, all of whom were diagnosed with USI without coexistent pelvic organ prolapse. Preoperative and postoperative examinations included structured urogynecological questionnaires, 1-hour pad tests, and complete urodynamic testing. Patient demographics, urodynamic parameters, and 12-months surgical outcomes were compared between the Ajust and Solyx groups. ResultsThere were no significant differences between the Ajust and Solyx groups in terms of subjective cure rate (93.3% vs 90.0%), objective cure rate (89.3% vs 89.3%), and de novo urgency or urge urinary incontinence (13.3% vs 16.7%) 12 months after surgery. Postoperatively, both Urogenital Distress Inventory-6 and Incontinence Impact Questionnaire-7 scores were significantly improved in the Ajust and Solyx groups. In comparison with preoperative data, postoperative urodynamic results revealed a significant decrease in maximal urethral closure pressure in the Ajust group (n = 28) and a significant increase in residual urine in the Solyx group (n = 28). However, significant differences were not observed in the postoperative pad test and urodynamic data between the Ajust and Solyx groups, and no major complications occurred in either group. ConclusionsIn this paper describing the preliminary experience of 30 patients, both adjustable and nonadjustable SIMS performed by an experienced surgeon were safe and effective in correcting USI at 12-month postoperative follow-up.

The association between mesh-to-urethra distance and lower urinary tract symptoms in stress urinary incontinence patients surgically treated with an intra-operatively trimmed single incision mini-sling

The association between mesh-to-urethra distance and lower urinary tract symptoms in stress urinary incontinence patients surgically treated with an intra-operatively trimmed single incision mini-sling

Single-Incision Mini-Slings for Stress Urinary Incontinence in Women

BackgroundUntil recently, synthetic midurethral slings (made of mesh or tape) were the standard surgical treatment worldwide for female stress urinary incontinence, if conservative management failed. Data comparing the effectiveness and safety of newer single-incision mini-slings with those of standard midurethral slings are limited.MethodsWe performed a pragmatic, noninferiority, randomized trial comparing mini-slings with midurethral slings among women at 21 U.K. hospitals during 36 months of follow-up. The primary outcome was patient-reported success (defined as a response of very much or much improved on the Patient Global Impression of Improvement questionnaire) at 15 months after randomization (approximately 1 year after surgery). The noninferiority margin was 10 percentage points.ResultsA total of 298 women were assigned to receive mini-slings and 298 were assigned to receive midurethral slings. At 15 months, success was reported by 212 of 268 patients (79.1%) in the mini-sling group and by 189 of 250 patients (75.6%) in the midurethral-sling group (adjusted risk difference, 4.6 percentage points; 95% confidence interval [CI], −2.7 to 11.8; P<0.001 for noninferiority). At the 36-month follow-up, success was reported by 177 of 246 patients (72.0%) and by 157 of 235 patients (66.8%) in the respective groups (adjusted risk difference, 5.7 percentage points; 95% CI, −1.3 to 12.8). At 36 months, the percentage of patients with groin or thigh pain was 14.1% with mini-slings and 14.9% with midurethral slings. Over the 36-month follow-up period, the percentage of patients with tape or mesh exposure was 3.3% with mini-slings and 1.9% with midurethral slings, and the percentage who underwent further surgery for stress urinary incontinence was 2.5% and 1.1%, respectively. Outcomes with respect to quality of life and sexual function were similar in the two groups, with the exception of dyspareunia; among 290 women responding to a validated questionnaire, dyspareunia was reported by 11.7% in the mini-sling group and 4.8% in the midurethral-sling group.ConclusionsSingle-incision mini-slings were noninferior to standard midurethral slings with respect to patient-reported success at 15 months, and the percentage of patients reporting success remained similar in the two groups at the 36-month follow-up. (Funded by the National Institute for Health Research.)

Single-incision mini-sling and trans-obturator sling for stress urinary incontinence: A 5-year comparison

ObjectiveThe aim of our study was to compare objective and subjective outcomes in women with stress urinary incontinence (SUI) submitted to either trans-obturator sling (TVT-ABBREVO®) or single incision mini-sling (SIMS-ALTIS®) at 5-year follow up. Study designA monocentric, retrospective study including women with isolated SUI and with concomitant proved urodynamic stress incontinence (USI), treated with an TVT-ABBREVO® or SIMS-ALTIS®. At 60-month follow up each woman was assessed subjectively, with two validated questionnaires (UDI-6 and ICQI-SF), and objectively with a cough stress test. Adverse events were collected. ResultsForty-two patients were evaluated in the ABBREVO® group and 58 in the ALTIS® group. No significant difference was found in subjective (88.1% vs 89.7%, p = 0.806) and objective (81.0% vs 86.2%, p = 0.479) cure rates between the two groups. Subjectively, improvement in urinary distress after surgery resulted statistically significant in both groups compared to baseline (p < 0.001). Long-term post-operative complications rate (i.e. de novo OAB and sling exposure) was similar in the two groups. They were, in fact, mainly classified as Dindo II grade and conservatively managed (i.e. antimuscarinics or β3 agonists for de novo OAB). ConclusionThis comparative study did not reveal significant difference between single-incision (ALTIS®) and trans-obturator (TVT-ABBREVO®) slings in terms of efficacy and morbidity at 5-year follow up.

Obez Kadınlardaki Stress Üriner İnkontinansın Cerrahi Tedavisinde Transobturator Bant ve Tek İnsizyon Mini-Sling Prosedürlerinin Karşılaştırılması: Retrospektif Kohort Çalışması

Obez Kadınlardaki Stress Üriner İnkontinansın Cerrahi Tedavisinde Transobturator Bant ve Tek İnsizyon Mini-Sling Prosedürlerinin Karşılaştırılması: Retrospektif Kohort Çalışması

Stress urinary incontinence in the mesh complication era: current Australian trends.

To examine available data relating to the surgical management of stress urinary incontinence (SUI) in Australia before, during and after a well-publicized Senate Inquiry into transvaginal mesh use and to consider outcomes in the context of global guideline changes. The annual number of surgical procedures for the management of SUI by procedure type and age group for the years 2008/2009-2017/2018 was obtained from the Australian Government Department of Human Services database using Medicare Benefits Schedule item numbers. The data extracted were limited to women aged 25years and older. These data were used to calculate age-specific and age-standardized rates, so as to accurately analyse trends in the usage of different procedures. Hospital Episode Statistics for mid-urethral sling (MUS) insertions were obtained for England's National Health Service from the Health and Social Care Information Centre for the years 2008/2009-2016/2017. These data were also used to calculate annual age-standardized rates for comparison purposes. Rates declined for most SUI procedures over time (MUS, colposuspension, fascial slings) except for urethral bulking agents. The absolute number of MUSs implanted in 2008/2009 was 5729, which decreased to 3127 in the 2017/2018 financial year. Over the decade, the annual rate for MUS implantation per 100000 population halved from 78 to 36. Over this same period, the rate of usage of bulking agents doubled, although represented a low volume of procedures (overall numbers increased from 304 to 698, representing an increase from four to eight procedures per 100000 population). The age-specific peak rate for MUS and Burch colposuspension changed over the decade from 55-64years to 65-74years, suggesting that women are deferring surgical treatment until later in life. Over the last decade, the total number of surgical procedures performed in Australia to treat SUI has decreased markedly from 6812 to 4279. This represents a decrease in the annual rate per 100000 population from 93 to 49. There are clear changes evident for SUI management in the past decade in Australia, including an overall decline in operative numbers, which correlate with international advisory notifications and local investigations. The results of the Australian Senate inquiry, including removal of single-incision mini-slings, greater availability of patient resources, and greater regulation of SUI procedures, will probably have ongoing effects. Surgeons need to ensure that sufficient training and patient education continue in order to maintain appropriate access to treatment of SUI in the future.

Comparison of Two Single-Incision Mini-Slings for the Treatment of Incontinence

Introduction: This study aimed to compare the safety and efficacy of 2 single-incision mini-sling (SIMS) systems with different designs of anchoring mechanism. Methods: The records of patients who have been operated for the treatment of female stress urinary incontinence (SUI) with 2 different SIMS systems were retrospectively evaluated. Patient characteristics, physical examination results, and quality of life (QoL) questionnaires were used to evaluate the patients. Primary efficacy endpoints were the cure and failure rates. Secondary efficacy endpoints were complications and differences in QoL questionnaires. Results: Eighty-three patients from group 1 (Ophira SIMS system) and 77 patients from group 2 (Gallini SIMS system) were evaluated. There was no significant difference between the 2 groups regarding patient characteristics. The objective cure rates were found to be 83.1 and 79.2% in group 1 and group 2, respectively (p = 0.09). Mesh-related complications, such as anchor displacement, bladder erosion, vaginal erosion, and groin pain, were more common in group 1. No severe complications were observed. For both groups, a significant improvement in all scores of QoL questionnaires was observed after surgery; however, the differences between 2 groups were not significant. Conclusions: The present study showed that the treatment of female SUI with 2 different SIMS systems had similar efficacy, complication rates, and scores in QoL questionnaires.

Surgical treatments for women with stress urinary incontinence: a systematic review of economic evidence

BackgroundSurgical interventions for the treatment of stress urinary incontinence (SUI) in women are commonly employed following the failure of minimally invasive therapies. Due to the limited information available on the relative cost-effectiveness of available surgeries for treating SUI, a de novo economic analysis was conducted to assess costs and effects of all relevant surgeries. To inform the economic analysis, the objective of this review was to identify and assess the quality of existing economic evaluation studies on different surgical interventions for the treatment of SUI in women.MethodsThe following databases were searched during the review process: Medical Literature Analysis and Retrieval System Online (MEDLINE), MEDLINE In-Process, Excerpta Medica Database (Embase), National Health Service Economic Evaluation Database (NHS EED), and Health Management Information Consortium and Cost-Effectiveness Analysis Registry (CEA registry). The key criteria for inclusion were that the study population included women with SUI and that the surgical interventions considered were utilised as either a primary or a follow-up surgery. The review included only full economic evaluations. Studies were quality assessed using the Drummond checklist for economic evaluations. No quantitative synthesis of the results by meta-analysis was conducted due to the high methodological heterogeneity.ResultsTwenty-six economic evaluations were included, of which 13 were model-based analyses. Surgical treatments assessed most frequently were mid-urethral slings and open and laparoscopic colposuspension. There were some differences in the methodological approaches taken, including differences in type of economic analysis, perspective, time horizon, types of resource use, and costs and outcomes that were included in the analysis. The majority of studies conducted a cost-utility analysis from a health system perspective and applied a time horizon of between 1 and 5 years. The cost-effectiveness results suggest that single-incision mini-sling and mid-urethral slings are among the most cost-effective options.ConclusionsThe review has shown that methods used for the economic evaluation of surgical treatments for SUI vary widely in terms of study design, analysis type, compared alternatives, time horizon, costing methodologies and effect outcomes. Future economic evaluation studies on surgical treatments for SUI may be improved by the application of available guidelines.Systematic review registrationRegistered in PROSPERO in 2016, CRD42016049339

The Comparison of Adjustable Single-incision Mini-Sling and Transobturator Tape for the Treatment of Stress Urinary Incontinence

The Comparison of Adjustable Single-incision Mini-Sling and Transobturator Tape for the Treatment of Stress Urinary Incontinence