Single-incision Sling Research Articles

Patient Satisfaction and QoL in SUI: Results With Single-Incision or Full-Length Slings.

Understanding treatment impact on quality of life of patients with stress urinary incontinence (SUI) in the short- and long-term is vital to optimizing treatment success. This study aimed to report 36-month patient satisfaction and quality of life results from a 522 study of single-incision and full-length slings in SUI. This was a secondary analysis of the Altis 522 study, a prospective, multicenter, nonrandomized, noninferiority cohort study comparing the Altis single-incision sling to full-length slings for the treatment of SUI. The current study endpoints are patient-reported outcomes on quality of life related to continence status at 6, 12, 18, 24, and 36 months, measured through patient-reported, validated questionnaires: Urogenital Distress Inventory, Incontinence Impact Questionnaire, Patient Global Impression of Improvement, and Surgical Satisfaction Questionnaire. A total of 355 women underwent the sling procedure (184, Altis group; 171, comparator group). At 36 months, 140 (76.0%) of Altis and 101 (59.1%) of comparator group patients were assessed. Patient Global Impression of Improvement at 36 months indicated that 92.9% of Altis and 90.1% of comparator patients reported that their condition was "very much better" or "much better" (P = 0.444). Urogenital Distress Inventory at 36 months indicated improvement in quality of life in both groups with a mean change from baseline of 41.7 ± 19.3 (Altis group; n = 140) versus 44.4 ± 22.2 (comparator group; n = 101) (P = 0.305). The Incontinence Impact Questionnaire indicated average quality-of-life improvement of 50% in both groups from presurgery to 36 months, with a mean change from baseline of 51.8 ± 25.8 (Altis group) versus 50.2 ± 25.1 (comparator group) (P = 0.619). This 36-month study demonstrated the lasting, positive effect that surgical intervention can have on patients with SUI.

An update on surgical management for stress urinary incontinence.

Stress urinary incontinence (SUI) is a common condition for which women often opt for surgical management. Synthetic midurethral slings (MUS) have been the dominant treatment for decades. Single-incision slings (SIS) have been introduced to lower the morbidity associated with trocar passage during MUS placement. Urethral bulking has been used less frequently owing to its lower cure rates. New data have recently emerged in support of single-incision slings (SIS) and urethral bulking with Bulkamid polyacrylamide hydrogel (PAHG). Several studies with a follow-up ≥10 years have shown stable efficacy and complication rates of retropubic (RMUS) and transobturator (TMUS) midurethral slings over time. SIS products show equivalent efficacy to traditional TMUS and RMUS at up to 3 years of follow-up and can be placed under local anesthesia. While urethral bulking with PAHG results in lower cure rates compared to slings, satisfaction rates are high and responders have sustained improvement at 7 years follow-up. All three types of available slings, TMUS, RMUS, and SIS, are now considered appropriate surgical options for the treatment of SUI. Although the absence of comparative data precludes a formal recommendation for one injectable over another, urethral bulking with PAHG has favorable long-term results and an excellent safety profile.

Single Incision Sling Surgery for Female Stress Urinary Incontinence: A Retrospective Cohort Single-Institution Study.

Background: Stress urinary incontinence (SUI) affects around 35% of adult women and has a significant impact on quality of life. A single incision sling (SIS), such as Altis®, was introduced to improve original slings and avoid complications. The present study aimed to evaluate the SIS Altis® subjective and objective cure rates of women with SUI, mixed urinary incontinence (MUI), recurrent SUI, and SUI with concomitant prolapse and report its complications from one single medical center. Methodology: A retrospective cohort, unsponsored study was conducted at the Jordan University Hospital. All women patients were treated with the SIS Altis® procedure, and prolapse procedures were also completed as necessary. The chi square analysis for the cure rates was conducted between the subgroups. Results: From June 2016 to June 2019, 111 women patients with a mean age of 48.0 ± 11.3 years underwent a SIS Altis® procedure. The overall outcome resulted in 81% and 85% of patients being subjectively and objectively cured. The subjectively cured MUI patients were significantly fewer than SUI patients (70% versus 86%, p < 0.05), and patients with recurrent SUI had significantly lower rates (56% for subjective and objective cure rates; p < 0.01 and 0.001). Of the 44 patients who underwent SIS Altis® and concomitant vaginal repair surgery, no significant differences in subjective and objective cure rates were observed. Only 2.7% of women had mild pain, 2.7% had vaginal tape erosion, and 9% had to be re-operated on. Conclusions: The Altis® procedure is effective in women who suffer from SUI for a 19-month follow-up period. However, recurrent SUI patients had lower subjective and objective cure rates than primary SUI patients. Further research is needed with a larger sample size in a prospective study design to determine the effectiveness of single SIS in patients with recurrent SUI.

A prospective multicenter European observational study of a single incision sling (Altis®): A safe and effective treatment option for women

Introduction:Single-incision slings were introduced for female stress urinary incontinence (SUI) treatment to decrease surgery time, postoperative pain, and the amount of mesh used. Objective:This multicenter study aims to examine Altis® usage in real-world clinical practice, its effectiveness in treating SUI, patient satisfaction, quality of life, sexual function, and complication rates. Methods:Between 2015 and 2022, a prospective single-arm observational cohort study was conducted across 33 European centers involving 564 patients, investigating the clinical effectiveness of the Altis® sling. Patients were monitored for 36 months. The primary endpoint (success) was a positive impression of improvement and absence of serious/severe/Clavien Dindo (CD) ≥ III-related adverse events at 12 months. Secondary endpoints included effectiveness at 36 months, impact on quality of life, and risk factors for failure. Results:An Altis® was implanted in 564 women. At 12-months, 86.6% of patients achieved success, 97.2% endorsed the surgery, and 90.4% were satisfied with the outcomes. At 36 months, 83.0% reported significant improvement, 94.5% endorsed the surgery, and 89.9% were satisfied. Altis® demonstrated decreased daily pad usage and improved quality of life. Dyspareunia and sexual function largely remained unchanged. However, 11.3% reported pain, and there were instances of serious adverse events. Conclusion:The Altis® implant demonstrated substantial improvements in symptoms and overall quality of life for a majority of women with SUI. Potential complications such as mesh exposure, reoperation, voiding dysfunction, and urinary retention emphasize the importance of preoperative counseling. The Altis® implant is a viable option within the available surgical treatments of SUI.

A randomized trial of retropubic vs single-incision sling among patients undergoing vaginal prolapse repair

The choice of midurethral sling type may impact efficacy and complications in women undergoing transvaginal native tissue repair of pelvic organ prolapse. The primary aim was to determine if the single-incision sling is noninferior to retropubic sling for the management of stress urinary incontinence among patients undergoing reconstructive or obliterative native tissue vaginal repair. The secondary aims were to compare adverse events and surgeon ease of use with sling assignment. A multicenter, noninferiority, randomized trial of women with ≥ stage II pelvic organ prolapse and objectively confirmed stress urinary incontinence undergoing reconstructive or obliterative vaginal repair was performed. Women were randomized to concomitant single-incision (Altis sling, Coloplast Minneapolis, MN) with suprapubic sham incisions or retropubic slings. The primary dichotomous outcome was abnormal lower urinary tract function within 12 months postsurgery, defined as bothersome stress urinary incontinence symptoms (>1 Pelvic Floor Distress Inventory question no. 17); retreatment for stress urinary incontinence or treatment for urinary retention. Secondary outcomes were adverse events, Patient Global Impression of Improvement of bladder function, and surgeon ease of use (1, worst; 10, best). All subjects completed validated questionnaires and underwent a Pelvic Organ Prolapse Quantification, cough stress test, and postvoid residual preoperatively, at 6 weeks and 12 months postoperatively. Assuming a subjective cure rate for retropubic of 82%, 80% power, and 1-sided 5% significance level, we estimated that 127 patients in each arm were needed to declare noninferiority of the single-incision sling if the upper bound of the 95% confidence interval for the between-group difference per protocol in abnormal bladder function was <12%. Assuming a 10% loss to follow-up, the total enrollment goal was280. Between December 2018 and January 2023, 280 subjects were enrolled across 7 sites, and 255 were randomized: 126 were for single-incision, and 129 were for retropubic sling. There were no preoperative or operative characteristic differences between groups. Overall, 81% had reconstructive, and 19% had obliterative native tissue repairs. The primary outcome, abnormal lower urinary tract function at 12 months, occurred in 29 (25%) of single-incision vs 24 (20%) of the retropubic sling group (risk difference, 0.04472 [95% confidence interval,-0.03 to 0.1133]; P=.001 for noninferiority). Bothersome stress urinary incontinence occurred in 20% vs 17% (P=.27) and was retreated in 4% vs 2% (P=.44) of single-incision vs retropubic groups, respectively. Adverse events were reported in 24 (16%) of single-incision vs 14 (9%) of the retropubic group (95% confidence interval, 0.95-3.29; P=.70) and included de novo or worsening urgency incontinence symptoms, urinary tract infection, mesh exposure, need for prolonged catheter drainage, and de novo pain, without differences between groups. Patient Global Impression of Improvement (very satisfied and satisfied) was 71% vs 67% (P=.43), and median surgeon ease of sling use was 8 (7-10) vs 9 (8-10), P=.03 in single-incision vs retropubic, respectively. For women undergoing vaginal repair, single-incision was noninferior to retropubic sling for stress urinary incontinence symptoms, and complications, including treatment for urinary retention, did not differ.

Minimally Invasive Treatment of Stress Urinary Incontinence in Women: A Prospective Comparative Analysis between Bulking Agent and Single-Incision Sling.

The study aims to compare the efficacy and safety of bulking agents and single-incision slings in the treatment of urinary incontinence in 159 patients during a 29-month follow-up period. Of the 159 patients suffering from stress urinary incontinence, 64 were treated with bulking agents (PAHG Bulkamid®) and 75 with a single-incision sling (Altis®). The ICIQ-UI-SF (Incontinence Questionnaire-Urine Incontinence-Short Form), PISQ-12 (Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaires short form), FSFI (Female Sexual Function Index), FSDS (Female Sexual Distress Scale), and PGI-I (Patient Global Improvement Index) were used to assess efficiency and quality of life. The bulking agents showed high efficacy and safety during the 29-month follow-up. Post-operative complications were recorded in both groups, with only two significant differences. The Bulkamid group experienced no pain, while 10.8% of the ALTIS group experienced groin pain and 5% experienced de novo urgency. Furthermore, patients treated with bulking agents experienced reduced nicturia (0.78 vs. 0.92 in patients treated with single-incision slings.). In both groups, we noticed a significant improvement in QoL (quality of life), with a halved ICIQ-UI-SF (International Consultation on Incontinence Questionnaire-Urine Incontinence-Short Form) score which was completed to assess the impact of urine symptoms. After 24 months of therapy, the Bulkamid group saw a decrease from 14.58 ± 5.11 at baseline to 5.67 ± 1.90 (p < 0.0001), whereas the ALTIS group experience a decrease from 13.75 ± 5.89 to 5.83 ± 1.78. Similarly, we observed an improvement in sexual function, with the number of sexually active patients increasing from 29 to 44 (56.4%) in the Bulkamid group (p = 0.041) and from 31 to 51 (61.7%) in the ALTIS group (p = 0.034). According to the most recent statistics, the PISQ-12, FSFI, and FSDS scores all demonstrated an improvement in women's sexual function. In terms of efficacy and safety, bulking agents had notable results over the 29-month follow-up period. Furthermore, the patients treated with bulking agents reported a lower incidence of postoperative complications and a no discernible difference in terms of quality of life and sexual activity compared to the ones treated with single-incision slings. Bulking agents can be considered a very reliable therapeutic option based on accurate patient selection.

Long-Term Outcomes of the Altis® Single-Incision Sling: Up to 10 Years' Follow-up.

Single-incision slings (SIS) have emerged as a less invasive alternative to conventional slings for stress urinary incontinence (SUI) treatment. However, long-term efficacy and safety results remain uncertain owing to a lack of studies. A retrospective review of 155 patients treated with Altis® for SUI between February 2012 and June 2017, held in 2022, as a continuation of a prospective study in which all patients (197) were reviewed for 2 years after surgery (1, 6, 12, and 24months). Preoperative demographic data, comorbidities, and pressure-flow studies were also recorded. Continence status and satisfaction rates were assessed using the International Consultation on Incontinence Questionnaire-short form (ICIQ-SF) and the Patient Global Impression of Improvement (PGI-I) respectively. The assessment in the 2022 retrospective review was performed via a telephone survey. Mean follow-up time after surgery was 85.3months (82.5-88.1). In 2022, complete continence was present in 75.4% of the patients. The presence of urinary urgency conditioned the ICIQ-SF score (10.9 vs 1.7 points, p < 0.01), with the ICIQ-SF = 0 in 84.5% of the patients with no associated urgency. Satisfaction assessed by the PGI-I was high, with 84.6% of the patients showing improvement. De novo urgency was present in 37,9% of the patients by 2022. Urinary tract infections were the most frequent complication (9.7%), with only 5 documented cases of mesh erosion. Altis® SIS is a safe and effective device for SUI treatment, with satisfaction rates comparable with those of the conventional slings. Persistence or development of urinary urgency influences the results.

More With Less: Single-Incision Sling Insertion Techniques

To demonstrate reproducible procedures for efficient single-incision sling insertion and troubleshooting. Narrated video footage with stepwise demonstration of single-incision sling insertion technique with anchor system. The mesh midurethral sling is a highly effective and safe procedure that is considered the gold standard for surgical treatment of stress urinary incontinence. Retropubic and transobturator approaches for midurethral slings have similar subjective cure rates with differing surgical risk profiles [1,2]. The retropubic route has a higher risk of injury to the bladder, nerves, and vascular structures, whereas the obturator approach carries a risk of groin or thigh pain [3-5]. Use of a single-incision sling decreases these risks and allows flexibility to perform the procedure without sedation or general anesthesia. Recent literature demonstrates similar subjective and objective success and safety of single-incision slings compared with both retropubic and transobturator approaches, although long-term data are forthcoming [5]. We demonstrate a stepwise approach for the insertion of a single-incision sling using a helical trocar. Easily reproducible procedures for setup and sling anchor management allow for efficient placement without assistance. In addition, we outline hand positioning, trocar management, and anchor deployment with troubleshooting techniques for potential placement difficulties. Finally, we review methods for sling tensioning to prevent complications such as voiding dysfunction and mesh or suture exposures. Given that single-incision slings are more likely to be performed under local anesthesia and are less invasive with decreased recovery time, it has the potential to become the preferred approach in the future. This video demonstrates clear and detailed steps to facilitate successful placement of the single-incision mesh midurethral sling.

Serious complications and recurrences after retropubic vs transobturator midurethral sling procedures for 2682 patients in the VIGI-MESH register

BackgroundMidurethral slings are the gold standard for treating stress urinary incontinence, but their complications may raise concerns. Complications may differ by the approach used to place them. Objective(s)To compare serious complications and reoperations for recurrence after midurethral sling procedures by the retropubic and transobturator routes for female stress urinary incontinence. Study DesignThis analysis covers patients included in the French multicenter VIGI-MESH register since February 2017 who received a midurethral sling for female stress urinary incontinence by the retropubic or transobturator route, excluding single-incision slings. Follow-up continued to October 2021. Serious complications (Clavien-Dindo classification ≥ Grade III) imputable to the midurethral sling and reoperations for recurrence were compared by Cox proportional hazard models including any associated surgery (hysterectomy or prolapse) and a frailty term to consider the center effect. Baseline differences were balanced by propensity score weighting. Analyses using the propensity score and Cox models were adjusted for baseline differences, center effect, and associated surgery. Results1830 participants received a retropubic sling and 852 a transobturator sling in 27 French centers, placed by 167 surgeons. The cumulative two-year estimate of serious complications was 5.8% (95% CI 4.8%-7.0%)) in the retropubic group and 2.9% (95% CI, 1.9%–4.3%) in the transobturator group, that is, after adjustment, half that of the retropubic group (adjusted HR 0.41; 95% CI 0.3-0.6). The cumulative two-year estimate of reoperation for recurrence of stress urinary incontinence was 2.7% (95% CI 2.0-3.6) in the retropubic group and 2.8% (95% CI 1.7-4.2) in the transobturator group, with risk of revision for recurrence higher in the transobturator group after adjustment (adjusted HR 1.9; 95% CI 1.2-2.9); this surplus risk disappeared after exclusion of the patients with a previous surgery for stress urinary incontinence. ConclusionsThe transobturator route for midurethral slings is associated with a lower risk of serious complications but a higher risk of surgical reoperation for recurrence than the retropubic route. Despite the large number of surgeons involved, these risks were low. The data are therefore reassuring.

Long-term outcomes of surgical interventions for stress urinary incontinence: a systematic review and network meta-analysis.

Stress urinary incontinence is common among women, and surgical interventions have significantly improved patients' symptoms. The long-term effectiveness of these surgeries is increasingly drawing attention, yet it remains sparsely documented in the literature. To compare the long-term effectiveness and safety of retropubic tension-free vaginal tape (TVT-RP), tension-free vaginal tape-obturator (TVT-O), transobturator tape (TOT), single-incision sling (SIS), Burch colposuspension, and pubovaginal sling (PVS). A comprehensive and systematic literature review was conducted in PubMed, EMBASE, MEDLINE, Cochrane Library, Medicine, and clinicaltrials.gov from inception to May 2023. Selected trials were evaluated for potential bias using the Cochrane tool. Treatment modalities were compared using network meta-analysis to assess objective success rate, subjective success rate, and complications as outcomes. A total of 37 studies involving 5720 patients were included. No significant statistical differences were found among the interventions regarding objective success rate. PVS had the highest surface under the cumulative ranking curve SUCRA value (93.1). For subjective success rate, TVT-RP, TVT-O, and PVS demonstrated superiority over SIS, with PVS having the highest SUCRA value (80.1). SIS had lower overall complication and pain rates compared to other methods, with statistical significance. There were no differences in reoperation rate, exposure rate, and urinary tract infection occurrence among the surgical approaches. In terms of long-term effectiveness and safety, TVT-RP and TVT-O appear to be the preferred options for patients opting for synthetic slings, while for patients seeking nonsynthetic slings, PVS may represent the optimal choice.

A Novel Technique of Post-Operative Adjustment of Single Incision Sling

A Novel Technique of Post-Operative Adjustment of Single Incision Sling

Three-year Follow-up of a Single Incision Sling Procedure Performed Under Local Anesthesia in an Office Setting

To assess the 3-year success of placing a single-incision midurethral sling (SIMS) using the Dynamic Intraoperative Standing Sling Technique (DISST) in an office setting under local anesthesia. This is a prospective case series of 20 women who underwent in-office SIMS procedure by the DISST from July 2019 to February 2020. This is an extension of our pilot study (11) and all 20 patients were evaluated at a mean follow-up of 34.3months. Success was defined as a composite score of objective success (negative standing cough test at bladder fullness), subjective success based on the modified PGI-I score of "very much better" or "much better," and no retreatment for stress urinary incontinence. Secondary objectives were adverse events, de novo overactivity of the bladder, recurrent urinary tract infections, voiding dysfunction, pain/dyspareunia, and influence on sexual function. The composite success rate was 95% (95% CI [75.1, 99.9]) at the 36-month follow-up. The significant improvement in MESA scores was maintained over the study period. There were no cases of de novo urgency, mesh exposure, postop voiding dysfunction or recurrent urinary tract infections. There were no cases of de novo dyspareunia. SIMS placed by the DISST technique under local anesthesia in an office setting has shown sustained efficacy over a 3-year period with no decrease in cure. Subjects remained dry and reported excellent improvement in symptoms and quality of life at the 36-month follow-up visit.

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.

Is detrusor underactivity associated with voiding dysfunction after single incision sling surgery?

Some women experience voiding dysfunction after stress urinary incontinence (SUI) surgery. We explore if detrusor underactivity (DU) found in urodynamic study (UDS) prior to SUI surgery using an adjustable single incision sling (SIS) may be related to voiding dysfunction after surgery. This is a prospective, diagnostic, transversal, single center study comparing voiding dysfunction after SUI surgery with a SIS (Altis®; Coloplast, Humlebæk, Denmark) between women with DU (cases) or normal detrusor (controls). Inclusion criterium was women ≥18 years with SUI/mixed UI (stress predominant) operated between June 2013 and December 2020. Exclusion criteria were: women without UDS prior to surgery or without voiding phase in the P/Q, previous incontinence surgery, POP stage ≥2, neurogenic conditions, other pelvic floor surgery. Urinary symptoms were assessed using structured questions evaluating storage/voiding symptoms. Patients were divided into two groups according to projected Isovolumetric Pressure Index (PIP<inf>1</inf>) with 30-75 cmH<inf>2</inf>O indicating normal contractility. A total of 139 women were included, 29 (20.9%) in DU group and 110 (79.1%) in control group. Control and DU groups have shown similar objective (75.5% vs. 71.4% P=0.66) and subjective (85.4% vs. 96.1% P=0.22) success rates, respectively, without statistical differences. Voiding symptoms increased after surgery in both groups (+20.7% DU group vs. +8.1% normal group, P=0.29). More voiding symptoms (persistent/de novo) were found in DU group vs. normal group, but without statistically significant differences. According to our results, the presence of DU previous to SUI surgery with a SIS (Altis®, Coloplast) has no impact on objective and subjective success rates. On the other hand, patients with preoperative DU showed higher proportion of voiding dysfunction but no statistical difference.

Efficacy and Adverse Effects After Single-Incision Slings for Women with Stress Urinary Incontinence: A 12-Year Follow-Up.

Single-incision slings (SISs) are not considered the first surgical choice for stress urinary incontinence due to few data about long-term results. Our aim was to evaluate the outcomes of SISs 12 years after implantation and to search for consequences such as deterioration after a certain amount of time. We included women with stress urinary incontinence both clinically and urodynamically proven who underwent SISs procedure. Objective and subjective cure rates were compared to short-term outcomes to detect possible deterioration over time. A total of 85 patients were analysed with a median follow-up of 12.0 (IQR 10.4-12.8) years. Objective and subjective cure rates were 81.0% and 82.1%, respectively. Median (IQR) PGI-I scores and ICIQ-SF, respectively, were 1 (1-2) and 0 (0-6.8). No significant deterioration of outcomes over time was shown after comparison between short-term and long-term follow-ups (objective cure rate 84.5% vs 81.0%, p=0.684; subjective cure rates 92.9% vs 82.1%, p=0.060). Also, voiding symptoms and overactive bladder did not differ over time (20.2% vs 21.4%, p=1.000; 20.2% vs 33.3%, p=0.080, respectively). SISs were shown to be a procedure with a great efficacy and safety profile at very long-term follow-up.

Local anesthesia for Altis® single incision sling in women with stress urinary incontinence

Objective Local anesthesia for single incision slings has shown a good objective and subjective cure rate in women with stress urinary incontinence. The aim of the present study was to verify the efficacy and safety of local anesthesia during Altis® single incision placement. Material and methods One hundred sixty-six consecutive patients (83 patients for each group: local resp. spinal anesthesia) were selected from our database for this retrospective study among women who underwent an Altis® implantation for SUI from September 2016 to June 2021, after unsuccessful previous conservative treatment. Primary endpoints were objective and subjective cure rates; secondary endpoint was the evaluation of complications linked to this procedure. Results A total of 155 included patients completed our 12 months follow-up. Baseline characteristics were similar between the groups. Operative time (percentage difference of 50%; p < 0.05) and the Intraoperative Difficulty Scale resulted lower in spinal patients. No differences were found between populations in terms of objective (cough stress test and urodynamics) and subjective (PGI-I and FSDS questionnaires) cure rate and postoperative complications. Conclusion Local anesthesia for Altis® implantation could be considered a safe alternative to spinal anesthesia and an effective opportunity to avoid general anesthesia, increasing the possibility of outpatient implantation of this sling system.

Could infiltration anesthesia decrease anchor-fixation quality of midurethral slings in the obturator complex?

Single-incision miduretral slings (SIMS) were withdrawn from the market in many countries due to lower efficacy. In some countries they are still in use, preferred primarily because it is possible to perform the procedure under local anesthesia. Based on our previous clinical experience we postulated that local anesthesia decreased primary anchor fixation in the obturator complex. The aim of the study is to assess how local infiltration anesthesia influences anchor fixation of the tape in porcine obturator complex. The experiment was designed to determine the maximum force necessary to extract an implant anchor from a porcine obturator complex. The implant was extracted at a constant speed and data sampling frequency, and the data on displacement of the testing system, achieved force and time were recorded. The implant arms were divided into groups on the right and left sides. In the first group, the anchored arms were used for two implantations - primary and secondary without infiltration anesthesia - and in the second group they were used in the same way, using infiltration anesthesia. A total of 40 implanted anchors were tested in the experiment, totaling ten single-incision slings (each anchor was implanted twice). An average of 8.28 N (Newton) (SD 6.73, min. 2.11, max. 30.34 N) is required to remove the implant anchor from the obturator complex without infiltration by local anesthesia. An average force of 4.40 N (SD 2.99 min. 1.2, max. 9.48) is required to remove the anchor from the obturator complex after infiltration. Local anesthesia reduces anchor fixation in the obturator complex by 47%. The local infiltrative anesthesia decreases anchor fixation in the porcine obturator complex.

Safety and Efficacy of Single Incision Sling Versus Midurethral Sling in the Treatment of Stress Urinary Incontinence: A Randomized Controlled Trial

ABSTRACT The midurethral sling (MUS) is the criterion standard for SUI treatment in women, with a third-generation MUS utilizing a single vaginal incision (single-incision sling [SIS]) becoming a means for preventing postoperative groin pain associated (rarely) with transobturator sling. However, SIS requires additional long-term evidence of effectiveness through randomized trials comparing their use with MUS. The goal of this study was an evaluation of safety and efficacy of the use of Ophira SIS as compared with inside-out full-length transobturator tape (TOT) sling (MUS) use over long-term follow-up. Primary randomized controlled trial outcomes included SUI objective cure rate evaluations 4 years after MUS operation. Secondary study end points included quality of life, early and late operative complications, subjective cure, recurrent surgery need, and urgency incontinence occurrence. This study, which took place at the Czech tertiary referral Brno University Hospital Urogynecology Center, was a randomized noninferiority controlled trial held from January 2015 through December 2019. Women with urodynamic SUI, as confirmed via positive cough test during cystometry, were included in this nonblinded study. Exclusion criteria were as follows: urgency or predominant urgency incontinence, pelvic organ prolapse stage 2 or greater, intrinsic sphincter deficiency, previous SUI surgery, previous pelvic organ prolapse surgery, and presence of additional organ pathology. The International Consultation on Incontinence Questionnaire—Short Form was completed to assess symptom impact on patient quality of life. Baseline patient characteristics including body mass index, age, and parity were recorded, and written informed consent for enrollment in the study was collected from all patients. Randomization occurred via the envelope technique (sequentially numbered opaque envelopes distributed at the time of surgery) to assign patients to an SIS anti-incontinence procedure or MUS. The SIS procedures used Ophira (Promedon) surgical kits, and the MUS procedure used the inside-out Gynecare TVT Obturator System (Ethicon). Senior surgeons with more than 200 previous MUS or SIS procedures performed the operations. The authors assumed a minimum sample size of 64 patients in each group was needed to identify noninferiority. An independent clinician performed follow-up visits at 4 years postoperation, including an evaluation of objective cure (absence of urinary leakage) as primary study outcome. Subjective cure included the International Consultation on Incontinence Questionnaire—Short Form tiers of 1 (“very much improved),” 2 (“much improved),” or 3 (“improved).” A total of 192 eligible patients participated, with 24 declining randomization for a total of 168 patients (87.5%) being randomized into SIS (n = 84) and MUS groups (n = 84). From these, full completion of the 4-year follow-up took place for 66 SIS patients (78.6%) and 64 MUS patients (76.2%). The results of the analysis indicated that the MUS and SIS groups demonstrated no statistically significant differences in cure rates at 4 years after surgery, with objective (86.4% vs 84.4%) and subjective (83.3% vs 81.3%) cure rates, respectively. The study was not powered to determine differences in secondary outcomes, but a similar proportion in both groups required reoperation for recurrent SUI (6.9%), and no significant pain outcomes were observed in either group. A strength of the trial is its thorough standardization, as all procedures were implemented by the same urogynecology surgeons with ample experience. The randomized study design coupled with long-term follow-up provided high-quality data. A limitation of the trial is the lack of blinding of the patient (via absence or presence of additional MUS incisions), postoperative assessments were done by unblinded members of the team, and a portion of both groups was lost to follow-up. A similar, but not insignificant, portion of both treatment groups was lost to follow-up, introducing risk of selection bias. Finally, not all SISs on the market can be assumed to be equal because of differing materials, anchoring systems, and insertion techniques, and the specific device used in this study is not commercially available in the United States. The findings of this study are that the Ophira SIS had comparable curative rates to transobturator MUS among women undergoing SUI surgery. Additional external validation studies are necessary. However, these results can be included in future meta-analyses for fostering understanding of SUI management via SIS systems.

Three-year patient-reported outcomes of single-incision versus transobturator slings for female stress urinary incontinence are equivalent.

Patient-reported outcome measures (PROMs) are important for understanding the success of surgery for stress urinary incontinence, as patient perception of success does not always correlate with physician perception of success. We report PROMS after single-incision slings (SIS) and transobturator mid-urethral slings (TMUS). This was a planned outcome analysis of secondary endpoints in a study in which the primary aim was to compare efficiency and safety using a non-inferiority design (results reported previously). In this analysis of quality of life (QOL), validated PROMs were collected at baseline, 6, 12, 18, 24, and 36 months to quantify incontinence severity (Incontinence Severity Index), symptom bother (Urogenital Distress Inventory), disease-specific QOL impact (Urinary Impact Questionnaire), and generic QOL impact (PGI-I; not applicable at baseline). PROMs were analyzed within treatment groups as well as between groups. Propensity score methods were used to adjust for baseline differences between groups. A total of 281 subjects underwent the study procedure (141 SIS, 140 TMUS). Baseline characteristics were balanced after propensity score stratification. Participants had significant improvement in incontinence severity, disease-specific symptom bother, and QOL impact. Improvements persisted through the study and PROMs were similar between treatment groups in all assessment at 36 months CONCLUSIONS: Following SIS and TMUS, patients with stress urinary incontinence had significant improvement in PROMs including Urogenital Distress Inventory, Incontinence Severity Index, and Urinary Impact Questionnaire at 36 months, indicating disease-specific QOL improvement. Patients have a more positive impression of change in stress urinary incontinence symptoms at each follow-up visit, indicating generic QOL improvement.