Retropubic Sling Research Articles

Development and Validation of a Simulation Model for Ureteral Stent Placement.

Currently, there are no validated training models for cystoscopy with ureteral stent placement. The objectives of this study were to develop and validate a novel endoscopic simulation model for training in ureteral stent placement. A low-cost, low-fidelity training model was developed to simulate ureteral stent placement. Recruited participants were divided into 3 groups: novices (postgraduate year 3/4 gynecology residents), advanced learners (urogynecology and reconstructive pelvic surgery fellows), and experts (urology residents, urogynecology faculty, and urology faculty). Construct validity was measured using de-identified video-recorded performances on the model, which were evaluated by 2 expert reviewers using validated scales (Global Operative Assessment of Laparoscopic Skills [GOALS], Global Rating Scale [GRS]) and procedure-specific metrics. The model was created using a hollow Styrofoam sphere, plastic tubing from a retropubic sling, and a silicone pacifier. Thirty-six surgeons were assessed performing the procedure using the model with cystoscopic equipment. The experts (n = 12) performed significantly better than the advanced learners (n = 17) and novices (n = 7) in total scores (max 75, median [IQR]: 75 [75-75], 61 [56.5-68.5], 45 [43-46], respectively; P < 0.001) and within each individual scale domain. Increasing experience with ureteral stent placement had a significant correlation (P < 0.001) with better performance on the model. A minimum total passing score of 63 was established. On post simulation assessment, most participants "agreed" or "strongly agreed" that the model closely approximates the feel of ureteral stent placement. This ureteral stenting simulation model is easy to construct, affordable, and reproducible. The model is valid and reliable for practicing the procedure in preparation for live surgery.

Comparison of Surgical Outcomes of Autologous Mid-Urethral Fascia Slings and Retropubic Mid-Urethral Slings for Women Undergoing a Primary Surgery for Stress Urinary Incontinence: A Systematic Review and Meta-Analysis.

Current guidelines on surgical treatment of stress urinary incontinence (SUI) recommend an informed decision making process between the physicians and patients reviewing all available surgical options with and without mesh. However, there is a lack of synthesized clinical evidence on some of the comparisons that can feed into patient counseling processes. The aim of this study was to review the available studies comparing clinical outcomes of an autologous fascial sling (AFS) and a retropubic (RP) synthetic sling for women undergoing a primary surgery for SUI. We conducted a literature search from 1990 to 2024 following international guidelines. We have included studies reporting on comparative outcomes of AFS and RP synthetic sling surgeries as a primary procedure. Three randomized studies were included with follow-up durations ranging from 24 months to 10 years. The mean percentage change in symptom scores ranged from 27.7% to 44.9%, with no significant difference between the two sling types. There was no difference between groups with regard to objective cure rates, subjective cure rates and length of hospital stay between AFS and RP slings. AFS surgeries had longer operative times. There were concerns about bias, particularly related to allocation, blinding, and missing outcome data. Overall, both types of slings had similar cure rates but AFSs were associated with longer operative times. The study highlights the need for more research on the comparative effectiveness of AFS and synthetic slings for SUI surgery to guide decision-making for SUI surgical treatments.

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.

Impact of Obesity on Midurethral Sling Failure in a Highly Hispanic Population.

Mixed data exist in the literature regarding the impact of obesity on midurethral sling (MUS) failure rates. The aim of this study was to evaluate the impact of obesity and Hispanic ethnicity on MUS failure. This was a retrospective cohort study of females who underwent MUS surgery, alone or with concomitant prolapse repair, with at least 1 year of follow-up. Body mass index (BMI) classes were categorized as normal (<25 kg/m2), overweight (25-29.9 kg/m2), obese (30-39.9 kg/m2), and severe obesity (≥40 kg/m2). The primary outcome was MUS failure, defined as a composite of subjectively unchanged or worsened symptoms or need for additional procedures. Secondary outcomes included risk factors related to MUS failure and the effect of ethnicity on MUS failure rates. A total of 322 women were included for analysis. The mean age was 52.3 years. Increasing BMI was associated with higher MUS failure, with multivariate logistic regression showing a 5% increased risk for each 1 kg/m2 BMI increase. Failure rates were significantly different between normal BMI and severe obesity (16.7% vs 36.4%, P = 0.04). After adjusting for other variables, transobturator slings had a higher risk of failure compared with retropubic slings, whereas surgeon training and patient ethnicity did not affect failure rates. We found that increasing BMI was associated with higher MUS failures, with significantly higher failure rates in the severely obese population. Although MUS remains the standard of care for treatment of SUI, based on our findings, counseling should be individualized to the patient, taking into account each patient's unique characteristics.

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.

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.

Insufficient utilization of care in male incontinence surgery: health care reality in Germany from 2006 to 2020 and a systematic review of the international literature

PurposeData suggest that the utilization of care in male incontinence surgery (MIS) is insufficient. The aim of this study was to analyse the utilization of care in MIS from 2006 to 2020 in Germany, relate this use to the number of radical prostatectomies (RP) and provide a systematic review of the international literature.MethodsWe analysed OPS codes using nationwide German billing data and hospitals’ quality reports from 2006 to 2020. A systematic review was performed according to the Preferred Reporting Items for Systematic Review and Meta-Analyses (PRISMA).ResultsMIS increased by + 68% from 2006 to 2011 (1843–3125; p = 0.009) but decreased by − 42% from 2011 to 2019 (3104–1799; p < 0.001). In 2020, only 1435 MISs were performed. In contrast, RP increased from 2014 to 2019 by 33% (20,760–27,509; p < 0.001). From 2012 to 2019, the number of artificial urinary sphincters (AUSs) changed minimally (− 12%; 1291–1136; p = 0.02). Sling/sling systems showed a decrease from 2011 to 2019 (− 68% 1632–523; p < 0.001). In 2019, 63% of patients received an AUS, 29% sling/sling systems, 6% paraurethral injections, and 2% other interventions. In 2019, few high-volume clinics [n = 27 (13%)] performed 55% of all AUS implantations, and few high-volume clinics [n = 10 (8%)] implanted 49% of retropubic slings.ConclusionMIS have exhibited a relevant decrease since 2011 despite the increase in RP numbers in Germany, indicating the insufficient utilization of care in MIS. The systematic review shows also an international deficit in the utilization of care in MIS.

Complications following retropubic versus transobturator midurethral synthetic sling placement.

Transobturator slings (TOS) are inferior to retropubic slings (RPS) based on long-term outcomes; data on complications is critical for patient counseling. We hypothesized rates of urinary retention would be higher for RPS, while pain and repeat sling surgery would be higher for TOS. Using the Premier healthcare database we identified encounters for patients undergoing a midurethral sling procedure between 2010 and 2020. Patients were stratified by sling type, either RPS or TOS. The primary outcome was the difference in the composite complication rate between groups within 12months. Statistical analysis was performed using Kruskal Wallis test for continuous variables and χ2-test for categorical variables. Multivariable logistic regression was used to determine risk factors for complications and risk of specific complications after sling placement. 36,991 patients were included in the RPS group and 16,371 in the TOS group. 7,880 patients (14.8%) had at least one sling specific complication. On multivariable logistic regression, RPS patients were more likely to have urinary retention (OR 1.29, 95%CI 1.16-1.43), sling lysis/excision (OR 1.29, 95%CI 1.10-1.53), and hematoma/hemorrhage (OR 1.82, 95%CI 1.16-2.86); they were less likely to have a UTI (OR 0.88, 95%CI 0.82-0.96) or repeat sling (OR 0.60, 95%CI 0.46-0.78). In patients with urinary retention, RPS patients were more likely to undergo sling lysis than TOS (p = 0.012). Significant complications after midurethral synthetic sling are overall rare. RPS are associated with a higher rate of perioperative bleeding and sling lysis/excision due to urinary retention, but less likely to be associated with UTI and treatment failure.

C-Clamp Technique: A Retrospective Review of a Novel Technique to Prevent Bladder Injury in Retropubic Midurethral Slings

ABSTRACT The original technique for mesh midurethral sling, which utilized a retropubic approach for sling placement, also recognized a risk of simultaneous iatrogenic bladder injury. While synthetic mesh midurethral slings have the criterion standard for SUI treatment, there is still no available technique that entirely eliminates the risk of bladder injury at the time of implantation. The retropubic approach holds a 0.7% to 34% rate of bladder injury. Some providers still opt for the transobturator approach because of a perceived decreased risk of intraoperative bladder perforation. This article describes the “C-clamp technique,” a method directly addressing the perceived key causes of bladder injury via the retropubic approach. This study aimed to determine bladder injury rates upon surgical implantation of retropubic synthetic mesh midurethral sling by 1 provider using the C-clamp technique. The article provides step-by-step instructions for this technique, as well as a link to a video (https://links.lww.com/FPMRS/A362). Briefly, the technique involves use of a deflecting catheter guide in steep Trendelenburg, “clamping” the pubis with the operator's nondominant hand to decrease the retropubic distance, and using the nondominant thumb on the inner curve of the trocar to guide the trocar passage toward the nondominant finger tips and suprapubic exit through the skin. This retrospective review identified 201 bottom-up retropubic synthetic mesh midurethral slings placed using the C-clamp technique between April 2012 and June 2022. General data collected included average age (51 years), average weight (46–139 kg), average body mass index (BMI, 15–57 kg/m2), and a range of prior surgical procedures and concomitant procedures. Approximately 15% of patients had a history of prior retropubic urethropexy or some form of midurethral sling. There were no lower urinary tract injuries in the entire cohort. Strengths of this study include its description of the C-clamp technique, the extremes and range of data points included within the study, and the 10-year range of the study. Limitations include its retrospective nature, the single surgeon provider, the vast majority of slings used produced by 1 manufacturer, and limited comprehensive data collection. Using data from 201 consecutive bottom-up synthetic mesh midurethral sling outcomes during a 10-year span, the authors argue that this technique addresses key anatomic issues contributing to bladder and urethral injury during placement of such slings, with a promising ability to eliminate bladder and urethral injury. Favorable data in a larger number of patients and by multiple providers could provide further support to this technique and support retropubic sling as a preferred method of midurethral sling.

MP37-08 PATIENT SATISFACTION AND QUALITY OF LIFE IN A MULTICENTER PROSPECTIVE STUDY OF SINGLE INCISION MINI-SLING (ALTIS®) IN THE MANAGEMENT OF FEMALE STRESS URINARY INCONTINENCE

You have accessJournal of UrologyCME1 Apr 2023MP37-08 PATIENT SATISFACTION AND QUALITY OF LIFE IN A MULTICENTER PROSPECTIVE STUDY OF SINGLE INCISION MINI-SLING (ALTIS®) IN THE MANAGEMENT OF FEMALE STRESS URINARY INCONTINENCE Craig Hanson, Ty Erickson, and Rebecca Mccrery Craig HansonCraig Hanson More articles by this author , Ty EricksonTy Erickson More articles by this author , and Rebecca MccreryRebecca Mccrery More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003275.08AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: To compare the non-inferiority of the Altis® Single Incision Sling (SIS) with standard midurethral transobturator and/or retropubic sling, including an evaluation of patient satisfaction, improvement in quality of life, return to normal, and pain at 6 months post surgery. METHODS: Prospective, nonrandomized FDA 522 cohort study comparing the Altis SIS to FDA cleared transobturator and/or retropubic slings for the treatment of stress urinary incontinence (SUI) through 36 months. Surgical Satisfaction Questionnaire (SSQ-8) for patient satisfaction at 6 months post surgery, Incontinence Impact Questionnaire (IIQ-7), Urodynamic Distress Inventory (UDI-6), and Visual Analog Scale (VAS) for pain were assessed at baseline and 6 months post surgery. RESULTS: 355 women underwent the sling procedure (Altis n=184 vs Comparator n=171). Subjects in both treatment groups had a high degree of satisfaction with their surgery as indicated on the SSQ-8 at 6 months Altis (n=165) 28.1±4.9 vs Comparator (n=148) 28.7±4.3 (p=0.257). There was no difference in satisfaction between groups in the amount of time to return to daily activities (p=0.877) and return to work (p=0.939). The IIQ-7 at 6 months indicated a trend of improvement in quality of life in both groups, of an average of 50%, with a mean change from baseline Altis (n=164) 50.6±25.3 vs Comparator (n=146) 49.9±27.9 (p=0.816). The UDI-6 at 6 months indicated an improvement in quality of life in both groups with a mean change from baseline Altis (n=164) 40.9±20.2 vs Comparator (n=145) 43.0±22.7 (p=0.387). Dyspareunia, de Novo, related to the procedure and/or device, was similar between groups (Altis 1.6% vs Comparator 1.2%, p=1.00). Pelvic/Urogenital Pain (Groin) was also similar between groups for all events (Altis 6.0% vs Comparator 2.9%, p=0.205). CONCLUSIONS: The patients had a high degree of satisfaction with their surgery and pain decreased similarly following either SIS or standard midurethral slings for treatment of SUI. Improvement in Quality of Life and Return to Normal increased similarly at 6 months following either SIS or Midurethral slings for treatment of SUI. Source of Funding: Coloplast funding for this FDA 522 required comparative trial. © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e516 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Craig Hanson More articles by this author Ty Erickson More articles by this author Rebecca Mccrery More articles by this author Expand All Advertisement PDF downloadLoading ...

V12-07 ROBOTIC-ASSISTED TRANSABDOMINAL REMOVAL OF ERODED MID-URETHRAL MESH SLING

You have accessJournal of UrologyCME1 Apr 2023V12-07 ROBOTIC-ASSISTED TRANSABDOMINAL REMOVAL OF ERODED MID-URETHRAL MESH SLING Shreeya Popat, Gjanje Smith-Mathus, Alvaro Lucioni, and Una Lee Shreeya PopatShreeya Popat More articles by this author , Gjanje Smith-MathusGjanje Smith-Mathus More articles by this author , Alvaro LucioniAlvaro Lucioni More articles by this author , and Una LeeUna Lee More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003347.07AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Depending on the indication for excision, there are multiple surgical approaches for the removal of mid-urethral mesh slings: transvaginal, endoscopic, open abdominal, and robotic. In this video, we demonstrate the robotic approach to treat mid-urethral mesh slings that have eroded into the bladder. The robotic approach offers excellent exposure, visualization, and accessibility. Compared to endoscopic approaches, the entire arm of the sling can be removed from the bladder wall, the bladder repaired, and the foreign body thereby completely eliminated from the bladder. Robotic mid-urethral mesh sling excision is ideal in any patient that would be best served by maximal removal of the mesh from the bladder in order to prevent future complications. METHODS: In this video, we display two different cases to show two unique approaches to robotic mid-urethral mesh sling excision depending on the location of the mesh sling erosion: 1) If a retropubic sling is eroded through the anterior bladder, we begin by dropping the bladder and entering the space of Retzius to locate the mesh arm. 2) If the sling is eroded into the posterior bladder, a cystotomy is made on the anterior dome to visualize the posterior bladder wall. RESULTS: Once the mesh is identified, we follow the mesh graft carefully and delicately and dissect it away from surrounding tissues. The dissection is immediately close to the mesh, without fragmenting it, to allow for complete excision. This also allows for protection of adjacent critical structures. The surgical principles and instrument techniques of robotic mesh excision mirror the surgical technique utilized for transvaginal mesh excision. CONCLUSIONS: For treatment of mesh erosion into the bladder, a robotic approach offers excellent visualization, is feasible, and well-tolerated. Compared to fragmenting the mesh using an endoscopic approach, the robotic approach has the advantage of excising the mesh definitively, eliminating the foreign body in the bladder and preventing future recurrences of mesh erosion. Properly selected patients should be offered the robotic approach to mesh excision. Source of Funding: None © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e1066 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Shreeya Popat More articles by this author Gjanje Smith-Mathus More articles by this author Alvaro Lucioni More articles by this author Una Lee More articles by this author Expand All Advertisement PDF downloadLoading ...

V09-04 REPAIR OF URINARY INCONTINENCE AND VENTRAL DEHISCENCE AFTER MASCULINIZING GENITAL GENDER AFFIRMATION SURGERY

You have accessJournal of UrologyCME1 Apr 2023V09-04 REPAIR OF URINARY INCONTINENCE AND VENTRAL DEHISCENCE AFTER MASCULINIZING GENITAL GENDER AFFIRMATION SURGERY Joshua Sterling and Dmitriy Nikolavsky Joshua SterlingJoshua Sterling More articles by this author and Dmitriy NikolavskyDmitriy Nikolavsky More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003317.04AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Stress urinary incontinence (SUI) is an infrequently reported complication following transmasculine genital gender affirming surgery (gGAS), thus far there are no reports to help with management of severe SUI post gGAS. In this video, we demonstrate a case of de novo SUI following vaginectomy and metoidioplasty. These were treated with autologous fascial sling and staged urethral repair. METHODS: Patient is a 22 year old transgender male who underwent vaginectomy and metoidioplasty and developed severe SUI. Three months of pelvic therapy improved incontinence to 168g daily. He was referred for treatment of SUI and correction of ventral shaft dehiscence. Stage-1 included placement of an autologous fascial retropubic sling, and stage 1 urethroplasty with buccal mucosa graft (BMG). In the time interval before the Stage 2, the patient was monitored for evidence of recurrent SUI or urinary retention. Stage 2 involved tubularization of the neourethra. The procedure was done in dorsal lithotomy position. Perineum (site of prior vaginectomy) and previously created pars fixa were opened ventrally. Using the balloon of the Foley at the bladder neck as a palpable landmark, the native urethra and the bladder neck were dissected to the inferior aspect of the pubic symphysis. A 1.5x8cm segment of rectus fascia was harvested for the autologous sling. Full length 2-0 polypropylene suture was secured to either end of the fascial sling and delivered retropubicly to the abdominal incision from the perineal incision using a fine tonsil clamp. The sling was appropriately tensioned and secured. Ventral penile chordee was released sharply and a stage 1 urethroplasty was performed with dorsal BMG inlay. After a 6-month delay the patient did not show any signs of recurrence of SUI or retention and the Stage 2 urethroplasty was performed. The patient's urethral plate was augmented with an additional BMG to achieve 3cm width. The neourethra was tubularized and the neophallus was closed in multiple layers with non-overlapping suture lines. RESULTS: The procedure resulted in the successful repair of the patient’s SUI and metoidioplasty shaft dehiscence. The patient achieved durable social continence (completely dry) with normal voiding patterns and low residuals after placement of autologous retropubic sling. CONCLUSIONS: SUI is a real and devastating complication following masculinizing gGAS. Here we show it can be safely and effectively treated using an established pelvic floor reconstructive technique for a new indication. Source of Funding: None © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e837 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Joshua Sterling More articles by this author Dmitriy Nikolavsky More articles by this author Expand All Advertisement PDF downloadLoading ...

PD14-12 SEXUAL FUNCTION IN WOMEN FOLLOWING TENSION-FREE VAGINAL TAPE-OBTURATOR PROCEDURE: A PROSPECTIVE STUDY

You have accessJournal of UrologyCME1 Apr 2023PD14-12 SEXUAL FUNCTION IN WOMEN FOLLOWING TENSION-FREE VAGINAL TAPE-OBTURATOR PROCEDURE: A PROSPECTIVE STUDY Aymen Sakly, Walid Zakhama, Nejm Jleli, Aymen Mnasser, and Yassine Binous Aymen SaklyAymen Sakly More articles by this author , Walid ZakhamaWalid Zakhama More articles by this author , Nejm JleliNejm Jleli More articles by this author , Aymen MnasserAymen Mnasser More articles by this author , and Yassine BinousYassine Binous More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003261.12AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Midurethral tapes have shown favorable clinical outcomes for treating stress urinary incontinence (SUI). In the last decade, tension-free vaginal tape-obturator (TVT-O) lead to less complications with comparable results to conventional open surgeries and retropubic sling procedure. However, the effects of TVT-O on women’s sexual function are unclear. The aim of this study was to assess sexual function among women who underwent TVT-O for SUI. METHODS: From February 2018 to January 2022, we have enrolled a prospective study in which we recruited 63 women scheduled for correction of SUI by TVT-O procedure. Exclusion criteria were women without sexual activity, previous surgery for urinary incontinence or concomitant surgery for urogenital prolapse. Participants were required to complete the Female Sexual Function Index (FSFI) questionnaire. Preoperative and postoperative results were evaluated. Female sexual dysfunction was defined for a cutoff FSFI<26,55. The paired T-Student test was used to compare the scores. The significance level of p was set at 0,05. RESULTS: The mean age of our population was 64,4 years. Before surgery, the mean total FSFI score was 23.48±5.74. A female sexual dysfunction was observed in 68.2% of patients. The lowest score was attributed to desire, orgasm, and arousal items. Only 17 women (26,98%) have concomitant coital incontinence. Postoperatively, the mean resumption of sexual intercourses was at 2.7 months. The mean total FSFI score significantly increased to 28.617±5.21 (p<0.05). We found a significant improvement related to desire, satisfaction, and pain domains (p=0.03, p=0.01, p<0.001). In patients who had concomitant coital incontinence before surgery, the FSFI scores was higher than patients who did not have coital incontinence (1.67±1.84 vs. -0.13±2.15, p<0.05). CONCLUSIONS: TVT-O procedure provides significant improvement in the sexual lives of women. However, the patients who suffer from concomitant coital incontinence before the surgery will have a better sexual function improvement. Source of Funding: No funding © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e417 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Aymen Sakly More articles by this author Walid Zakhama More articles by this author Nejm Jleli More articles by this author Aymen Mnasser More articles by this author Yassine Binous More articles by this author Expand All Advertisement PDF downloadLoading ...

Retropubic slings are more efficient than transobturator at 10-year follow-up: a Swedish register-based study

Introduction and hypothesisLong-term performance of mid-urethral slings (MUS) and potential differences between the retropubic and the transobturator technique for insertion are scarcely studied. This study aims to evaluate the efficacy and safety 10 years after surgery and compare the two main surgical techniques used.MethodsWomen who underwent surgery with a MUS between 2006 and 2010 were identified using the Swedish National Quality Register of Gynecological Surgery and were invited 10 years after the operation to answer questionnaires regarding urinary incontinence and its impact on quality-of-life parameters (UDI-6, IIQ-7) and impression of improvement, as well as questions regarding possible sling-related complications and reoperation.ResultsThe subjective cure rate reported by 2421 participating women was 63.3%. Improvement was reported by 79.2% of the participants. Women in the retropubic group reported higher cure rates, lower urgency urinary incontinence rates and lower UDI-6 scores. No difference was shown between the two methods regarding complications, reoperation due to complications or IIQ-7 scores. Persisting sling-related symptoms were reported by 17.7% of the participants, most commonly urinary retention. Mesh exposure was reported by 2.0%, reoperation because of the tape by 5.6% and repeated operation for incontinence by 6.9%, significantly more in the transobturator group (9.1% vs. 5.6%). Preoperative urinary retention was a strong predictor for impaired efficacy and safety at 10 years.ConclusionsMid-urethral slings demonstrate good results for the treatment of stress urinary incontinence and tolerable complication profiles in a 10-year perspective. The retropubic approach displays higher efficacy than the transobturator, with no difference regarding safety.

Impact of Weight Gain on Surgical Outcomes and Quality of Life among Women after Sling Surgeries

To investigate the impact of body weight gain after sling surgeries on outcomes in women with stress urinary incontinence. A single-center, retrospective study. Department of Obstetrics and Gynecology, Mackay Memorial Hospital, Taiwan. A total of 248 women who underwent sling surgeries from 2010 to 2015 were reviewed. Patients who gained more than 10% body weight were compared with those with stable body weight. Midurethral sling surgery with single-incision, transobturator, or retropubic slings. Objective success was defined as no urine leakage during the stress test in the filling phase of urodynamic studies. De novo overactive bladder (OAB) was defined as the appearance of urgency, frequency, and/or nocturia, with or without urinary incontinence after midurethral sling surgery persisting after 6 months. Quality of life evaluations included the short forms of the Urogenital Distress Inventory-6 and Incontinence Impact Questionnaire-7. A total of 248 women who underwent sling surgeries and had complete weight measurement and evaluation data before and after the surgeries were included, of whom 47 gained body weight, and 201 had a stable body weight. The median follow-up duration was 18 months (range, 6-47 months). There were no significant differences in surgical outcomes between the 2 groups regarding objective cure rate (86% vs 87%, p=.834), 1-hour pad test (4.5 ± 17.8 vs 3.6 ± 18.6 g, p=.770), or postoperative quality of life (Urogenital Distress Inventory-6: 1.9 ± 2.8 vs 2.8 ± 3.2, p=.122; Incontinence Impact Questionnaire-7: 1.8 ± 3.9 vs 2.6 ± 4.3, p=.307). A trend toward increased de novo OAB rate was observed, although this finding was not adequately powered. Weight gain after sling surgeries did not influence surgical outcomes, but there was a nonsignificant trend toward increased OAB in the weight gain group. It may be beneficial to counsel patients with regard to body weight maintenance after sling surgeries.

Transobturator-tape outside in (TVT-O) as saviour for female stress urinary incontince without available cystoscope for gynecologist: A case series

SUI affects quality of life. Ulmsten and Petros reported mid urethral sling operations using Tension-free Vaginal Tape (TVT) and Delorme used Transobturator Tape (TOT). Cystoscopy is often used in retropubic sling procedures to identify lower urinary tract injury. Cystoscopy protects patients and accurately identifies iatrogenic injuries. The goal is to evaluate the efficacy of a standard Trans-Obturator (TOT-O) mid urethral sling for female Stress Urinary Incontinence (SUI) without intraoperative cystoscopy. A total of 120 female SUI patients from 2014 to 2019 were studied. Stress-related incontinence and diaper use were preoperative variables. Under spinal anesthesia, the procedure improved stress incontinence, sexual dysfunction, complications, and overall satisfaction. All patients improved after the procedure, and 116 (96.6%) completely resolved. Post-operative complications included urinary retention in 3 patients (2.5%), increased daytime urinary frequency in 3 (2.5%), urge incontinence in 4 (3.33%), groin/thigh pain in 2 (1.66%), and local mesh excision for mesh erosion in 1 (0.83%). Open EPI software calculated insignificant p values for clinical profile and satisfaction with symptom resolution. Brief Index of SF for Women was used to assess sexual function. At 6-month followup, all patients were satisfied with sexual function. TOT-O technique for female stress urinary incontinence is easy to learn and reproducible for beginners.

Incontinence outcomes in women undergoing retropubic mid-urethral sling: a retrospective cohort study comparing Safyre™ and handmade sling.

ABSTRACTPurpose This study examined and compared efficacy, safety, satisfaction, and complications of the retropubic Safyre™ sling and a retropubic hand-made synthetic sling (HMS) in a short-, mid- and long-term follow-up.Methods We retrospectively reviewed a prospectively maintained database of women who underwent Safyre™ or HMS between March 7ths 2005 and December 27ths, 2017. Patients had first assessment (7-10 days), second (40-45 days), and third (sixth month) postoperatively. Between September and December 2018, patients who completed at least one year of surgery, received a telephone call. Follow-up compared quartiles of follow-up time to determine complications (Clavien-Dindo), success rates (International Consultation on Incontinence Modular Questionnaire for Urinary Incontinence Short Form – ICIQ-UI SF), and patient satisfaction.Results Three hundred fifty-one patients underwent surgery and 221 (63%) were evaluated after a median of 78.47 (± 38.69) months, 125 (55%) in the HMS, and 96 (45%) in the Safyre™ group. Higher intraoperative bladder injury was observed with Safyre™ (0% vs. 4.2%, p=0.034), and a tendency for urinary retention, requiring indwelling urinary catheter over 24 hours (2.4% vs. 8.3%, p=0.061). Both HMS (p<0.001) and Safyre™ (p<0.001) presented improvements on ICIQ-UI SF. There were no differences in satisfaction, subjective cure rates, ICIQ-UI SF, or complications between groups.Conclusions Both HMS and Safyre™ have similar satisfaction and subjective cure rates, with marked ICIQ-UI SF score improvement. Higher rates of intraoperative bladder injury were seen in patients who received Safyre™ retropubic sling.

Cost-effectiveness of prophylactic retropubic sling at the time of vaginal prolapse surgery

Prophylactic midurethral sling placement at the time of prolapse repair significantly reduces the risk for de novo stress urinary incontinence, but it is associated with some small but significant morbidities. Because there has not been a standardized approach to midurethral sling utilization, decision analysis provides a method to evaluate the cost and effectiveness associated with varying midurethral sling placement strategies in addressing the risk for de novo stress urinary incontinence. We aimed to compare the cost effectiveness of the 3 midurethral sling utilization strategies in treating de novo stress urinary incontinence 1 year after vaginal prolapse repair. The 3 approaches are (1) staged strategy in which prolapse repair is done without prophylactic midurethral sling placement, (2) universal sling placement in which prolapse repair is accompanied by prophylactic midurethral sling placement, and (3) selective sling placement in which prolapse repair is accompanied by prophylactic midurethral sling placement only in patients with a positive prolapse-reduced cough stress test. We created a decision analysis model to compare staged strategy, universal sling placement, and selective sling placement. We modeled probabilities of de novo stress urinary incontinence, patients choosing subsequent midurethral sling surgery for de novo stress urinary incontinence, and outcomes related to midurethral sling placement. De novo stress urinary incontinence rates were determined for each strategy from published data. The likelihood of patients with de novo stress urinary incontinence choosing midurethral sling surgery as their first-line treatment was also determined from the literature, and this scenario was only applied to patients without prophylactic midurethral sling placement at their index prolapse repair. Finally, outcomes related to midurethral sling placement, including recurrent or persistent stress urinary incontinence, voiding dysfunction requiring sling lysis, mesh exposure requiring excision, and de novo overactive bladder requiring medications, were all derived from publicly available data. All midurethral sling placement procedures were assumed to be retropubic. The costs for each procedure were obtained from the 2020 Centers for Medicare & Medicaid Services Physician Fee Schedule or from previous literature with convertion to 2020 equivalent US dollar prices using the Consumer Price Index. The primary outcome was modeled as the incremental cost-effectiveness ratio. We performed multiple 1-way sensitivity analyses to assess model robustness. The lowest-cost strategy was the staged strategy, which cost $1051.70 per patient, followed by $1093.75 for selective sling placement and $1125.54 for universal sling placement. The selective sling approach, however, had the highest health utility value; therefore, universal sling placement was dominated by selective sling placement because it is both less costly and more effective. When compared with the staged strategy, selective sling placement was cost effective with an incremental cost-effectiveness ratio of $2664 per quality adjusted life-years, meeting the predetermined threshold. In multiple 1-way sensitivity analyses, the variable with the largest effect was the percentage of patients electing to undergo subsequent midurethral sling surgery for de novo stress urinary incontinence after the index surgery. Only when this proportion exceeded 62% did universal sling placement become the cost-effective option because selective sling placement surpassed the predetermined incremental cost-effectiveness ratio threshold and became dominated. Selective sling placement was the preferred and cost-effective strategy in treating de novo stress urinary incontinence 1 year after vaginal prolapse repair. Surgeons should counsel their patients preoperatively regarding the possibility of de novo stress urinary incontinence after prolapse repair, as well as on the benefits and risks of prophylactic midurethral sling placement surgery.

Predictors of prolonged hospitalization and perioperative complications following mid-urethral sling mesh removal.

To assess preoperative and perioperative characteristics associated with increased length of stay and major complications after mid-urethral sling mesh removal. We performed an IRB-approved retrospective analysis of patients who underwent mid-urethral sling mesh removal. Demographic data and baseline surgical characteristics were collected. Operative reports and hospital/clinic notes were reviewed for complications which were categorized using the Clavien-Dindo Classification scheme. Length of stay was deemed abnormal if greater than 1day. Complications were assessed using multivariate regression analysis. A total of 468 patients were identified as having undergone mid-urethral sling mesh removal. Mean age was 56 (± 11.1). 431 patients had either retropubic or transobturator slings. 241 patients underwent retropubic or groin exploration as a part of their mesh removal. A prolonged length of stay was noted in 73 patients (15.6%) and 13 patients (2.8%) experienced a Clavien Grade 3 complication. Pre-operative narcotic/benzodiazepine use, concomitant surgical procedure, bladder injury, increased ASA class, and major complications had an increased odds of a prolonged length of stay. Patients who experienced a bladder injury, groin/suprapubic incision, and estimated blood loss of over 400mL had an increased odds of Clavien Grade 3 complications. Patient characteristics and perioperative factors are associated with increased length of stay and major complications after mid-urethral sling mesh removal.

EDITORIAL COMMENT

Success rates of retropubic sling in Latina women compare with those published in the clinical trial literature. Urinary urgency and urgency incontinence symptoms may be more predominant in Latina women, and Gonzalez et al. emphasize need for further investigation of potential underlying structural, cultural, environmental, or lifestyle-related factors that may be at play. This amplifies generalizability of sling clinical trial results to an important demographic that is otherwise not well-represented in phase III trials for stress urinary incontinence.