Defining success after surgical treatment of stress urinary incontinence.

BACKGROUND: A consensus standardized definition of success after stress urinary incontinence surgical treatment is lacking, which precludes comparisons between studies and affects patient counseling. OBJECTIVE: This study aimed to identify optimal patient-centric definition(s) of success after stress urinary incontinence surgical treatment and to compare the identified "more accurate" treatment success definitions with a commonly used composite definition of success (ie, no reported urine leakage, negative cough stress test result, and no retreatment). STUDY DESIGN: We evaluated 51 distinct treatment success definitions for participants enrolled in a previously conducted randomized trial of stress urinary incontinence treatments concomitantly performed with sacrocolpopexy (NCT00934999). For each treatment success definition, we calculated the mean (SD) of participant-assessed symptom improvement and participant-assessed surgical success scores with an 11-point Likert scale among those achieving success and failure. The "more accurate" treatment success definition(s) were identified by measuring the magnitude of the mean difference of participant assessments with Hedges g values. The treatment success definitions with the highest Hedges g values were considered "more accurate" treatment success definitions and were then compared with the composite definition of success. RESULTS: The percentage of participants who had treatment success (6.4% to 97.3%) and Hedges g values (-4.85 to 1.25) varied greatly according to each treatment success definition. An International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form score ≤5, Urogenital Distress Inventory-6 score ≤33.3, and a no/mild stress urinary incontinence response on Urogenital Distress Inventory-6 question 3 had the highest Hedges g values and were considered the top 3 "more accurate" treatment success definitions. Paradoxically, treatment success definitions that required a negative cough stress test result or no persistent urinary leakage greatly reduced the ability to differentiate between participant-assessed symptom improvement and surgical success. When the "more accurate" treatment success definitions were compared with the composite definition, patients with failed treatment according to the composite definition had lower Urinary Impact Questionnaire-7 scores and a higher proportion of survey responses indicating complete satisfaction or some level of satisfaction and very good/perfect bladder condition. In addition, the composite definition had considerably fewer favorable outcomes for participants than did the top 3 "more accurate" treatment success definitions. CONCLUSION: Successful outcomes of stress urinary incontinence surgical treatments for women undergoing concurrent sacrocolpopexy varied greatly depending on the definition used. However, stringent definitions (requiring complete dryness) and objective testing (negative cough stress test result) had decreased, rather than increased, participant-assessed symptom improvement and surgical success scores. The "more accurate" treatment success definitions better differentiated between participant-assessed symptom improvement and surgical success than the composite definition. The composite definition disproportionately misidentified participants who reported minor symptoms or complete/partial satisfaction with their outcome as having treatment failures and yielded a considerably lower proportion of women who reported favorable outcomes than did the top 3 "more accurate" treatment success definitions.

The effect of subsequent pregnancy and childbirth on stress urinary incontinence recurrence following midurethral sling procedure: a meta-analysis.

OBJECTIVE: This study aimed to assess the risk of stress urinary incontinence recurrence and reoperation after a midurethral sling procedure in women with subsequent childbirth and to assess the effect of delivery mode on this risk. DATA SOURCES: An electronic database search was performed using MEDLINE with the OvidSP interface and PubMed, Embase, Web of Science, and the Cochrane Library up to September 20, 2023. STUDY ELIGIBILITY CRITERIA: This study included experimental and nonexperimental studies, composed of randomized controlled and observational (case-control, cohort, and cross-sectional) studies assessing the risk factors for stress urinary incontinence recurrence and reoperation after childbirth in women who had previously undergone a midurethral sling procedure for stress urinary incontinence. METHODS: Analysis was performed using RevMan (version 5.3; Cochrane Collaboration, Oxford, United Kingdom). Quantitative synthesis was used if the included studies were sufficient in numbers and homogeneity. The overall certainty of the evidence was assessed using criteria recommended by the Grading of Recommendations Assessment, Development, and Evaluation Working Group. RESULTS: A total of 2001 studies were identified, of which 6 were eligible for analysis, composed of 381 patients who had at least 1 childbirth after a midurethral sling procedure (study group) and 860 patients who underwent a midurethral sling without having a subsequent childbirth (control group). All included studies were observational, the patients' mean age at the time of the midurethral sling procedure ranged from 34 to 36 years, and the mean time from midurethral sling procedure to delivery ranged from 21 to 31 months. No difference in stress urinary incontinence recurrence (relative risk, 0.1.02; 95% confidence interval, 0.78-1.33) or reoperation (relative risk, 1.37; 95% confidence interval, 0.87-2.17) was found between the study and control groups. The average follow-up time among the included studies of this comparison was 9.8 years (range, 2-18). Furthermore, the mode of delivery (vaginal vs cesarean) did not seem to affect the risk of stress urinary incontinence recurrence. CONCLUSION: Subsequent pregnancy and childbirth did not increase the risk of stress urinary incontinence recurrence or reoperation after a midurethral sling procedure.

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

BACKGROUND: Midurethral 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: This study aimed to compare serious complications and reoperations for recurrence after midurethral sling procedures when using the retropubic vs the transobturator route for female stress urinary incontinence. STUDY DESIGN: This analysis was of patients included in the French, multicenter VIGI-MESH register since February 2017 who received a midurethral sling for female stress urinary incontinence either by the retropubic or the transobturator route and excluded patients with single-incision slings. Follow-up continued until October 2021. Serious complications (Clavien-Dindo classification ≥ grade III) attributable to the midurethral sling and reoperations for recurrence were compared using 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. RESULTS: A total of 1830 participants received a retropubic sling and 852 received a transobturator sling in 27 French centers that were placed by 167 surgeons. The cumulative 2-year estimate of serious complications was 5.8% (95% confidence interval, 4.8-7.0) in the retropubic group and 2.9% (95% confidence interval, 1.9-4.3) in the transobturator group, that is, after adjustment, half of the retropubic group was affected (adjusted hazard ratio, 0.41; 95% confidence interval, 0.3-0.6). The cumulative 2-year estimate of reoperation for recurrence of stress urinary incontinence was 2.7% (95% confidence interval, 2.0-3.6) in the retropubic group and 2.8% (95% confidence interval, 1.7-4.2) in the transobturator group with risk for revision for recurrence being higher in the transobturator group after adjustment (adjusted hazard ratio, 1.9; 95% confidence interval, 1.2-2.9); this surplus risk disappeared after exclusion of the patients with a previous surgery for stress urinary incontinence. CONCLUSION: The transobturator route for midurethral sling placement is associated with a lower risk for serious complications but a higher risk for surgical reoperation for recurrence than the retropubic route. Despite the large number of surgeons involved, these risks were low. The data are therefore reassuring.

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

BACKGROUND: The choice of midurethral sling type may impact efficacy and complications in women undergoing transvaginal native tissue repair of pelvic organ prolapse. OBJECTIVE: 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. STUDY DESIGN: 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 was 280. RESULTS: 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. CONCLUSION: 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.

Supporting the Choice for Conservative and Surgical Treatment in Female Stress Urinary Incontinence: Development and Evaluation of a Patient Decision Aid.

INTRODUCTION: Making a treatment decision for female stress urinary incontinence (SUI) can be challenging for patients and healthcare providers. Dutch guidelines advise to counsel both pelvic floor muscle therapy and midurethral sling surgery as primary treatment options in uncomplicated moderate to severe cases. The use of a patient decision aid (PDA) can support decision-making, reduce decisional conflict and decisional regret, and increase knowledge. The aim of this study was to develop and evaluate an online PDA for females (SUI). METHODS: This mixed-methods study was performed in consecutive stages by a multidisciplinary working group. PDA design was based on the International Patient Decision Aids Standards (IPDAS) and on outcomes of needs assessments amongst patients and healthcare providers. Content was based on Dutch guidelines, targeted literature searches and patient information from the Dutch scientific society for gynecology. The concept version was evaluated by patients, patients' advocates, and healthcare providers. RESULTS: Using the nominal group technique, the working group established the design and format of the PDA. Fifty-six out of 58 applicable items of the IPDAS were met. The PDA contains information on the condition, advice on lifestyle adaptations, and describes surgical and nonsurgical treatment options. The option grid contains comparisons of the primary treatment options. Furthermore, value clarification exercises and narratives were included. Acceptability and usability evaluation of the concept version was performed by 15 healthcare providers, three patients, and two patients' advocates. Comments were processed in the working group, resulting in the final version of the PDA, which was supported by all assessors. CONCLUSION: Our multidisciplinary working group developed an online PDA for women with moderate to severe SUI including conservative and surgical treatment options, based on IPDAS criteria, guidelines, scientific evidence, and needs assessments from patients and healthcare providers. This PDA is supported by patients, healthcare providers, scientific societies, and the Dutch patients' association. The next step is to evaluate and implement this PDA in daily practice. TRIAL REGISTRATION: ID 2014-308.

Comparison of perioperative adverse events following suburethral sling placement using synthetic mesh, autologous rectus fascia, and autologous fascia lata in a national surgical registry.

AIMS: To assess and compare 30-day perioperative adverse events following suburethral sling surgery using synthetic mesh, autologous rectus fascia, and autologous fascia lata in women. METHODS: This was a retrospective cohort study of patients who underwent fascial or synthetic sling placement for stress urinary incontinence between 2008 and 2021 using the American College of Surgeons' National Surgical Quality Improvement Program database. Current Procedural Terminology codes were used to identify patients undergoing each type of sling procedure. Multivariable regression analysis with stepwise regression was used to assess the odds of composite adverse events (e.g., urinary tract infection, surgical site infection, pulmonary embolism, and other reportable events) between cohorts. RESULTS: Of the 41 533 female patients who underwent isolated suburethral sling placement without concurrent procedures, 41 292 (99.4%) received a synthetic mesh sling, and 241 (0.6%) received an autologous facial sling. In the fascial sling cohort, 160 (66.4%) underwent rectus fascia harvest and 81 (33.6%) underwent fascia lata harvest. Sling surgeries involving autologous fascia were associated with increased odds of adverse events compared to those involving synthetic mesh, even after adjusting for confounders (adjusted odds ratio [aOR]: 3.63, 95% confidence interval [CI]: 2.56-5.15). Compared to fascial slings from rectus fascia, slings from fascia lata were associated with increased odds of composite adverse events (aOR: 2.11, 95% CI: 1.03-4.04). However, with the exclusion of urinary tract infections, the adverse event rate was similar between slings using the two fascial harvest techniques (aOR: 1.93, 95% CI: 0.81-4.63). CONCLUSIONS: In this retrospective database study, suburethral sling surgeries using autologous fascia were independently associated with a 3.6-fold increase in odds of 30-day perioperative adverse events compared to sling surgeries using synthetic mesh.

Robotic-assisted intravesical mesh excision following retropubic midurethral sling.

INTRODUCTION AND HYPOTHESIS: Intravesical mesh is an uncommon complication following synthetic midurethral sling placement. Management options have included endoscopic techniques such as laser ablation or surgical excision. We present our technique for robotic-assisted excision of intravesical mesh following a retropubic midurethral sling. METHODS: The patient is a 66-year-old woman with a remote history of laser ablation of intraurethral mesh after midurethral sling, and persistent symptomatic intravesical mesh with associated stone at the bladder neck and right bladder wall. Robotic excision of the intravesical mesh and stone was performed by entering the space of Retzius, carrying the dissection along the right arm of the retropubic sling, performing two cystotomies to free and remove the mesh, and finally closing the cystotomies in two layers. RESULTS: The patient was discharged on postoperative day 1. A cystogram prior to catheter removal showed no extravasation and a competent bladder neck. She reported no new stress incontinence and had improvement in overactive bladder symptoms. CONCLUSIONS: Robotic excision of intravesical mesh after synthetic midurethral sling was safely performed in this patient who had multiple areas of intravesical mesh. Management aspects reported here may be helpful for complex presentations of intravesical mesh.

Evaluation of Outcomes Between the Top-down Versus the Bottom-up Approach for Retropubic Midurethral Sling.

INTRODUCTION AND HYPOTHESIS: Retropubic midurethral sling (MUS) placement is the gold standard for the treatment of stress urinary incontinence in the USA. The procedure can be approached from either a top-down or a bottom-up direction, but there is a paucity of contemporary data regarding outcomes between these approaches. The aim of this study was to provide updated clinical outcomes data. METHODS: This was a retrospective cohort study of women undergoing the retropubic MUS procedure alone or at the time of pelvic organ prolapse repair between 2010 and 2020 at a single academic medical center. The electronic medical record was used to extract demographic data, operative approach, and perioperative complications. The primary outcome was a composite incidence of any perioperative complication. RESULTS: Of the 309 patients analyzed, 140 (45.3%) underwent top-down and 169 (54.7%) underwent bottom-up retropubic MUS placement. Patients undergoing top-down MUS placement were more likely to be older (mean age 58 vs 54, p=0.02), have a history of diabetes mellitus (20% vs 8.9%, p=0.004), and have had a prior hysterectomy (27% vs 16%, p=0.02). They were less likely to have a concurrent anterior (p<0.001) or posterior repair (p<0.001). Patients undergoing the top-down procedure were less likely to experience sling exposure (p=0.02); complications in the two groups were otherwise similar. CONCLUSIONS: The top-down approach to retropubic MUS placement was associated with lower rates of mesh erosion in this population of patients. Neither approach is associated with an increased overall risk of complications or de novo overactive bladder symptoms.

Impact of Preoperative Urinary Tract Infection Screening in Asymptomatic Women Undergoing Midurethral Sling.

INTRODUCTION: There is limited information regarding the utility of preoperative urine culture (Ucx) screening to decrease postoperative UTI rates following midurethral sling (MUS). HYPOTHESIS: The primary objective of this study was to determine if the rate of postoperative UTI within the first 6 weeks after surgery is lower in women undergoing MUS when preoperative Ucx is obtained compared to when it is not. Secondary objectives were to determine clinical factors associated with postoperative UTI risk. METHODS: This is a retrospective cohort study of women who did not have symptoms of or a diagnosis of cystitis at the time of their preoperative evaluation and are undergoing MUS. Patients were grouped into those who had preoperative Ucx screening within 6 weeks preceding surgery and those who did not. UTI rates 6 weeks following surgery were compared between groups. Additionally, factors impacting the risk of developing a UTI within 6 weeks of surgery were assessed. RESULTS: Among 661 patients, 13.2% had a UTI within the first 6 weeks. There was no significant difference in UTI rates between those who did and did not have preoperative Ucx, respectively (14.9% vs 10.2%, p = 0.09). On multivariable analysis, current smoker status (OR 3.02, 95% CI 1.10-8.26), history of recurrent UTI (OR 3.00, 95% CI 1.14-7.86), and requiring postoperative SIC (OR 8.75, 95% CI 1.83-41.74) were independently associated with a UTI within 6 weeks of MUS. CONCLUSION: Obtaining preoperative Ucx in asymptomatic women prior to MUS does not appear to be associated with lower postoperative UTIs rates within 6 weeks of surgery.

Midurethral Sling Mesh Exposure Confers a High Risk of Persistent Stress Urinary Incontinence.

INTRODUCTION AND HYPOTHESIS: The objective was to investigate the relationship between mesh exposure and persistent stress urinary incontinence (SUI) post-midurethral sling (MUS) surgery. METHODS: Extensive data collection including patient demographics, obstetric history, existing medical conditions, previous surgeries, and surgical outcomes, encompassing both perioperative and postoperative complications. RESULTS: Out of 456 patients who underwent the MUS procedure within the specified period, the persistence of SUI was noted in 6.4% of cases. Mesh exposure was observed in 8.8% of these cases. Notably, 25% of patients with mesh exposure suffered from persistent SUI, in stark contrast to 4.6% of those without mesh exposure (p < 0.0001). Further, multivariate analysis indicated that patients with mesh exposure had an approximately 6.5-fold increased likelihood (95% CI: 2.71-15.44) of experiencing persistent SUI compared with those without mesh exposure. CONCLUSIONS: Mesh exposure is a significant independent risk factor for persistent SUI post-MUS surgery. Patients with mesh exposure are about 6.5 times more prone to persistent SUI than those without. Although mesh exposure is typically managed with expectant measures, vaginal estrogen or mesh excision, current evidence does not support surgical revision of MUS affected by mesh exposure or additional incontinence procedures during mesh excision.

Racial and ethnic disparity in national practice patterns for stress urinary incontinence surgery.

INTRODUCTION AND HYPOTHESIS: There is a paucity of information assessing whether race/ethnicity is associated with differences in surgical treatment of stress urinary incontinence (SUI). The primary objective was to assess for racial/ethnic disparities in SUI surgeries. Secondary objectives were to assess for surgical complication differences and trends over time. METHODS: Using the American College of Surgeons National Surgical Quality Improvement Program database, we conducted a retrospective cohort analysis of patients undergoing SUI surgery from 2010 to 2019. Chi-squared or Fisher's exact test and ANOVA were used for categorical and continuous variables respectively. Breslow day score and multinomial and multiple logistic regression models were used. RESULTS: A total of 53,333 patients were analyzed. Using White race/ethnicity and sling surgery as references, Hispanic patients underwent more laparoscopic surgeries (OR1.17 [CI 1.03, 1.33]) and anterior vesico-urethropexy/urethropexies (OR 1.97 [CI 1.66, 2.34]); Black patients underwent more anterior vesico-urethropexy/urethropexies (OR 1.49 [CI 1.07, 2.07]), abdomino-vaginal vesical neck suspensions (OR 2.19 [CI 1.05-4.55]), and inflatable urethral slings (OR 4.28 [CI 1.23-14.90]). White patients had lower rates of inpatient stay (p < 0.0001) and blood transfusion (p < 0.0001) compared with patients who were Black, indigenous, people of color (BIPOC). Over time, Hispanic and Black patients were more likely to undergo anterior vesico-urethropexy/urethropexies than White patients (RR 2.03:1 [CI 1.72-2.40]) and (RR 1.59 CI [1.15-2.20]) respectively. Adjusting for possible confounders, Hispanic and Black patients had a greater chance of having a nonsling surgery, 37% (p < 0.0001) and 44% (p = 0.0001) greater chances respectively. CONCLUSION: We observed racial/ethnic differences in SUI surgeries. Although causality cannot be proven here, our results confirm previous findings suggesting inequities in care.

Surgeon Upper Extremity Kinematics During Error and Error-Free Retropubic Trocar Passage.

INTRODUCTION AND HYPOTHESIS: Surgeon kinematics play a significant role in the prevention of patient injury. We hypothesized that elbow extension and ulnar wrist deviation are associated with bladder injury during simulated midurethral sling (MUS) procedures. METHODS: We used motion capture technology to measure surgeons' flexion/extension, abduction/adduction, and internal/external rotation angular time series for shoulder, elbow, and wrist joints. Starting and ending angles, minimum and maximum angles, and range of motion (ROM) were extracted from each time series. We created anatomical multibody models and applied linear mixed modeling to compare kinematics between trials with versus without bladder penetration and attending versus resident surgeons. A total of 32 trials would provide 90% power to detect a difference. RESULTS: Out of 85 passes, 62 were posterior to the suprapubic bone and 20 penetrated the bladder. Trials with versus without bladder penetration were associated with more initial wrist dorsiflexion (-27.32 vs -9.03°, p = 0.01), less final elbow flexion (39.49 vs 60.81, p = 0.03), and greater ROM in both the wrist (27.48 vs 14.01, p = 0.02), and elbow (20.45 vs 12.87, p = 0.04). Wrist deviation and arm pronation were not associated with bladder penetration. Compared with attendings, residents had more ROM in elbow flexion (14.61 vs 8.35°, p < 0.01), but less ROM in wrist dorsiflexion (13.31 vs 20.33, p = 0.02) and arm pronation (4.75 vs 38.46, p < 0.01). CONCLUSIONS: Bladder penetration during MUS is associated with wrist dorsiflexion and elbow flexion but not internal wrist deviation and arm supination. Attending surgeons exerted control with the wrist and forearm, surgical trainees with the elbow. Our findings have direct implications for MUS teaching.

Precision in Practice: The Critical Role of Mesh and Procedure Type Specification in Urogynecological Surgeries and Research.

Recently, the debate surrounding the use of mesh in urogynecological procedures has intensified, leading to FDA warnings and heightened safety concerns. This clinical opinion emphasizes the vital need to specify mesh types in these procedures, drawing attention to the risk profiles and clinical outcomes associated with various meshes and the procedures that utilize them. A significant issue identified in contemporary literature is the tendency to group diverse mesh types under the same umbrella, disregarding their unique characteristics and applications. We describe the range of mesh types, their application routes, and associated complications, highlighting the risks of this nonspecific approach to patient safety and informed decision making. We critically examine the generalization of mesh terminology in clinical and research dialogues. Concluding with specific recommendations for health care providers and researchers, the paper advocates for a more nuanced understanding and communication in the field, ultimately aiming to improve patient care and safety in urogynecological practice.

More With Less: Single-Incision Sling Insertion Techniques.

STUDY OBJECTIVE: To demonstrate reproducible procedures for efficient single-incision sling insertion and troubleshooting. DESIGN: Narrated video footage with stepwise demonstration of single-incision sling insertion technique with anchor system. SETTING: 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]. INTERVENTIONS: 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. CONCLUSION: 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.

Randomized Trial of Single-Incision Midurethral Sling and Laparoscopic Burch Colposuspension: Postoperative Surgical Outcomes and Complications.

STUDY OBJECTIVE: Various retropubic and midurethral sling techniques have shown high cure rates in the treatment of stress urinary incontinence (SUI). This study aimed to compare single-incision midurethral sling (SIMS) and laparoscopic Burch colposuspension (LBC) procedures in patients with SUI in terms of the effectiveness, patient satisfaction, surgical complications and results. DESIGN: This is a prospective randomized study. SETTING: A university tertiary hospital. PATIENTS: Forty patients with clinically and/or urodynamically proven SUI who agreed to surgical treatment were randomized to the SIMS and LBC groups and included in the study. INTERVENTIONS: Patients were treated with SIMS and LBC operations. MEASUREMENTS AND MAIN RESULTS: Demographic characteristics of patients, physical and pelvic examination, preoperative and postoperative clinical findings, Kings Health Questionnaire form, Female Sexual Function Index and Prolapse Quality of Life Questionnaire form, postoperative day 1 visual analog scale score, and postoperative complications were recorded. Objective and subjective success rates were recorded by re-evaluating the patients in the first and sixth months of the operation. Objective success was defined as having a negative stress test and subjective success was defined as the absence of stress-induced urine leakage after surgery in a validated questionnaire. The primary result of our study was considered to be objective success, whereas the secondary result was subjective success and life quality tests. Twenty patients each in the SIMS group and the LBC group were included in the study. No significant difference was found in objective success (90% vs 85%, p = .633) or subjective success (85% vs 75%, p = .695) between the 2 groups at 6-month follow-up. A significant improvement in life quality was observed in the postoperative period for both groups; however, the difference between the groups was not significant. There was an improvement in sexual function in both groups. Nonetheless, although this improvement was significant in the SIMS group, it was not significant in the LBC group. In addition, surgery time, catheterization time, and hospitalization time were shorter in the SIMS group than in the LBC group. The visual analog scale score on postoperative day 1 was lower in the SIMS group. Groups were not different in terms of preoperative and postoperative complications. CONCLUSION: This preliminary study is the first randomized study that compares the LBC and SIMS procedures in the literature. It shows that SIMS and LBC procedures have not different objective and subjective success rates in the short term. It was also observed that they increase both sexual and life quality results in a positive and similar way.

Assessment of Urinary Dysfunction After Midurethral Sling Placement: A Comparison of Two Voiding Trial Methods.

STUDY OBJECTIVE: Temporary urinary retention after midurethral sling (MUS) surgery requiring indwelling catheter or self-catheterization usage is common. Different methods for assessment of immediate postoperative urinary retention have been described. This study aimed to compare postoperative voiding trial (VT) success after active vs passive VT in women undergoing MUS surgery. DESIGN: Comparative retrospective cohort study. SETTING: Female pelvic medicine and reconstructive surgery practice at a university-affiliated tertiary medical center. PATIENTS: Patients with stress urinary incontinence who underwent surgical treatment during the study period were eligible for inclusion. Excluded were patients younger than the age of 18 years, combined cases with other surgical services, planned laparotomy, and a history of urinary retention and patients for whom their VT was performed on postoperative day 1. The cohort was divided into 2 groups: (1) patients who underwent an active retrofill of their bladder using a Foley catheter and (2) patients who were allowed to have a spontaneous void. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: A total of 285 patients met the inclusion criteria for the study. Of these subjects, 94 underwent an active VT and 191 underwent a passive VT. There were no statistically significant differences in immediate postoperative urinary retention (30.8% vs 29.3%; p = .79) or time from surgery end to VT (233.0 ± 167.6 minutes vs 203.1 ± 147.8 minutes; p = .13) between groups. Urinary retention, as defined by a failed VT, increased from 10% to 29.3% when MUS placement was accompanied by concomitant prolapse repair procedure. Multivariate logistic regression analysis revealed that undergoing a combined anterior and posterior colporrhaphy (odds ratio [OR], 5.13; p <.001) and undergoing an apical prolapse procedure (OR, 2.75; p = .004) were independently associated with immediate postoperative urinary retention whereas increased body mass index (OR, 0.89; p <.001) lowered likelihood of retention. CONCLUSION: The method used to assess immediate postoperative urinary retention did not affect VT success. Concomitant combined anterior and posterior colporrhaphy and apical suspension were correlated with greater likelihood of VT failure whereas increased body mass index decreased odds of retention.

Midurethral Sling With Concomitant Sacrocolpopexy: Does the Sequence Matter? A Retrospective Cohort Study.

The objective is to determine if the timing of midurethral sling (MUS) placement has an impact on the recurrence rate of stress urinary incontinence. We conducted a retrospective cohort study of patients who underwent robot sacrocolpopexy (RSC) with MUS placement at a large community hospital. Our data demonstrated that there was no significant difference in stress urinary incontinence recurrence when the MUS was placed before or after the RSC (15% vs. 11%, P = 0.41, respectively). We concluded that physician preference may dictate surgical approach to sequence of retropubic MUS placement at the time of RSC.

A randomized prospective comparison of the needleless mini-sling "hammock" and "U-shape" configurations for management of stress urinary incontinence: 60-month follow-up results.

OBJECTIVE: To compare needleless mini-slings placed in a retropubic (U-shape) or trans-obturator (hammock-shape) configuration for treating stress urinary incontinence at 60th month. METHODS: All surgeries, conducted by a senior surgeon, involved objective and subjective assessments preoperatively and at 6, 12, 18, and 60 months postoperatively using cough-stress tests, ICIQ-SF, PGI-I, and a Likert scale. RESULTS: After 60 months, no significant differences were found in cure rates, mesh complications, or reinterventions between U-shaped and hammock-shaped groups. However, a significant decrease in cure rates was observed at 18 and 60 months in both groups. Notable differences in ICIQ-SF, Likert scale, and PGI-I scores were seen in the hammock-shaped group, while the U-shaped group showed differences in ICIQ-SF and PGI-I scores, but not in the Likert scale. CONCLUSION: Given the lack of significant differences, asserting the superiority of either retropubic (U-shape) or transobturatorly (hammock-shape) needleless mini-slings for treating stress urinary incontinence is challenging.

The prostate in women: an updated histological and immunohistochemical profile of the female periurethral glands and their relationship to an implanted midurethral sling.

BACKGROUND: There is evidence of glandular tissue in the region of the anterior vaginal wall-female periurethral tissue (AVW-FPT) that has similar morphology and immunohistochemistry to the prostate in men. Surgical injury to this tissue has been suggested as a potential cause of sexual dysfunction following midurethral sling (MUS) procedures. However, the anatomy and embryology of these glands have not been fully resolved. This has led to difficulties in classifying this tissue as a prostate and defining its clinical significance related to MUS procedures. AIM: To describe the histological and immunohistochemical characteristics of the female periurethral glands using markers of prostate tissue and innervation and to examine their anatomical relationships to an implanted MUS. METHODS: Using gross and fine dissection, the AVW-FPT was dissected from 9 cadavers. Prior to dissection, 2 cadavers underwent simulation of the MUS procedure by a urogynecologist. Samples were paraffin embedded and serially sectioned. Immunohistochemistry was performed using markers of prostate tissue and innervation. OUTCOMES: Immunohistochemical localization of markers for prostatic tissue and innervation of the glandular tissue of the AVW-FPT, including the region of MUS implantation. RESULTS: Female periurethral glands were immunoreactive for markers of male prostatic tissue, including prostate-specific antigen, androgen receptor, HOXB13, and NKX3.1. Markers of innervation (protein gene product 9.5, choline acetyl transferase, and vasoactive intestinal polypeptide) also localized to certain regions of the glandular tissue and associated blood supply. Surgical simulation of the MUS procedure demonstrated that some periurethral glands are located in close proximity to an implanted sling. CLINICAL TRANSLATION: The AVW-FPT contains glandular tissue in the surgical field of MUS implantation. Iatrogenic damage to the female periurethral glands and the associated innervation during surgery could explain the negative impacts on sexual dysfunction reported following MUS procedures. STRENGTHS AND LIMITATIONS: This is the first study to characterize the female periurethral glands using markers of prostatic tissue in concert with markers of general and autonomic innervation and characterize their anatomical relationships within the surgical field of MUS implantation. The small sample size is a limitation of this study. CONCLUSION: We provide further evidence that the AVW-FPT contains innervated glands that are phenotypically similar to the male prostate and may share a common embryonic origin. The microscopic and immunohistochemical features of the periurethral glands may be indicative of their functional capacity in sexual responses. The location of these glands in the surgical field of MUS procedures underscores the clinical significance of this tissue.

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

PURPOSE: 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 US Food and Drug Administration (FDA) 522 cohort study. MATERIALS AND METHODS: 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. RESULTS: Three hundred fifty-five women 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. CONCLUSION: 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.