Mid-term results of ReMEEX sling system in female stress urinary incontinence with various indications and feasibility of readjustment.

PURPOSE: To examine efficacy and safety of ReMEEX implantation in patients with female stress urinary incontinence (SUI) associated with detrusor underactivity (DU), recurrence, or intrinsic sphincter deficiency (ISD). MATERIALS AND METHODS: Retrospective cohort study included 303 females who underwent ReMEEX system (March 2008 to May 2021). Patients were stratified into three groups by purpose of surgery (SUI with DU, reoperation, and SUI with ISD) and evaluated with following criteria: cure (absence of subjective complaint of leakage and objective leakage in the stress test), improvement (rare leakage subjectively, but satisfaction regardless of stress test), and failure. Primary outcome was success rate of surgery assessed through patient interviews and a stress test. Surgical outcomes and complications were evaluated. RESULTS: Mean follow-up was 34.4 months (range, 6.0-145.0 months). At the final follow-up visit, 42.9% and 49.2% of patients were cured and improved. Twenty-one point five percent required tension readjustment (mean number, 1.2). The total complication rate was 19.5% (none for grade ≥4). Preoperative Qmax was significantly higher in the ISD group (p<0.001) and preoperative total International Prostate Symptom Score (IPSS) score was significantly higher in the DU group (p=0.044). Moreover, at postoperative 1 year, both total IPSS score and IPSS quality of life score were significantly higher in the DU group (both p=0.001). CONCLUSIONS: The success rate of ReMEEX system was 92.1% at mean follow-up of 34.4 months in female SUI with DU, reoperation, or ISD. It also enabled postoperative readjustment of sling tension, as needed, up to 130 months after surgery.

Laser excision of urethral mesh erosion: a 10-year experience.

PURPOSE: To review our 10-year experience with laser excision for urethral mesh erosion (UME) of mid-urethral slings (MUS). METHODS: Following Institutional Review Board approval, the charts of female patients with endoscopic laser excision of UME were retrospectively reviewed. Demographics, clinical presentation, surgical history, pre- and post-operative Urinary Distress Inventory-6 scores and quality of life ratings, operative reports, and outcomes were obtained from electronic medical records. UME cure was defined as no residual mesh on office cystourethroscopy 5-6 months after the final laser excision procedure. RESULTS: From 2011 to 2021, 23 patients met study criteria; median age was 56 (range 44-79) years. Twenty (87%) had multiple prior urogynecologic procedures. Median time from MUS placement to presentation with UME-related complaints was 5.3 [interquartile range (IQR) 2.3-7.6] years. The most common presenting symptom was recurrent urinary tract infection (rUTI) (n = 10). Median operating time was 49 (IQR 37-80) minutes. Median duration of follow-up was 24 (IQR 12-84) months. Fourteen (61%) required more than 1 laser excision procedure for UME. Although 5 were asymptomatic (22%), new (n = 5) or persistent (n = 8) urinary incontinence was the most common symptom on follow-up (57%). CONCLUSION: UME presenting symptoms are highly variable, necessitating a high index of suspicion in patients with a history of MUS, especially in the case of rUTI. Endoscopic laser excision is a minimally invasive, brief, safe, outpatient procedure with a high UME cure rate.

Active Compared With Passive Voiding Trials After Midurethral Sling Surgery: A Systematic Review.

OBJECTIVE: To compare active with passive voiding trials on the rate of passing a trial of void and discharge rates with catheter in women who have undergone midurethral sling for treatment of stress urinary incontinence (SUI). DATA SOURCES: MEDLINE, EMBASE, and ClinicalTrials.gov were searched through February 24, 2023. METHODS OF STUDY SELECTION: Our population included women undergoing midurethral sling, with or without anterior or posterior repair, for treatment of SUI. Our two primary outcomes were rate of passing voiding trial and rate of discharge with a catheter. Our secondary outcome was the rate of delayed postoperative urinary retention, when a patient initially passes a trial of void but then subsequently presents in retention. TABULATION, INTEGRATION, AND RESULTS: Abstracts were doubly screened; full-text articles were doubly screened; and accepted articles were doubly extracted. In single-arm studies evaluating either passive or active voiding trial, random-effects meta-analyses of pooled proportions were used to assess outcomes. Of 3,033 abstracts screened, 238 full-text articles were assessed, and 26 met inclusion criteria. Ten studies including 1,370 patients reported active trial of void. Sixteen studies including 3,643 patients reported passive trial of void. We included five randomized controlled trials, five comparative retrospective studies, five prospective single group studies, and 11 retrospective single group studies. Five of the studies included patients with a concomitant anterior or posterior colporrhaphy. On proportional meta-analysis, the active trial of void group was less likely to pass the voiding trial (81.0%, 95% CI, 0.76-0.87% vs 89.0%, 95% CI, 0.84-0.9%3, P =.029) with high heterogeneity ( I2 =93.0%). Furthermore, there were more discharges with catheter in active trial of void compared with passive trial of void (19.0%, 95% CI, 0.14-0.24% vs 7.0%, 95% CI, 0.05-0.10%, P <.01). The rates of delayed postoperative urinary retention were low and not different between groups (0.6%, 95% CI, 0.00-0.02% vs 0.2%, 95% CI, 0.00-0.01%, P =.366) with low heterogeneity ( I2 =0%). Sling revisions were statistically lower in the active trial of void group (0.5%, 95% CI, 0.00-0.01% vs 1.5%, 95% CI, 0.01-0.02%, P =.035) with low heterogeneity ( I2 =10.4%). CONCLUSION: Passive trial of void had higher passing rates and lower discharge with catheter than active trial of void. Rates of most complications were low and similar between both groups, although passive trial of void had higher sling revisions. SYSTEMATIC REVIEW REGISTRATION: PROSPERO, CRD42022341318.

Increased Rate of Mesh Erosion in Breast Cancer Survivors Taking Antiestrogen Therapy.

IMPORTANCE: There are no current data investigating the relationship between mesh-exposure complications after midurethral sling surgery and antiestrogen therapy. OBJECTIVES: We sought to determine if there are increased mesh-exposure complications between a breast cancer population versus a noncancer population particularly in conjunction with hormone suppression (HS) therapy. STUDY DESIGN: A retrospective chart review was performed on patients with a history of breast cancer undergoing tension-free vaginal tape (TVT) surgery at our institution between 2013 and 2021. A group of patients who underwent TVT surgery without a history of cancer served as our control. Univariate and multivariate logistic regression analyses were performed to identify predictors of mesh exposure complications. RESULTS: One hundred twenty-one patients with breast cancer had TVT surgery. Two hundred ninety-seven patients without cancer had TVT surgery during the same period. Baseline characteristics across all groups were similar. Twenty-nine patients (6.9%) experienced mesh exposure. This occurred at a higher rate in our cancer (15.7%) versus the noncancer population (3.4%). Women with breast cancer taking HS therapy had a higher rate of mesh exposure complications compared with those not taking HS therapy (25.0% versus 6.6%; P = 0.005). The highest rate of mesh exposure complications occurred in the cohort taking estrogen receptor modulators, selective estrogen receptor modulator (10/36 [27.8%]) versus aromatase inhibitors (5/24 [20.8%]) versus no HS therapy (4/61 [6.6%]; P = 0.014). On multivariate analysis, HS therapy use (odds ratio, 1.57; P = 0.007) and diabetes mellitus (odds ratio, 4.53; P = 0.018) were associated with increased TVT-related complications. CONCLUSION: Women with breast cancer had a higher rate of mesh exposure complications from TVT surgery compared with women without cancer, particularly those taking antiestrogenic therapy.

A Full Bladder Is Not Needed for the Male Stress Incontinence Grading Scale.

INTRODUCTION: Our objectives were to evaluate the Male Stress Incontinence Grading Scale to stratify male patients with stress urinary incontinence for either artificial urinary sphincter or sling using a standing cough test and determine if an emptier bladder at the time of assessment carries increased risk of treatment failure. METHODS: Retrospective chart review of male patients undergoing sling and artificial urinary sphincter placement. The standing cough test score and bladder scan results were documented at initial evaluation. RESULTS: Forty patients underwent sling and 43 underwent naïve artificial sphincter placement. Median follow-up was 7.11 months. Thirty-six/forty slings had complete incontinence resolution or reduction to a safety pad vs 40/43 after sphincter (90% vs 93%, P = .62). Four sling patients (10%) had persistence or recurrence of incontinence. Cough test scores were similar between sling failure (67% grade 0, 33% grade 1) and success groups (83% grade 0, 3% grade 1, 14% grade 2). Bladder scan mean was 18.5 cc in the sling failure (SD 21.1) and 38.0 cc in the success groups (38.3), with 32% of success patients having bladder scans of 0 cc, and 63% of < 50 cc. Mean for sphincter patients was 45 cc (56.9). Ten patients with scan = 0 and 7 patients with scans < 30 cc demonstrated grade 4 incontinence. CONCLUSIONS: Cough test is a noninvasive, reliable tool to assess stress urinary incontinence severity. Our data suggest it is reliable even when bladders are nearly empty and can effectively stratify patients for sling vs artificial urinary sphincter with a high rate of success.

Risk Factors for De Novo Overactive Bladder After Midurethral Sling.

IMPORTANCE: The low incidence of de novo overactive bladder (OAB) symptoms after a midurethral sling (MUS) procedure better informs preoperative counseling. OBJECTIVE: The study aimed to measure the incidence and risk factors for de novo OAB after MUS. STUDY DESIGN: This was a retrospective cohort study of de novo OAB symptoms in patients who underwent MUS surgery in a health maintenance organization between January 1, 2008, and September 30, 2016. Patients were identified using Current Procedural Terminology codes for MUS and International Classification of Diseases, Tenth Revision codes for urinary urgency, frequency, nocturia, OAB, and urgency urinary incontinence (UUI). The cohort of patients was identified by the absence of these International Classification of Diseases, Tenth Revision codes 12 months preoperatively and the presence of these codes within 6 months after surgery. This cohort was used to calculate the rate of de novo OAB after MUS surgery. Clinical and demographic factors were abstracted. Statistical analysis was performed using descriptive, χ2 , simple logistic, and multiple logistic regression. RESULTS: During the study period, 13,893 patients underwent MUS surgery and 6,634 met the inclusion criteria. The mean age was 56.9 years, mean parity was 2.76, and mean body mass index was 28.9 (calculated as weight in kilograms divided by height in meters squared). Of these, 410 (6.1%) developed de novo OAB within 12 months. The most common symptoms were urgency (65.4%), UUI (42.2%), and frequency (19.8%). On multivariable regression modeling, de novo urgency and UUI were not associated with concurrent surgery ( P < 0.05). Increasing age and body mass index were associated with an increased risk of nocturia ( P < 0.05). CONCLUSIONS: The incidence of de novo OAB after MUS surgery was 6.1%. This aligns with current literature and critically informs preoperative counseling for MUS surgery.

A modified sling mid-urethral suspension + subcutaneous tunnel-double point fixation technique for male stress urinary incontinence: a pilot study.

OBJECTIVES: The aim of this study was to demonstrate the feasibility of a modified sling mid-urethral suspension + subcutaneous tunnel-double point fixation technique for the treatment of male urinary incontinence and to preliminarily evaluate the short-term clinical efficacy of this technique. PATIENTS AND METHODS: The clinical data of patients treated with the modified sling mid-urethral suspension + subcutaneous tunnel-double point fixation technique using a Pelvimesh pelvic floor repair patch as a sling were collected. The primary evaluation criteria were surgery-related indicators and daily urinal pad usage before and after treatment, and the secondary evaluation criteria were the corresponding incontinence scores and the results of surgery-related questionnaires. RESULTS: After 1-12 months of follow-up, seven patients were clinically cured. Follow-up 1 month after surgery showed that one patient (14.3%) used one pad daily, and six patients (85.7%) did not need pads. The incontinence quality of life questionnaire (I-QOL) scores at 3 days and 1 month postoperatively were 89.4 ± 2.5 and 88.1 ± 6.7, respectively, which were significantly higher than the preoperative scores (31.5 ± 18.9) (P < 0.05). The scores of the International Continence Control Association Incontinence Questionnaire Short Form (ICI-Q-SF) at 3 days and 1 month postoperatively were 3.2 ± 0.9 and 4.2 ± 1.7, respectively, which were significantly lower than the preoperative scores of 19.4 ± 5.0 (P < 0.05). In addition, the results of the surgery-related questionnaires were positive. No serious complications occurred in any of the patients. CONCLUSION: The modified sling mid-urethral suspension + subcutaneous tunnel-double point fixation technique for the treatment of male urinary incontinence patients is safe, effective, minimally invasive, and has few complications. However, further validation in large sample, randomized, comparative, and longer-term follow-up studies is still needed.

Safety and Efficacy Report for the Use of Poly-4-Hydroxybutyrate as a Retropubic Mid-Urethral Sling (MUS) for Stress Urinary Incontinence: A Prospective 24 Months Follow-Up of New Poly-4-Hydroxybutyrate TephaFlex SUI Bioresorbable MUS.

STUDY OBJECTIVE: To investigate the feasibility and safety of the retropubic mid-urethral sling (MUS) procedure with a resorbable mesh implant made of poly-4-hydroxybutyrate (P4HB). DESIGN: A prospective clinical cohort study with 24 months follow-up. SETTING: A tertiary academic hospital. PATIENTS: Seventeen women with moderate to severe stress urinary incontinence (SUI). INTERVENTIONS: A retropubic MUS procedure with P4HB sling. MEASUREMENTS AND MAIN RESULTS: Seventeen women underwent an uncomplicated MUS procedure with a new sling made of resorbable P4HB. Following safety criteria, there has been no need to stop the study before 24 months' end point. Three serious adverse events were reported during follow-up: (1) inability to void urine after 1 week postsurgery, (2) a hysterectomy and bilateral oophorectomy performed due to a precancerous endometrial lesion at 16 months after initial MUS procedure and (3) exposed mesh with a part of device sheath left behind. These participants underwent an uncomplicated reintervention with no additional and/or permanent harm. Reinterventions because of failure of cure contained 3 second MUS procedures and one admission of urethral bulking agent. Seventy-six percent and 47 percent of patients were objectively cured of SUI at 12 and 24 months, respectively. CONCLUSIONS: Preliminary evidence suggests that a sling made of P4HB can be safely used for MUS procedures and could be an alternative for permanent polypropylene slings in patients that prefer the use of nonpermanent material.

Should endoscopic laser excision be offered as the first-line management for patients with eroded mesh? Outcomes of a systematic review of literature.

PURPOSE OF REVIEW: Mesh erosions following previous synthetic sling/mesh surgery for stress urinary incontinence (SUI) have become increasingly common. This systematic review provides evidence for the role of laser excision as a first-line management in patients with eroded mesh. RECENT FINDINGS: Fourteen articles (173 patients) were included for the final review. Among these, 138 patients (79.8%) were submitted to trans-urethral laser excision of eroded urethral/bladder mesh over a median time to presentation of 36.6 months. Over a median follow-up of 23.6 months, 88 (63.7%) reported a complete resolution, 32 (23.2%) reported persistence or recurrence of SUI and 17 (12.3%) presented with recurrent mesh erosion. The success rate after a single endoscopic procedure was 66.5, vs. 93.5% after additional endoscopic procedures, with only 9 (6.6%) requiring open surgical excision. Overall, there were seven (5.1%) postoperative complications including two urethrovaginal fistulas, two UTIs and haematuria each, and one case of urethral diverticulum. SUMMARY: Laser excision of eroded mid-urethral slings into either the bladder or urethra is a challenging complication of minimally invasive incontinence surgery. Laser excision was able to achieve a good success rate with single or staged endoscopic procedure with a low risk of complication. It represents a valid first treatment option, although patients should be managed in mesh referral centres in collaboration with uro-gynaecology teams.

Cost-Utility Analysis of Midurethral Sling Timing Among Women Undergoing Prolapse Surgery.

IMPORTANCE: There are no guidelines regarding the ideal timing of midurethral sling (MUS) placement following prolapse repair. OBJECTIVE: The objective of this study was to estimate the cost-utility of concomitant MUS versus staged MUS among women undergoing apical suspension surgery for pelvic organ prolapse. STUDY DESIGN: Cost-utility modeling using a decision analysis tree compared concomitant MUS with staged MUS over a 1-year time horizon. The primary outcome was the incremental cost-effectiveness ratio (ICER). Six scenarios were modeled to estimate cost-utilities for women with preoperative overt, occult, or no stress urinary incontinence (SUI) who underwent either minimally invasive sacrocolpopexy or vaginal native tissue apical suspension. Possible complications of de novo overactive bladder, urinary retention requiring sling lysis, mesh exposure, and persistent SUI were included. Costs from a third-party payer perspective were derived from Medicare 2022 reimbursements. One-way sensitivity analyses were performed. RESULTS: Among women without preoperative SUI, staged MUS was the dominant strategy for both surgical routes with higher utility and lower costs. For women with either occult or overt SUI undergoing sacrocolpopexy or vaginal repair, concomitant MUS was cost-effective (ICER = $21,114-$96,536 per quality-adjusted life-year). Therefore, concomitant MUS is preferred for patients with preoperative SUI as higher costs were offset by higher effectiveness. One-way sensitivity analyses demonstrated that ICERs were most affected by probability of cure following MUS. CONCLUSIONS: A staged MUS procedure is the dominant strategy for women undergoing apical prolapse repair without preoperative SUI. In women with either overt or occult SUI, the ICER was below the willingness-to-pay threshold of $100,000 per quality-adjusted life-year, suggesting that concomitant MUS surgery is cost-effective.

Adjustable transobturator male system (ATOMS) for stress urinary incontinence: the evidence is mounting.

OBJECTIVES: To evaluate the New Zealand clinical experience with the adjustable transobturator male system (ATOMS), a novel continence device in the management of all degrees of stress urinary incontinence (SUI), focusing on efficacy and safety outcomes. PATIENTS AND METHODS: A retrospective review of all ATOMS devices placed between May 2015 and November 2020 was conducted. Severity of SUI was assessed (pad usage) before and after surgery. SUI was defined as mild (1-<3 pads/day), moderate (≥3-5 pads/day) or severe (>5 pads/day). The primary outcome measures considered were the overall success rate (improvement in pad use) and the dry rate (with dry defined as either no or 1 safety pad/day). The number of outpatient adjustments and total filling volumes were also documented in each case. Additionally, we documented incidence and severity of device complications and an analysis of treatment failures. RESULTS: A total of 140 patients were reviewed, with the most common indication for ATOMS placement being SUI after radical prostatectomy (82.8%). Of the patients included, 53 (37.9%) had previous radiotherapy, with 26 (18.6%) patients having had a previous continence procedure performed. No intraoperative complications were noted. The median preoperative pad usage was 4 pads/day. After a median follow-up of 11 months, median postoperative pad usage reduced to 1 pad/day. In our cohort, 116 patients (82.9%) reported an improvement in their pad usage and were considered successful with 107 (76.4%) patients reporting themselves to be dry. Complications within the first 90-days after surgery occurred in 20 (14.3%) of patients. CONCLUSION: Treatment of SUI with the ATOMS is safe and effective. The option of long-term, minimally invasive adjustment to respond to patient needs is a significant advantage.

Dyspareunia and pelvic pain: comparison of mid-urethral sling methods 10 years after insertion.

INTRODUCTION AND HYPOTHESIS: The mid-urethral sling (MUS) has been used for more than 30 years to cure stress urinary incontinence. The objective of this study was to assess whether surgical technique affects the outcome after more than ten years, regarding dyspareunia and pelvic pain. METHODS: In this longitudinal cohort study we used the Swedish National Quality Register of Gynecological Surgery to identify women who underwent MUS surgery in the period 2006-2010. Out of 4348 eligible women, 2555 (59%) responded to the questionnaire sent out in 2020-2021. The two main surgical techniques, the retropubic and the obturatoric approach, were represented by 1562 and 859 women respectively. The Urogenital Distress Inventory-6 (UDI-6) and the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12), as well as general questions concerning the MUS surgery, were sent out to the study population. Dyspareunia and pelvic pain were defined as primary outcomes. Secondary outcomes included PISQ-12, general satisfaction, and self-reported problems due to sling insertion. RESULTS: A total of 2421 women were included in the analysis. Among these, 71% responded to questions regarding dyspareunia and 77% responded to questions regarding pelvic pain. In a multivariate logistic regression analysis of the primary outcomes, we found no difference in reported dyspareunia (15% vs 17%, odds ratio (OR) 1.1, 95% CI 0.8-1.5) or in reported pelvic pain (17% vs 18%, OR 1.0, 95% CI 0.8-1.3) between the retropubic and obturatoric techniques among study responders. CONCLUSION: Dyspareunia and pelvic pain 10-14 years after insertion of a MUS do not differ with respect to surgical technique.

Obesity is not an independent risk factor for peri- and post-operative complications following mid-urethral sling (MUS) surgeries for the treatment of stress urinary incontinence (SUI).

OBJECTIVE: To inquire whether obesity is a risk factor of peri- and post-operative complications following Mid-urethral sling (MUS) surgeries for SUI repair using the Clavien-Dindo classification system (CDcs). METHODS: This retrospective cohort included 304 women who undergone a MUS in a 1000 beds tertiary University medical center between the years 2012-2018. Univariate analysis was conducted to compare clinical and operative traits by BMI group and to examine associations of obesity and complications rates and severity according to the CDcs. Multivariate analysis was conducted to assess the risk for post-operative complications and adjust to potential confounders. RESULTS: The study group included 106 (34.9%) women with BMI 30 or higher and the comparison group included 198 (65.1%) women with BMI lower than 30. In the study group we found a significantly higher prevalence of hypertension (P = 0.019), previous abdominal surgeries (P = 0.012) including cesarean section (P = 0.025), previous pelvic floor surgeries (P = 0.005) and pelvic organ prolapse (P = 0.02). In the control group we found a significantly higher rates of concomitant hysterectomy which performed during the MUS (P = 0.005). Obesity was not associated with increased rates of peri and post-operative complications (P = 0.973). CONCLUSIONS: In our study, obesity was not associated with peri- and post-operative complications following MUS.

Risk factors for 5-year complications after midurethral sling surgery for stress urinary incontinence: a retrospective cohort study from Taiwan.

Midurethral sling surgery is the current gold standard worldwide for stress urinary incontinence (SUI) surgery, with over 90% of surgeons worldwide using the midurethral sling for SUI between 2008 and 2018. However, concerns surround mesh-related adverse events associated with the midurethral sling. The decision to use the midurethral sling for surgical treatment has become a challenging one for clinicians, surgeons and patients. We sought to determine the factors for 5-year complications after midurethral sling surgery, to improve the clinical decision-making process. Records were reviewed from a total of 1961 female patients who underwent their first midurethral sling surgery for SUI between 2003 and 2018 at a single teaching hospital in Taiwan. A multivariable Cox proportional hazard model calculated the hazard ratios of risk factors for surgical complications, after adjusting for confounders. Surgical complications (i.e., secondary surgery and urinary retention) occurred in 93 (4.7%) patients within 5 years following the index operations. These patients were more likely to be older, to have a history of menopausal syndrome within 1 year prior to the index operation, a medication history of oral antidiabetic drug use, hormone replacement therapy (HRT), slower average flow rate, and longer voiding time compared with patients without surgical complications. In the multivariate analysis, HRT (adjusted hazard ratio, 1.787; 95% confidence interval, 1.011-3.158, p = 0.04) was significantly associated with surgical complications at 5 years, after adjusting for age, gender, diabetes, menopause syndrome, average flow rate, and sling type. Our findings suggest that a medication history of HRT may be a risk factor associated with surgical complications, especially urinary retention, at 5 years in women undergoing midurethral sling surgery for SUI.

Modified Sling Midurethral Suspension+Hemolock Fixation Technique for Male Urinary Incontinence: A Pilot Study.

OBJECTIVE: To demonstrate the feasibility of a modified midurethral sling+hemolock fixation technique for treating male urinary incontinence. This study aims to provide a preliminary assessment of the short-term clinical efficacy of this technique. METHODS: We collected the clinical data of patients treated with modified sling midurethral suspension+ hemolock fixation technique. The primary evaluation criteria were surgery-related indicators and daily urinal pad usage by patients before and after treatment, and the secondary evaluation criteria were the corresponding incontinence scores and the results of surgery-related questionnaires. RESULTS: Follow-up 1-7months, eight patients achieved a clinical cure. Follow-up 1month after surgery showed that two patients (25.0%) used one pad daily and six patients (75.0%) did not need pads. The incontinence quality of life questionnaire (I-QOL) scores were (86.0 ± 7.0) and (89.0 ± 3.0) at three postoperative days and one postoperative month, respectively, which were significantly higher than the preoperative scores (26.0 ± 6.0) (P <.05). The scores of the International Continence Control Association Incontinence Questionnaire Short Form (ICI-Q-SF) at three postoperative days and one postoperative month were (4.0 ± 2.0) and (4.0 ± 1.0), respectively, which were significantly lower than the preoperative scores of (18.0 ± 1.0) (P <.05). Besides, the results of the surgery-related questionnaires were positive. CONCLUSION: The short-term efficacy of the modified sling midurethral suspension+ hemolock fixation technique for the treatment of male urinary incontinence patients is safe, effective, minimally invasive, and has few complications. However, further validation in large samples, randomized, comparative, and longer-term follow-up studies is still needed.

The clinical efficacy and safety of outside-in transobturator sling with additional paraurethral fixation - The prospective longitudinal study.

Stress urinary incontinence (SUI) is a common condition that affect 30-40% of women in their lifetime. Midurethral slings (MUS) either suprapubic or transobturator can be safely used in the surgical treatment of SUI. The aim of this study was to collect clinical long-term data regarding safety and performance of transobturator sling with an additional tape fixation in women with urinary incontinence. This prospective longitudinal study was conducted on a group of 2086 female patients diagnosed with stress urinary incontinence. Follow up visits where scheduled 6 weeks, 6 and 12 months after surgery followed by annual checking when possible. Patients underwent transobturator sling procedure from 01.01.2011 to 31.12.2021. All patients had a monofilament tape inserted at the mid-urethra using outside-in technique (TOT) with 2 absorbable sutures parallel to the urethra. Success of surgery was defined as lack of any leakage during cough stress test whereas the subjective cure rate was determined by Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-SF). 87% of patients who were operated at least 10 years before assessment reported ICIQ -SF < 6. Main postoperative complications were storage symptoms - de novo urgency and voiding difficulties. TOT is safe and highly effective surgical treatment for (SUI) in a long-term observation.

Guiding Clinical Decision Making for Surgical Incontinence Treatment After Prostatectomy: A Review of the Literature.

PURPOSE OF REVIEW: Stress urinary incontinence after prostatectomy is a common and debilitating side effect. Immediate post-prostatectomy management emphasizes pelvic floor muscle exercises. Per American Urologic Association guidelines, if incontinence persists for more than 12 months postoperatively, surgical interventions are the mainstay of treatment. Treatment decisions depend on a multitude of factors. The goal of this paper is to review recent literature updates regarding the diagnosis of male SUI to better guide surgical treatment decision-making. RECENT FINDINGS: Patient history is a critical component in guiding surgical decision making with severity and bother being primary factors driving treatment decisions. Recent studies indicate that a history of pelvic radiation continues to impact the overall duration and complication rate associated with artificial urinary sphincters (AUS). Cystoscopy should be done on every patient preparing to undergo surgical SUI treatment. Urodynamics and standing cough stress tests are additional diagnostic testing options; these tests may augment the diagnosis of SUI and better delineate which patients may benefit from a male sling versus AUS. Treatment of SUI after prostatectomy can improve health-related quality of life. A patient history focused on severity and degree of bother in addition to the use of ancillary office testing can help guide surgical treatment decisions to optimize patient continence goals.

The effect of 12-month postoperative weight change on outcomes following midurethral sling for stress urinary incontinence: a secondary analysis of the ESTEEM and TOMUS randomized trials.

INTRODUCTION AND HYPOTHESIS: Prior studies demonstrate mixed results on the impact of obesity on the success of midurethral slings (MUS), with little known about how postoperative weight change affects outcomes. We aimed to examine the effect of postoperative weight change on outcomes 12 months after MUS for stress urinary incontinence (SUI). METHODS: This secondary analysis utilized data from two multicenter randomized trials of women undergoing MUS placement. Subjects were categorized into cohorts based on change in body weight at 12 months postoperatively: weight gain (≥5% increase); weight loss (≥5% decrease), and weight stable (<5% change). The primary outcome was SUI cure (no SUI episodes in a 3-day bladder diary). Patients with mixed urinary incontinence (MUI) were analyzed for changes in daily average urge incontinence (UUI) episodes in a 3-day diary. Penalized logistic regression assessed the impact of demographic and perioperative variables on the primary outcome. RESULTS: Of the 918 women included, 635 (70%) were weight stable, 144 (15%) had weight gain, and 139 (15%) had weight loss. Patients in the weight loss cohort had a higher smoking rate and a higher baseline body mass index (SD 0.29, 2.7 respectively). All cohorts experienced high SUI cure rates ranging from 77 to 81%, with no significant difference in SUI cure between cohorts (p = 0.607). Of 372 subjects with MUI, the weight loss cohort had significantly greater improvement in UUI episodes. CONCLUSIONS: Weight change at 12 months postoperatively did not significantly alter efficacy of MUS for treatment of SUI. Patients with MUI who lost ≥5% body weight had significantly greater improvement in UUI episodes.

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

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

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

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.