Clinical and Urodynamic results of the Argus T® sling in moderate and severe male stress urinary incontinence after radical prostatectomy - a 5 year prospective study

ABSTRACT Purpose: Sling as a therapeutic option for male stress urinary incontinence (SUI) has been reviewed in the last two decades, as it is a relatively simpliest surgery compared to artificial urinary sphincter and has the ability to modulate urethral compression. This study aims to evaluate the efficacy, rate of complications, quality of life and the effects on bladder emptying of the Argus T® compressive and ajustable sling in moderate and severe male SUI treatment. Materials and Methods: Men eligible for stress urinary incontinence treatment after radical prostatectomy were recruited and prospectively evaluated, from March 2010 to November 2016. It was selected outpatient men with moderate and severe SUI, after 12 months of radical prostatectomy, who have failed conservative treatment. All patients had a complete clinical and urodynamic pre and post treatment evaluation, by means of clinical history, physical examination, urine culture, 1-hour pad test and ICIq-SF questionnaire. The UDS was performed after 12, 18 and 24 months postoperatively. Results: Thirty-seven men underwent sling surgery, 19 patients (51.4%) with moderate and 18 (48.6%) with severe SUI. The minimum follow-up time was 5 years. Overall, we had a success rate of 56.7% at 60 months follow-up. After surgery, we did not observe significant changes in the urodynamic parameters evaluated during the follow-up. No patient had urodynamic bladder outlet obstruction (BOO) after sling implantation. Readjustment of the Argus T® sling was performed in 16 (41%) of the patients and 51% of the patients reported some adverse event. Conclusion: We demonstrate a long-term efficacy and safety of Sling Argus T® as an alternative to moderate and severe male SUI treatment. Furthermore, in our study bulbar urethra compression does not lead to bladder outlet obstruction.

Clinical and Urodynamic results of the Argus T® sling in moderate and severe male stress urinary incontinence after radical prostatectomy - a 5 year prospective study.

PURPOSE: Sling as a therapeutic option for male stress urinary incontinence (SUI) has been reviewed in the last two decades, as it is a relatively simpliest surgery compared to artificial urinary sphincter and has the ability to modulate urethral compression. This study aims to evaluate the efficacy, rate of complications, quality of life and the effects on bladder emptying of the Argus T® compressive and ajustable sling in moderate and severe male SUI treatment. MATERIALS AND METHODS: Men eligible for stress urinary incontinence treatment after radical prostatectomy were recruited and prospectively evaluated, from March 2010 to November 2016. It was selected outpatient men with moderate and severe SUI, after 12 months of radical prostatectomy, who have failed conservative treatment. All patients had a complete clinical and urodynamic pre and post treatment evaluation, by means of clinical history, physical examination, urine culture, 1-hour pad test and ICIq-SF questionnaire. The UDS was performed after 12, 18 and 24 months postoperatively. RESULTS: Thirty-seven men underwent sling surgery, 19 patients (51.4%) with moderate and 18 (48.6%) with severe SUI. The minimum follow-up time was 5 years. Overall, we had a success rate of 56.7% at 60 months follow-up. After surgery, we did not observe significant changes in the urodynamic parameters evaluated during the follow-up. No patient had urodynamic bladder outlet obstruction (BOO) after sling implantation. Readjustment of the Argus T® sling was performed in 16 (41%) of the patients and 51% of the patients reported some adverse event. CONCLUSION: We demonstrate a long-term efficacy and safety of Sling Argus T® as an alternative to moderate and severe male SUI treatment. Furthermore, in our study bulbar urethra compression does not lead to bladder outlet obstruction.

A 10- to 20-year follow-up after tension-free vaginal tape for stress urinary incontinence.

INTRODUCTION AND HYPOTHESIS: Midurethral slings (MUS) have become the gold standard in the treatment of stress urinary incontinence (SUI). Some information is already available on the outcome of tension-free vaginal tape (TVT) after 10 years or more. Our objective was to assess the current outcome (efficacy, adverse events) of women who had been successfully operated upon for SUI by means of a TVT procedure 10 to 20 years ago. METHODS: We performed a retrospective cohort study including 291 women (mean age 69.4 years) who underwent a successful TVT procedure (retropubic bottom-to-top route) in a teaching hospital between January 2001 and December 2010. The main outcome measure was the incidence of SUI at 10-20 years' follow-up. Others were incidence of re-operation, tape exposure and de novo overactive bladder symptoms. We carried out a univariate logistic regression analysis to examine the relationship between outcomes and a set of clinical variables. RESULTS: After a median of 15 years, TVT remains highly effective: 272 women (94%) experienced either no leakage under any circumstance (214=74%) or leakage less than weekly (58=20%). Mesh exposure (8=2.7%; 1.8 events per 1,000 patient-years) and repeat surgery for SUI (11=3.8%; 2.5 events per 1,000 patient-years) were low. Three women (1%) needed to perform intermittent self-catheterisation. Bothersome overactive bladder symptoms (45=15%) were common and associated with polypharmacy, cardiovascular medication and obesity. CONCLUSION: The efficacy of TVT is demonstrated up to 20 years. The presence of bothersome OAB symptoms in the population may be an indicator of multimorbidity.

Synthetic Mid-urethral Sling for the Treatment of Urinary Incontinence in Women With Neurogenic Lower Urinary Tract Dysfunction: A Multicentric Retrospective Study.

PURPOSE: We assess the efficacy, safety, and predictive factors for failure of synthetic mid-urethral slings for the treatment of urinary incontinence in a large cohort of women with neurogenic lower urinary tract dysfunction. MATERIALS AND METHODS: Women aged 18 years or older who received a synthetic mid-urethral sling for stress urinary incontinence or mixed urinary incontinence in 3 centers between 2004 and 2019 and who had a neurological disorder were included. Exclusion criteria were less than 1 year of follow-up, concomitant pelvic organ prolapse repair, previous synthetic sling implantation, and no baseline urodynamics. The primary outcome was surgical failure, defined as recurrence of stress urinary incontinence during follow-up. Kaplan-Meier analysis was used to estimate the 5-year failure rate. Adjusted Cox proportional hazard model was used to identify factors associated with surgical failure. Complications and reoperations during the follow-up have also been reported. RESULTS: A total of 115 women with a median age of 53 years were included. The median follow-up duration was 75 months. The 5-year failure rate was 48% (95 CI 46%-57%). Age above 50 years, negative tension-free vaginal tape test and transobturator route were associated with surgical failure. Thirty-six patients (31.3%) underwent at least 1 reoperation for complications or failure, and 2 required definitive intermittent catheterization. CONCLUSIONS: Synthetic mid-urethral slings may be an acceptable alternative to autologous slings or artificial urinary sphincters for the treatment of stress urinary incontinence in a selected group of patients with neurogenic lower urinary tract dysfunction.

Use of intraoperative ultrasound to improve tension-free vaginal tape-obturator placement: A pilot study.

OBJECTIVE: To evaluate the use of intraoperative ultrasound (IUS) to achieve a postoperative optimal placement of the tension-free vaginal tape-obturator (TVT-O). METHODS: A cohort study was performed among women who underwent TVT-O placement. In 25 women, ultrasound was used for the placement, and based on current evidence, the optimal intraoperative and postoperative ultrasound pattern was selected. They were compared with 25 women where IUS was not used. RESULTS: IUS increased operative time (by 7.5 min), and in 36% (9/25) of cases it was necessary to perform some corrections based on the ultrasound findings. After 1 month, in patients of the IUS group, the tapes were more frequently placed at a distance of 3-5 mm (P = 0.01), and it was more common for it to be placed between 40% and 70% relative to the urethral length (P = 0.011). Of tapes placed with IUS, 76% (met the optimal postoperative ultrasound pattern, as opposed to only 48% placed without IUS (P = 0.041). No differences were found in the complications or the functional results at 1 month post-surgery. CONCLUSION: The use of IUS for the placement of TVT-O allows us to position them optimally and avoid erroneous placements, although IUS increases the operative time without improving the functional results and the rate of complications.

Evaluation of the efficacy and safety of single incision sling vs TVT-O in obese patients with stress urinary incontinence: Quality of life and sexual function analysis.

OBJECTIVES: The aim of the study is to demonstrate the best stress urinary incontinence (SUI) surgical technique for women with a Body mass index higher than 30. The results of Transvaginal Tension Free Vaginal Tape-Obturator and Mini-sling surgery were analyzed and compared through both clinical examination and standardized questionnaires at 36 months of follow-up. MATERIALS AND METHODS: This is a retrospective multicenter study over 159 women with SUI who underwent surgery. Seventy-eight women underwent TVT-O and 81 Mini-sling technique. Intra and post-operative complications were recorded. Patients were monitored for 36 months by analyzing symptoms, voiding diary, quality of life and sexual activity through standardized questionnaires. RESULTS: Complications had a low incidence in both groups and inter-group differences were superimposable. Only groin pain was statistically higher after TVT-O than after Mini-sling (12.8% vs1.2%, p = 0.03). At 36 months of follow-up, a statistically significant decrease in Positive stress test (%) and Q-Tip test (grade) was observed in both groups with no differences between them (p = 0.54 and p = 0.32 respectively). The mean number of daily voids was higher after TVT-O (p = 0.04) than after Altis (p = 0.22) with a significant difference in favor of the Altis group (p = 0.03). After 36 months, there were no significant differences between groups in terms of quality of life and sexual activity. PGI-I did not show any difference between groups (p = 0.21). CONCLUSION: TVT-O and Minisling had the same efficacy and results in the surgical treatment of SUI in obese women. Both techniques relieved their symptoms and improved their quality of life without any significant difference except for a lower incidence of post- Mini-sling complications.

Short and Medium-Term Results of the Autologous Adult Mucosa Stem Cell Therapy Compared with Mini-Sling Surgery in the Treatment of Women's Stress Urinary Incontinence; A Randomized Clinical Trial.

OBJECTIVE: This study aimed to compare the results of stem cell therapy with mini-sling for women's stress urinary incontinence. METHODS: This study was a parallel groups noninferiority randomized clinical trial. Patients with pure stress urinary incontinence who did not improve after three months of conservative and medical therapy were included. Patients were divided into two groups mini-sling insertion or peri-urethral injection of the autologous mucosa stem cell with simple equal randomization. Standard Incontinence Impact Questionnaire (IIQ) for patients' satisfaction as well as objective Marshal Test as primary outcomes were compared. RESULTS: From October 2016 to March 2018, 30 patients (mean age of 52 years) were randomly divided equally into two groups. Finally, a negative Marshal test was observed in 73% of the stem cell group vs. 80% in the mini-sling group (p = 0.6). The mean decrease in the IIQ results was 12 points in the stem cell group vs. 25 points in the mini-sling group (p = 0.05). Favorable results at 6 m and 26 m follow-up were 40% vs. 80% (p = 0.06) and 53% vs. 60% (p = 0.7) in stem cell and mini-sling group, respectively. Patients in the mini-sling group experienced a higher rate of dyspareunia. Intervention time and hospital stay were 6.46 ± 1.24 minutes vs. 19.40 ± 4.30 minutes (p = 0.001) and 4.33 ± 1.23 vs. 9.20 ± 3.16 hours (p = 0.001) in stem cell and mini-sling groups, respectively. CONCLUSION: Results of the periurethral injection of the autologous adult mucosa-derived stem cells are not inferior to the less invasive mini-sling procedure; while, the stem cell group showed shorter intervention time and hospital stay as well as fewer complications. This noninferiority pilot randomized trial compared the results of stem cell therapy with mini-sling surgery and showed that in the medium-term followup, the results are comparable.

A modified mid-urethral sling technique for stress urinary incontinence: Three-year results of a prospective randomized trial in comparison with original transobturator tape procedure.

INTRODUCTION AND HYPOTHESIS: Stress urinary incontinence (SUI) is the most common subtype of urinary incontinence, which causes many social, psychological, and economic problems. Mid-urethral sling (MUS) surgery is popular worldwide for the treatment of SUI. We aimed to define a new modified mid-urethral sling technique (mMUS) in SUI treatment and to compare it with transobturator tape (TOT) surgery in terms of safety and efficiency. METHODS: A prospective, randomized study was planned with 126 women suffering from SUI. The patients were randomly divided into two groups, TOT and mMUS. In mMUS, the obturator membrane was not perforated. The objective and subjective symptoms, pain, quality-of-life measures, and side effect profiles were assessed in a 3-year follow-up. The visual analogue scale (VAS) was used for postoperative pain assessment. The International Consultation on Incontinence Questionnaire-Female Lower Urinary Tract Symptoms (ICIQ-FLUTS) and Patient Global Impression of Improvement (PGI-I) were used for cure assessment scales. RESULTS: In total, 96 patients completed 3-year follow-up (TOT, n = 49 and mMUS, n = 47). There was no statistical difference between the procedures in terms of cure rates (87.75% and 87.23%, respectively; p = 0.614). Mean VAS scores at 8 and 24 h postoperatively were significantly higher in the TOT group (p < 0.05). There was no significant difference between the groups in VAS scores after 24 h. There was no significant difference between groups in terms of pad test results, ICIQ, or PGI scores at baseline and 36 months after surgery. CONCLUSIONS: We showed that the mMUS procedure was as safe and effective as TOT, with less postoperative groin pain and complications.

Prevalence and Predictors of Bladder Outlet Obstruction in Women With Chronic Urinary Symptoms and a History of Urethral Sling Surgery.

PURPOSE: The objective of this study is to review patients with chronic urinary symptoms and remote urethral sling surgery to determine the prevalence and predictors of obstruction. MATERIALS AND METHODS: A single-center retrospective review was performed on patients referred with chronic lower urinary tract symptoms (>6 months) and a history of urethral sling surgery. Obstruction was identified by urodynamics using the Blaivas criteria or fluoroscopy. Clinical findings for patients with and without obstruction were compared. Logistic regression was applied to identify predictors of urodynamic obstruction. The need for sling revision and post-revision outcomes were evaluated. RESULTS: In total 105 patients were included, median age 61 years (IQR 19), median time since sling surgery 5.0 years (IQR 8). Sixty percent (63/105) met the definition for obstruction. Patients with obstruction had higher mean detrusor pressure at maximum urinary flow rate (35 vs 19 cm H2O) and lower maximum urinary flow rate (6.0 vs 14 mL/s; P < .05). A tight suburethral band and increased post-void residuals were significantly associated with urodynamic obstruction (P < .05). Fifty-nine (59/105; 56%) patients underwent suburethral sling excision. The incidence of improvement in storage and voiding symptoms at 6 months was 43% and 87%, respectively. At 30 months post-excision, the probability of being incontinence-free was 56% (95% CI 41, 69) and the probability of being free from redo sling surgery was 75% (95% CI 55, 87). CONCLUSIONS: Obstruction is common in patients with chronic urinary symptoms and history of urethral sling surgery. Patients undergoing sling revision should be observed for persistent storage symptoms and recurrent incontinence.

Tension-Free Vaginal Tape and Polyacrylamide Hydrogel Injection for Primary Stress Urinary Incontinence: 3-Year Followup from a Randomized Clinical Trial.

PURPOSE: We sought to determine whether polyacrylamide hydrogel (PAHG) is noninferior to tension-free vaginal tape (TVT) in the treatment of women with primary stress urinary incontinence (SUI). MATERIALS AND METHODS: In this noninferiority trial, 223 women eligible for operative SUI treatment were randomized for TVT (110) or PAHG (113). Primary outcome was patient satisfaction and the noninferiority margin for the difference was 20%. Secondary outcomes were effectiveness and complications. RESULTS: At 3 years, 188 (84.3%) women attended the followup. The satisfaction score (visual analogue scale 0-100) median was 98.5 (IQR 90-100) in the TVT group and 90.0 (IQR 70-100) in the PAHG group, whereas a score ≥80 was reached in 87 (94.6%) and 65 (67.7%), respectively (difference 26.9%, 95% CI 16.7% to 36.8%). Thus, PAHG did not meet the noninferiority criteria set in our study. The cough stress test was negative in 88 (95.7%) of TVT patients vs 75 (78.1%) of PAHG patients (difference 17.5%, 95% CI 8.6% to 26.9%). Any peri- or postoperative complication before crossover between the groups was detected in 40 (43.5%) women in the TVT group and 23 (24.0%) women in the PAHG group (difference 19.5%, 95% CI 6.8% to 31.4%). CONCLUSIONS: In midterm followup, PAHG did not reach in patient satisfaction the noninferiority set in our study. Furthermore, mid urethral TVT slings show better subjective and objective cure rates than PAHG. However, complications were more often associated with TVT. Since the majority of PAHG treated women were also cured or improved, primary SUI women can be offered PAHG as a safe and durable alternative treatment.

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

ABSTRACT Purpose 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.

Twenty-Five Years of the Midurethral Sling: Lessons Learned.

Midurethral slings (MUS) are widely accepted for the surgical treatment of stress urinary incontinence (SUI) in cases where conservative treatment has failed. They have been shown to be a safe and effective surgical treatment for the management of SUI. However, there have recently been growing concerns regarding the safety profile of mesh procedures, generating international debate and leading to national inquiries into the effectiveness and safety of mesh implants. A multitude of clinical, technical, manufacturer-related, and other health jurisdictional factors are involved in the outcomes of MUS. Appropriate patient selection and informed consent to all treatment options, with proper guidance from healthcare providers, are critical for empowering women to choose an appropriate treatment option based on a personalized decision.

Sexual Function Following Treatment for Stress Urinary Incontinence With Bulk Injection Therapy and Mid-Urethral Sling Surgery.

BACKGROUND: Peri-urethral bulking injections (PBI) gain popularity for the treatment of stress urinary incontinence (SUI), but - in contrast to mid-urethral sling (MUS) surgery - little is known about its impact on sexual function. METHODS: This was a secondary analysis of a prospective cohort study that included patients with moderate to severe SUI undergoing either MUS surgery or PBI with polydimethylsiloxane Urolastic (PDMS-U). The validated Dutch and English version of the 'Pelvic Organ Prolapse and/or Urinary Incontinence Sexual Function Questionnaire - IUGA Revised' (PISQ-IR) was used to assess sexual function at baseline, at 6 and 12 months of follow-up. For between-group analysis, differences in baseline characteristics were corrected using multivariate analysis of covariance. OUTCOMES: The primary outcome was the PISQ-IR single summary score of sexually active (SA) women following both procedures, calculated by mean calculation. Secondary outcomes were the PISQ-IR subscale scores of SA and non-sexually active (NSA) women, the proportions of sexual activity and subjective improvement ('Patient Global Impression of Improvement' (PGI-I)). RESULTS: A total of 259 women (MUS: n = 146, PBI: n = 113) were included in this study. The PISQ-IR single summary score of SA women improved following both interventions (in the MUS group from 3.2 to 3.4 and in the PBI group from 3.0 to 3.3 after 12 months). After correcting for differences in baseline characteristics, the PISQ-IR summary score at 6 and 12 months was similar for both treatment groups. For SA women, condition-specific and condition-impact subscale scores significantly improved following both procedures. CLINICAL IMPLICATIONS: In treating SUI, PBI is inferior to MUS surgery. However, there is a need for less invasive strategies, especially for women who are unfit for surgery or have contraindications. Sexual function improves after PBI using PDMS-U, which is relevant for the counselling of women with SUI about available treatment options. STRENGTHS & LIMITATIONS: Strength: until this study, there was a lack of knowledge about the effects of PBI on sexual function. LIMITATION: there may be indication bias as we did not perform a randomized controlled trial. CONCLUSION: PBI using PMDS-U and MUS surgery for the treatment of SUI improve sexual function equally in SA women, mainly by decreasing the condition's impact on sexual activity and quality. Latul YP, Casteleijn FM, Zwolsman SE, et al. Sexual Function Following Treatment for Stress Urinary Incontinence With Bulk Injection Therapy and Mid-Urethral Sling Surgery. J Sex Med 2022;19:1116-1123.

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

PURPOSE: 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.

[Urinary incontinence in women and its impact on quality of life].

The prevalence of urinary incontinence at a young age is 20-30%, gradually increasing to 40% among older women. Urinary incontinence affects many areas of the patient's life, including social, psychological, work, sexual, etc. The main causative factors, which also influence on its severity, include age, pregnancy, childbirth and obesity. To date, there are many treatment methods for stress urinary incontinence. However, more preference is given to the sling procedures, in which mesh is placed under the middle part of the urethra. Despite being the "gold" standard for the treatment of stress urinary incontinence, it is difficult to determine indications for surgical treatment, since "nonmedical" view of the patient's problem is often required. The low awareness of primary care physicians about the possibilities of treating urinary incontinence often leads to an erroneous opinion in patients about their disease and methods of treatment. Many patients regard this condition as an integral part of aging, avoid situations in which urinary incontinence is possible, which limits daily activities, sexual activity, sports and other areas of life. Based on the latest data, a review of the literature on urinary incontinence in women, risk factors, as well as existing methods of surgical correction are presented in the lecture. Particular attention is paid to the impact of urinary incontinence on the quality of life of patients and current methods for its assessment.

Using clinical estimate or catheter measurement of urethral mid-point result in similar retropubic mid-urethral sling position: a randomized trial.

INTRODUCTION AND HYPOTHESIS: The objective was to determine whether standardized, intraoperative urethral measurement improves retropubic mid-urethral sling (RPMUS) positioning and if the intraoperative position remains stable at 2 weeks postoperatively. METHODS: Participants undergoing a RPMUS were randomized to mid-urethral placement as per usual surgical care (no Foley catheter measurement, no-FCM) vs urethral mid-point Foley catheter measurement (FCM). The primary outcomes were RPMUS location as determined by 2D and 3D ultrasound 2 weeks postoperatively (as percentage from urethral meatus - relative to the urethral length) and intraoperatively following the RPMUS placement. RESULTS: Forty-four women enrolled, underwent RPMUS, and provided baseline data and intraoperative ultrasound measurements; of these, 36 (82%) had interpretable intraoperative and postoperative ultrasound measurements. Demographic data were similar in the two groups. The mean RPMUS mid-point was 57 % and 55 % in measured and controls (p = 0.685); this same measurement was relatively unchanged at 2 weeks postoperatively at 57% and 54% respectively (p = 0.538). Very much and much improvement was reported on the PGI-I by 84% and 85% of participants in the FCM and no-FCM groups respectively. CONCLUSIONS: Intraoperative RPMUS position at 2 weeks after surgery is similar to the intraoperative position. Compared with usual surgical care, intraoperative measurement of urethral mid-point with a Foley catheter did not affect RPMUS sling position.

Exploratory safety study of an umbilical cord derived urethral sling in bilateral pudendal nerves injury-induced urinary incontinence in female rats.

PURPOSE: Mid-urethral slings are the standard treatment for women with refractory stress urinary incontinence (SUI) but are at risk of infection or erosion due to host-prothesis interaction. In this proof-of-concept study, we aimed at evaluating umbilical vessel sling (UVS) in incontinent female rats. MATERIAL AND METHODS: UVS was extracted from human umbilical cord lining and was placed on female rats who underwent bilateral pelvic nerve injury (PNI) to reproduce SUI (Group 3, N = 10). Two control groups were also studied: rats with no PNI (Group 1, N = 4) and rats with PNI but no UVS (Group 2, N = 10). Micturition calendar was frequently recorded using a metabolic cage, and leak point pressure (LPP) test was performed on Day 28. After the LPP test, rats were euthanized, and bladder/urethra were collected for histopathological analysis. RESULTS: Overall, 24 rats were included, of whom 10 had both PNI and UVS placement. Compared with Group 2, Group 3 had increased maximal LPP but the difference did not reach significance (respectively 21.8 ± 2.1 mmHg vs. 28.4 ± 4.1 mmHg, p = 0.2). Micturition frequencies were similar between the groups. Total voided volume was higher in Group 3 at the end of the study compared with Group 2 (12.5 ± 1.1 ml vs. 9.4 ± 0.6 ml, respectively, p < 0.05). Histopathological findings evidenced a good local tolerance and a moderate to high tissue integration of the UVS. CONCLUSIONS: Biological sling derived from human umbilical vessel could be safely placed with a slight improvement of LPP in a population of rats who had bilateral PNI without major modification of micturition calendar. UVS could be a promising biomaterial in the management of SUI in women. Clinical studies are needed.

Frailty Is Associated with an Increased Risk of Complications and Need for Repeat Procedures after Sling Surgery in Older Adults.

PURPOSE: Sling surgery is the gold standard treatment for stress urinary incontinence in women. While data support the use of sling surgery in younger and middle-aged women, outcomes in older, frail women are largely unknown. MATERIALS AND METHODS: Data were examined for all Medicare beneficiaries ≥65 years old who underwent sling surgery with or without concomitant prolapse repair from 2014 to 2016. Beneficiaries were stratified using the Claims-Based Frailty Index (CFI) into 4 categories: not frail (CFI <0.15), prefrail (0.15 ≤CFI <0.25), mildly frail (0.25 ≤CFI <0.35) and moderately to severely frail (CFI ≥0.35). Outcomes included rates and relative risk of 30-day complications, 1-year mortality and repeat procedures for persistent incontinence or obstructed voiding at 1 year. RESULTS: A total of 54,112 women underwent sling surgery during the study period, 5.2% of whom were mildly to moderately to severely frail. Compared to the not frail group, moderately to severely frail beneficiaries demonstrated an increased adjusted relative risk (aRR) of 30-day complications (56.5%; aRR 2.5, 95% CI: 2.2-2.9) and 1-year mortality (10.5%; aRR 6.7, 95% CI: 4.0-11.2). Additionally, there were higher rates of repeat procedures in mildly to severely frail beneficiaries (6.6%; aRR 1.4, 95% CI: 1.2-1.6) compared to beneficiaries who were not frail. CONCLUSIONS: As frailty increased, there was an increased relative risk of 30-day complications, 1-year mortality and need for repeat procedures for persistent incontinence or obstructed voiding at 1 year. While there were fewer sling surgeries in performed frail women, the observed increase in complication rates was significant. Frailty should be strongly considered before pursuing sling surgery in older women.

Predictors of cure and overactive bladder syndrome after a mid-urethral sling procedure in women with stress urinary incontinence.

OBJECTIVES: To determine predictive factors for the cure of stress urinary incontinence (SUI) or persisting or de novo overactive bladder syndrome (OAB) after a mid-urethral sling procedure (MUS) for women with SUI, especially for menopausal women. STUDY DESIGN: All women who had consecutively received MUS for SUI between January 2008 and July 2019 in a tertiary referral center were reviewed. MAIN OUTCOME MEASURES: Multivariable Cox proportional hazards model or logistic regression analysis was used to assess the predictors of cure and persisting or de novo OAB after MUS. RESULTS: A total of 385 women had undergone MUS, of whom 265 (68.8%) were menopausal. The multivariable Cox proportional hazards model revealed that age (hazard ratio = 1.04), and preoperative detrusor overactivity (hazard ratio = 2.26) were independent predictors of persisting/recurrent SUI. Among the 216 women with preoperative OAB, 109 (50.5%) experienced resolution of their OAB after MUS; and among 169 women without preoperative OAB, twenty-five (14.8%) women developed de novo OAB after MUS (p < 0.0001). Preoperative OAB (hazard ratio = 3.97), small voided volume (hazard ratio = 0.83), and preoperative detrusor overactivity (hazard ratio = 1.62) were predictors of postoperative OAB. In addition, six (1.6%) women had mesh extrusion. Parity (odds ratio = 2.08) was the sole predictor of mesh extrusion. Menopause (hazard ratio = 1.69) was a predictor of postoperative OAB in the univariate analysis. However, menopause was not a predictor of cure or OAB in the multivariable analysis. CONCLUSIONS: Age and preoperative detrusor overactivity were independent predictors of persisting/recurrent SUI. In addition, preoperative OAB, small voided volume, and preoperative detrusor overactivity were predictors of postoperative OAB. These findings could serve as a guide for preoperative consultation for MUS.

A modified Altis® mid-urethral sling that allows immediate post-operative adjustment: experience in 197 patients.

OBJECTIVES: The transobturator mid-urethral Altis® "mini-sling" uses a static and a dynamic anchor on either end of a pulley suture for intraoperative tension adjustment. Given the potential for incorrect tensioning with sling placement, we adopted a modification for post-operative adjustment should stress urinary incontinence (SUI) persist. The objective is to describe technique, rate of postoperative adjustment driven by patient symptoms, and impact of preoperative/intraoperative variables. METHODS: In this single-surgeon experience, retrospective chart review, demographic and clinical data were collected on patients who received the Altis® sling for SUI between 2014 and 2019. We used descriptive statistics and three-group comparison tests to assess difference in variables among tightening, loosening, or no adjustment. RESULTS: Altis® sling placement was performed on 197 female patients with an average age of 58.7 years. Eighty-four percent (165/197) did not receive post-operative adjustment. Of the 32 patients with post-operative adjustment, 8 (4.1%) had loosening and 24 (12.2%) had tightening at an average of 10.5 days post-operatively. All tightening procedures were done in the clinic. Of the 8 patients with post-operative loosening, 6 were performed in clinic and 2 in the operating room. Preoperative and intraoperative variables were not significantly different among tightening, loosening, and no adjustment cohorts. CONCLUSIONS: This modification of the Altis® sling provides surgeons with the ability to tighten and loosen the sling for persistent SUI. All tightening and most loosening procedures were able to be performed in the clinic. The ability to easily tighten a sling in the early post-operative period may be a critical advantage.