Perspectives on technology: urethral slings in a post-mesh world.

OBJECTIVES: To detail the history of synthetic mid-urethral slings (SMUSs) and fascial slings, their efficacy, associated complications, and changes to practice that have occurred after the issuing of the 2011 US Food and Drug Administration (FDA) Safety Communication statement on transvaginal mesh (TVM), and to highlight the need for surgical registries and high-quality randomised controlled data to guide recommendations for continence procedures, in view of current concerns regarding mesh. METHODS: A literature search was conducted in EMBASE, PubMed, and the Cochrane Database of systematic reviews to identify articles published from 2011 onward, following the FDA Safety Communication regarding TVM. RESULTS: Prior to the formal FDA Safety Communication in 2011, TVM was considered a safe option for the treatment of both pelvic organ prolapse (POP) and stress urinary incontinence (SUI). The 2011 FDA safety communications and ensuing widely publicised litigation against TVM manufacturers have shifted both surgeon and patient acceptance of mesh products. Several efforts by medical and government bodies have been made to establish ways to monitor the surgical outcomes and safety of mesh products. The Australasian Pelvic Floor Procedure Registry is one such example. Although SMUSs have a long and established safety profile, perceptions of mesh products for SUI have also been negatively affected. The extent of this, however, has yet to be adequately measured through qualitative and quantitative data. The available data suggest it has been difficult for patients and consumers to distinguish between TVM morbidity for POP vs SUI. Furthermore, there remains a lack of high-quality randomised or real-world registry data to definitively exclude the SMUS from the SUI treatment algorithm. Since SMUSs are a viable option for SUI treatment, the concept of a 'post-mesh world' remains contentious. CONCLUSION: Controversies surrounding SMUSs have changed the treatment landscape of SUI. Against the background of significant litigious action following the FDA warnings against mesh use, there has been significant reduction in the uptake of synthetic mesh products. Although there are ample data related to surgical outcomes and safety for both autologous fascial and retropubic SMUSs in carefully selected patients, informed consent and surgical training will be of paramount importance as newer synthetic materials reach clinical maturity.

Long-term sexual function after mid-urethral slings for stress urinary incontinence in women.

INTRODUCTION: There has been increasing concern about potential negative impact of mid-urethral slings (MUS) on sexual life. Our aim was to study sexual activity 10-20 years after MUS surgery and changes in impact of incontinence on sexual life over time and to compare subjective cure, pain, satisfaction, and incontinence between sexually active and inactive women 10-20 years after MUS. MATERIAL AND METHODS: Historical cohort study using the Norwegian Female Incontinence Registry to identify women who underwent MUS between 2001-2006 and 2011-2012. They answered validated questionnaires about sexual activity, incontinence, pain, and satisfaction with MUS. We assessed changes in urinary incontinence during intercourse and compared symptoms and satisfaction between sexually active and inactive women. The study was registered in Clinical Trials (NCT04912830). RESULTS: In total, 1210/1903 (64%) responded. Of women responding to questions about sexual activity, 63% (735/1166) were sexually active. 31.3% experienced negative impact of incontinence on sexual life preoperatively, decreasing to 5.9% at 10-20 years follow-up. A higher proportion of sexually inactive vs sexually active women had urinary incontinence (63.5% vs. 47.5%, aOR 1.60 [1.18-2.17]). In a subanalysis, only urgency and mixed urinary incontinence remained significant. A higher proportion of sexually inactive were dissatisfied with MUS (30.1% vs. 12.9%, aOR 2.53 [1.82-3.51]). Persistent pain after MUS was similar for sexually inactive and active women (4.0% vs. 3.2%, aOR 1.10 [0.55-2.19]). Furthermore, 3.4% of sexually inactive had persistent pain after MUS and stated pain as a reason for not being sexually active, whereas 1.7% of sexually active women had persistent pain after MUS and pain during intercourse. CONCLUSIONS: Negative impact of incontinence on sexual life was less prevalent at 10-20 years follow-up after sling surgery compared to preoperative assessment. A higher proportion of sexually inactive had urgency and mixed urinary incontinence and were dissatisfied with MUS. Only 3%-4% of sexually active and inactive women had persistent pain after MUS and this was not associated with sexual activity. This indicates that incontinence has a greater negative impact on sexual activity than persisting pain after MUS at long-term follow-up.

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

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

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

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

[Multidisciplinary meetings in pelvic floor disease in women: A national survey by the CUROPF among French urologists]. / Réunion de concertation pluridisciplinaire en pelvipérinéologie en France : résultats d'une enquête nationale du CUROPF auprès des urologues français.

INTRODUCTION: Multidisciplinary team meetings (MTMs) in the field of pelvic floor diseases in women tend to generalize, as they are required as mandatory before mid-urethral sling implantation or sacrocolpopexy by recent decrees published by the French health authorities. However, access to these meetings is variable in the French territory. The goal of the present study was to describe the existence and the settings of these kinds of meetings in France. MATERIEL AND METHODS: An on-line survey was conducted between June and July 2020 (stage 1) then between November 2021 and January 2022 (stage 2). A 15-item questionnaire was sent to all members of the Association française d'urologie (AFU). A descriptive analysis was conducted. RESULTS: Three hundred and twenty-two completed questionnaires were sent back during stage 1 and 158 during stage 2. Early 2022, 61.3% of respondents had access to a pelviperineology MTM, with important difference according to geographical areas. Main activity of MTMs was case discussion of complex situations (68% of meetings). At the end of 2021, 22% of the respondents declared willing to stop partially or totally their pelviperineology activity, given the new regulations set in place by the authorities. CONCLUSION: Despite being absolutely mandatory in current clinical practice, MTMs in pelvic floor disease have spread slowly. MTMs implementation was still insufficient in 2022, and variable on the French territory. Some urologists declare having no access to such resources and about 1 out of 5 were considering to voluntary stop of decrease significantly their activity in this difficult context.

Use of EPIC 26 to identify men likely to benefit from surgical interventions for urinary incontinence after radical prostatectomy.

PURPOSE: To examine outcomes of surgical procedures for urinary incontinence after radical prostatectomy (post-RP UI) and to identify patients who may benefit from a surgical intervention to treat post-RP UI. METHODS: A retrospective chart review identified men who underwent radical prostatectomy (RP) from July 2004 through July 2016 at our institution. Cases underwent surgical interventions for UI following RP. Controls had RP during the study period but did not have an intervention for UI following RP. We used the UI scale of the Expanded Prostate Index Composite (EPIC) 26 to: (1) quantify post-RP UI before and after UI intervention overall and for specific surgical procedures; (2) evaluate the significance of improvement in post-RP UI before and after UI intervention and (3) identify controls with levels of post-RP UI that were comparable to the cases. RESULTS: Two thousand nine hundred and sixty-eight RPs were performed; 48 patients underwent further surgical intervention (39 slings, 9 artificial urinary sphincter, AUS). For 20 cases with complete EPIC UI data (15 slings, 5 AUS), the median (IQR) pre-UI intervention score was 27.00 (IQR 22.75-42.75). Improvement was significant overall (p < 0.001) and for slings (p = 0.001). 71/2085 controls had post-prostatectomy UI scores ≤ 27.0, suggesting that they may have benefited from a post-RP surgical intervention for UI. CONCLUSION: Data support the effectiveness of surgery to treat post-RP UI. A sizeable population of unidentified men may benefit from a surgical intervention to treat urinary incontinence after RP.

Is antibiotic prophylaxis necessary in mid-urethral sling surgery?

INTRODUCTION AND HYPOTHESIS: Antibiotic prophylaxis is commonly used when implanting a mid-urethral sling (MUS) for female stress urinary incontinence. Use of antibiotics may lead to adverse events and the development of antibiotic resistance. This study compared a variety of outcomes after MUS surgery with and without antibiotic prophylaxis using data from the national Norwegian Female Incontinence Registry. METHODS: Preoperative and 6-12 months postoperative subjective and objective data from 28,687 patients who received MUS surgery from 1998 through 2017 were extracted from the registry. Categorical outcomes were compared between women with or without antibiotic prophylaxis using chi-square test for independence. Primary outcome was incidence of postoperative surgical site infection (SSI). Secondary outcomes were incidence of tape exposure, de novo or persistent urgency urinary incontinence, postoperative pain > 3 months, subjective and objective cure rates, and patient satisfaction. RESULTS: Antibiotic prophylaxis was used in 9131 and not used in 19,556 patients. SSIs and prolonged postoperative pain occurred significantly more often without antibiotic prophylaxis. Subjective and objective cure rates were significantly higher and tape exposures significantly lower in women not receiving prophylactic antibiotics. There were no significant differences in other outcomes. CONCLUSIONS: Antibiotic prophylaxis resulted in fewer women developing postoperative infections or prolonged postoperative pain after MUS surgery, but did not offer protection against tape exposure. The differences in cure rates were small and probably without clinical relevance. If a small increase in surgical site infections is accepted, the routine use of antibiotic prophylaxis can probably be omitted.

Placement of mid-urethral mesh slings at the time of vaginal prolapse repair does not affect post-operative sexual function or orgasm.

INTRODUCTION AND HYPOTHESIS: Because of the relationship between the clitoral neurovascular supply and the urethra, the dissection for placement of mid-urethral slings (MUS) may negatively impact orgasmic function. We aimed to analyze the role of MUS in orgasmic and overall sexual function in patients undergoing prolapse surgery. METHODS: A single institution retrospective review was performed on 157 patients undergoing prolapse surgery with and without MUS from 2008 to 2014. Pelvic Organ Prolapse Incontinence Sexual Questionnaires (PISQ-12) scores at baseline, 6, and 12 months post-operatively were compared. The difference in overall mean post-operative PISQ-12 scores at 6 and 12 months in those undergoing POP with or without MUS placement was assessed using Wilcoxon rank tests. RESULTS: Of 157 women who underwent prolapse surgery, 81 (52%) had concomitant MUS. Mean baseline PISQ-12 scores were 32 in both groups (p = 0.98). Post-operative PISQ-12 scores between the two groups did not differ at 6 (p = 0.96) or 12 months (p = 0.65). Within the MUS group, mean overall PISQ-12 scores improved at 6 (p = 0.05) and 12 months (p < 0.01). Mean overall PISQ-12 scores did not improve in patients who did not have slings placed at 6 (p = 0.10) or 12 months (p = 0.15). Orgasm frequency and intensity did not differ between the two groups at 6 (p = 0.39, p = 0.91, respectively) or 12 months (p = 0.11, p = 0.44, respectively). CONCLUSION: MUS at the time of prolapse repair did not affect orgasmic or overall sexual function. PISQ-12 scores improved after prolapse surgery with concomitant MUS placement. Our findings may help counsel patients regarding the risk of MUS placement affecting sexual function.

Comparing risk of repeat surgery for stress urinary incontinence after mid-urethral slings and polyacrylamide hydrogel.

INTRODUCTION: Over the last two decades synthetic mid-urethral slings (MUS) have become established as the main surgical method for correcting stress urinary incontinence (SUI). However, transurethral injections with polyacrylamide hydrogel are gaining popularity. We used surgical codes from a national registry to explore potential differences in risk of later surgery for SUI comparing retropubic slings, obturator slings, and polyacrylamide hydrogel injections. MATERIAL AND METHODS: This cohort study used surgical codes from The Norwegian Patient Registry. All women recorded as having had surgery for SUI coded as retropubic sling, obturator sling, or polyacrylamide hydrogel injection from 2008 until end-of-study censoring in 2017, were included. Main outcome was time to any recorded new SUI procedure later in the study period. Unadjusted comparison between groups was done using Kaplan-Meier. A Cox regression analysis was then performed to adjust for hospital unit size and patient age at surgery. RESULTS: The unadjusted analyses showed significant differences between the chosen index method and the risk of later SUI surgery favoring retropubic slings (p < 0.01). The proportions of patients without any recorded new SUI procedure at 1 and 5 years were 99.3% and 97.7% for retropubic MUS, 98.7% and 96.1% for obturator MUS, and 82.7% and 72.4% for polyacrylamide hydrogel injections. The majority of women having a repeat procedure for SUI after a polyacrylamide hydrogel injection underwent repeat treatment within 1 year (63%). After adjusting for age at time of surgery and hospital size, obturator slings (hazard ratio 1.8, 95% CI 1.4-2.4) and polyacrylamide hydrogel (hazard ratio 23.1, 95% CI 17.6-30.3) remained associated with a higher risk of later incontinence surgery. CONCLUSIONS: Both retropubic and obturator slings have low long-term risks of repeat incontinence surgery compared with polyacrylamide hydrogel injections. Retropubic slings were found to have superior longevity of the surgical result.

Has the use of preoperative urodynamics for stress urinary incontinence surgery changed following the VALUE study?

AIMS: To assess whether routine urodynamic testing (UDT) in women undergoing slings for uncomplicated stress urinary incontinence (SUI) has decreased following publication of the landmark VALUE study, which recommended against routine UDT in uncomplicated SUI. METHODS: We identified women in the Virginia All Payers Claims Database diagnosed with SUI between 2011 and 2016 using International Classification of Disease (ICD) codes (N39.3, 625.6). Appropriate ICD/CPT (current procedural terminology) codes were used to exclude non-index patients (prior anti-incontinence/prolapse surgery, urge incontinence, neurogenic bladder). Beta regression was used to assess for changes in the monthly proportion of urethral slings with preoperative UDT. Interventional ARIMA modeling was used to assess for a relationship between the date of VALUE (The Value of Urodynamic Evaluation) publication and the incidence of slings with preoperative UDT. RESULTS: Analysis identified 6740 women with SUI undergoing sling placement, with 343 non-index patients excluded. Of 6397 remaining women, 4026 (62.9%) underwent preoperative UDT. The annual number of slings with preoperative UDT declined from 748 to 402 between 2011 and 2016. Beta regression analysis demonstrated a decrease in the proportion of slings with preoperative UDT over the study (68%, 2011; 58%, 2016), with a statistically significant decrease in the proportion of slings with UDT after May 2012 (ß coefficient, -.0093; P < .001). Interventional ARIMA models showed a trend toward decreasing slings with preoperative UDT after the VALUE trial (P = .057). CONCLUSIONS: Our analysis demonstrated a decrease in the proportion of women undergoing preoperative UDT in uncomplicated SUI patients following the VALUE study. Further research is needed to examine factors underlying UDT utilization trends and promote value-driven care.

Evolution of patients with and without preoperative stress urinary incontinence after surgical cystocele repair by mesh implantation using a vaginal approach.

INTRODUCTION: To review the short-term evolution of stress urinary incontinence (SUI) after Uphold™ LITE mesh implantation for genital prolapse repair. MATERIAL AND METHODS: Retrospective, descriptive, single centre study of women undergoing genital prolapse surgery with Uphold™ LITE mesh insertion between July 2016 and April 2019. Pre-, peri- and 1-year postoperative follow-up data were collected. RESULTS: Thirty-six women were included (mean age: 72±7years). Most patients (75%) had grade III cystocele and three (8.3%) had recurrent prolapse. Mean operative time was 41±12min. During surgery, no visceral injury or haemorrhagic complications were noted but there were three intraoperative bladder injuries (8.3%). Twelve patients (33.3%) had preoperative SUI, half of which (n=6; 50%) responded to prolapse repair. De novo SUI was noted in 6/24 (25%) patients. The risk of having persistent postoperative SUI was 50% in patients with preoperative SUI, and the risk of developing de novo postoperative SUI was 25% in patients without preoperative SUI. Thus, patients with preoperative SUI were twice as likely to have persistent postoperative SUI as those without preoperative SUI (RR=2.0 [95% CI: 0.8175-4.8928]; P=0.128). Five patients with de novo SUI and three patients with persistent postoperative SUI were subsequently treated with insertion of a mid-urethral sling (MUS). The other patients improved with physiotherapy. CONCLUSION: Risk of persistent SUI after implantation of an Uphold™ LITE mesh is higher in patients with preoperative SUI. Surgical correction with a MUS can be offered in cases of de novo SUI before or after physiotherapy. LEVEL OF EVIDENCE: 4.

A nationwide surveillance of surgical site infection after mid-urethral slings in Japan.

We performed a questionnaire-based, retrospective, nationwide survey on perioperative management and antimicrobial prophylaxis for mid-urethral sling surgery for stress urinary incontinence in Japan to realize the clinical practice and risk factors for SSI. Records of women receiving transobturator tape (TOT) and tension-free vaginal tape (TVT) surgeries from 2010 to 2012 were obtained from hospitals belonging to the Japanese Society of Pelvic Organ Prolapse Surgery. The questionnaire addressed hospital volume, perioperative management, and SSI. Risk factors for SSI were investigated by comparing cases with and without SSI. The data from 97 hospitals and a total 1627 TOT and 1045 TVT surgeries were analyzed. Mean case volumes of TOT and TVT surgeries were 7.3 ± 14.9 and 7.1 ± 17.8 cases per year, respectively. Preoperative hair removal, bowel preparation, and urine culture were routinely performed at 44 (45.3%), 31 (32.0%), and 22 (22.7%) hospitals, respectively. First-generation (51.5%) or second-generation (34.0%) cephalosporin was mostly used for antimicrobial prophylaxis. SSI was reported only in 6 patients (0.22%) and none of them developed abscesses. None of the factors we could evaluate from the questionnaire were found to be significantly associated with SSI. SSI after mid-urethral slings rarely occurred in Japan (0.22%) and no parameters about perioperative managements significantly increased SSI. However, further studies with more detail information of each patient and operation are required to confirm their appropriate perioperative managements for mid-urethral slings.

Usefulness of Ospemifene in the treatment of urgency in menopausal patients affected by mixed urinary incontinence underwent mid-urethral slings surgery.

The aim of this study was to assess the effectiveness and safety of Ospemifene in the improvement of urgency component in women affected by mixed urinary incontinence (MUI) who underwent surgery with mid-urethral sling (MUS). Eighty-one patients with MUI underwent surgical intervention with MUS were enrolled. After surgical intervention 38 patients received Ospemifene 60 mg one tablet daily per os for 12 weeks. Physical examination, 3-day voiding diary, urodynamic testing were performed at the start and the follow-up after 12 weeks in the Trans-Obturator-Tape (TOT)-Alone group and TOT-Ospemifene. Patients completed the Overactive Bladder Symptom and Health-Related Quality of Life Short-Form (OAB-Q SF), International Consultation on Incontinence Questionnaire (ICIQ-UI-SF), and King' s Health Questionnaire (KHQ). A significant difference between the two groups was observed in peak flow (ml/s), in first voiding desire (ml), in maximum cystometric capacity (ml), and in detrusor pressure at peak flow (cmH2O) at urodynamic evaluation. A significative difference between the two groups at voiding diary was observed in the mean number of voids, urgent micturition episodes/24 h, urge urinary incontinence, and in nocturia events. The OAB-Q symptoms and OAB-Q (HRQL) scores after 12 weeks showed a significative difference between the two groups. Ospemifene is an effective potential therapy after MUSs in women with MUI improving urgency symptoms and quality of life.

Long-term outcomes of transobturator tension-free vaginal tapes as secondary continence procedures.

PURPOSE: To assess the long-term patient-reported outcomes following TO-TVT as a secondary continence procedure in women with recurrent stress urinary incontinence (R-SUI). METHODS: A secondary analysis of the 9-year follow-up of the E-TOT study was performed: 341 women with predominant SUI symptoms were randomised to undergo either Inside-out or Outside-in TO-TVT between April 2005 and April 2007. Forty-six women had R-SUI following previously failed continence surgery at time of randomisation and are the basis of this analysis as a one single cohort. Primary outcome was the patient-reported success rate defined as very/much improved on Patient's Global Impression of Improvement (PGI-I). Secondary outcomes included late adverse events and impact on women's quality of life and sexual function. Statistical analysis was performed using SPSS version 23. RESULTS: Sixty-three per cent completed the 9-year follow-up. The success based on the PGI-I was 62.1% with no significant difference between groups (OR 5.33; 95% CI 1.03, 27.76; p = 0.094). Clinically significant improvement in QoL was found in 84.2%. Adverse events included vaginal erosions (n = 3) and groin pain (n = 2). The small sample size is a limitation in this study; nevertheless, this is one of the largest cohorts reported for women with R-SUI and the first to report the long-term outcomes of TO-TVT as a secondary continence procedure. CONCLUSIONS: TO-TVT operations are associated with good patient-reported success rates (62%) in women with previous failed continence surgery with up to 9-years follow-up. There is a non-significant trend towards better outcomes with the inside-out TO-TVT.

Surgical trends in the correction of female stress urinary incontinence in academic centers within the United States.

AIMS: There is a lack of data describing the current state of stress urinary incontinence (SUI) procedures in academic centers. Urologists, gynecologists, and urogynecologists perform these operations, but the relative volume each group accounts for is unknown. The purpose of this study was to evaluate the distribution of cases in academic centers between specialties and associated patient characteristics. METHODS: A hospital consortium database was used to identify patients treated surgically for SUI between 2009 and 2014. Patient and surgeon variables were evaluated. Patient variables (age, region, insurance, race) and surgeon volume were analyzed. Sub-analysis was conducted to determine concomitant prolapse repairs. RESULTS: Of the 50,315 stress urinary incontinence procedures performed, 22% were performed by urologists. Overall volume dropped 39% and mean surgeon volumes for all three groups decreased with time. Average median volume for urogynecologists (29/year) differed from both urologists (3/year) and non-urogynecologists (2/year). There was a significant difference in rate of concomitant prolapse repairs performed by urogynecologists (56%), gynecologists (54%), and urologists (26%). CONCLUSIONS: These data portray the changing pattern of SUI procedure practice in academic centers. Academic urologists are performing less than 25% of SUI procedures, with an overall decline in number of procedures across all specialties. Urogynecologists and gynecologists are performing a significantly higher proportion of concomitant prolapse repairs. Neurourol. Urodynam. 36:394-398, 2017. © 2015 Wiley Periodicals, Inc.

Long-term outcomes for transobturator tension-free vaginal tapes in women with urodynamic mixed urinary incontinence.

AIMS: To assess the long-term patient reported outcomes following transobturator tension-free vaginal tapes (TO-TVT) in women with urodynamic mixed urinary incontinence (MUI). METHODS: A secondary analysis of the 9-year follow-up of the E-TOT study: 341 women with predominant stress urinary incontinence symptoms were randomized to undergo either inside-out or outside-in TO-TVT between April 2005 and April 2007. Forty-eight women had preoperative urodynamic MUI and were available for 9-year follow-up. Primary outcome was the patient-reported success rate defined as very/much improved on Patient's Global Impression of Improvement PGI-I. Secondary outcomes included impact on women's quality of life, sexual function, overactive bladder symptoms,and late adverse events. Statistical analysis was performed using SPSS v.23. RESULTS: Forty-eight women completed the 9-year follow-up, with adjusted response rate of 63%. The success based on the PGI-I was 64.6% (n = 31), with a further 14.6% (n = 7) who reported "improved." There was no significant difference between groups (OR 1.11; 95%CI 0.33, 3.70; P > 0.999). Clinically significant improvement in quality of life was found in 85.3%. Cure of urgency and UUI was reported by 35% and 41%, whereas worsening was reported in 6.5% and 2.3%, respectively. One patient reported chronic groin/leg pain. The small sample size and the sizeable loss to follow-up are limitations in this study. CONCLUSIONS: This is the first study to report the long-term outcomes of TO-TVT in women with urodynamic MUI; TO-TVT is associated with a good and sustained patient-reported success rate in women with MUI up to 9-years follow-up.

De novo overactive bladder following midurethral sling procedures: a systematic review of the literature and meta-analysis.

INTRODUCTION AND HYPOTHESIS: De novo overactive bladder (OAB) is a known complication of midurethral sling surgery for the treatment of stress urinary incontinence. To date, differences in the incidence of de novo OAB following the use of different types of midurethral sling remain relatively unknown. The purpose of the present systematic review was to evaluate this incidence and summarize current evidence. METHODS: We systematically searched the literature using the MEDLINE, Embase, Scopus, ClinicalTrials.gov, LILACS and Cochrane Central Register of Controlled Trials databases as well as the grey literature and references from the electronically retrieved articles. For comparisons of proportions, we used the chi-squared test. All reported analyses were designed as two-tailed. Statistical significance was set at p < 0.05. RESULTS: Finally, 32 studies were included in this systematic review, with a total of 3,139 patients who had undergone midurethral sling procedures that included transobturator tapes (TOT), retropubic tapes (TVT) or single-incision tapes (mini-slings). The overall incidence of de novo OAB was 11.5% in nonrandomized studies (280 women) and 6.4% in randomized studies (50 women). In relation to the type of midurethral sling, the incidence of de novo OAB was 9.7% for mini-slings, 11.2% for TVT-O, 8.7% for TOT and 9.8% for TVTs. The chi-squared test did not reveal significant differences (p = 0.58). CONCLUSIONS: Current evidence suggests that the overall incidence of de novo OAB following midurethral sling procedures is approximately 9%. There is not enough evidence to support differences in the effects of the different types of sling with regard to this particular postoperative complication.

Adjustable mini-sling compared with conventional mid-urethral slings in women with urinary incontinence. A randomized controlled trial.

INTRODUCTION: The primary aim of this study was to compare the objective and subjective outcomes and short-term complication rates of an adjustable single-incision mini-sling (SIMS) vs. standard mid-urethral slings (SMUS). The secondary aim was to report pain perception and complications at the one-year follow up. MATERIAL AND METHODS: The study was designed as a multicenter prospective randomized trial where women were included from eight centers in Denmark, Norway and Sweden. The trial was registered at ClinicalTrials.gov: NCT01754558. A total of 305 women less than 60 years old with verified stress urinary incontinence were included. All women were randomized to SIMS (Ajust® ; n = 155) or SMUS (TVT, TVT-O or TOT; n = 150) and were evaluated by stress test and bladder diary before and after surgery and symptoms related to incontinence using ICIQ-SF, PISQ-12 and PGI-S and PGI-I. Objective cure was defined as no leakage during a stress test and subjective cure defined as no leakage stated in the bladder diary or no indication of urinary leakage in the ICIQ-SF. Furthermore, mesh exposure and dyspareunia were recorded. RESULTS: In total, 280 women [141 (91%) in the SIMS and 139 (94%) in the SMUS groups] participated in the one-year follow up. No difference between the groups was observed regarding objective and subjective outcomes. VAS score disclosed a lower postoperative pain perception in the SIMS group than in the SMUS group. CONCLUSIONS: Ajust® appears to be as efficient as SMUS regarding objective and subjective outcomes and was associated with less pain perception during the postoperative period.

Retropubic or transobturator mid-urethral slings for intrinsic sphincter deficiency-related stress urinary incontinence in women: a systematic review and meta-analysis.

INTRODUCTION AND HYPOTHESIS: Stress urinary incontinence is a common problem affecting 12-46% of women. A cohort of women have a more severe form of stress urinary incontinence usually due to intrinsic urethral sphincter deficiency that has traditionally resulted in lower success rates with standard treatment modalities. We aim to address the question of whether transobturator sling insertion is more effective than retropubic sling insertion in the treatment of intrinsic sphincter deficiency-related stress urinary incontinence in women. METHODS: We searched MEDLINE, CINAHL, CENTRAL, journals, and major conferences (up to 30 June 2014). All randomised controlled trials in women with stress urinary incontinence or mixed urinary incontinence with associated intrinsic sphincter deficiency who underwent a retropubic or transobturator mid-urethral sling operation were included in this meta-analysis. The Cochrane risk of bias tool and the GRADE system were used to assess the quality of evidence. RESULTS: Fifty-five randomised controlled trials compared transobturator and retropubic mid-urethral slings. Twelve trials included women with intrinsic sphincter deficiency, but only 8 trials (399 women) reported data specifically for this cohort. There was a statistically significant difference in short- and medium-term (≤5 years) subjective cure rates, with the number of women reporting a cure in the transobturator group at 150 out of 199 and the retropubic group at 171 out of 200. This gives a 12% relative risk reduction in achieving cure with the transobturator route (RR 0.88, 95% CI 0.80 to 0.96, I(2) = 0%, moderate quality evidence [GRADE]). Objective cure was reported by five trials of 324 women and showed no statistically significant difference between the two groups, with a rate of 110 out of 159 in the transobturator group and 126 out of 165 in the retropubic group (RR 0.90, 95% CI 0.79 to 1.03). Post-operative voiding dysfunction and de novo urgency or urgency urinary incontinence in the two treatment groups showed no significant difference. The need to undergo repeat incontinence surgery in the long term (≥5 years) was higher with the transobturator route (RR 14.4, 95% CI 1.95 to 106, 147 women). CONCLUSIONS: Mid-urethral slings are effective in treating women with intrinsic sphincter deficiency-associated stress urinary incontinence. The retropubic route resulted in higher subjective cure rates compared with transobturator routes. Both routes improved the overall quality of life.

[Intrinsic sphincter deficiency and female urinary incontinence]. / Insuffisance sphinctérienne et incontinence urinaire de la femme.

OBJECTIVE: Stress urinary female incontinence (SUI) is primary due to intrinsic sphincter deficiency (ISD) and urethral hypermobility. Despite a lack of standardised international definition, ISD needs to be clearly diagnosed in order to be correctly treated. This work is an update about the female ISD produced from a review of a published article. MATERIAL AND METHODS: This review of article published on this subject in the Medline (Pubmed database), selected according to their scientific relevants, of consensus conferences and published guidelines, has been performed by the committee for women pelvic floor surgery of the French Urological Association. RESULTS: Although there is no international consensus definition, we can consider that the ISD is a composite concept combining urodynamic data (MUCP < 20 or 30 cmH20) and one or more clinical information (no urethral mobility, negative urethral support test, failure of a first surgery, leakage during abdominal straining, high stress incontinence scores). Imaging can provide additional evidence for intrinsic sphincter deficiency diagnosis, but the correlation between imaging and function remains low. By standardizing methodology and interpretations to better diagnose women with ISD, it may be possible to improve preoperative planning and outcomes for these patients. A retropubic midurethral sling can be performed as a first surgery. In case of a lack of urethral mobility, the artificial urinary sphincter (AUS) remains the gold standard. Adjustable continence therapy (ACT(®)) can be proposed as an alternative option. The efficacy and safety of muscle-derived cell therapy in ISD needs more studies. Injection of bulking agents may be an option according to the severity and the expectations of the patient. Bladder overactivity needs to be treated as first-line in case of mixed urinary incontinence. In elderly women, a careful evaluation of the bladder contractility and comorbidity must be performed. A geriatric evaluation can be necessary. CONCLUSION: Clinical and paraclinical assessment allow to confirm the diagnosis of female ISD, to estimate its severity, and to identify associated mechanisms of incontinence (urethral hypermobility, bladder overactivity) to choose the most adapted treatment.