Intra/inter-observer reliability of cystoscopic sphincter evaluation in men undergoing sling surgery.

OBJECTIVES: To assess the intra/inter-observer reliability of cystoscopic sphincter evaluation (CSE) in men undergoing sling surgery for urinary incontinence and if possible to evaluate its correlation with the final clinical decision. PATIENTS AND METHODS: Two expert urologists prospectively filmed and recorded, incontinent patient's cystoscopies according to a standard scenario. Anonymised recordings where randomly offered to the same observer twice. The observers (medical students, urology residents and full urologist with 0-5, 5-10, >10 years of practice, respectively) were asked to assess and score the recordings without knowing any of the patients' characteristics. RESULTS: In total, 37 recordings were scored twice by the 26 observers. The intraclass correlation coefficient (ICC) for intra-observer reliability of the CSE was 0.54 (moderate), 0.58 (moderate) and 0.60 (substantial) for medical students, residents, and urologists, respectively. However, when stratifying observers according to their experience, the lowest agreement values were found between experts with >10 years of experience. The inter-observer reliability for the CSE ICCs ranged between 0.31and 0.53, with the lowest ICC value observed between urologists (0.31). CONCLUSIONS: The study demonstrates poor intra- and inter-observer reliability of the CSE. According to these results, a CSE does not add valuable information to the clinical evaluation. In this scenario, it should not be considered in isolation from the patient's characteristics.

Bladder pain syndrome AKA interstitial cystitis - a condition with severe unmet medical need: an exploration of brimapitide as a potential treatment opportunity.

PURPOSE OF REVIEW: The purpose of this article is to present recent findings of KU002 (brimapitide) as a novel treatment option for interstitial cystitis/bladder pain syndrome (IC/BPS). RECENT FINDINGS: IC/BPS is a complex and poorly understood heterogeneous syndrome, with many burdensome symptoms that severely affect patients' quality of life. Treatment options beyond conservative and nonpharmacologic approaches remain limited, and there is an unmet medical need for effective medical treatments. While there are multiple ongoing clinical trials in this area, only a few explore new treatment options. This article summarizes current ongoing development and reports the findings of one such trial. SUMMARY: In a phase 1/2a exploratory trial, intravesical instillation of brimapitide confirmed local action while eliciting in minimal systemic exposure, resulting in a promising and favorable safety profile. Efficacy exploration suggests that brimapitide reduces pain, improves signs and symptoms of IC/BPS and improves the general wellbeing of the study participants.

Safety and medium-term outcome of redo laparoscopic sacrocolpopexy: a matched case-control study.

INTRODUCTION AND HYPOTHESIS: In the case of recurrent apical prolapse following laparoscopic sacrocolpopexy (LSCP), one may consider a "redo" procedure. We hypothesized that redo LSCP may carry an increased complication risk and less favorable outcomes when compared with primary procedures. METHODS: This is a single-center, matched case-control (1:4) study, comparing all 39 women who had a redo LSCP and 156 women who had a primary LSCP for symptomatic apical prolapse between 2002 and 2020 with a minimum follow-up of 12 months. Matching was based on proximity to the operation date. The primary outcome was the occurrence of intraoperative and early postoperative complications within 3 months. Secondary outcomes included subjective (Patient Global Impression of Change [PGIC] ≥4) and objective (Pelvic Organ Prolapse Quantification [POP-Q] stage <2) success rates, surgical variables, graft-related complications and reinterventions. RESULTS: There was no difference in the rate of intraoperative and early postoperative complications (redo: 21.1% vs control: 29.8%, OR: 0.63, 95% CI 0.27-1.48). The conversion rate was higher in redo patients (redo: 10.3% vs control: 0.6, OR: 17.71, 95% CI 1.92-163.39). Early postoperative complications were comparable: they were mainly infectious and managed by antibiotics. At a comparable follow-up (redo: 81 months (IQR: 54) vs control: 71.5 months (IQR: 42); p=0.37), there were no differences in graft-related complications (redo: 17.9% vs control: 9.6%, p=0.14) and reinterventions for complications (redo: 12.8% vs control: 5.1%, p=0.14) or prolapse (redo: 15.4% vs control: 8.3%, p=0.18). Subjective (redo: 88.5% vs control: 80.2%, p=0.41) and objective (redo: 31.8% vs control: 24.7%, p=0.50) success rates were also comparable. CONCLUSIONS: In our experience, redo LSCP is as safe and effective as a primary LSCP, but there is a higher risk of conversion.

How I Do It: Transcutaneous tibial nerve stimulation TENSI+ system.

Overactive bladder (OAB) is a common condition that significantly impacts the quality of life (QoL), well-being and daily functioning for both men and women. Among various treatments, peripheral tibial nerve stimulation (PTNS) emerges as an effective third-line treatment for OAB symptoms, with options for either a percutaneous approach (P-PTNS) or by transcutaneous delivery (T-PTNS). Recent studies have shown negligible differences between P-PTNS and T-PTNS efficacy in alleviating urinary urgency and frequency and QoL improvement and, overall no difference in efficacy over antimuscarinic regimens. The TENSI+ system offers a cutting-edge transcutaneous approach, allowing patients to self-administer treatment conveniently at home with electrical stimulation delivery through surface electrodes. It stands out for its ease of preparation, tolerability, and high levels of patient satisfaction. Prospective multicentric data highlights TENSI+ to be an effective and safe treatment for lower urinary tract symptoms with high treatment adherence at 3 months. This paper aims to familiarize readers with the TENSI+ system, current studies, device assembly, operation, and treatment recommendations.

Long-term outcomes and patient satisfaction after artificial urinary sphincter implantation.

PURPOSE: To evaluate long-term functional outcomes of artificial urinary sphincter implantation in men for the treatment of stress urinary incontinence. MATERIALS AND METHODS: Patients who underwent artificial urinary sphincter implant for non-neurogenic stress urinary incontinence between June 1989 and January 2020 were included in this single-centre retrospective series. All patients with a functional artificial urinary sphincter in situ were contacted to evaluate long-term functional outcomes using validated questionnaires. RESULTS: A total of 263 patients were included in this retrospective series with a mean follow-up of 61 months. Explant-free survival after 5 years was 75% with a median time to explant of 16.2 years. Revision-free implant survival was 62% after 5 years with a median revision-free implant survival rate of 10.8 years. Previous pelvic irradiation, history of stricture disease and previous artificial urinary sphincter implant were associated with decreased implant survival. Overall social continence rate after 5 years was 60%. Prior radiation therapy, anticoagulation therapy and previous anti-incontinence surgery were associated with a higher incontinence risk. On long-term evaluation of 158 patients with their artificial urinary sphincter currently in situ, 51% were socially continent and 29% reported they were totally dry. Of these patients, 92% indicated to be satisfied with their current continence status. CONCLUSION: A significant proportion of patients undergoing artificial urinary sphincter implant incontinence needed revision or explant surgery. Long-term continence rates are acceptable but tend to decrease by time. Nonetheless, if patients can maintain a functional AUS in situ, long-term patient satisfaction rates remain high.

The key role of levator ani thickness for early urinary continence recovery in patients undergoing robot-assisted radical prostatectomy: A multi-institutional study.

BACKGROUND: Urinary continence (UC) recovery dramatically affects quality of life after robot-assisted radical prostatectomy (RARP). Membranous urethral length (MUL) has been the most studied anatomical variable associated with UC recovery. OBJECTIVE: To investigate whether levator ani thickness (LAT), assessed with multi-parametric magnetic resonance imaging (mpMRI), correlates with UC recovery after RARP. DESIGN, SETTING, AND PARTICIPANTS: The study included 209 patients treated with RARP by expert surgeons with extensive robotic experience from 2017 to 2019. All patients had complete, clinical, mpMRI, pathological, and postoperative data including pelvic floor muscle training (PFMT) protocols. INTERVENTION: After a radiologist-specific training, two urologists independently examined the files, blinded to clinical and pathological findings as well as to postoperative continence status. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: On mpMRI, LAT, bladder neck (BN) shape, MUL, and apex overlapping (AO) were measured. UC recovery was defined as use of 0 or 1 safety pad at follow-up. Multivariable models were used to assess the association between variables and UC recovery. RESULTS AND LIMITATIONS: Overall, 173 (82.8%) patients were continent after a median follow-up of 23 months (interquartile range [IQR]: 17-28). Of these, 98 (46.9%) recovered within 3 months after surgery, 42 (20.1%) from 3 to 6 months, and 33 (15.8%) from 6 months onwards. A significant higher rate of patients with LAT > 10 mm (88.1 vs.75.8%; p = 0.03) experienced UC recovery, compared to those with LAT < 10 mm. This difference was observed in the first 3 months after surgery. At multivariable analysis, LAT (odds ratio [OR]: 1.18, 95% confidence interval [CI]: 1.02-1.37; p = 0.02), Preoperative ICIQ score (OR: 0.91, 95% CI: 0.82-0.98, p = 0.03) and PFMT (OR: 1.98, 95% CI: 1.01-3.93; p = 0.04) independently predict higher UC recovery within 3 months, after accounting for age, BMI, preoperative PSA, D'Amico risk group, MUL, BN shape and AO. CONCLUSIONS: LAT greater than 1 cm was associated with greater UC recovery. Specifically, LAT greater than 1 cm seems to be associated with higher UC rate at 3 months after RARP, compared to those with LAT < 1 cm. PATIENT SUMMARY: Magnetic resonance features can help in predicting the risk of incontinence after robot-assisted radical prostatectomy and should be taken into account when counseling patients before surgery.

Cytokeratin 5 and cytokeratin 20 inversely correlate with tumour grading in Ta non-muscle-invasive bladder cancer.

Cytokeratin 5 is a marker of basal molecular subtypes of muscle-invasive bladder cancer (MIBC), which correlates with worse overall survival compared to luminal subtypes. Our observations have not confirmed CK5 as a marker of high-grade (HG) disease in Ta non-muscle-invasive bladder cancer (NMIBC). Therefore, to understand the basal-luminal immunohistochemistry profile in Ta NMIBC, we performed immunohistochemistry for CK5, P40, P63 (basal), GATA3 and CK20 (luminal) and studied the correlation with HG and clinical outcome in 109 patients with Ta NMIBC. HG and low-grade (LG) diseases were scored in each patient. Four different CK5 patterns were evaluated: absent (median 41.3%), normal (72.5%), rising (84.4%) and full thickness (23.9%). The median percentage of GATA3 was 100%. HG disease and CK5 expression and rising CK5 pattern had a significant inverse correlation, whereas HG disease and CK20 expression had a significant positive correlation. We also found a significant inverse correlation between CK5 expression and CK20 expression. Quantitative PCR confirmed that the presence of CK5 correlated with up-regulation of CK5 RNA. None of the markers could differentiate patients with regard to clinical outcome. Our results suggest a role for CK5 and CK20 in differentiating between LG and HG disease in Ta NMIBC.

A novel tool to predict functional outcomes after robot-assisted radical prostatectomy and the value of additional surgery for incontinence.

OBJECTIVES: To develop and validate a model to predict 12-month continence status after robot-assisted radical prostatectomy (RARP) from preoperative and 3-month postoperative data; this model could help in informing patients on their individualised risk of urinary incontinence (UI) after RP in order to choose the best treatment option. PATIENTS AND METHODS: Data on 9421 patients in 25 Belgian centres were prospectively collected (2009-2016) in a compulsory regional database. The primary outcome was the prediction of continence status, using the International Consultation on Incontinence Urinary Incontinence Short Form (ICIQ-UI-SF) at 12-months after RARP. Linear regression shrinkage was used to assess the association between preoperative 3-month postoperative characteristics and 12-month continence status. This association was visualised using nomograms and an online tool. RESULTS: At 12 months, the mean (sd) score of the ICIQ-UI-SF questionnaire was 4.3 (4.7), threefold higher than the mean preoperative score of 1.4. For the preoperative model, high European Association of Urology risk classification for biochemical recurrence (estimate [Est.] 0.606, se 0.165), postoperative radiotherapy (Est. 1.563, se 0.641), lower preoperative European Organisation for Research and Treatment of Cancer quality of life questionnaire 30-item core (EORCT QLQ-C30)/quality of life (QoL) score (Est. -0.011, se 0.003), higher preoperative ICIQ-UI-SF score (Est 0.214, se 0.018), and older age (Est. 0.058, se 0.009), were associated with a higher 12-month ICIQ-UI-SF score. For the 3-month model, higher preoperative ICIQ-UI-SF score (Est. 0.083, se 0.014), older age (Est. 0.024, se 0.007), lower 3-month EORCT QLQ-C30/QoL score (Est. -0.010, se 0.002) and higher 3-month ICIQ-UI-SF score (Est. 0.562, se 0.009) were associated with a higher 12-month ICIQ-UI-SF score. CONCLUSIONS: Our models set the stage for a more accurate counselling of patients. In particular, our preoperative model assesses the risk of UI according to preoperative and early postoperative variables. Our postoperative model can identify patients who most likely would not benefit from conservative treatment and should be counselled on continence surgery.

The feasibility and efficacy of catheterizable stoma's in adults.

PURPOSE OF REVIEW: A continent vesicostomy represents a useful alternative for adult patients with impaired bladder emptying who are unable to perform clean intermittent (self-) catheterization through the urethra. In a pediatric setting, there exists a vast experience in these procedures. But experience with continent catheterizable vesicostomies is less abundant in adult patients. We want to give an overview and discuss recent literature about catheterizable conduits in the adult population. RECENT FINDINGS: Adult patients who undergo continent vesicostomy comprise a diverse cohort. Because of this very heterogeneous population, it can be difficult to make an objective analysis and draw conclusions on both the success rate and complication rate of these diversions. We will discuss short- and long-term surgical outcomes and changes in quality of life after the procedure in these patients. SUMMARY: A continent vesicostomy is a valuable and durable reconstructive technique for adult patients with impaired bladder emptying. Surgery can be challenging and a better knowledge of complications can help with patient counseling. In the future we hope that minimally invasive surgery will decrease the morbidity of such surgery and hopefully also improve functional outcomes and diminish the complication rate.

Robot-assisted artificial urinary sphincter implantation.

PURPOSE OF REVIEW: The aim of the present manuscript was to provide an overview on the current state of robotic artificial urinary sphincter (AUS) implantation in male and female patients. RECENT FINDINGS: Over the past few years, several series have been reported, with promising outcomes for the most part. This has contributed to expand the use of bladder neck AUS, especially in female patients, which was, until then, hampered by its perioperative morbidity. SUMMARY: Robotic AUS has been developed to overcome the technical challenge of bladder neck implantation in female patients and in specific male subgroups, especially self-catheterizing neurological patients. All the series of robotic AUS implantation published in the past few years reported much lower rates of cuff erosion and AUS explantation than the historical open cohorts suggesting that the robotic approach might become the standard for female AUS implantation. This less morbid approach along with technological improvement of the AUS device may contribute to make it a more popular option in the treatment of female stress urinary incontinence due to intrinsic sphincter deficiency. There are much less data available on robotic bladder neck AUS implantation in male patients.

Prophylactic ureteral catheterization in the intraoperative diagnosis of iatrogenic ureteral injury.

BACKGROUND: Iatrogenic ureteral injury (IUI) is a rare but feared complication in pelvic surgery. Prophylactic ureteral catheterization (PUC) is inconsistently used to reduce this risk, however no strong evidence exists for this practice. The objective is to investigate whether prophylactic ureteral catheterization can enhance intraoperative detection of IUI and reduce associated patient morbidity. METHODS: The database of our tertiary referral hospital was retrospectively queried for ureter repairs due to iatrogenic injuries. The search yielded 845 unique patient files. After application of exclusion criteria and manual review of files, 155 individual cases remained. Statistical analysis was performed on the following parameters: timing of ureteral injury discovery, duration until catheter removal and postoperative complications. RESULTS: Prophylactic ureteral catheterization was able to significantly enhance intraoperative diagnosis of IUI (OR = 5.09; 95%CI = 2.26-11.48). The number needed to treat is 2.6 patients. Furthermore, when the IUI was diagnosed during surgery, a significant reduction in postoperative complications was observed (RR = 0.64; 95%CI = 0.42-0.98). CONCLUSION: Although the beneficial effects of PUC on IUI incidence remain controversial, when a ureteral injury occurs during pelvic surgery, the presence of prophylactic ureteral catheters can significantly reduce both diagnostic delay and postoperative morbidity. By promoting an immediate repair, ureteral catheterization reduces need for further diagnostics and secondary interventions.

Patient-reported outcomes after buccal mucosal graft urethroplasty for bulbar urethral strictures: results of a prospective single-centre cohort study.

OBJECTIVES: To describe patient-reported outcome measures (PROMs) after buccal mucosa graft (BMG) urethroplasty. MATERIALS AND METHODS: We prospectively collected PROMs in patients who underwent BMG urethroplasty for bulbar urethral strictures between October 2009 and February 2017. Preoperatively and at the first, second and third postoperative follow-up visits, patients completed five PROM questionnaires: the International Prostate Symptom Score (IPSS); the IPSS Quality of Life questionnaire; the Urogenital Distress Inventory Short-Form questionnaire (UDI-6); the International Index of Erectile Function (IIEF)-5 questionnaire, combined with IIEF-Q9 and IIEF-Q10 for assessing ejaculatory and orgasmic functions; and the International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTS-QOL) questionnaire. In addition to using these questionnaires, we evaluated maximum urinary flow rate (Qmax ), post-void residual urine volume and total voided urine volume at each follow-up visit. Buccal pain and discomfort were assessed using a visual analogue scale (VAS). Comparison of questionnaire scores was performed using a paired Wilcoxon rank-sum test. Treatment failure was defined as any need for urinary diversion or urethral instrumentation after surgery. RESULTS: A total of 97 patients met the inclusion criteria. The first postoperative follow-up visit was at a median of 2.1 months (n = 97/97), and the second and third visits were after a median of 7.8 (n = 82/97) and 17.0 months (n = 70/97), respectively. Significant improvements compared to baseline were observed in IPSS, and IPSS-QOL, UDI-6 and ICIQ-LUTS-QOL scores at the first follow-up, and remained improved during the follow-up period (P ≤ 0.001). Patients with mild to no baseline erectile dysfunction experienced a significant decline in erectile function at the first follow-up (median [interquartile range {IQR}] preoperative IIEF-5 score 23.0 [21.0-25.0] vs median [IQR] IIEF-5 score at first follow-up 19.5 [16.0-23.8]; P ≤ 0.001). This decline fully recovered during further follow-up (median [IQR] IIEF-5 score at third follow-up 24.0 [20.5-25.0]; P = 0.86). No significant changes in median orgasmic and ejaculatory function were noted. The first postoperative median (IQR) VAS score was 3.0 (2.0-4.45), and a significant improvement in local pain and discomfort was observed during the follow-up (median [IQR] VAS at third follow-up: 0.0 [0.0-1.0]; P ≤ 0.001). Nine patients (9/97; 9.3%) had treatment failure. Stratifying recurrence based on a difference of <10 mL/s vs ≥10 mL/s between preoperative and postoperative Qmax could not demonstrate a significant difference (P = 0.06). CONCLUSION: Significant improvements in voiding symptoms and quality of life after surgery were reported. Patients with good baseline erections recovered erectile function during follow-up, although a significant decrease in erectile function was observed at the first follow-up. This study highlights the importance of PROMs in urethral reconstructive surgery, emphasizing that success should not be defined only by stricture-free survival.

Two-year safety and efficacy outcomes for the treatment of overactive bladder using a long-lived rechargeable sacral neuromodulation system.

AIMS: Sacral neuromodulation (SNM) therapy for overactive bladder (OAB) has proven long-term safety and efficacy. Historically, the only commercially available SNM device was nonrechargeable requiring replacement surgery due to battery depletion. The Axonics System is the first rechargeable SNM device and is qualified to last a minimum of 15 years in the body. The study objective was to evaluate the safety and efficacy of this rechargeable SNM system. This study reports 2-year outcomes. METHODS: A total of 51 subjects were implanted with the Axonics System in a single nonstaged procedure. Subjects had OAB, confirmed on a 3-day voiding diary (≥8 voids/day and/or ≥2 incontinence episodes over 72 hours). Test Responders were defined as subjects that were responders at 1 month postimplant. The efficacy analysis included therapy responder rates, change in the quality of life, and subject satisfaction reported in Test Responders (n = 30) and all implanted subjects (n = 37) that completed the follow-up visits. Adverse events (AEs) are reported in all implanted subjects. RESULTS: At 2 years, 90% of the Test Responders continued to respond to the therapy based on voiding diary criteria. Satisfaction with therapy was reported by 93% of subjects and 86% found their charging experience acceptable. Of the urinary incontinence Test Responders, 88% continued to be responders at 2 years, and 28% were completely dry. There were no unanticipated (AEs) or serious device-related AEs. CONCLUSIONS: The Axonics System® provides sustained clinically meaningful improvements in OAB subjects at 2 years. There were no serious device-related AEs. Subjects reported continued satisfaction with their therapy.

Development of a flowchart reflecting the current attitude and approach towards idiopathic overactive bladder treatment in Belgium: A Delphi study.

AIMS: Idiopathic overactive bladder syndrome (iOAB) is a prevalent condition in urological practice. The variability in management between specialists and between centers remains high. Even existing guidelines contain inconsistencies. We aimed to develop a treatment algorithm for iOAB for use in daily clinical practice. METHODS: From October 2018 till November 2019, a Delphi study was conducted to obtain expert consensus on the management of iOAB. Members from the Belgian Working Group of Functional Urology were asked to rate online statements, based on gaps and variabilities between the American Urology Association (AUA), European Association of Urology (EAU) and International Consultation on Incontinence (ICI) guidelines on iOAB. The consensus was reached if ≥75% of the panel agreed on the level of appropriateness. Two Delphi rounds and an open discussion session were held. RESULTS: Twenty out of 49 members completed the first round and 18 completed the second round. The consensus was reached on 44/143 statements and 15/56 statements in the first and second round, respectively. The consensus was reached on criteria by which to phenotype OAB patients, the terminology relating to the first-, second- and third-line treatment, the duration of therapies, the chronological order, and the choice between therapies. No consensus was reached on the role of percutaneous tibial nerve stimulation (PTNS) in the treatment algorithm. CONCLUSIONS: A flowchart reflecting the current attitude and approach of a Delphi expert panel towards the treatment of iOAB was developed. We propose its use in daily clinical practice to increase the standardization of OAB treatment.

Survey on surgery for stress urinary incontinence in an era mid-urethral slings are being questioned.

INTRODUCTION: Concerns about vaginal mesh have reduced the use of mid-urethral slings (MUS) in some countries. In view of their potential withdrawal in Belgium and The Netherlands, we polled urogynaecologists on their practice for treating stress urinary incontinence (SUI) and what their experience is with alternative procedures, and we asked them how their patients perceive the risk and success rates. METHODS: A survey among members of the pelvic floor special interest group of the Flemish Society for Obstetrics and Gynaecology, Belgian Association of Urology and Dutch Society of Obstetrics and Gynaecology. RESULTS: Their primary procedure of choice is the MUS (99%). Sixty-five per cent performs at least 25 MUS yearly; they report high success (90%; IQR [85-92]) and low adverse outcome rates. Physicians anticipate complications as reported in the literature: 5% (IQR [410]) overactive bladder, 5% (IQR [2-10]) voiding problems, 2% (IQR [15]) exposures, 2% (IQR [1-5]) dyspareunia and 1% (IQR [1-3]) chronic pain. Eighty-five per cent of physicians report their patients express fears about having a MUS though usually they cannot precisely tell why. Reportedly they tell their physicians of concerns about pain (54%), exposure (45%), dyspareunia (25%), voiding problems (15%) or overactive bladder (8%). Only half of respondents had ever performed a colposuspension. The majority of these were older and performed colposuspension via laparotomy. Only six (4%) had performed > 20 colposuspensions yearly. CONCLUSION: Dutch and Belgian urogynaecologists estimate success and adverse effect rates of MUS in line with the literature. Their patients most cited worries were fear of chronic pain and exposure. Only half of respondents had ever performed a colposuspension. They were older and performed the procedure via laparotomy.

Tolerability and safety of urotainer® polihexanide 0.02% in catheterized patients: a prospective cohort study.

BACKGROUND: In patients with indwelling bladder catheters for > 2 weeks, bacterial colonization is inevitable, leading to urinary tract infections or encrustations with subsequent catheter blockage. Currently, bladder irrigations are the most frequently used prophylactic means, but the best solution remains yet to be determined. In vitro studies demonstrate that polihexanide is a promising option for catheter irrigation, but no data about safety and tolerability exist. METHODS: In a prospective observational study in patients with indwelling bladder catheter for > 2 weeks, a 0.02% polihexanide solution was used to rinse the catheter on five consecutive days. Adverse events, tolerability and vital signs were assessed before, during, after and at the end of the treatment period. RESULTS: There was no serious adverse event in the study. A total of 28 adverse events (AEs) in 15 (46.88%) participants were experienced. Absolute changes in pain scores were not clinically relevant. No incidences of either flushing or sweating were found during instillation. Bladder spasms during instillation were reported in two cases during a single instillation. Mean pulse rates did not change by more than 3 beats per minute. Mean changes in body temperature did not exceed 0.12 °C. Clinically relevant changes in blood pressure were recorded for 3 patients. CONCLUSIONS: This is the first study to demonstrate that a 0.02% polihexanide solution can safely be used for catheter irrigation. TRIAL REGISTRATION: ClinicalTrials.gov ( NCT02157415 ), June 6th, 2014.

Current Use of the Artificial Urinary Sphincter in Adult Females.

PURPOSE OF REVIEW: The aim of the present report was to review the recent evidences regarding the use of artificial urinary sphincter (AUS) in adult females. RECENT FINDINGS: While the excellent functional outcomes of AUS in female patients with stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD) have been reported for decades, its use has remained confidential in most countries likely due to its challenging implantation and inherent morbidity. Over the past few years, laparoscopic and, more recently, robotic techniques of AUS implantation in female patients have been described with promising perioperative outcomes. As a result, the use of AUS has increased in several countries. The indications are mostly recurrent or persistent SUI after previous anti-incontinence procedures and neurogenic SUI. Owing to its unique potential to restore continence while maintaining low outlet resistance during the voiding phase, AUS may be of special interest in female patients with detrusor underactivity. High level of evidence data from trials which are underway, along with developments in robotic surgery and technological refinements of the device, may well, almost 50 years after its introduction, give to the AUS its momentum as a major contributor in the female SUI armamentarium. While the use of AUS in female patients has been restricted to some countries and a few high-volume centers, it has started spreading again over the past few years, thanks to the rise of minimally invasive approaches which facilitate its implantation, and this is yielding promising outcomes.

Medium-term outcome of laparoscopic sacrocolpopexy using polivinylidene fluoride as compared to a hybrid polyglecaprone and polypropylene mesh: A matched control study.

AIM: To compare 2-year outcomes of laparoscopic sacrocolpopexy (LSCP) either with polyvinylidene fluoride (PVDF) or hybrid polypropylene containing a resorbable polyglecaprone (PP+ PG) mesh. MATERIALS AND METHODS: Retrospective audit on 105 consecutive patients undergoing LSCP a with PVDF-mesh (DynaMesh, FEG Textiltechniken), matched by prolapse stage and cervicopexy or vault suspension to 105 controls undergoing LSCP with a hybrid PP + PG-mesh (Ultrapro, Ethicon). Patients are part of an ongoing prospective study. The primary outcome measure was the Patient Global Impression of Change score (PGIC), the coprimary variable was failure rate at the vault (≤1 cm). Other outcomes were intraoperative and postoperative complications within 3 months categorized by the Clavien-Dindo classification, reinterventions, graft-related complications (GRCs) and functional outcomes. All assessments were performed by an independent assessor. Data are reported as median (interquartile range) number and percent as appropriate, the Mann-Whitney U, χ2 , or Fisher exact were used for comparison. RESULTS: Patient satisfaction in the PVDF group, as measured with the PGIC, was high (90.9% PGIC, ≥4) as well as was the anatomical success (97.3%) at a follow-up of 26 months. These outcomes were comparable to those of PP + PG-patients (84.8% PGIC, ≥4; 94.9% anatomical success). There were five patients (2.4%) with Dindo-III or higher complications and three patients had GRCs (1.5%), without differences between mesh type. Level-II posterior defects (Bp ≥ -1) were less likely in PVDF patients (34.1% vs 50% for PP + PG-patients; P = .003). Women in the PVDF group also were less bothered by prolapse (7.5% vs 26.4%; P = .001), yet they complained more of constipation (15.0% vs 9.0%; P = .01). CONCLUSION: There were no differences in patient satisfaction and anatomical outcomes after LSCP either with PVDF or PP + PG mesh.

A prospective, multicenter study of a novel, miniaturized rechargeable sacral neuromodulation system: 12-month results from the RELAX-OAB study.

AIMS: Historically, providing SNM therapy required use of a non-rechargeable implantable pulse generator (IPG) with an average device lifespan of 4.4 years. Multiple device replacement surgeries are necessary with this device for long-term overactive bladder (OAB) management. A longer-lived device can reduce and potentially eliminate the need for replacement surgeries, thereby improving the long-term safety and cost-effectiveness of SNM therapy. The objective of this study was to evaluate the safety and efficacy of a miniaturized, rechargeable SNM system. METHODS: This prospective, multi-center study implanted 51 subjects with the SNM system in a single stage procedure without an external trial period. Subjects had overactive bladder as demonstrated on a 3-day voiding diary (≥8 voids/day and/or ≥2 incontinence episodes over 72-h). Outcome measures at 1-year follow-up included quality of life (evaluated by ICIQ-OABqol questionnaire), therapy responder rates (≥50% reduction in voids and/or leaks or <8 voids per day), subject satisfaction questionnaire, and adverse events (AEs). RESULTS: At 1-year, 94% of Test Responders continued to respond to r-SNM therapy based on bladder diary criteria. Subjects experienced significant improvement of 21.1 points on the ICIQ-OABqol. 84% of subjects were satisfied with r-SNM therapy and 98% found their charging experience acceptable. Device-related AEs occurred in 21% of subjects, with discomfort due to stimulation occurring in 20% of subjects. This AE was resolved with reprogramming in all instances. CONCLUSIONS: The Axonics r-SNM System provides sustained clinically significant improvements in OAB subjects after 1-year. Subjects were satisfied with r-SNM therapy and reported an easy and acceptable recharging experience.

Efficacy and safety of artificial urinary sphincter (AUS): Results of a large multi-institutional cohort of patients with mid-term follow-up.

AIMS: To assess efficacy and safety as well as predictive factors of dry rate and freedom from surgical revision in patients underwent AUS placement. The artificial urinary sphincter (AUS) is still considered the standard for the treatment of moderate to severe post-prostatectomy stress urinary incontinence (SUI). However, data reporting efficacy and safety from large series are lacking. METHODS: A multicenter, retrospective study was conducted in 16 centers in Europe and USA. Only primary cases of AUS implantation in non-neurogenic SUI after prostate surgery, with a follow-up of at least 1 year were included. Efficacy data (continence rate, based on pad usage) and safety data (revision rate in case of infection and erosion, as well as atrophy or mechanical failure) were collected. Multivariable analyses were performed in order to investigate possible predictors of the aforementioned outcomes. RESULTS: Eight hundred ninety-two men had primary AUS implantation. At 32 months mean follow-up overall dry rate and surgical revision were 58% and 30.7%, respectively. Logistic regression analysis showed that patients without previous incontinence surgery had a higher probability to be dry after AUS implantation (OR: 0.51, P = 0.03). Moreover institutional case-load was positively associated with dry rate (OR: 1.18; P = 0.005) and freedom from revision (OR: 1.51; P = 0.00). CONCLUSIONS: The results of this study showed that AUS is an effective option for the treatment of SUI after prostate surgery. Moreover previous incontinence surgery and low institutional case-load are negatively associated to efficacy and safety outcomes.