Cohort profile: COBLAnCE: a French prospective cohort to study prognostic and predictive factors in bladder cancer and to generate real-world data on treatment patterns, resource use and quality of life.

PURPOSE: Bladder cancer is a complex disease with a wide range of outcomes. Clinicopathological factors only partially explain the variability between patients in prognosis and treatment response. There is a need for large cohorts collecting extensive data and biological samples to: (1) investigate gene-environment interactions, pathological/molecular classification and biomarker discovery; and (2) describe treatment patterns, outcomes, resource use and quality of life in a real-world setting. PARTICIPANTS: COBLAnCE (COhort to study BLAdder CancEr) is a French national prospective cohort of patients with bladder cancer recruited between 2012 and 2018 and followed for 6 years. Data on patient and tumour characteristics, treatments, outcomes and biological samples are collected at enrolment and during the follow-up. FINDINGS TO DATE: We describe the cohort at enrolment according to baseline surgery and tumour type. In total, 1800 patients were included: 1114 patients with non-muscle-invasive bladder cancer (NMIBC) and 76 patients with muscle-invasive bladder cancer (MIBC) had transurethral resection of a bladder tumour without cystectomy, and 610 patients with NMIBC or MIBC underwent cystectomy. Most patients had a solitary lesion (56.3%) without basement membrane invasion (71.7% of Ta and/or Tis). Half of the patients with cystectomy were stage ≤T2 and 60% had non-continent diversion. Surgery included local (n=298) or super-extended lymph node dissections (n=11) and prostate removal (n=492). Among women, 16.5% underwent cystectomy and 81.4% anterior pelvectomy. FUTURE PLANS: COBLAnCE will be used for long-term studies of bladder cancer with focus on clinicopathological factors and molecular markers. It will lead to a much-needed improvement in the understanding of the disease. The cohort provides valuable real-world data, enabling researchers to study various research questions, assess routine medical practices and guide medical decision-making.

Single-Probe Percutaneous Cryoablation with Liquid Nitrogen for the Treatment of T1a Renal Tumors.

Kidney cancer accounts for 3% of adult malignancies and is increasingly detected through advanced imaging techniques, highlighting the need for effective treatment strategies. This retrospective study assessed the safety and efficacy of a new single-probe percutaneous cryoablation system using liquid nitrogen for treating T1a renal cancers. From May 2019 to May 2022, 25 consecutive patients from two academic hospitals, with a median age of 64.8 years [IQR 59; 75.5], underwent cryoablation for 26 T1a renal tumors. These tumors had a median size of 25.3 mm [20; 30.7] and a median RENAL nephrometry score, indicating tumor complexity, of 7 [5; 9]. No major complications arose, but three non-clinically relevant perirenal hematomas were detected on post-procedure CT scans. With a median follow-up of 795 days [573; 1020], the primary local control rate at one month stood was 80.8% (21 out of 26). The five recurrent lesions, which exhibited a higher renal score (p = 0.016), were treated again using cryoablation, achieving a secondary local control rate of 100%. No patient died, and the disease-free survival rate was 92% (23 out of 25). In conclusion, single-probe percutaneous cryoablation emerges as a promising modality for managing small renal masses. Notably, recurrence rates appear influenced by RENAL nephrometry scores, suggesting a need for further research to refine the technique.

Artificial intelligence to improve cytology performance in urothelial carcinoma diagnosis: results from validation phase of the French, multicenter, prospective VISIOCYT1 trial.

PURPOSE: Cytology and cystoscopy, the current gold standard for diagnosing urothelial carcinomas, have limits: cytology has high interobserver variability with moderate or not optimal sensitivity (particularly for low-grade tumors); while cystoscopy is expensive, invasive, and operator dependent. The VISIOCYT1 study assessed the benefit of VisioCyt® for diagnosing urothelial carcinoma. METHODS: VISIOCYT1 was a French prospective clinical trial conducted in 14 centers. The trial enrolled adults undergoing endoscopy for suspected bladder cancer or to explore the lower urinary tract. Participants were allocated either Group 1: with bladder cancer, i.e., with positive cystoscopy or with negative cystoscopy but positive cytology, or Group 2: without bladder cancer. Before cystoscopy and histopathology, slides were prepared for cytology and the VisioCyt® test from urine samples. The diagnostic performance of VisioCyt® was assessed using sensitivity (primary objective, 70% lower-bound threshold) and specificity (75% lower-bound threshold). Sensitivity was also assessed by tumor grade and T-staging. VisioCyt® and cytology performance were evaluated relative to the histopathological assessments. RESULTS: Between October 2017 and December 2019, 391 participants (170 in Group 1 and 149 in Group 2) were enrolled. VisioCyt®'s sensitivity was 80.9% (95% CI 73.9-86.4%) and specificity was 61.8% (95% CI 53.4-69.5%). In high-grade tumors, the sensitivity was 93.7% (95% CI 86.0-97.3%) and in low-grade tumors 66.7% (95% CI 55.2-76.5%). Sensitivity by T-staging, compared to the overall sensitivity, was higher in high-grade tumors and lower in low-grade tumors. CONCLUSION: VisioCyt® is a promising diagnostic tool for urothelial cancers with improved sensitivities for high-grade tumors and notably for low-grade tumors.

Prostatic artery embolisation versus medical treatment in patients with benign prostatic hyperplasia (PARTEM): a randomised, multicentre, open-label, phase 3, superiority trial.

Background: Prostatic artery embolisation (PAE) is a minimally invasive treatment of symptomatic benign prostatic hyperplasia (BPH). Our aim was to compare patient's symptoms improvement after PAE and medical treatment. Methods: A randomised, open-label, superiority trial was set in 10 French hospitals. Patients with bothersome lower urinary tract symptoms (LUTS) defined by International Prostatic Symptom Score (IPSS) > 11 and quality of life (QoL) > 3, and BPH ≥50 ml resistant to alpha-blocker monotherapy were randomly assigned (1:1) to PAE or Combined Therapy ([CT], oral dutasteride 0.5 mg/tamsulosin hydrochloride 0.4 mg per day). Randomisation was stratified by centre, IPSS and prostate volume with a minimisation procedure. The primary outcome was the 9-month IPSS change. Primary and safety analysis were done according to the intention-to-treat (ITT) principle among patients with an evaluable primary outcome. ClinicalTrials.gov Identifier: NCT02869971. Findings: Ninety patients were randomised from September 2016 to February 2020, and 44 and 43 patients assessed for primary endpoint in PAE and CT groups, respectively. The 9-month change of IPSS was -10.0 (95% confidence interval [CI]: -11.8 to -8.3) and -5.7 (95% CI: -7.5 to -3.8) in the PAE and CT groups, respectively. This reduction was significantly greater in the PAE group than in the CT group (-4.4 [95% CI: -6.9 to -1.9], p = 0.0008). The IIEF-15 score change was 8.2 (95% CI: 2.9-13.5) and -2.8 (95% CI: -8.4 to 2.8) in the PAE and CT groups, respectively. No treatment-related AE or hospitalisation was noticed. After 9 months, 5 and 18 patients had invasive prostate re-treatment in the PAE and CT group, respectively. Interpretation: In patients with BPH ≥50 ml and bothersome LUTS resistant to alpha-blocker monotherapy, PAE provides more urinary and sexual symptoms benefit than CT up to 24 months. Funding: French Ministry of Health and a complementary grant from Merit Medical.

Machine-learning approach for prediction of pT3a upstaging and outcomes of localized renal cell carcinoma (UroCCR-15).

OBJECTIVES: To assess the impact of pathological upstaging from clinically localized to locally advanced pT3a on survival in patients with renal cell carcinoma (RCC), as well as the oncological safety of various surgical approaches in this setting, and to develop a machine-learning-based, contemporary, clinically relevant model for individual preoperative prediction of pT3a upstaging. MATERIALS AND METHODS: Clinical data from patients treated with either partial nephrectomy (PN) or radical nephrectomy (RN) for cT1/cT2a RCC from 2000 to 2019, included in the French multi-institutional kidney cancer database UroCCR, were retrospectively analysed. Seven machine-learning algorithms were applied to the cohort after a training/testing split to develop a predictive model for upstaging to pT3a. Survival curves for disease-free survival (DFS) and overall survival (OS) rates were compared between PN and RN after G-computation for pT3a tumours. RESULTS: A total of 4395 patients were included, among whom 667 patients (15%, 337 PN and 330 RN) had a pT3a-upstaged RCC. The UroCCR-15 predictive model presented an area under the receiver-operating characteristic curve of 0.77. Survival analysis after adjustment for confounders showed no difference in DFS or OS for PN vs RN in pT3a tumours (DFS: hazard ratio [HR] 1.08, P = 0.7; OS: HR 1.03, P > 0.9). CONCLUSIONS: Our study shows that machine-learning technology can play a useful role in the evaluation and prognosis of upstaged RCC. In the context of incidental upstaging, PN does not compromise oncological outcomes, even for large tumour sizes.

[French language validation of the SSIPI questionnaire assessing the satisfaction of patients with penile implant]. / Validation linguistique française du questionnaire SSIPI évaluant la satisfaction des patients porteurs d'une prothèse pénienne.

INTRODUCTION: The objective of this study was to propose a French version of the satisfaction survey for inflatable penile implant (SSIPI) questionnaire. MATERIAL: Questionnaire validation was performed in three steps: translation into French by two urologists, its validation by the committee of andrologist and sexual medicine (CAMS) and an independent translation in English by another urologist to exclude any distortion with the original version. Furthermore, the questionnaire was tested in few patients having penile implant. RESULTS: The andrology committee approved the French version of the questionnaire. The final version of the questionnaire was successfully tested on all patients. Every patient (n=10) confirmed the good comprehension and pertinence of the questions, and the easy response selection. CONCLUSION: This French version of the SSIPI questionnaire will allow French-speaking urologists to assess the satisfaction of their patients with a penile implant on a large scale. LEVEL OF EVIDENCE: IV.

Efficacy and safety of prostate artery embolization for patients with lower urinary tract symptoms and indwelling urinary catheter: A retrospective multicenter study.

PURPOSE: The purpose of this multicenter study was to evaluate the clinical success at three months of prostate artery embolization (PAE), assess PAE safety in centers with various experiences and identify factors associated with PAE success. PATIENTS AND METHODS: This multicenter, retrospective study included patients who underwent PAE for lower urinary tract symptoms (LUTS) including those with indwelling urinary catheter. PAE clinical success was defined as either 25% improvement of the International Prostate Symptom Score (IPSS) or 1-point improvement of quality of life (QoL) score, or catheter removal at three months. Multivariable analyses were performed using a logistic regression adjusted on patient variables, technical parameters and center experience in PAE. RESULTS: A total of 383 men (mean age, 68.4 ± 9.7 [standard deviation] years; range: 46-94) with LUTS, including 99 (25.8%) patients with indwelling urinary catheter, were included in seven centers from January 2017 to March 2019. Five patients reported major complications (1.3%), three (0.8%) penile ulceration, three (0.8%) acute urinary retention, one (0.3%) prostatic abscess, and 56 (14.6%) minor complications. Follow up data were available for 271 patients (center 1: n = 159; other centers: n = 112). Clinical success was reported in 232 patients (85.6%). In multivariable analyses, presence of cardiovascular comorbidities (diabetes, stroke history, myocardial infarction and lower limb artery disease) was the single independent variable inversely associated with PAE clinical success (odds ratio = 0.396; 95% confidence interval: 0.17-0.91; P = 0.029). There was no center effect. CONCLUSION: Our results show that PAE is safe and effective in centers with various PAE experiences. Cardiovascular comorbidity is the single independent variable associated with PAE failure.

Assessment of a New Formulation of Sildenafil on Common Practice: An Observational Study.

Erectile dysfunction (ED) has a significant impact on the quality of life of patients. Xybilun® (IBSA Pharma SAS, France) is a new formulation of sildenafil in an orodispersible film (ODF). This study aims to assess the response rate (RR), satisfaction with, and safety of sildenafil-ODF in daily practice in France. Patients aged ≥18 years with ED were included in four groups: Group 1 mild, Group 2 moderate, Group 3 severe ED, according to the International Index for Erectile Function (IIEF)-6 subscore, never treated with phosphodiesterase inhibitors (PDE)5-I; Group 4, patients previously treated with another PDE5-I. Patients were evaluated at baseline (V1), one (V2), and three (V3) months. The RR and satisfaction were assessed using the IIEF-6 subscore questionnaire, a 5-point Likert scale, and a Global Assessment Question (GAQ). The primary endpoint for Groups 1 to 3 was the RR according to Rosen criteria at V3 compared to V1. For Group 4, the primary endpoint was the RR, defined as the satisfaction compared with previous treatment. Secondary endpoints were the RR at V2 compared to V1, the evolution of IIEF-6 and IIEF-15 scores, dose adjustment, satisfaction, convenience, and safety. One hundred and five patients were enrolled, 83 analysed. The RR at V3 was 100% (Group 1); 75% (Group 2); 65.2% (Group 3); and 84.2% (Group 4). The overall RR was 78.3%. Secondary parameters confirmed the satisfaction with sildenafil-ODF, with 81.6% of patients very satisfied at V3. No Serious Adverse Events (SAEs) were observed. In conclusion, sildenafil-ODF seems beneficial for patients irrespective of the severity of the ED. This study confirms in the context of daily clinical practice the satisfaction of patients with sildenafil-ODF. Data suggest that the availability of the intermediate dose of 75 mg could add greater flexibility to the therapy.

Dementia Associated with Anticholinergic Drugs Used for Overactive Bladder: A Nested Case-Control Study Using the French National Medical-Administrative Database.

PURPOSE: We analyzed the relationship between use of anticholinergic drugs to treat overactive bladder (OAB) and risk of incident dementia in older patients, overall and for each drug separately. MATERIALS AND METHODS: We conducted a nested case-control study using the French National Medical-Administrative Database. We identified incident dementia cases and controls from January 1, 2013 to December 31, 2018 in individuals aged ≥60 years. Controls were matched 5:1 to cases by date of case diagnosis (index date), age, sex, and income. We set a 5-year exposure period ending 2 years before the index date (lag-time period to avoid protopathic bias). We quantified cumulative exposure to flavoxate, oxybutynin, solifenacin, trospium, and fesoterodine using defined daily doses (DDDs). We performed conditional logistic regression analyses adjusted for factors known to be associated with OAB and/or dementia including obesity, diabetes, stroke, coronary heart disease, and psychotic disorders. RESULTS: We analyzed 4,810 cases and 24,050 matched controls with a median age of 82 years. OAB anticholinergic use was associated with an increased risk of dementia (adjusted OR [aOR]=1.23, 95% CI 1.10-1.37) with a cumulative dose-response: aOR=1.07 (95% CI 0.91-1.25) for 1-90 DDDs, aOR=1.29 (1.05-1.58) for 91-365 DDDs and aOR=1.48 (1.22-1.80) for >365 DDDs. Considering each OAB anticholinergic separately showed a particularly marked increased risk of dementia for oxybutynin and solifenacin, but no increased risk for trospium. CONCLUSIONS: When treating OAB in older patients, OAB anticholinergics should be used with caution, taking into account the patient's cognitive status, the anticholinergic load, and the different therapeutic options.

EQUINOXE study: Impact of relational cohesion and sexuality on the quality of life of patients treated with gonadotropin-releasing hormone agonist for prostate cancer.

Objectives: To measure the effect of dyadic adjustment on changes in patients' quality of life when initiating treatment with gonadotropin-releasing hormone (GnRH) agonist. Patients and methods: A prospective, multicenter, longitudinal, and non-interventional study (NCT02630641) that included patients with prostate cancer starting GnRH agonist therapy, and their partners, in 157 centers in France. Data were collected at inclusion and after 6 months of treatment on quality of life (WHOQOL-BREF), disease perception (B-IPQ), disease symptoms (QLQ-PR25), and perception of cohesion within the couple (dyadic adjustment, DAS-16). Results: The Full Analysis Set included 492 patients (median age [Q1;Q3]: 74 [68;80] years). An improvement of the quality of life (defined as the improvement of at least one of the four dimensions of WHOQOL-BREF) was reported in 290/434 (67%) patients between baseline and follow-up. Quality of life was better at baseline and follow-up in patients with good cohesion within the couple than in those with medium or poor cohesion. Factors associated with improvement in quality of life of patients were the following: initial presence of QLQ-PR25 hormonal treatment-related symptoms (OR [95% CI]: 3.00 [1.46, 6.17]) suggesting testosterone deficiency symptoms at baseline and initial low level (2.04 [1.12, 3.72]) or absence of sexual activity (2.23 [1.11, 4.50]) before GnRH agonist initiation. Conclusion: Men with the greatest improvement in quality of life after initiating hormone therapy were those with, at baseline, testosterone deficiency symptoms (identified by QLQ-PR25 treatment-related symptoms score) or no/low sexual activity. Cohesion within the couple was not confirmed as an influence on the evolution of quality of life.

Can childbearing spinal cord injury women with continent cutaneous urinary diversion have child?

Over the last half century, significant improvements in health outcomes for individuals with spinal cord injury (SCI) and growing recognition those women with SCI can become pregnant. However, pregnancy must be rated as high risk and requires multidisciplinary medical care as higher rate of complication compare to general population. Most of published literature grouped all patients with lower urinary tract reconstruction (LUTR) like exstrophy-epispadias complex, spina bifida, interstitial cystitis urogenital sinus or fistula, but our article is focusing in the childbearing SCI women who undergone cutaneous continent urinary diversion (CCUD) with mitrofanoff procedure. We report two cases of three successful pregnancies in this population.

Prognostic Impact of pT3 Subclassification in a Multicentre Cohort of Patients with Urothelial Carcinoma of the Renal Pelvicalyceal System Undergoing Radical Nephroureterectomy: A Propensity Score-weighted Analysis After Central Pathology Review.

BACKGROUND: The current pathological tumour-node-metastasis (pTNM) classification for upper tract urothelial carcinoma (UTUC) does not include any risk stratification of pT3 renal pelvicalyceal tumours. OBJECTIVE: To assess the prognostic impact of pT3 subclassification in a multicentre cohort of patients with UTUC of the renal pelvicalyceal system undergoing radical nephroureterectomy (RNU). DESIGN, SETTING, AND PARTICIPANTS: Data from all consecutive patients treated with RNU for pT3 renal pelvicalyceal UTUC at 14 French centres from 1995 to 2013 were reviewed retrospectively. INTERVENTION: A central pathology review (CPR) was used to stratify pT3 patients into those with infiltration of the renal parenchyma on a microscopic level (pT3a) versus those with infiltration of the renal parenchyma visible on gross inspection of the resection specimen and/or invasion of peripelvic fat (pT3b). OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Inverse probability weighting (IPW)-adjusted Cox regression analyses were used to compare recurrence-free survival (RFS) and cancer-specific survival (CSS) between pT3a and pT3b patients. RESULTS AND LIMITATIONS: Overall, 202 patients were included and further stratified into pT3a (n = 98; 48.5%) and pT3b (n = 104; 51.5%) subgroups. Median time to follow-up in the weighted population was 68 (interquartile range, 50-95) mo. In IPW-adjusted Cox regression analyses, pT3b versus pT3a substage was associated with a significant adverse effect on RFS (hazard ratio [HR] = 2.02; 95% confidence interval [CI] = [1.36-3.01]; p < 0.001) and CSS (HR = 1.84; 95% CI = [1.20-2.82]; p = 0.005). The study is limited by its retrospective design. CONCLUSIONS: Using IPW-adjusted analyses after the CPR, we observed that RNU patients with pT3b renal pelvicalyceal UTUC had adverse prognosis as compared with those with pT3a disease. As such, this subclassification could help refine the current pTNM system for UTUC. PATIENT SUMMARY: In this report, we looked at the prognostic interest of stratifying patients with pT3 renal pelvicalyceal upper tract urothelial carcinoma based on the extent of local invasion. We found that those with extensive infiltration (pT3b) had adverse prognosis as compared with those with limited infiltration (pT3a). This information could be provided on pathology reports to further guide clinical decision making.

Fertility outcome after Intracytoplasmic Sperm Injection with surgically retrieved sperm.

BACKGROUND: Surgically retrieved sperm samples and Intra Cytoplasmic Sperm Injection are indicated when we face severe sperm abnormalities such as azoospermia. The objective of this study was to assess the rates of clinical pregnancies and live births with sperm from testicular biopsies. DESIGN: This was a retrospective descriptive study of all Intra Cytoplasmic Sperm Injection (ICSI) cycles performed with surgically retrieved sperm at the Nîmes University Hospital from January 1st, 2015 to December 31st, 2018. The main outcome was the clinical pregnancy rate. The secondary outcomes were the fertilization rate, the implantation rate and the live birth rate. RESULTS: In all, 99 couples were treated at our center during this period and 164 ICSI cycles using surgically-collected sperm were performed. The men were 34.7 ± 7.4 years old on average at the time of undergoing testicular biopsy and the women were 32.15 ± 5.07 years at the time of ICSI. Out of 127 fresh embryo transfers, we observed 47 clinical pregnancies (37 %) and 45 live births (35.4 %). The average fertilization rate was 45 % and the implantation rate was 23.7 %. Among these infertile couples, 53 % obtained at least one clinical pregnancy and 42 % at least one live birth. CONCLUSION: Testicular sperm extraction combined with ICSI is indicated in cases of male infertility linked with azoospermia or severe semen alteration. This technique offers couples a marvelous opportunity to have children with their own gametes.

Early Results of Unilateral Prostatic Artery Embolization as a Focal Therapy in Patients with Prostate Cancer under Active Surveillance: Cancer Prostate Embolisation, a Pilot Study.

PURPOSE: To evaluate the feasibility of prostatic artery embolization in patients with low-risk prostate cancer (PC) under active surveillance (AS). METHODS: This monocentric prospective pilot study, running from June 2018 to June 2019, included 10 patients with low-risk PC under AS, median age 72 years (range, 62-77 years), with a unilateral focal lesion visible on magnetic resonance (MR) imaging, with Prostate Imaging Reporting and Data System v2 score ≥3/5 confirmed by multiparametric MR imaging-targeted biopsy and Gleason score 6. The patients underwent unilateral prostatic artery embolization with 300-500 µm Embospheres in the affected prostatic lobe. The primary endpoint was technical feasibility (prostate and no off-target ischemia in the imaging). The secondary endpoints included safety, negative biopsies/MR imaging response/functional outcomes at 6 months, and oncologic efficacy at 1 year. RESULTS: Embolization was successfully achieved in all patients; prostate ischemia was confirmed on multiparametric MR imaging, and no off-target ischemia was reported. No major complications were reported. Four patients (40%) presented with both negative targeted and systematic biopsies at 6 months. No lesions were seen on the MR imaging in 30% of patients. The mean International Prostate Symptom Score and International Index of Erectile Function score were 7 and 19 and 5 and 20 at baseline and 6 months, respectively, with no significant difference. Nine patients (90%) were still under AS at 1 year. One patient (10%) had PC progression outside the target lesion and was switched over to curative radiotherapy. CONCLUSIONS: Prostatic artery embolization is feasible and appears safe for prostate cancer patients under AS, with no impact on erectile function or continence status. These results justify the pursuit of further studies.

What if artificial urinary sphincter is not possible? Feasibility and effectiveness of ProACT for patients with persistent stress urinary incontinence after radical prostatectomy treated by sling.

BACKGROUND: Stress urinary incontinence (SUI) is a major component of the post radical prostatectomy (RP) trifecta. Surgical treatments are sub-urethral slings, artificial urinary sphincter (AUS) and adjustable peri-urethral balloons (PUB) ProACT. All options are imperfect at best and persistent SUI is challenging when AUS is not manageable. AIMS: This study analyzed the cumulate experience of our 2 centers with offering PUB implantation for SUI post RP in patients with insufficient improvement from slings. MATERIALS & METHODS: This retrospective study reviewed all patients implanted with second line ProACT. The primary endpoint was continence, defined as 0 pads per day (PPD). The secondary endpoints were 50% decrease in PPD and increases in the Incontinence Quality of Life score (IQOL). Refilling and complications were reported. RESULTS: Between 2007 and 2016, 26 patients were implanted. Five patients have had adjuvant radiotherapy (18%). The mean follow-up was 36 months (±20; min 14-max 128). All patient presented with persistent SUI, using 2.3 PPD (±1; min 1-max 6), and only one sling was removed due to infection. After ProACT with an average 3 mL refilling (±1.2 min 2-max 6), 18 patients (66.7%) were continent. Eight of the remaining patients (29.6%) were improved; their number of PPD decreased from 2.6 to 1. The average IQOL score of those 8 patients increased by 20 points, from 53.4 up to 74.2 (P = .005). Overall 26 patients (96.3%) were improved. The remaining patient was not implanted because of an intraoperative urethral injury and is considered a failed case (3.7%). He had instead an AUS implantation. Three patients (14.8%) needed PUB replacement. CONCLUSION: The limited population of patients from both our centers who presented with persistent SUI after RP, despite sling placement, improved with PUB ProACT implantations without significant complications.

A Multicenter, Randomized, Placebo-Controlled Study Evaluating the Efficacy of a Combination of Propolis and Cranberry (Vaccinium macrocarpon) (DUAB®) in Preventing Low Urinary Tract Infection Recurrence in Women Complaining of Recurrent Cystitis.

OBJECTIVES: The purpose of the study was to compare the efficacy of a product containing cranberry and propolis (DUAB) to placebo for reducing frequency of cystitis in women with recurrent acute cystitis. METHOD: A multicenter, placebo-controlled, randomized study of women aged >18 years with at least 4 episodes of cystitis in the previous 12 months was performed. The number of cystitis episodes over a 6-month follow-up was the primary end point. RESULTS: Forty-two women were included in the cranberry + propolis group, and 43 women were in the placebo group. The mean age was 53 ± 18 years, with 6.2 ± 3.6 cystitis episodes in the previous year, with no differences between the 2 groups. The mean number of infections was lower in the propolis + cranberry group (respectively, 2.3 ± 1.8 vs. 3.1 ± 1.8). The total number of cystitis episodes in the first 3 months was lower in the propolis + cranberry group (0.7 ± 1.1 vs. 1.3 ± 1.1, p = 0.0257) after adjusting for water consumption. The mean time to onset of the first urinary tract infection (UTI) was also significantly longer in the propolis + cranberry group (69.9 ± 45.8 days vs. 43.3 ± 45.9, p = 0.0258). Tolerance to the treatments was good and comparable in both groups. CONCLUSIONS: We demonstrate for the first time that cranberry and propolis supplementation significantly reduces the incidence of UTIs during the first 3 months and delays the onset of an episode of cystitis.

Long-term anatomic and functional results of laparoscopic sacrocolpopexy: a prospective study.

PURPOSE: The aim of our study was to assess the impact of laparoscopic sacrocolpopexy on pelvic symptoms, quality of life and sexual function in patients with symptomatic pelvic organ prolapse. Secondary goals included the assessment of anatomical correction, recurrence and complication rates. METHODS: This is a prospective, single-center study that included 82 patients between 2009 and 2016. A clinical evaluation took place before surgery, and was repeated at 3, 12, 36 and 60 months postoperatively. Patients routinely received an anterior prosthesis, associated with a posterior prosthesis in case of symptomatic rectocele. Patients included self-administered questionnaires for functional pelvic problems (PFDI-20), quality of life (PFIQ-7), and sexual function (PISQ-12), and a clinical examination with POP-Q staging, at each medical visit. RESULTS: Functional pelvic problems derived from prolapse (PFDI-20 scores) and their impact on patients' quality of life (PFIQ-7 score) significantly improved at 3, 12, 36 and 60 months postoperatively. Improvement on sexual activity was significant at 3 and 60 months postoperatively. Effective prolapse anatomical correction (POP-Q score < 2) was found in 94.4% and 97.2% of patients at the anterior and middle stages, respectively, at the end of follow-up, but only in 80.3% at the posterior stage. Symptomatic recurrence required surgical intervention in 4 patients (5.3%). CONCLUSIONS: This long-term follow-up prospective analysis confirms the good functional and anatomical results of laparoscopic sacrocolpopexy for pelvic organ prolapse.

Needs and Expectations of Patients with Erectile Dysfunction: An Update on Pharmacological Innovations in Phosphodiesterase Type 5 Inhibition with Focus on Sildenafil.

INTRODUCTION: Phosphodiesterase type 5 inhibitors (PDE5-Is) have an excellent efficacy and tolerability profile and remain the first-line choice for the treatment of erectile dysfunction (ED). However, ED is still an underdiagnosed and undertreated condition, and many men prematurely discontinue therapy with conventional dosage formulations despite successful intercourse. AIM: To review the unmet needs and expectations of patients with ED and describe the latest pharmaceutical innovations in the field of PDE5-I formulations designed to address these needs, with particular reference to a new orodispersible film (ODF) formulation of the PDE5-I, sildenafil. METHODS: Online literature search in PubMed and the Cochrane Library. MAIN OUTCOME MEASURE: To identify English-language publications relevant to the aims of the present review. RESULTS: Improved recognition and management of ED would enable the early diagnosis of underlying and comorbid conditions that contribute to ED, leading to improved patient health and health-related quality of life. To ensure successful outcomes and patient and partner satisfaction, the complex and personal issues that influence the patient's needs and expectations regarding treatment for ED must be considered along with their personal experiences and preferences. Innovative drug delivery systems, including orally disintegrating formulations, have been developed as alternatives to conventional dosage forms with the aim of improving patient convenience and acceptability and enhancing compliance. These alternative formulations include the sildenafil ODF, which is designed to improve acceptance and compliance over conventional solid dosage forms and extend the treatment options for men with ED by offering a convenient and discrete dosage form of a drug with proven efficacy. CONCLUSION: The sildenafil ODF is an example of an innovative dosage formulation for ED that can be used interchangeably with the conventional film-coated formulation to better address the needs and expectations of men with ED. Jannini EA, Droupy S. Needs and Expectations of Patients with Erectile Dysfunction: An Update on Pharmacological Innovations in Phosphodiesterase Type 5 Inhibition with Focus on Sildenafil. Sex Med 2019;7:1-10.