Juliette Cotte

To evaluate the feasibility, safety, and efficacy during the first year of use of the UroActive^® device in males with stress urinary incontinence (SUI). This prospective, multicenter, single-arm, first-in-human study enrolled six male patients with bothersome SUI unresponsive to conservative or surgical treatments. After UroActive^® implantation, follow up was planned for 5 years (post-activation). Study endpoints included successful device activation, revision, and explantation rates. Other endpoints assessed 24 h pad-weight test reduction, pad usage, uroflowmetry, post-void residual urine, patient-reported outcomes (ICIQ-UI SF, EQ-5D, I-QOL, USP). Adverse events were collected throughout the study. All six patients underwent successful implantation and device activation (100%). No explants or revisions were required during the 365 days post-activation. At 365 days post-activation, the pad weight was reduced by ≥50% in all patients and reduced by ≥75% in five (83.3%). Median pad use decreased from 3.7 to 1.0 pads/day. Uroflowmetry remained within acceptable ranges, and post-void residual urine was minimal. Quality of life scores significantly improved across all instruments. Nine device deficiencies were reported, all involving the patient remote control. No unanticipated serious adverse events occurred. In men with SUI, the UroActive^® device demonstrates promising feasibility, safety, and functional outcomes during the 365 days post-activation. Patients experienced substantial symptom improvement and high satisfaction, with no surgical revisions. Larger studies with extended follow-up are needed to confirm these findings and assess long-term device performance.

Background: Curative surgery for prostate cancer is uncommonly offered to patients aged ≥ 75, balancing functional outcomes against survival benefit. The increased adoption of robotic‐assisted radical prostatectomy (RARP) and improved overall life expectancy challenges this paradigm. The objective of this study was to compare functional outcomes between elderly and younger patients following RARP. Methods: Retrospective review of a prospective multicentre database including all RARP patients between October 2016 and December 2023. Patients were divided into cohorts based on age; elderly (≥ 75 years) and younger (< 75 years). Variables included baseline demographics (body mass index [BMI], American Society of Anaesthesiologists [ASA] classification, prostate specific antigen [PSA], and Gleason score), surgical (technique, complications, and length of stay), pathological (histopathology, margins, and PSA) and functional (incontinence, International Prostate Symptom Score [IPSS], International Index of Erectile Function [IIEF‐5], and Expanded Prostate Index Composite [EPIC]) outcomes. Univariate (chi‐square and t ‐tests) and multivariate analysis were performed to compare cohorts against the primary outcome of continence at 1‐year (number of pads/day), with p ‐values < 0.05 considered statistically significant. Results: A total of 397 patients were included (< 75; n = 332, ≥ 75; n = 65). No statistically significant differences were detected in continence at 1‐year in ≥ 75 (< 75; 0.73 [0.59–0.87], ≥ 75; 0.66 [0.37–0.95] mean pads/24 h, p = 0.8), despite significantly lower nerve preservation and bladder‐neck spare rates (< 75; 37.3%, ≥ 75; 21.5%). IIEF‐5 scores were worse in the ≥ 75 group (1.60 ± 1.17 vs. 5.73 ± 6.93 p < 0.001), however there were no significant differences in IPSS. Patient in the elderly cohort had more severe disease (67.7% T3, ≥ 75 vs. 47.3%, < 75, p < 0.05). Rates of positive surgical margins (28.3% vs. 30.8% [≥ 75]) and PSA recurrence (25% vs. 23% [≥ 75]) were similar. Complication rates were low in both groups with no significant differences (3% vs. 6.6% [≥ 75]) and were of lower severity in the ≥ 75 group. Conclusion: RARP in carefully selected elderly patients does not increase risk of urinary incontinence and should not be disregarded in an aging population with higher overall life expectancy.

Purpose: Artificial urinary sphincter (AUS) AMS 800 has been used for many years in women in Europe for the treatment of stress urinary incontinence. However, there is a lack of studies evaluating its impact on women's sexual function. This study aimed to assess impacts of AUS implantation on women's sexual activity.Materials and Methods: This retrospective cohort study included all women seen in clinics between February 2019 and April 2020 for follow‐up after an AMS 800 AUS's implantation. The primary outcome was the modification of sexuality, comparing sexual function before and after implantation of the device using a Likert scale called PGII (Patient Global Impression of Improvement). Our secondary outcomes were the assessment of sexual function (Questionnaries FSFI and ICIQ‐FLUTSsex) and continence (number of pads). Two groups were separately assessed: patients who were sexually active at the time of surgery and those who were not sexually active at the time of surgery.Results: A total of 55 women were included from a single large tertiary center. The median time from the first implantation of AUS was 7.5 years (5.3–14.2). 60% of patients reported no change on sexual activity after the implantation of the AMS 800 AUS. There was a modification of sexual activity in 40% of patients: 20% showing improvement, 20% showing deterioration. In patients having sexual intercourse before AUS implantation, the rate of change in sexuality was higher (61.7%). Regarding postoperative improvement, 91% of women attributed it to the disappearance of coital incontinence. For patients experiencing deterioration in their sexuality, all reported that it was related to the presence of the AUS.Conclusions: This study suggests that AMS 800 AUS implantation can modify the sexuality of women. Talking about the subject of sexuality, assessing sexual function, and educating patients are necessary before the surgery.Trial Registration: The clinical trial was registered at the “Commission Nationale de l'Informatique et des Libertés” (CNIL) under the number 20201020155100.

Background: Prostate cancer (PCa) is a prevalent malignancy in men, with increasing incidence and longer wait times for curative surgery, particularly in public health systems. While the impact of surgical wait time (SWT) on oncological outcomes in PCa remains controversial, its influence on patient‐reported outcomes has not been thoroughly evaluated. Objective: To assess the impact of SWT on both oncological and psychological outcomes in patients undergoing robot‐assisted radical prostatectomy (RARP) for preoperative ISUP grade 2 and 3 PCa. Methods: This retrospective single‐center study included patients who underwent RARP for intermediate risk localized PCa between April 2016 and August 2024. Patients were stratified into two groups based on SWT: < 6 months vs. ≥ 6 months. The primary outcome was recurrence‐free survival (RFS) for all patients. Secondary outcomes included RFS in a high‐risk subgroup defined by pathological features (pT3 stage, seminal vesicle invasion, extracapsular extension, and positive surgical margins), as well as a comparison of functional outcomes between the two groups. Patient‐reported outcomes were evaluated using SF‐36 (mental and physical components) and the Decision Regret Scale (DRS) at 6 weeks, 3 months, 6 months, and 1 year. Statistical analyses included Kaplan–Meier survival estimates, Cox proportional hazard models, and comparative tests with p < 0.05 considered significant. Results: 218 patients have been included. RFS did not significantly differ between groups ( p = 0.98), including among high‐risk patients ( p = 1.00). No significant differences were found in extraprostatic extension, seminal vesicle invasion, positive surgical margins, or ISUP upgrading between groups. Similarly, changes in both SF‐36 physical and mental and DRS scores showed no statistically significant differences at all time points. Conclusion: In this cohort of patients with intermediate‐risk PCa, SWT beyond 6 months did not adversely affect oncological or health‐related quality of life outcomes.

Purpose Artificial urinary sphincters (AUS) are largely used to treat severe urinary incontinence in men, due to reduced outlet resistance. The aim of this animal study was to assess safety of a new electronic artificial urinary sphincter (UroActive™, UroMems, France) on a castrated ram model. Methods RAM study was a non-clinical study, led in a center agreed for animal good laboratory practice studies. In 2019, 20 rams have been implanted with the UroActive device. There were 4 groups of rams, followed respectively 4, 13, 26 and 52 weeks after activation. Similarly to the test animals, 6 rams were operated and left unimplanted (sham group). The animals were implanted, and then let in recovery during 4 weeks before activation. At the activation, a pressure of 120 cmH₂O ± 10 cmH₂O was set. The occlusive cuff was in open position during the day, and in close position during the night, with an opening frequency of 15 min every 1 h and 45 min. At the end of the study, the animals were euthanized and expert pathologists analyzed the urinary system. Results Implantation was successfully performed. Two implanted animals presented a infection at control unit site, which one required a premature euthanasia. In all other animals, no signs of discomfort or pain were noted. No urethral erosion or stenosis was observed. Conclusion This non-clinical study showed an objective analyze of consequences of an artificial urinary sphincter on local tissues in rams. Under the conditions of this safety study, the UroActive™ device is considered suitable for implantation around urethra.

Purpose: The artificial urinary sphincter is the reference treatment for stress urinary incontinence in men, but it remains rarely used in women. This study aimed to compare long‐term device survival between women and men, after the first implantation of an AMS800™ artificial urinary sphincter (Boston Scientific) for the treatment of a non‐neurogenic stress urinary incontinence.Materials and Methods: This retrospective cohort study included all patients with nonneurogenic stress urinary incontinence who underwent surgery in a large‐volume university hospital between 2000 and 2013. The primary outcome was the overall survival of the device, defined as the absence of any repeated surgery (revision or explantation) during follow‐up. Men and women were matched 3:1 according to age and year of implantation. Differences were analyzed using a Cox model accounting for matching and applying time intervals because hazards were not proportional over time. Sensitivity analyzes were performed, excluding firstly a population with a history of radiotherapy and secondly a population with more than one previous surgery for urinary incontinence.Results: A total of 107 women were matched to 316 men. Median follow‐up was 6.0 years (Q1–Q3 1.8–9.4): 7.0 years (Q1–Q3 3.1–10.3) for women and 5.1 years (Q1–Q3 1.3–9.1) for men. During the follow‐up, 56 patients had an explantation of the device: 44 men (13.9%) and 12 women (11.2%), and 113 had a revision: 85 men (26.9%) and 28 women (26.1%). Men have a significantly higher risk of explantation or revision than women between 6 months and 8 years after implantation (hazard ratio 2.12 [1.29–3.48]). Before 6 months and after 8 years, there were no significant differences. Both sensitivity analyses found consistent results.Conclusions: This study suggests that device survival seems better in women after the first 6 months.