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.
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.