The Rigicon ContiClassic® is a new sphincteric device designed to treat male stress urinary incontinence. This study evaluates the surgical outcomes and safety profile of the first 116 patients who received the implant between September 2021 and April 2022. Data were collected from patient information forms completed at the time of the implant and submitted by implanting surgeons, nursing staff in the Operating Room or company representatives present during the surgery. The study analyzed patient demographics, surgical details, and etiology of incontinence. The mean age of patients was 68.3 years +/- 9.65 yrs. Minimum age was 23 and maximum age was 83. The most common reason for implantation was urinary incontinence (58.6%) after radical prostatectomy. The results showed a revision rate of 6.90%, with three cases of fluid loss, four cases of iatrogenic mistaken sizing, and one case of patient dissatisfaction. There were no reported infections. Kaplan-Meier calculation showed survival rate of 93.2% at 12 months. This study shows the early safety outcomes for the Rigicon ContiClassic® sphincter device to be comparable to others presently on the market.
PURPOSE: The artificial urinary sphincter (AUS) is one of the most effective surgical treatments for male urinary incontinence regardless of its severity. Current knowledge comes from high-volume centers, but little is known about the performance of this surgery from community practices. This study aims to report contemporary AUS performance in a nationwide observational study in Colombia. METHODS: Male patients who underwent AUS surgery with AMS 800™ between 2000 and 2020 in more than 17 centers and four cities were identified. Pre, intra, and postoperative characteristics were evaluated, mainly addressing patient reported outcomes measurements in the postoperative period. Retrospective and prospective data collection and descriptive analysis were completed. Kaplan-Meier analysis was used to determine AUS survival rate. RESULTS: Out of an initial 667 cases, a total of 215 patients met inclusion and exclusion criteria and were included. Mean age was 67 ± 9.4 years, and mean follow-up was 6.0 ± 4.4 years with maximum range of 14 years. The etiology of urinary incontinence was prostate cancer surgery in 141 (81%) of the cases. The rest of the cases were related to benign prostatic disease or spinal cord injury. It is noteworthy that out of 115 patients, only 59 (51.3%) reported previous formal pelvic floor rehabilitation. Subjective severity of urinary incontinence determined by a visual analog scale showed a decrease in 4.5 points after sphincter implantation. Sphincter removal was required in 50 (23.2%) cases. The main reasons for implant removal were urethral erosion and infection. The sphincter survival rate at 2, 5, 8, 10, and 14 years was 76%, 70%, 60%, 57%, and 17%, respectively. Of the subjects at the last follow-up with the device still in place, 80.7% defined their urinary condition as "does not cause or causes minor discomfort," and 99% would recommend the device to a friend or relative in the same condition. CONCLUSIONS: This series from a community-based practice shows the lack of adherence to clinical practice guidelines and the lack of standardized data collection. In contrast, this study provides real-world data on explantation and revision rates, allows physicians to inform patients and to have clear metrics for a shared decision-making process before the procedure.
Urinary Incontinence, Stress , Urinary Incontinence , Urinary Sphincter, Artificial , Adolescent , Humans , Male , Prosthesis Implantation/methods , Retrospective Studies , Treatment Outcome , Urinary Incontinence/complications , Urinary Incontinence/surgery , Urinary Incontinence, Stress/surgery , Urinary Sphincter, Artificial/adverse effects
La prostatectomía radical de salvamento viene siendo usada como tratamiento con intención curativa en aquellos pacientes que cursan con recaída bioquímica local luego de radioterapia1. En el Hospital Militar Central se ha realizado rutinariamente este procedimiento desde 1999 para aquellos pacientes que no poseen coomorbilidades, con una expectativa de vida mayor a 10 años y con enfermedad localizada. A diferencia de las publicaciones, en nuestra experiencia las complicaciones intraoperatorias han sido pocas. Por lo cual recomendamos este tipo de procedimiento con fines curativos.
Male , Intraoperative Complications/surgery , Prostatectomy/classification , Prostatectomy/instrumentation
Los desordenes del piso pélvico incluyen la incontinencia urinaria, incontinencia fecal y prolapso de órgano pélvico que son prevalentes en la población femenina y se pueden presentar al mismo tiempo. El manejo de estos desordenes debe ser realizado por Urólogos y Ginecólogos al mismo tiempo y en un mismo momento quirúrgico para mejorar resultados y como beneficio para las pacientes.
Humans , Fecal Incontinence/surgery , Fecal Incontinence/therapy , Urinary Incontinence/surgery , Pelvic Floor/surgery
