Urologia internationalis · 2016
Long-Term Outcomes of the Implant of a Periurethral Constrictor for Stress Urinary Incontinence Following Radical Prostatectomy.
Клиническое исследованиеСтатьяНазвание и аннотация: Перевод пока не подготовлен
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Favro Michele, Billia Michele, Volpe Alessandro, Zacchero Monica, Terrone Carlo
Аннотация
OBJECTIVES: To assess morbidity, effectiveness and quality of life (QoL) of implant of Silimed periurethral constrictor (PC) in a consecutive series of patients who had stress urinary incontinence following radical prostatectomy.
MATERIAL AND METHODS: A prospective non-randomized study designed on patients who underwent implant of Silimed PC. Primary end point was postoperative morbidity and secondary end points were effectiveness of implant and QoL. We performed a sub-analysis of men who received previous radiation and we compared the subpopulation with radiation-naïve patients.
RESULTS: Nineteen patients (31.6%) received pelvic radiation therapy prior implant. All procedures were completed successfully with median operative time of 55 (IQR 50-62.5) min. We recorded 47 (78.3%) postoperative complications in 30 men. Twenty-three men (38.3%) developed urethral erosion at median follow-up of 27.5 (IQR 21-35) months, and 1 man (1.9%) had rectourethral fistula at 2 months. Risk of urethral erosion increased significantly among patients who received radiation (63.1 vs. 26.8%; p < 0.001). In 12 cases (20%), we recorded malfunctioning of the reservoir requiring replacement.
CONCLUSION: The implant of Silimed device is not safe due to a high risk of urethral erosion. Careful patient selection and detailed counseling are mandatory when considering the implant of PC in adult patients.
MATERIAL AND METHODS: A prospective non-randomized study designed on patients who underwent implant of Silimed PC. Primary end point was postoperative morbidity and secondary end points were effectiveness of implant and QoL. We performed a sub-analysis of men who received previous radiation and we compared the subpopulation with radiation-naïve patients.
RESULTS: Nineteen patients (31.6%) received pelvic radiation therapy prior implant. All procedures were completed successfully with median operative time of 55 (IQR 50-62.5) min. We recorded 47 (78.3%) postoperative complications in 30 men. Twenty-three men (38.3%) developed urethral erosion at median follow-up of 27.5 (IQR 21-35) months, and 1 man (1.9%) had rectourethral fistula at 2 months. Risk of urethral erosion increased significantly among patients who received radiation (63.1 vs. 26.8%; p < 0.001). In 12 cases (20%), we recorded malfunctioning of the reservoir requiring replacement.
CONCLUSION: The implant of Silimed device is not safe due to a high risk of urethral erosion. Careful patient selection and detailed counseling are mandatory when considering the implant of PC in adult patients.