Single center pilot study for the application of a magnetic endourethral sphincter for the treatment of stress urinary incontinence and secondary to prostate surgery
Project objectivesTo evaluate the applicability, safety, acceptability, usability, and efficacy of a magnetic endourethral sphincter in patients with primary or secondary stress urinary incontinence. Primary objective of the study: The primary objective of the study is to establish whether the system can be implanted in a safe and reproducible manner, whether it is well tolerated by the patient from the point of view of the positioning procedure and any irritative symptoms due to its presence. Secondary objective of the study: The secondary objective of the study is to evaluate the usability and efficacy of the magnetic endourethral sphincter by the patient, and also the feasibility of treating stress incontinence with endoscopic sphincter application. |
Start and end date |
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2019 - 2020 |
Project Manager |
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Prof R. Papalia |
Coordinating institution of the project |
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Università Campus Bio-Medico di Roma |