Study for a Magnetic Endourethral Sphincter Against Stress Urinary Incontinence (RELIEF-2)
Urinary Incontinence
About this trial
This is an interventional treatment trial for Urinary Incontinence
Eligibility Criteria
Inclusion Criteria:
- Male patients aged from 45 to 85 years-old suffering from secondary Stress Urinary Incontinence (SUI) to prostate surgery in which medical and rehabilitative treatment have failed;
- women patients aged from 45 to 85 years-old suffering from SUI in which medical, rehabilitative and surgical treatment have failed;
- sterile urine culture;
- urodynamic test with evidence of sphincter dysfunction, Valsalva Leak Point Pressure (VLPP) < 60 cm H2O (water) and exclusion of detrusor over-activity;
- flexible cystoscopy demonstrating sphincter dysfunction and excluding stenosis of the urethra or vesicourethral anastomosis.
Exclusion Criteria:
- No-autonomous patients;
- People where the use of magnetic field is not suggested (i.e. patients with pacemaker).
- Patients with urinary infections;
- Patients with intolerances to the materials included in the sphincter or to expected drug subministration.
- Patients already participating a clinical study within the last 30 days.
Sites / Locations
- Casa di Cura San CamilloRecruiting
- Azienda Ospedaliero Universitaria Pisana UO UrologiaRecruiting
- Policlinico Universitario Campus Bio-Medico UOC UrologiaRecruiting
Arms of the Study
Arm 1
Experimental
Main group
A second no-random open interventional pilot study sponsored by Relief srl. The primary objectives of the study were to assess the safety and reproducibility of the implantation of the magnetic endo-urethral sphincter, if the procedure was well tolerated by the patients, and if possible irritation symptoms due to the device presence emerged in patients with severe stress urinary incontinence where standard medical treatments failed. The device will be implanted by endoscopic procedure by a standard resectoscope. Up to 20 patients of both gender affected by severe stress urinary incontinence will be involved in the study by means of prospective enrollment.