The study will include an implantation of the iTind device and 4 follow up visits up to 12 months after the implantation.
After screening , eligible patients will undergo an an implantation procedure (operative), using the iTind device. Implantation will be performed according to the Instructions For Use. Between the 5th - 7th days, the iTind will be retrieved through a rigid cystoscope sheath, under direct vision. Before retrieval the subject will be asked for subjective discomfort evaluation and level of urgency in the past days after device insertion, about any AE and then the device will be retrieved. The next visits will be at 4 weeks (post device retrieval), 3 months, 6 months, and 12 months post implantation with an optional extension of follow up period (up to 36 months). In the visits the following will be assessed: Uroflow and residual urine volume tests, AE recording, IPSS, and Questions on sex performing capability and ejaculation filled out by the subjects, in the local languages.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
81
An implant
Edith Cavell
Brussels, Belgium
Gent Hospital University
Ghent, Belgium
San Orbessano
Turin, Italy
La Paz Hospital
Madrid, Spain
IPSS
Change of IPSS score by at least 3 points, in at least 75 % of the subjects, at 6 months follow-up. IPSS - The International Prostate Symptom Score. Scale: minimum 0 (zero), maximum 35. Lower values are better.
Time frame: 6 months.
SAE
The incidence of unexpected serious adverse events related to Meditate iTind and/or implantation/retrieval procedures, as determined by the investigator and the study medical monitor.
Time frame: 5-7 days
Urinary peak flow
Increase of maximal urinary peak flow
Time frame: 12 months
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Kantonsspital Frauenfeld
Frauenfeld, Switzerland
Lausanne University Hospital
Lausanne, Switzerland
Frimley Health NHS
London, United Kingdom
University College Hospital
London, United Kingdom