Benign Prostatic Hyperplasia (BPH)
Conditions
Keywords
BPH
Brief summary
The study will include an implantation of the iTind device and 4 follow up visits up to 12 months after the implantation.
Detailed description
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.
Interventions
DEVICETIND System
An implant
Sponsors
Medi-Tate Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
iTind
Eligibility
Sex/Gender
MALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Subject signed informed consent prior to the performance of any study procedures. * Male with symptomatic BPH. IPSS symptom severity score above 10. Peak urinary flow of below 12 ml/sec * Prostate volume below 75 ml * Blood CBC and biochemistry up to two weeks before screening demonstrating: Normal values of the PT, PTT and INR tests (anticoagulants should be stopped according to GCP) * Subject that able to complete the study protocol. * Normal Urinalysis and urine culture
Exclusion criteria
* cardiac arrhythmias, cardiac disease including congestive heart failure, uncontrolled diabetes mellitus, significant respiratory disease, or known immunosuppression; * neurogenic bladder and/or sphincter abnormalities due to Parkinson's disease, multiple sclerosis, cerebral vascular accident, diabetes, etc.; * a post void residual (PVR) volume above 250 ml measured by ultrasound or acute urinary retention * compromised renal function (i.e., serum creatinine level above 1.8 mg/dl, or upper tract disease); * confirmed or suspected bladder cancer; * recent (within 3 months) cystolithiasis or hematuria; * urethral strictures, bladder neck contracture, Urinary bladder stones * or other potentially confounding bladder pathology; * an active urinary tract infection. * Enrolled in another treatment trial for any disease within the past 30 days. * previous rectal surgery (other than hemorrhoidectomy) or history of rectal disease if the therapy may potentially cause injury to sites of previous rectal surgery, e.g., if a transrectal probe is used; * previous pelvic irradiation or radical pelvic surgery; * previous prostate surgery, balloon dilatation, stent implantation, laser prostatectomy, hyperthermia, or any other invasive treatment to the prostate * Cancer that is not considered cured, except basal cell or squamous cell carcinoma of the skin (cured defined as no evidence of cancer within the past 5 years). * Subject has an interest in future fertility and is not willing to undergo fertility treatments whatsoever. * Any serious medical condition likely to impede successful completion of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IPSS | 6 months. | 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. |
| SAE | 5-7 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Urinary peak flow | 12 months | Increase of maximal urinary peak flow |
Countries
Belgium, Italy, Spain, Switzerland, United Kingdom
Outcome results
None listed