Clinical trial NCT02145208: Study to Assess the Efficacy of Medi-Tate iTind Device
Official title: One-arm, Multi-center, International Prospective Study to Assess the Efficacy of Medi-Tate Temporary Implantable Nitinol Device (iTindTM) in Subjects With Benign Prostatic Hypertrophy (BPH).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Benign Prostatic Hyperplasia (BPH)
Keywords: BPH
Lead sponsor: Medi-Tate Ltd.
Sponsor class: INDUSTRY
First posted: 2014-05-22
Enrollment: 81
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: iTind
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: IPSS
timeFrame: 6 months.
measure: SAE
timeFrame: 5-7 days
Secondary outcomes:
measure: Urinary peak flow
timeFrame: 12 months
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Edith Cavell
city: Gent
country: Belgium
facility: Gent Hospital University
city: Turin
country: Italy
facility: San Orbessano
city: Madrid
country: Spain
facility: La Paz Hospital
city: Frauenfeld
country: Switzerland
facility: Kantonsspital Frauenfeld
city: Lausanne
country: Switzerland
facility: Lausanne University Hospital
city: London
country: United Kingdom
facility: Frimley Health NHS
city: London
country: United Kingdom
facility: University College Hospital
Study officials:
affiliation: Edith cavell clinic, Belgium
name: Claude Schulman, MD
role: PRINCIPAL_INVESTIGATOR
References: