Study to Assess the Efficacy of Medi-Tate iTind Device

Medi-Tate

Status

Completed

Conditions

Benign Prostatic Hyperplasia (BPH)

Treatments

Device: TIND System

Study type

Interventional

Funder types

Industry

Identifiers

NCT02145208

MT-02

Details and patient eligibility

About

The study will include an implantation of the iTind device and 4 follow up visits up to 12 months after the implantation.

Full 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.

Enrollment

81 patients

Sex

Male

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.