Multi-center Prospective Study to Assess the Safety and Effectiveness of Medi-Tate i-Temporary Implantable Nitinol Device (iTind) in Subjects With Symptomatic Benign Prostatic Hyperplasia (BPH)

Medi-Tate Ltd.13 sites in 2 countries185 target enrollmentJuly 2015

ConditionsBenign Prostate Hyperplasia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Benign Prostate Hyperplasia
Sponsor: Medi-Tate Ltd.
Enrollment: 185
Locations: 13
Primary Endpoint: Month 3 Results in the IPSS Score in Both Arms.
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The study objectives are to demonstrate the efficacy and safety of the Medi-Tate iTIND as compared to control group (catheter only).

Detailed Description

Medi-Tate i-Temporary Implantable Nitinol Device (iTind) is intended to treat subjects with symptomatic BPH. A total of 150 subjects with symptomatic BPH will be enrolled into this study, according to eligibility criteria. Study duration is 12 months and includes 7 visits: screening, screening follow up, implantation, retrieval, 6 weeks follow up, 3 months follow up and 12 months follow up. iTind Device will be implanted for 5-7 days. Sham will be a routine Foley catheter procedure.

Registry

clinicaltrials.gov

Start Date

July 2015

End Date

October 2018

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Medi-Tate Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subject signed informed consent form (ICF)
•Age 50 and above
•Male with symptomatic BPH.
•IPSS symptom severity score ≥ 10
•Peak urinary flow of \< 12 ml/sec . Meeting the criterion on (2) two separate voiding trials , on a minimum voided volume of at least 125 cc for each voiding trial.
•Prostate volume between 25 ml to 75 ml (assessed by ultrasound)
•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 able to comply with 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
•A post void residual (PVR) volume \> 250 ml measured by ultrasound or acute urinary retention
•Compromised renal function (i.e., serum creatinine level \> 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 colo- 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;

Outcomes

Primary Outcomes

Month 3 Results in the IPSS Score in Both Arms.

Time Frame: 3 months

Month 3 results in the IPSS Score in both arms IPSS - The International Prostate Symptom Score. Scale: minimum 0 (zero), maximum 35. Lower values are better.