Assessing Safety & Efficacy of MediTate Temporary Implant in Subjects With Benign Prostate Hyperplasia

One-arm Feasibility and Prospective Pivotal Study to Assess the Safety and Efficacy of MediTate Temporary Implantable Nitinol Device (TIND) in Subjects Presenting Bladder Outlet Obstruction Secondary to BPH

The purpose of this study is to assess the safety and efficacy of MediTate Temporary Implantable Nitinol Device (TIND) used to alleviate symptoms of Bladder Outlet Obstruction (BOO) secondary to Benign Prostate Hyperplasia (BPH).The TIND is inserted in the bladder neck and prostatic urethra under local anesthesia for few days and taken out some 5 days later in the doctors office.

Study Overview

• Status: Completed
• Conditions: Benign Prostate Hyperplasia; Bladder Neck Obstruction
• Intervention / Treatment: Device: Insertion of Temporary Implantable Nitinol Device (TIND)

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Kfar Saba, Israel
    • Meir Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

Main IC:

• Subject signed informed consent prior to the performance of any study procedures.
• Male with BPH, who are at least 50 years of age and that were diagnosed with BOO.
• IPSS symptom severity score ≥ 10.
• Peak urinary flow of < 12 ml/sec
• No pathology found with kidney US
• Prostatic urethra length < 30 mm
• Prostate volume < 35 cc
• Normal Urinalysis and urine culture.

Exclusion Criteria:

Main EC:

• Any prior prostate treatment
• Suspected or proved carcinoma of prostate
• Urethral stricture
• Urinary bladder stones
• Serum prostate specific antigen level > 4 ng/ml (unless proved to be carcinoma free by biopsy).
• Active urinary tract infection as determined by positive culture, bacterial prostatitis within the past year documented by positive culture.
• Median prostatic lobe enlargement or a prominent obstructing "ball valve" prostatic lobe.
• 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

Intraoperative EC:

• Irregular findings by the implanting physician during the implantation procedure by the cystoscopy that to the best of the implanting physician are exerting non compliance with the exclusion or inclusion criteria and that were not noticed previously during screening

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: device; Insertion of Temporary Implantable Nitinol Device (TIND)	Device: Insertion of Temporary Implantable Nitinol Device (TIND); Subjects will be inserted with the Temporary Implantable Nitinol Device (TIND) to the bladder neck and urethral prostate for 5 days and thereafter the TIND will be withdrawn in the doctor office.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device related and unanticipated SAE	Device related and unanticipated SAEs will be followed. No such SAEs are expected.	At 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduce at least 3 point in the International Prostate Symptom Score (IPSS) in at least 75% of subjects	Questionnaire of IPSS will be done in each visit.	At 3 months
Increase of maximal urinary peak flow by at least 3 ml/s in at least 75% of subjects	Maximal uroflow will be measured in each visit	At 3 months

Collaborators and Investigators

• Sponsor: Medi-Tate Ltd.
• Investigators: Principal Investigator: Roy Farfara, MD, Bnai Zion Medical Center, Haifa, Israel

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: September 14, 2011
• First Submitted That Met QC Criteria: September 18, 2011
• First Posted (Estimate): September 20, 2011

Study Record Updates

• Last Update Posted (Actual): December 21, 2018
• Last Update Submitted That Met QC Criteria: December 19, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: BPH; bladder neck obstruction; Bladder neck obstruction secondary to BPH
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Urinary Bladder Diseases; Prostatic Diseases; Urethral Diseases; Urethral Obstruction; Prostatic Hyperplasia; Hyperplasia; Urinary Bladder Neck Obstruction
• Other Study ID Numbers: MT-01