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

Not Applicable

Completed

• Conditions: Benign Prostate Hyperplasia; Bladder Neck Obstruction
• Interventions: Device: Insertion of Temporary Implantable Nitinol Device (TIND)

• Registration Number: NCT01436877
• Lead Sponsor: Medi-Tate Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-09-14
• Study First Submitted QC: 2011-09-18
• Study First Posted: 2011-09-20
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-19
• Last Update Posted: 2018-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
device	Insertion of Temporary Implantable Nitinol Device (TIND)	Insertion of Temporary Implantable Nitinol Device (TIND)

Primary Outcome Measures

Name	Time	Method
Device related and unanticipated SAE	At 3 months	Device related and unanticipated SAEs will be followed. No such SAEs are expected.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Meir Medical center; 🇮🇱 Kfar Saba, Israel