Clinical trial NCT01436877: Assessing Safety & Efficacy of MediTate Temporary Implant in Subjects With Benign Prostate Hyperplasia
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bladder Neck Obstruction
Benign Prostate Hyperplasia
Keywords: BPH
bladder neck obstruction
Bladder neck obstruction secondary to BPH
Lead sponsor: Medi-Tate Ltd.
Sponsor class: INDUSTRY
First posted: 2011-09-20
Enrollment: 32
Sex: MALE
Minimum age (years): 50
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Device related and unanticipated SAE
timeFrame: At 3 months
Secondary outcomes:
measure: Reduce at least 3 point in the International Prostate Symptom Score (IPSS) in at least 75% of subjects
timeFrame: At 3 months
measure: Increase of maximal urinary peak flow by at least 3 ml/s in at least 75% of subjects
timeFrame: At 3 months
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir Medical center
Study officials:
affiliation: Bnai Zion Medical Center, Haifa, Israel
name: Roy Farfara, MD
role: PRINCIPAL_INVESTIGATOR
References: