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

Medi-Tate

Status: Completed

Conditions: Benign Prostate Hyperplasia; Bladder Neck Obstruction

Treatments: Device: Insertion of Temporary Implantable Nitinol Device (TIND)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01436877

MT-01

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: Male

Ages: 50 to 95 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

device

Experimental group

Description:

Insertion of Temporary Implantable Nitinol Device (TIND)

Treatment:

Device: Insertion of Temporary Implantable Nitinol Device (TIND)