To Evaluate the Safety and Performance of the ProstaCare Water Electrolysis System in Relieving Symptoms of BPH.

ProstaCare

Status

Terminated

Conditions

Benign Prostatic Hyperplasia

Treatments

Device: prostaFix System

Study type

Interventional

Funder types

Industry

Identifiers

NCT02962674

CIP# PC 1.0

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and performance of the ProstaCare System in relieving symptoms of urinary outflow obstruction secondary to benign prostatic hyperplasia.

Enrollment

49 patients

Sex

Male

Ages

45+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

45 years of age or older with a diagnosis of BPH,
International Prostate Symptom Score (IPSS) of 12 or greater,
Prostate volume between 25 cm3 and 55 cm3,
Uroflow with peak flow rate (Qmax) no greater than 13 ml/sec with a corresponding voided volume of at least 100 ml and a post void residual (PVR) of 250 ml or less.
Prostate length, width and height must be at least 3.2 cm, 3.5 cm and 2.5 cm, respectively

Key Exclusion Criteria:

Obstruction due to an enlarged middle lobe, central gland or significant transverse asymmetry,
Subjects on 5 alpha reductase inhibitors (5-ARI) (inclusion only if washed out prior to treatment),
Subjects on alpha blockers (inclusion only if washed-out before treatment),
Active urinary tract infection at time of treatment,
Interest in maintaining fertility,
Past history of urologic surgery or minimally invasive treatment for BPH,
History of or current medical conditions contraindicating elective urological procedures.