Safety and Efficacy Study for the Treatment of BPH (Enlarged Prostate)

Inclusion Criteria

• Male subjects > 50 years of age who have symptomatic BPH.
• International Prostate Symptom Score (IPSS) score ≥ 13.
• Peak urinary flow rate (Qmax): ≥ 5ml/sec to ≤ 15 ml/sec with minimum voided volume of ≥ 125 ml.
• Post-void residual (PVR) ≤250 ml.
• Prostate volume > 30 and ≤ 80 gm.

Exclusion Criteria

• History of clinically significant congestive heart failure (i.e. NYHA Class III and IV).
• History of diabetes not controlled by a stable dose of medication over the past three months. Patients with a Hemoglobin A1c that is 10 ng/ml unless prostate cancer is ruled out by biopsy. If PSA is > 2.5 ng/ml and ≤ 10 ng/ml with free PSA 250 ml.
• Diagnosed or suspected bleeding disorder, or coagulopathies.
• Use of antiplatelet or anticoagulant medication except low dose aspirin (≤81 mg/day) within 10 days prior to treatment.
• Visible hematuria with subject urine sample without a known contributing factor.
• Subject interested in maintaining fertility.
• Use of beta-blockers, anticonvulsants, and antispasmodics where the dose is not stable. (Stable dose is defined as having the same medication and dose in the last six months).
• At the time of baseline assessment, in the absence of a qualifying exception, subjects who are using or have used the following medications, and are unable or unwilling to discontinue using these medications for the prescribed washout period:
• Use of antihistamines within 1 week of treatment unless there is documented evidence of stable dosing for last 6 months (no dose changes).
• Use of the alpha blockers for BPH and anticholinergics or cholinergics (except for topical anti cholinergic eye drops), or within 4 weeks of baseline assessment.
• Use of Type II, 5-alpha reductase inhibitor (e.g., finasteride (Proscar, Propecia) within 3 months of baseline assessment.
• Use of a dual 5-alpha reductase inhibitor (e.g., dutasteride (Avodart)) within 6 months of baseline assessment.
• Use of estrogen, drug-producing androgen suppression, or anabolic steroids within 3 months of baseline assessment.
• Use of daily dose PD5 Inhibitors (e.g.Viagra, Levitra or Cialis) within 4 weeks of baseline assessment.
• Subjects who have had an incidence of spontaneous urinary retention either treated with indwelling transurethral catheter or suprapubic catheter six months prior to baseline. A provoked episode now resolved is still admissible.
• Compromised renal function defined as serum creatinine > 2.0 mg/dl.
• Inability to provide a legally effective Informed Consent Form (ICF) and/or comply with all the required follow-up requirements.
• Any cognitive or psychiatric condition that interferes with or precludes direct and accurate communication with the study investigator regarding the study or affect the ability to complete the study quality of life questionnaires.