Rezum I Pilot Study for Benign Prostatic Hyperplasia

Inclusion Criteria

• Male subjects > 45 years of age who have symptomatic / obstructive symptoms secondary to BPH requiring invasive intervention.
• IPSS score of ≥ 15.
• Qmax: Peak flow rate ≤ 15 ml/sec.
• Post-void residual (PVR) 30 mm.
• Prostate volume between 20 to 120 gm.
• Voided volume ≥ 125 mL
• Subject able to complete the study protocol in the opinion of the investigator.
• Life expectancy of at least one year.

Exclusion Criteria

• History of any illness or surgery that may confound the results of the study or have risk to subject.
• Presence of a penile implant.
• Any prior minimally invasive intervention (e.g. TUNA, Balloon, Microwave) or surgical intervention for the symptoms of BPH.
• Currently enrolled or has been enrolled in another trial in the past 30 days.
• Confirmed or suspected malignancy of prostate or bladder
• Previous rectal surgery (other than hemorrhoidectomy) or history of rectal disease.
• Previous pelvic irradiation or radical pelvic surgery.
• Documented active urinary tract infection by culture or bacterial prostatitis within last year documented by culture (UTI is defined as >100,000 colonies per ml urine from midstream clean catch or catherization specimen)
• Neurogenic bladder or sphincter abnormalities.
• Urethral strictures, bladder neck contracture or muscle spasms.
• Bleeding disorder or is currently on coumadin. (Note that use of anti-platelet medication is not an exclusion criteria.)
• Subjects interested in maintaining fertility.
• Use of concomitant medications to include the following:
• Use of, antihistamines, and antispasmodics within 1 week of treatment unless there is documented evidence stable dosing for last 6 months (no dose changes).
• Use of alpha blockers, androgens, or gonadotropin-releasing hormonal analogs within 2 weeks of treatment.
• Use of 5-alpha reductase inhibitor within the last 6 months
• Use of antidepressants, anticholinergics, anticonvulsants, and beta blockers unless there is documented evidence of stable dosing
• Subject is unable or unwilling to go through the "washout" period prior to treatment.
• Subject has chronic urinary retention.
• Post-void residual volume > 300 ml.
• Significant urge incontinence.
• Poor detrusor muscle function.
• Neurological disorders which might affect bladder or sphincter function.
• Urinary sphincter abnormalities.
• Bladder stones.
• Evidence of bacterial prostatitis or symptoms of epididymitis
• Renal impairment or serum creatinine > 2.0 mg/dl
• In the physician's opinion, subject cannot tolerate a cystoscopy procedure well.
• Unable or unwilling to sign the Informed Consent Form (ICF) and/or comply with all the required follow-up requirements.
• Any cognitive disorder that interferes with or precludes direct and accurate communication with the study investigator regarding the study.
• Peripheral arterial disease with intermittent claudication or Leriches Syndrome (i.e., claudication of the buttocks or perineum).
• Biopsy of prostate within 30 days of procedure.