Rezum I Pilot Study for Benign Prostatic Hyperplasia

Evaluate the safety and efficacy of the Rezum System for the treatment of BPH

Prospective, non-randomized clinical trial of subjects with benign prostatic hyperplasia. The objective of the study are to 1) determine the safety and efficacy of the BPH Rezum System and assess its effect on urinary symptoms secondary to benign prostatic hyperplasia (BPH), and 2) further document the safety and post-operative effects of the Rezum System in the treatment of obstructive BPH.

Eligibility Criteria:
Inclusion Criteria:

1. Male subjects \> 45 years of age who have symptomatic / obstructive symptoms secondary to BPH requiring invasive intervention.
2. IPSS score of ≥ 15.
3. Qmax: Peak flow rate ≤ 15 ml/sec.
4. Post-void residual (PVR) \< 300 ml.
5. Prostate transverse diameter \> 30 mm.
6. Prostate volume between 20 to 120 gm.
7. Voided volume ≥ 125 mL
8. Subject able to complete the study protocol in the opinion of the investigator.
9. Life expectancy of at least one year.

Exclusion Criteria:

1. History of any illness or surgery that may confound the results of the study or have risk to subject.
2. Presence of a penile implant.
3. Any prior minimally invasive intervention (e.g. TUNA, Balloon, Microwave) or surgical intervention for the symptoms of BPH.
4. Currently enrolled or has been enrolled in another trial in the past 30 days.
5. Confirmed or suspected malignancy of prostate or bladder
6. Previous rectal surgery (other than hemorrhoidectomy) or history of rectal disease.
7. Previous pelvic irradiation or radical pelvic surgery.
8. 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)
9. Neurogenic bladder or sphincter abnormalities.
10. Urethral strictures, bladder neck contracture or muscle spasms.
11. Bleeding disorder or is currently on coumadin. (Note that use of anti-platelet medication is not an exclusion criteria.)
12. Subjects interested in maintaining fertility.
13. Use of concomitant medications to include the following:

    1. Use of, antihistamines, and antispasmodics within 1 week of treatment unless there is documented evidence stable dosing for last 6 months (no dose changes).
    2. Use of alpha blockers, androgens, or gonadotropin-releasing hormonal analogs within 2 weeks of treatment.
    3. Use of 5-alpha reductase inhibitor within the last 6 months
    4. Use of antidepressants, anticholinergics, anticonvulsants, and beta blockers unless there is documented evidence of stable dosing
14. Subject is unable or unwilling to go through the "washout" period prior to treatment.
15. Subject has chronic urinary retention.
16. Post-void residual volume \> 300 ml.
17. Significant urge incontinence.
18. Poor detrusor muscle function.
19. Neurological disorders which might affect bladder or sphincter function.
20. Urinary sphincter abnormalities.
21. Bladder stones.
22. Evidence of bacterial prostatitis or symptoms of epididymitis
23. Renal impairment or serum creatinine \> 2.0 mg/dl
24. In the physician's opinion, subject cannot tolerate a cystoscopy procedure well.
25. Unable or unwilling to sign the Informed Consent Form (ICF) and/or comply with all the required follow-up requirements.
26. Any cognitive disorder that interferes with or precludes direct and accurate communication with the study investigator regarding the study.
27. Peripheral arterial disease with intermittent claudication or Leriches Syndrome (i.e., claudication of the buttocks or perineum).
28. Biopsy of prostate within 30 days of procedure.