Rezum FIM Optimization Study

Subjects with BPH symptoms were treated with the Rezum device with a range of thermal energies (as measured by calorie output) to optimize the setting for maximum lesion size with minimal intra and post-procedure discomfort. Lesion size and ablated tissue resorption rate was followed post-procedure at 1 week, 1 month, 3 months, and 6 months.

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) < 300 ml.
• Prostate transverse diameter > 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 Principal Investigator.
• Subject must be willing to undergo the procedure without anesthesia.

Exclusion criteria

• History of any illness or surgery that in the opinion of the Principal Investigator may confound the results of the study.
• Presence of a penile implant.
• Any prior minimally invasive intervention (e.g. TUNA,Laser, Microwave) or surgical intervention for the symptoms of BPH.
• Currently enrolled in another clinical trial.
• 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 catheterization specimen).
• Neurogenic bladder or sphincter abnormalities.
• Urethral strictures, bladder neck contracture or muscle spasms.
• Bleeding disorder (note that use of anti-platelet medication is not an exclusion criterion).
• Subjects who are interested in maintaining fertility.
• Use of concomitant (or recent) medications to include the following:

• Beta blockers, antihistamines, anticonvulsants, and antispasmodics within 1 week of treatment, unless there is documented evidence of stable dosing for last 6 months (e.g., no dose changes).
• Alpha blockers, antidepressants, anticholinergics, androgens, or gonadotropin-releasing hormonal analogs within 2 weeks of treatment.
• 5-alpha reductase inhibitor within the last 6 months
• Subject is unable or unwilling to go through a "washout" period for the above medications prior to treatment.
• Subject has chronic urinary retention.
• Significant urge incontinence.
• Poor detrusor muscle function.
• Neurological disorders which might affect bladder or sphincter function.
• Bladder stones.
• Renal impairment.
• In the opinion of the Principal Investigator, subject will not be able to adequately tolerate a rigid cystoscopy-type procedure.
• 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 a subject from directly and accurately communicating with the Principal Investigator regarding the study.
• Peripheral arterial disease with intermittent claudication or Leriches Syndrome (i.e., claudication of the buttocks or perineum).
• Biopsy of the prostate within 30 days prior to the Rezūm procedure.