RT-310 Dose Escalation BPH Study

Exclusion Criteria

• •Current urinary retention or at significant risk of urinary retention after drug washout
• •Have an obstructive or protruding median lobe of the prostate
• •Previous BPH surgical procedure or implants, urethral stricture, Any prior minimally invasive intervention (e.g. TUNA, Balloon, Microwave, Rezūm, UroLift) or surgical intervention of the prostate
• •Previous pelvic surgery or irradiation
• •History of neurogenic or atonic bladder
• •Stress urinary incontinence, mixed or urge incontinence
• •History of prostate or bladder cancer, confirmed or suspected malignancy of prostate or bladder
• •History of compromised renal function or upper urinary tract disease
• •Other co-morbidities that could impact the study results such as: severe cardiac arrhythmias uncontrolled by medications or pacemaker; congestive heart failure New York Heart Association (NYHA) III or IV; History of uncontrolled diabetes mellitus; significant respiratory disease in which hospitalization may be required
• •Known immunosuppression (i.e. AIDS, post-transplant, undergoing chemotherapy)
• •No more than two documented active urinary tract infections (UTI) 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)
• •Current gross hematuria and/or visible hematuria with participant urine sample without known contributing factor
• •Presence of a penile implant or stent(s) in the urethra or prostate
• •PSA \> 10 ng/ml unless prostate cancer is ruled out by biopsy. If PSA is \> 4 ng/ml and ≤ 10 ng/ml, prostate cancer must be ruled out to the satisfaction of the investigator via additional tests including digital rectal exam (DRE) and/or biopsy
• •Sensitivity to RT-310
• •Unable to undergo magnetic resonance imaging (MRI) such as presence of cardiac pacemaker or implanted cardiac defibrillator
• •Parkinson's disease or other neurologic disease that may impact bladder function such as stroke, TIA, multiple sclerosis