RT-310, is intended to deliver drug locally to the prostate gland for the management of prostate disease, while minimizing systemic exposure and its associated side-effects. The objectives of the study are to assess whether RT-310 is safe and feasible for the participant population.
Who can participate
Age range50 Years – 80 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male gender
* Diagnosis of symptomatic BPH
* Age ≥ 50 years up to 80 years
* International Prostate Symptom Score (IPSS) ≥ 13
* Peak urine flow rate ≥ 5mL/sec and ≤ 12 ml/sec, voided volume ≥ 100 ml
* Prostate volume 30 to 80 cc per ultrasound
* Post void residual (PVR) urine ≤ 250 ml
* Inadequate response and/or refusal of medical therapy for LUTS
Exclusion Criteria:
* Unable or unwilling to sign the informed consent form (ICF) and/or comply with the study follow-up requirements
* Current urinary retention requiring catheterization
* Unwilling to abstain from unprotected sexual intercourse for 3 months
* Unwilling to abstain from any child conceiving activities for 6 months
* Have an obstructive or protruding median lobe of the prostate
* High bladder neck determined by Investigator
* Active urinary tract infection at time of treatment
* 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
* Biopsy of the prostate within the past 6 weeks
* Life expectancy estimated to be less than 1 year
* History of prostate or bladder cancer, confirmed or suspected malignancy of prostate or bladder
* History of compromised renal function or upper urinary tract disease
* Known coagulopat…