RT-310 Safety and Feasibility BPH Study

Safety and Feasibility Study of RT-310 for Treatment of Lower Urinary Tract Symptoms (LUTS) Secondary to Benign Prostatic Hyperplasia (BPH)

NCT07264205•Resurge Therapeutics Inc.

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

50 - 80 years

Sex

MALE

Healthy Volunteers

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
+22 more criteria

Locations (1)

Research Site

Santo Domingo, Dominican Republic

Key Dates

Start Date

March 13, 2025

Primary Completion Date

March 1, 2026

Completion Date

June 1, 2026

Last Updated

March 20, 2026

Enrollment

ESTIMATED participants

Conditions

BPH (Benign Prostatic Hyperplasia)

Interventions

RT-310

COMBINATION_PRODUCT

RT-310 Dose Escalation BPH Study

NCT06136819

BPH (Benign Prostatic Hyperplasia)Lower Urinary Tract Symptoms

View study

ACTIVE_NOT_RECRUITINGNA

Safety and Effectiveness Study of the Zenflow Spring System

NCT04987138

BPH (Benign Prostatic Hyperplasia)Lower Urinary Tract Symptoms (LUTS)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 20, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

RT-310 Safety and Feasibility BPH Study

Inclusion Criteria

Exclusion Criteria

RT-310 Dose Escalation BPH Study

Safety and Effectiveness Study of the Zenflow Spring System

Tadalafil 5 mg on Storage Lower Urinary Tract Symptoms After Anatomical Endoscopic Enucleation of the Prostate