OPtilume™ BPH Catheter SystEm for Treatment of Men eXperiencing Symptomatic BPH

Launched by UROTRONIC INC. · Aug 16, 2024

Keywords

ClinConnect Summary

The OPtilume™ BPH Catheter System trial, known as the APEX study, is looking at how well this new treatment works for men who have benign prostatic hyperplasia (BPH), a condition that can cause uncomfortable urinary symptoms. This trial is currently recruiting participants and aims to gather real-world experiences from men who receive the Optilume BPH Catheter System as part of their treatment.

To be eligible for this study, participants must be male and have been treated with the Optilume BPH Catheter System according to the provided instructions. However, men who have certain medical conditions, such as an active urinary tract infection or certain types of prostate issues, will not be able to participate. After the procedure, participants will need to follow specific guidelines, such as avoiding sexual intercourse for a month and using effective contraception for a year. This study will help researchers better understand the effectiveness and safety of the Optilume BPH Catheter System for treating BPH symptoms.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients treated with the Optilume BPH Catheter System in accordance with the Instructions for Use (IFU).
• Exclusion Criteria:
• • 1. Unwilling to abstain from sexual intercourse or use a condom for 30 days post-procedure and utilize a highly effective contraceptive for at least 12 months post-procedure
• • 2. Presence of an artificial urinary sphincter, penile prosthesis, or stent(s) in the urethra or prostate
• • 3. Confirmed or suspected malignancy of prostate or bladder.
• • 4. Active urinary tract infection (UTI)
• • 5. Anatomy (e.g., presence of false passage or size of meatus) is not suitable for treatment with the Optilume BPH Catheter System