NCT06312722 Safety and Effectiveness of the Optilume® BPH Catheter System in a Post-Market Study
| NCT ID | NCT06312722 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Urotronic Inc. |
| Condition | Benign Prostatic Hyperplasia |
| Study Type | INTERVENTIONAL |
| Enrollment | 92 participants |
| Start Date | 2024-02-07 |
| Primary Completion | 2031-02-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 92 participants in total. It began in 2024-02-07 with a primary completion date of 2031-02-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to verify the continued safety and effectiveness for the Optilume BPH Catheter System.
Eligibility Criteria
Inclusion Criteria: 1. Male subject ≥ 50 years old 2. Diagnosed with lower urinary tract symptoms (LUTS) secondary to obstructive benign prostatic hyperplasia (BPH) 3. Able to be treated with the Optilume BPH Catheter System in accordance with the Instructions for Use 4. Prostate volume \< 80 g with a prostatic urethral length between 32-55 mm as determined by trans-rectal ultrasound (TRUS) 5. International Prostate Symptom Score (IPSS) ≥ 13 6. Peak urinary flow rate (Qmax) 5-15 mL/sec with minimum voided volume of 125 mL 7. Willing to provide informed consent and comply with protocol required follow-up 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. Any prior minimally invasive intervention (e.g., TUNA, Balloon, Microwave, Rezūm, UroLift) or surgical intervention of the prostate 4. Confirmed or suspected malignancy of prostate or bladder. Negative prostate biopsy required within 6 months of enrollment if PSA at baseline is \> 4 ng/mL with free PSA \< 25%. 5. Active urinary tract infection (UTI) confirmed by culture 6. Neurogenic bladder or sphincter abnormalities or neurological disorders that might affect bladder or sphincter function 7. History of overt urinary incontinence requiring the use of pads 8. Previous or current diagnosis of urethral strictures, bladder neck contracture or detrusor muscle spasms 9. Current post-void residual volume (PVR) \> 300 mL or catheter dependent bladder drainage 10. Known poor detrusor muscle function (e.g., Qmax \< 5 mL/sec) 11. Active bladder, ureteral, or urethral stones or stone passage within the last 3 months 12. Current poorly controlled diabetes (i.e., hemoglobin A1c ≥ 8%) 13. Anatomy (e.g., presence of false passage or size of meatus) is not suitable for treatment with the Optilume BPH Catheter System 14. Obstructive median lobe in the opinion of the investigator
Contact & Investigator
Steven Kaplan, MD, FACS
PRINCIPAL INVESTIGATOR
Professor of Urology
Frequently Asked Questions
Who can join the NCT06312722 clinical trial?
This trial is open to male participants only, aged 50 Years or older, studying Benign Prostatic Hyperplasia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06312722 currently recruiting?
Yes, NCT06312722 is actively recruiting participants. Contact the research team at kpalm@laborie.com for enrollment information.
Where is the NCT06312722 trial being conducted?
This trial is being conducted at Little Rock, United States, Tampa, United States, Shreveport, United States, Las Vegas, United States and 3 additional locations.
Who is sponsoring the NCT06312722 clinical trial?
NCT06312722 is sponsored by Urotronic Inc.. The principal investigator is Steven Kaplan, MD, FACS at Professor of Urology. The trial plans to enroll 92 participants.