Evaluating the Optilume BPH Catheter System for treating enlarged prostate

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to assess the ongoing safety and effectiveness of the Optilume BPH Catheter System in men suffering from benign prostatic hyperplasia (BPH). Participants will be monitored for improvements in urinary symptoms over a 12-month period, with specific attention to adverse events related to the device. The study will also evaluate changes in semen characteristics in a subset of participants. The trial includes a comprehensive follow-up to ensure thorough data collection and analysis.

Why it matters

Who can join: the full rules

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

Where it's running

• Arkansas Urology
  Little Rock, Arkansas, United States Recruiting
• Florida Urology Partners, LLP
  Tampa, Florida, United States Recruiting
• Ochsner LSU Health Shreveport - Regional Urology
  Shreveport, Louisiana, United States Recruiting
• Sheldon Freedman MD, Ltd
  Las Vegas, Nevada, United States Recruiting
• Oregon Urology Institute
  Springfield, Oregon, United States Recruiting
• Midtown Urology Associates
  Austin, Texas, United States Recruiting

Study contacts

• Principal investigator: Steven Kaplan, MD, FACS — Professor of Urology
• Study coordinator: Kaitlyn Palm
• Email: kpalm@laborie.com
• Phone: 612-816-0068

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Water Vapor Therapy vs Ejaculation-Sparing Enucleation for Benign Prostatic Hyperplasia

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.