Evaluating the Optilume BPH Catheter System for treating enlarged prostate

Safety and Effectiveness of the Optilume® BPH Catheter System in a Post-Market Study

This study is testing the Optilume BPH Catheter System to see if it can help men with an enlarged prostate feel better and improve their urinary symptoms over a year.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 92 (estimated)
• Ages: 50 Years and up
• Sex: Male
• Sponsor: Urotronic Inc. (Industry-sponsored)
• Locations: 5 sites (Little Rock, Arkansas and 4 other locations)
• Trial ID: NCT06312722 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are men aged 50 and older diagnosed with lower urinary tract symptoms due to obstructive BPH.

Not a fit: Patients with prior interventions for BPH or those unwilling to comply with post-procedure guidelines may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a safer and more effective treatment option for men with BPH, improving their quality of life.

How similar studies have performed: Previous studies on similar catheter systems have shown promising results, indicating potential for success in this approach.

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

Where this trial is running

Little Rock, Arkansas and 4 other locations

• 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)
• Midtown Urology Associates — Austin, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Steven Kaplan, MD, FACS — Professor of Urology
• Study coordinator: Jill Moland

Conditions Benign Prostatic Hyperplasia