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Tests treatment safety and results for Benign Prostatic Hyperplasia
Official title Safety and Effectiveness of the Optilume® BPH Catheter System in a Post-Market Study
ClinicalTrials.gov ID: NCT06312722
What this study is testing
- What it's testing
- The goal of this clinical trial is to verify the continued safety and effectiveness for the Optilume BPH Catheter System.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older, men only
You may be able to join if
- Male subject ≥ 50 years old
- Diagnosed with lower urinary tract symptoms (LUTS) secondary to obstructive benign prostatic hyperplasia (BPH)
- Able to be treated with the Optilume BPH Catheter System in accordance with the Instructions for Use
- Prostate volume \< 80 g with a prostatic urethral length between 32-55 mm as determined by trans-rectal ultrasound (TRUS)
- International Prostate Symptom Score (IPSS) ≥ 13
You likely can't join if
- 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...
- Presence of an artificial urinary sphincter, penile prosthesis, or stent(s) in the urethra or prostate
- Any prior minimally invasive intervention (e.g., TUNA, Balloon, Microwave, Rezūm, UroLift) or surgical intervention of the prostate
- Confirmed or suspected malignancy of prostate or bladder. Negative prostate biopsy required within 6 months of enrollment if PSA at baseline is \> 4...
- Active urinary tract infection (UTI) confirmed by culture
- Neurogenic bladder or sphincter abnormalities or neurological disorders that might affect bladder or sphincter function
See the full eligibility criteria
- Male subject ≥ 50 years old
- Diagnosed with lower urinary tract symptoms (LUTS) secondary to obstructive benign prostatic hyperplasia (BPH)
- Able to be treated with the Optilume BPH Catheter System in accordance with the Instructions for Use
- Prostate volume \< 80 g with a prostatic urethral length between 32-55 mm as determined by trans-rectal ultrasound (TRUS)
- International Prostate Symptom Score (IPSS) ≥ 13
- Peak urinary flow rate (Qmax) 5-15 mL/sec with minimum voided volume of 125 mL
- Willing to provide informed consent and comply with protocol required follow-up
- 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
- Presence of an artificial urinary sphincter, penile prosthesis, or stent(s) in the urethra or prostate
- Any prior minimally invasive intervention (e.g., TUNA, Balloon, Microwave, Rezūm, UroLift) or surgical intervention of the prostate
- 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%.
- Active urinary tract infection (UTI) confirmed by culture
- Neurogenic bladder or sphincter abnormalities or neurological disorders that might affect bladder or sphincter function
- History of overt urinary incontinence requiring the use of pads
- Previous or current diagnosis of urethral strictures, bladder neck contracture or detrusor muscle spasms
- Current post-void residual volume (PVR) \> 300 mL or catheter dependent bladder drainage
- Known poor detrusor muscle function (e.g., Qmax \< 5 mL/sec)
- Active bladder, ureteral, or urethral stones or stone passage within the last 3 months
- Current poorly controlled diabetes (i.e., hemoglobin A1c ≥ 8%)
- Anatomy (e.g., presence of false passage or size of meatus) is not suitable for treatment with the Optilume BPH Catheter System
- Obstructive median lobe in the opinion of the investigator
The study team makes the final eligibility decision.
Where it's taking place
- Little Rock, Arkansas, United States
- Tampa, Florida, United States
- Shreveport, Louisiana, United States
- Las Vegas, Nevada, United States
- Springfield, Oregon, United States
- Austin, Texas, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Little Rock, Arkansas, United States; Tampa, Florida, United States; Shreveport, Louisiana, United States; Las Vegas, Nevada, United States; Springfield, Oregon, United States; Austin, Texas, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.