BridgeMD
New treatment option for Benign Prostatic Hyperplasia (BPH)
Official title Evaluation of the Optilume BPH Catheter System and the Rezum Water Vapor Therapy in Treating Benign Prostatic Hyperplasia
ClinicalTrials.gov ID: NCT06769997
What this study is testing
- What it's testing
- Lower urinary symptoms (LUTS) affect older men and their frequency and severity increase with age. According to Berry et al., the histological diagnosis of benign prostatic hyperplasia (BPH) increases from 25% in the group age between 40 to 49 years to 80% in the group age between 70 to 79 years (1).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- Male subject with symptomatic BPH.
- Prostate size 30-100g.
- Able to complete the study protocol.
You likely can't join if
- Unable or unwilling to sign the Informed Consent Form (ICF) and/or comply with follow-up requirements
- Presence of an artificial urinary sphincter 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
- Active urinary tract infection (UTI) confirmed by culture
- History of overt urinary incontinence requiring use of pads NOTE: Pad usage for post-micturition dribble is acceptable
See the full eligibility criteria
- Male subject with symptomatic BPH.
- Prostate size 30-100g.
- Able to complete the study protocol.
- Unable or unwilling to sign the Informed Consent Form (ICF) and/or comply with follow-up requirements
- Presence of an artificial urinary sphincter 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
- Active urinary tract infection (UTI) confirmed by culture
- History of overt urinary incontinence requiring use of pads NOTE: Pad usage for post-micturition dribble is acceptable
- Presence of confounding diagnoses impacting lower urinary tract symptoms or bladder function (e.g., urethral strictures, bladder neck contracture, neurogenic bladder, detrusor instability, bladder stones, etc.)
- History of chronic urinary retention (e.g., PVR ≥300mL on two separate occasions, or catheter dependent drainage)
- Anatomy (e.g., presence of false passage or size of meatus) is not suitable for treatment with the Optilume BPH Catheter System
- Significant obstruction from median lobe (investigator opinion)
- Disease or other health condition that is not suitable for this study
The study team makes the final eligibility decision.
Where it's taking place
- Montreal, Quebec, Canada
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Montreal, Quebec, Canada. 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.