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New treatment option for Benign Prostatic Hyperplasia (BPH)
Official title Aquablation vs. Holmium Laser Enucleation of the Prostate in the Treatment of Benign Prostatic Hyperplasia in Medium to Large Size Prostates
ClinicalTrials.gov ID: NCT04560907
What this study is testing
- What it's testing
- Benign prostatic hyperplasia (BPH) is one of the most common diseases in men. As BPH progresses, surgical treatments often become necessary.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 and older, men only
You may be able to join if
- Men ≥45 years of age
- Patient must be a candidate for HoLEP
- Refractory to medical therapy or patient is not willing to consider (further) medical treatment
- Patient has a prostate size of at least 50 ml and not more than 150ml, measured by transrectal ultrasound (TRUS)
- IPSS ≥12
You likely can't join if
- Neurogenic lower urinary tract dysfunction
- Urethral stenosis
- Preinterventionally proven adenocarcinoma of the prostate
- Nickel allergy
- Not able to complete questionnaires due to cognitive or thought disorders
- Language skills insufficient for informed consent and / or completion of questionnaires
See the full eligibility criteria
- Men ≥45 years of age
- Patient must be a candidate for HoLEP
- Refractory to medical therapy or patient is not willing to consider (further) medical treatment
- Patient has a prostate size of at least 50 ml and not more than 150ml, measured by transrectal ultrasound (TRUS)
- IPSS ≥12
- QoL≥3
- Qmax ≤ 15 ml/s with a minimum voided volume ≥ 125 ml or patient in urinary retention
- Written informed consent
- Neurogenic lower urinary tract dysfunction
- Urethral stenosis
- Preinterventionally proven adenocarcinoma of the prostate
- Nickel allergy
- Not able to complete questionnaires due to cognitive or thought disorders
- Language skills insufficient for informed consent and / or completion of questionnaires
The study team makes the final eligibility decision.
Where it's taking place
- Sankt Gallen, Switzerland
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, 45 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sankt Gallen, Switzerland. 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.