Comparing Aquablation and Holmium Laser for Enlarged Prostate Treatment
Aquablation vs. Holmium Laser Enucleation of the Prostate in the Treatment of Benign Prostatic Hyperplasia in Medium to Large Size Prostates: A Prospective Randomized Trial
This study is testing if a new water-based treatment for enlarged prostates works as well as a traditional laser surgery for men who have symptoms from benign prostatic hyperplasia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 45 Years and up |
| Sex | Male |
| Sponsor | Cantonal Hospital of St. Gallen Academic / other |
| Locations | 1 site (Sankt Gallen) |
| Trial ID | NCT04560907 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of aquablation versus Holmium laser enucleation of the prostate (HoLEP) in treating benign prostatic hyperplasia (BPH) in men with medium to large size prostates. Aquablation utilizes real-time ultrasound imaging and a robotic water jet to remove prostate tissue, while HoLEP is a well-established surgical method. The study aims to determine if aquablation can achieve similar patient-reported and functional outcomes as HoLEP, providing a potentially less invasive option for patients. Participants will be men aged 45 and older who are candidates for HoLEP and have specific prostate size and symptom criteria.
Who should consider this trial
Good fit: Ideal candidates are men aged 45 and older with a prostate size between 50 ml and 150 ml who are refractory to medical therapy.
Not a fit: Patients with neurogenic lower urinary tract dysfunction or pre-existing prostate cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a less invasive and more accessible treatment option for men suffering from BPH.
How similar studies have performed: Previous studies have shown that aquablation can achieve functional results comparable to traditional methods for smaller prostates, but this specific comparison with HoLEP is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 Exclusion Criteria: * 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
Where this trial is running
Sankt Gallen
- Cantonal Hospital St. Gallen — Sankt Gallen, Switzerland (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.