NCT04560907 Aquablation vs. Holmium Laser Enucleation of the Prostate in the Treatment of Benign Prostatic Hyperplasia in Medium to Large Size Prostates
| NCT ID | NCT04560907 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Dr. med. Gautier Müllhaupt |
| Condition | Benign Prostatic Hyperplasia (BPH) |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2021-01-05 |
| Primary Completion | 2023-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2021-01-05 with a primary completion date of 2023-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Benign prostatic hyperplasia (BPH) is one of the most common diseases in men. As BPH progresses, surgical treatments often become necessary. Holmium enucleation of the prostate (HoLEP) is an established procedure in the surgical treatment of BPH, especially for medium to large prostates. The long learning curve, the length of surgery, and expensive equipment still limit the availability of HoLEP to a few specialized centers. Recently, a new method for treating BPH called aquablation has become commercially available. This technique uses real-time ultrasound imaging in combination with a robotic high-pressure water jet programmed and guided by the surgeon to resect prostate tissue. A RCT has shown functional results similar to transurethral resection of the prostate (TURP) for small to medium size prostates . However, so far there are no controlled studies assessing whether Aquablation provides patient reported and functional outcomes that are non-inferior compared to HoLEP in medium size to large prostates (the latter cannot be operated by TURP due to its size limitations). As aquablation offers some obvious advantages compared to HoLEP regarding learning curve and operation time, the aim of this study is to test whether efficacy and safety of aquablation are non- inferior compared to HoLEP in patients with medium to large size prostates, which would clearly support the use of aquablation and change everyday clinical practice.
Eligibility 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
Frequently Asked Questions
Who can join the NCT04560907 clinical trial?
This trial is open to male participants only, aged 45 Years or older, studying Benign Prostatic Hyperplasia (BPH). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04560907 currently recruiting?
Yes, NCT04560907 is actively recruiting participants. Visit ClinicalTrials.gov or contact Dr. med. Gautier Müllhaupt to inquire about joining.
Where is the NCT04560907 trial being conducted?
This trial is being conducted at Sankt Gallen, Switzerland.
Who is sponsoring the NCT04560907 clinical trial?
NCT04560907 is sponsored by Dr. med. Gautier Müllhaupt. The trial plans to enroll 120 participants.