Aquablation vs. Holmium Laser Enucleation of the Prostate in the Treatment of Benign Prostatic Hyperplasia in Medium to Large Size Prostates (ATHLETE)

Dr. med. Gautier Müllhaupt

Status

Enrolling

Conditions

Benign Prostatic Hyperplasia (BPH)

Treatments

Procedure: HoLEP

Procedure: Aquablation

Study type

Interventional

Funder types

Other

Identifiers

NCT04560907

CantonalHSG

Details and patient eligibility

About

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.

Enrollment

120 estimated patients

Sex

Male

Ages

45+ years old

Volunteers

No Healthy Volunteers

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