Clinical trial NCT04560907: Aquablation vs. Holmium Laser Enucleation of the Prostate in the Treatment of Benign Prostatic Hyperplasia in Medium to Large Size Prostates
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Benign Prostatic Hyperplasia (BPH)
Lead sponsor: Cantonal Hospital of St. Gallen
Sponsor class: OTHER
First posted: 2020-09-23
Enrollment: 120
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized, open-label, non-inferiority clinical trial
Primary purpose: TREATMENT

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

Primary outcomes:
measure: International Prostate Symptoms Score (IPSS)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Gallen
country: Switzerland
facility: Cantonal Hospital St. Gallen
Study officials:
References:
citation: Mullhaupt G, Gusewell S, Schmid HP, Zumstein V, Betschart P, Engeler DS, Abt D. Aquablation versus holmium laser enucleation of the prostate in the treatment of benign prostatic hyperplasia in medium-to-large-sized prostates (ATHLETE): protocol of a prospective randomised trial. BMJ Open. 2021 May 3;11(5):e046973. doi: 10.1136/bmjopen-2020-046973.