Actively Recruiting

Phase Not Applicable
Age: 45Years +
MALE
NCT04560907

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

Led by Dr. med. Gautier Müllhaupt · Updated on 2021-01-08

120

Participants Needed

1

Research Sites

355 weeks

Total Duration

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AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 45Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Male patients aged 45 years or older
  • Candidate for Holmium Laser Enucleation of the Prostate (HoLEP)
  • Refractory to medical therapy or unwilling to consider further medical treatment
  • Prostate size between 50 ml and 150 ml measured by transrectal ultrasound
  • International Prostate Symptoms Score (IPSS) of 12 or higher
  • Quality of life score of 3 or higher
  • Maximum urine flow rate of 15 ml/s or less with a minimum voided volume of 125 ml, or patient in urinary retention
  • Written informed consent provided
Not Eligible

You will not qualify if you...

  • Neurogenic lower urinary tract dysfunction
  • Urethral stenosis
  • Known prostate adenocarcinoma before the intervention
  • Nickel allergy
  • Unable to complete questionnaires due to cognitive or thought disorders
  • Insufficient language skills for informed consent or questionnaire completion

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Cantonal Hospital St. Gallen

Sankt Gallen, Switzerland, 9010

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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