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Search / Trial NCT04560907

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

Launched by DR. MED. GAUTIER MÜLLHAUPT · Sep 22, 2020

Trial Information

Current as of June 15, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is comparing two different methods for treating benign prostatic hyperplasia (BPH), a common condition in men where the prostate becomes enlarged and can cause urinary problems. The trial is specifically looking at aquablation, a newer technique that uses high-pressure water jets and ultrasound to remove prostate tissue, versus an established method called Holmium Laser Enucleation of the Prostate (HoLEP). While HoLEP has been used for medium to large prostates, it can be complicated and requires specialized training. The goal of this study is to see if aquablation is just as effective and safe for larger prostates as HoLEP, which could make this treatment more accessible for patients.

To participate in this trial, men aged 45 and older who have a prostate size between 50 and 150 ml and are experiencing significant urinary difficulties may be eligible. They should not be responding to other treatments or want to avoid further medication. Participants can expect to receive one of the two treatments and will be monitored for their urinary function and quality of life after the procedure. This research is important because if aquablation proves to be as effective as HoLEP, it could change the way BPH is treated, offering a quicker and easier option for many patients.

Gender

MALE

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

About Dr. Med. Gautier Müllhaupt

Dr. med. Gautier Müllhaupt is a distinguished clinical trial sponsor dedicated to advancing medical research and improving patient outcomes through innovative studies. With a robust background in medicine and clinical development, Dr. Müllhaupt leads initiatives that focus on cutting-edge therapies and evidence-based practices. Committed to ethical standards and regulatory compliance, he collaborates with multidisciplinary teams to ensure the integrity and success of clinical trials, fostering an environment that prioritizes patient safety and scientific rigor. His expertise and leadership contribute significantly to the advancement of healthcare solutions.

Locations

Saint Gallen, , Switzerland

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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