Actively Recruiting

Phase Not Applicable
Age: 45Years +
MALE
ID04560907

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

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

120

Participants Needed

1

Research Sites

239 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Benign prostatic hyperplasia (BPH) is a common condition in men that often requires surgical treatment as it progresses. This trial compares two surgical methods, aquablation and Holmium enucleation of the prostate (HoLEP), to see if aquablation is at least as effective and safe as HoLEP for treating medium to large prostate sizes. The study aims to support the use of aquablation, which may have advantages in learning curve and operation time, potentially changing clinical practice. Aquablation uses a robotic high-pressure water jet guided by real-time ultrasound imaging to remove prostate tissue without heat. HoLEP involves using a laser to remove prostate tissue endoscopically under general anesthesia. Both procedures include catheter placement and bladder irrigation after surgery. Participants will be randomly assigned to receive either aquablation or HoLEP. Participants will be men aged 45 or older with medium to large prostates who meet specific urinary symptom and flow criteria. Researchers will assess outcomes such as symptom scores using the International Prostate Symptoms Score (IPSS) at 6 months. The study includes monitoring for safety and functional results to compare both treatments' effects on urinary symptoms and quality of life.

CONDITIONS

Brief 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 aged 45 years or older
  • Candidate for Holmium Laser Enucleation of the Prostate (HoLEP) surgery
  • Refractory to medical therapy or unwilling to continue 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 (QoL) score of 3 or higher
  • Maximum urinary flow rate (Qmax) of 15 ml/s or less with minimum voided volume of 125 ml or patient in urinary retention
  • Able to provide written informed consent
Not Eligible

You will not qualify if you...

  • Neurogenic lower urinary tract dysfunction
  • Urethral stenosis
  • Prostate adenocarcinoma confirmed before 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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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Up to 2 days

Participants undergo either Aquablation or Holmium Laser Enucleation of the Prostate (HoLEP) surgery to treat benign prostatic hyperplasia. Post-surgery, participants have a catheter placed to assist healing and bladder irrigation is performed as part of immediate care.

1 surgical procedure and catheter care until discharge

Post-operative Follow-up

Duration - 6 months

Participants attend follow-up visits to monitor recovery and assess urinary symptoms and quality of life after surgery.

Regular follow-up visits over 6 months

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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Published Research Related To This Trial

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.

Gautier Müllhaupt, Sabine Güsewell, Hans-Peter Schmid...

https://pubmed.ncbi.nlm.nih.gov/33941632