Comparing Aquablation and Holmium Laser Surgery for Treating Enlarged Prostates in Men Aged 45 and Older
Led by Dr. med. Gautier Müllhaupt · Updated on 2021-01-08
120
Participants Needed
1
Research Sites
239 weeks
Total Duration
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
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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
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
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
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.