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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04560907
Recruitment Status : Recruiting
First Posted : September 23, 2020
Last Update Posted : January 8, 2021
Sponsor:
Information provided by (Responsible Party):
Dr. med. Gautier Müllhaupt, Cantonal Hospital of St. Gallen

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.


Condition or disease Intervention/treatment Phase
Benign Prostatic Hyperplasia (BPH) Procedure: Aquablation Procedure: HoLEP Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, randomized, open-label, non-inferiority clinical trial
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : January 5, 2021
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : November 2027

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Aquablation Procedure: Aquablation

By means of a high-pressure saline stream, parenchymal tissue of the prostate is removed endoscopically through a heat-free mechanism called hydrodissection. The intervention is supported by live ultrasound guidance and the required depth as well as the angle of the resection is planned out prior to the resection. The bladder is accessed using a 24-Fr hand-piece, which accommodates the scope. The handpiece is supported by an articulating arm attached to the operation table. Once placed in the optimal position, the system automatically adjusts the alignment as necessary.

Hemostasis is consecutively achieved through diathermy and post procedure, a threeway catheter is inserted and bladder irrigation is initiated.


Active Comparator: HoLEP Procedure: HoLEP
This is done endoscopically under general anesthesia the three lobes of the prostate that are cored out intact with the laser are pushed into the bladder before being morcellated by a special instrument inserted through the telescopic camera. A catheter is placed into the bladder to drain the urine while the raw surface heals, then left in place for around 24 hours before being removed on the day of discharge from hospital. Sterile saline fluid is also irrigated into the bladder through the catheter to dilute any blood in the urine and prevent clots from forming.




Primary Outcome Measures :
  1. International Prostate Symptoms Score (IPSS) [ Time Frame: 6 months ]
    The International Prostate Symptom Score (IPSS) can be utilized to measure the severity of lower urinary tract symptoms. The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms.



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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04560907


Locations
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Switzerland
Cantonal Hospital St. Gallen Recruiting
Saint Gallen, Switzerland, 9010
Contact: Gautier Müllhaupt, MD    0041714941424    gautier.muellhaupt@kssg.ch   
Sponsors and Collaborators
Dr. med. Gautier Müllhaupt
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. med. Gautier Müllhaupt, Staff member, Sponsor-Investigator, Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier: NCT04560907    
Other Study ID Numbers: CantonalHSG
First Posted: September 23, 2020    Key Record Dates
Last Update Posted: January 8, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Hyperplasia
Hyperplasia
Pathologic Processes
Prostatic Diseases