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NCT Number: NCT04560907

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

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.

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Key information

Conditions

Benign Prostatic Hyperplasia (BPH) Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Age range

45 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Cantonal Hospital St. Gallen

Sankt Gallen, 9010, Switzerland

Location status: Recruiting

Location contact

Gautier Müllhaupt, MD

CONTACT

[email protected]

0041714941424

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aquablation

Procedure

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.

Holep

Procedure

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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Dr. med. Gautier Müllhaupt

Other

Registry information

Official study 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

Acronym: ATHLETE

Important dates

Study start
2021
Primary completion
2023
Study completion
2027
First posted
Sep 23, 2020
Registry last updated
Jan 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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