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

NCT ID: NCT04560907

Last Updated: 2021-01-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-05
• Study Completion Date: 2027-11-30

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.

Conditions

Benign Prostatic Hyperplasia (BPH)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Aquablation

Group Type: EXPERIMENTAL

Aquablation

Intervention Type: 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

Group Type: ACTIVE_COMPARATOR

HoLEP

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Dr. med. Gautier Müllhaupt

OTHER

Sponsor Role: lead

Responsible Party

Dr. med. Gautier Müllhaupt

Staff member, Sponsor-Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Cantonal Hospital St. Gallen

Sankt Gallen, , Switzerland

Site Status: RECRUITING

Countries

Switzerland

Facility Contacts

Gautier Müllhaupt, MD

Role: primary

gautier.muellhaupt@kssg.ch

0041714941424

References

Mullhaupt G, Gusewell S, Schmid HP, Zumstein V, Betschart P, Engeler DS, Abt D. 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. BMJ Open. 2021 May 3;11(5):e046973. doi: 10.1136/bmjopen-2020-046973.

Reference Type: DERIVED

PMID: 33941632 (View on PubMed)

Other Identifiers

CantonalHSG

Identifier Type: -

Identifier Source: org_study_id