Benign Prostatic Hyperplasia (BPH)ATHLETENCT04560907
Aquablation vs. Holmium Laser Enucleation of the Prostate in the Treatment of Benign Prostatic Hyperplasia in Medium to Large Size Prostates
A study testing Aquablation and HoLEP in people with Benign Prostatic Hyperplasia (BPH), run by Dr. med. Gautier Müllhaupt at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia (BPH)
- What is being tested?
- Aquablation and HoLEP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSwitzerland
- Study dates
- 5 Jan 2021to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Cantonal Hospital St. Gallen
Sankt Gallen, 9010
Gautier Müllhaupt, MD, 0041714941424, gautier.muellhaupt@kssg.ch
About this study
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
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 .
Read more
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)
- Being tested
- Aquablation, HoLEP
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AquablationProcedure or surgery
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.
HoLEPProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Aquablation | Experimental | Not described Receives: Procedure: Aquablation |
| HoLEP | Active comparator | Not described Receives: Procedure: HoLEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Prostate Symptoms Score (IPSS)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start5 Jan 2021 (estimated)
- Primary completionApr 2023 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Benign Prostatic Hyperplasia (BPH)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, open-label, non-inferiority clinical trial
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. med. Gautier Müllhaupt
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. med. Gautier Müllhaupt, Cantonal Hospital of St. Gallen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04560907
- Sponsor's protocol ID
- CantonalHSG
- Acronym
- ATHLETE
- Status last verified
- Jan 2021
- First submitted
- 14 Sep 2020
- Last updated
- 8 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 33941632
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04560907
- Acronym / sponsor ID
- ATHLETE / CantonalHSG
- Conditions
- Benign Prostatic Hyperplasia (BPH)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Dr. med. Gautier MüllhauptUniversity, hospital or other
- Study start
- 5 Jan 2021 (estimated)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 23 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, randomized, open-label, non-inferiority clinical trial
| Arm | Type | Receives |
|---|---|---|
| Aquablation | Experimental | Procedure: Aquablation |
| HoLEP | Active comparator | Procedure: HoLEP |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Men ≥45 years of age
Key exclusion criteria (6 listed)
- Neurogenic lower urinary tract dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AquablationBy 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. | Procedure or surgery | Aquablation |
| HoLEPThis 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. | Procedure or surgery | HoLEP |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2021.
- Derived from this study: PubMed 33941632Mullhaupt 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.
- Individual participant dataSharing planned: Undecided
Related trials for Benign Prostatic Hyperplasia (BPH)
Recruiting
Clinical Study on Prostate Thermal Vapor Ablation Guided by MRI/TRUS Fusion Imaging
Benign Prostatic Hyperplasia (BPH)
Active, not recruitingPhase 4
Standard Versus Double Alpha Blockers Treatment for Symptomatic Benign Prostatic Obstruction
BPH (Benign Prostatic Hyperplasia)
RecruitingObservational study
ProVIDE Studies Post Exit Analysis
BPH With Symptomatic Lower Urinary Tract Symptoms
Recruiting
Learning Curve of Tri-lobar HoLEP Versus En-bloc HoLEP
Benign Prostatic Hyperplasia With Outflow Obstruction
RecruitingObservational study
Impact of Long-term Dutasteride Use on Perioperative Outcomes of HoLEP
Prostatic Hyperplasia, Benign
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aquablation and HoLEP in people with Benign Prostatic Hyperplasia (BPH), run by Dr. med. Gautier Müllhaupt at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Prostate Symptoms Score (IPSS) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04560907, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2021.