Benign Prostatic HyperplasiaNCT04236687
Prostate Artery Embolization Compared to Holmium Laser Enucleation of the Prostate for Benign Prostatic Hyperplasia
A study testing Holmium laser enucleation of the prostate and Artery embolization of the prostate in people with Benign Prostatic Hyperplasia, run by Germans Trias i Pujol Hospital at 1 site in Spain.
Trial summary
The purpose of this study is to evaluate improvement of symptoms from benign prostatic hyperplasia (BPH) as assessed by the International Prostate Symptom Score (IPSS) for prostate artery embolization (PAE) with microspheres (Embozene™, 400µm) compared to conventional Holmium laser enucleation of the prostate (HoLEP). Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- Holmium laser enucleation of the prostate and Artery embolization of the prostate
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2020to 1 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Patients evaluated in the urology department and candidates to surgical treatment
- Age > 45 years
- IPSS ≥ 10
- Maximum urinary flow < 12 milliliters (mL)/second (s)
- Post-void residual urinary volume < 300mL
- Prostatic volume between 20mL and 250mL assessed by ultrasound
- Signed informed consent
Who cannot join
- PSA > 10 (if not negative prostate biopsy)
- Life expectancy below 1 year
- Renal insufficiency defined as Glomerular Filtration Rate < 30 ml/min/1,73m2
- Known severe reactions to iodine-based contrast or gadolinium-based contrast
- CT examination reveals no access to the prostate arteries.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 08916
Fernando Agreda, MD, +34934893000, fagreda.germanstrias@gencat.cat
Jaume Sanpere, MD, +34934893000, fagreda.germanstrias@gencat.cat
About this study
Official title: Prospective, Controlled Investigation of Prostate Artery Embolization Compared to Holmium Laser Enucleation of the Prostate for the Treatment of Symptomatic Benign Prostatic Hyperplasia
The purpose of this study is to evaluate improvement of symptoms from benign prostatic hyperplasia (BPH) as assessed by the International Prostate Symptom Score (IPSS) for prostate artery embolization (PAE) with microspheres (Embozene™, 400µm) compared to conventional Holmium laser enucleation of the prostate (HoLEP).
Read the detailed description
This is a prospective randomized controlled study that collects data of patients with benign prostatic hyperplasia that are treated with prostatic artery embolization (PAE) or with Holmium laser enucleation of the prostate (HoLEP). For PAE a catheter is placed in the prostate artery, a fluid containing thousands of tiny particles (microspheres) is injected through the catheter into these small arteries which nourish the prostate. The injected microspheres will slow the blood flow to the prostate. For HoLEP a Holmium laser will be used to enucleate the prostatic hyperplasia trough the urethra. Clinical follow-up include clinical visit after 1, 6 and 12 months. Acute as well as long term complications will be recorded. The patients fill in the questionnaires for urologic disease. Urodynamic examination will record functional outcome.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- Holmium laser enucleation of the prostate, Artery embolization of the prostate
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Holmium laser enucleation of the prostateDevice
Holmium laser will be used to enucleate the prostatic hyperplasia trough the urethra
Artery embolization of the prostateProcedure or surgery
A catheter is placed in the prostate artery, a fluid containing thousands of tiny particles (microspheres) is injected through the catheter into these small arteries which nourish the prostate
| Study group | Role | What they receive |
|---|---|---|
| Holmium laser enucleation of the prostate | Experimental | Holmium laser will be used to enucleate the prostatic hyperplasia trough the urethra Receives: Device: Holmium laser enucleation of the prostate |
| Artery embolization of the prostate | Active comparator | A catheter is placed in the prostate artery, a fluid containing thousands of tiny particles (microspheres) is injected through the catheter into these small arteries which nourish the prostate. The injected microspheres will slow the blood flow to the prostate. Receives: Procedure: Artery embolization of the prostate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of symptoms assessed by International Prostate Symptom Score (IPSS)
Change in prostatic symptoms using the International Prostate Symptom Score (IPSS). IPSS score goes from 0 to 35. Higher values mean worse outcome (prostate symptons)
Measured: Baseline to 6 months after procedure
Secondary outcomes (6)
Maximum urinary flow
Maximum urinary flow rate (Qmax). Evaluated in milliliter per seconds (mL/s).
Measured: Baseline to 6 months after procedure
Post-void residual urinary volume
Post-void residual urinary volume (PVR). Post-void urinary volume: evaluated in milliliters (mL)
Measured: Baseline to 6 months after procedure
Prostate specific antigen (PSA)
Determination in plasma of the prostate specific antigen (PSA)
Measured: Baseline to 6 months after procedure
Procedure related adverse events
Evaluation of Procedure related adverse events assessed by Clavien-Dindo modified score. Clavien Dindo modified score: the score goes from 1 to 5. Higher values mean worse outcome (surgical complications)
Measured: Baseline to 6 months after procedure
Procedure related effects on sexual function
Changes in sexual function assessed by International Index of Erectile Function (IIEF) score. IIEF: the score goes from 6 to 75. Lower values mean worse outcome (overall male sexual function).
Measured: Baseline to 6 months after procedure
Procedure related effects on urinary continence
Changes in urinary continence assessed by the International Consultation on Continence Questionnaire Short Form (ICIQ-SF). ICIQ-SF: score goes from 0 to 21. Higher values mean worse outcome (urinary continence)
Measured: Baseline to 6 months after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2020
- Study start1 Feb 2020 (estimated)
- Primary completion1 Feb 2021 (estimated)
- Study completion1 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies 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
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Germans Trias i Pujol Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fernando Agreda, MD, Principal investigator, Germans Trias i Pujol Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04236687
- Sponsor's protocol ID
- HBP01
- Status last verified
- Jan 2020
- First submitted
- 15 Jan 2020
- Last updated
- 22 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Controlled Investigation of Prostate Artery Embolization Compared to Holmium Laser Enucleation of the Prostate for the Treatment of Symptomatic Benign Prostatic Hyperplasia
- ClinicalTrials.gov ID
- NCT04236687
- Acronym / sponsor ID
- HBP01
- Conditions
- Benign Prostatic Hyperplasia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Germans Trias i Pujol HospitalUniversity, hospital or other
- Study start
- 1 Feb 2020 (estimated)
- Primary completion
- 1 Feb 2021 (estimated)
- Study completion
- 1 Feb 2022 (estimated)
- First posted
- 22 Jan 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.
The purpose of this study is to evaluate improvement of symptoms from benign prostatic hyperplasia (BPH) as assessed by the International Prostate Symptom Score (IPSS) for prostate artery embolization (PAE) with microspheres (Embozene™, 400µm) compared to conventional Holmium laser enucleation of the prostate (HoLEP).
Detailed description
This is a prospective randomized controlled study that collects data of patients with benign prostatic hyperplasia that are treated with prostatic artery embolization (PAE) or with Holmium laser enucleation of the prostate (HoLEP). For PAE a catheter is placed in the prostate artery, a fluid containing thousands of tiny particles (microspheres) is injected through the catheter into these small arteries which nourish the prostate. The injected microspheres will slow the blood flow to the prostate. For HoLEP a Holmium laser will be used to enucleate the prostatic hyperplasia trough the urethra. Clinical follow-up include clinical visit after 1, 6 and 12 months. Acute as well as long term complications will be recorded. The patients fill in the questionnaires for urologic disease. Urodynamic examination will record functional outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Holmium laser enucleation of the prostate | Experimental | Device: Holmium laser enucleation of the prostateHolmium laser will be used to enucleate the prostatic hyperplasia trough the urethra |
| Artery embolization of the prostate | Active comparator | Procedure: Artery embolization of the prostateA catheter is placed in the prostate artery, a fluid containing thousands of tiny particles (microspheres) is injected through the catheter into these small arteries which nourish the prostate. The injected microspheres will slow the blood flow to the prostate. |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients evaluated in the urology department and candidates to surgical treatment
- Age > 45 years
- IPSS ≥ 10
- Maximum urinary flow < 12 milliliters (mL)/second (s)
- Post-void residual urinary volume < 300mL
Key exclusion criteria (5 listed)
- PSA > 10 (if not negative prostate biopsy)
- Life expectancy below 1 year
- Renal insufficiency defined as Glomerular Filtration Rate < 30 ml/min/1,73m2
- Known severe reactions to iodine-based contrast or gadolinium-based contrast
- CT examination reveals no access to the prostate arteries.
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 |
|---|---|---|
| Holmium laser enucleation of the prostateHolmium laser will be used to enucleate the prostatic hyperplasia trough the urethra | Device | Holmium laser enucleation of the prostate |
| Artery embolization of the prostateA catheter is placed in the prostate artery, a fluid containing thousands of tiny particles (microspheres) is injected through the catheter into these small arteries which nourish the prostate | Procedure or surgery | Artery embolization of the prostate |
Primary outcome
Improvement of symptoms assessed by International Prostate Symptom Score (IPSS)
Time frame: Baseline to 6 months after procedure
Change in prostatic symptoms using the International Prostate Symptom Score (IPSS). IPSS score goes from 0 to 35. Higher values mean worse outcome (prostate symptons)
6 secondary outcomes
Maximum urinary flow
Time frame: Baseline to 6 months after procedure
Post-void residual urinary volume
Time frame: Baseline to 6 months after procedure
Prostate specific antigen (PSA)
Time frame: Baseline to 6 months after procedure
Procedure related adverse events
Time frame: Baseline to 6 months after procedure
Procedure related effects on sexual function
Time frame: Baseline to 6 months after procedure
Procedure related effects on urinary continence
Time frame: Baseline to 6 months after procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Fernando Agreda, MD principal investigator
Germans Trias i Pujol Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Holmium laser enucleation of the prostate and Artery embolization of the prostate in people with Benign Prostatic Hyperplasia, run by Germans Trias i Pujol Hospital at 1 site in Spain.
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 7 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 22 Jan 2020. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fernando Agreda, MD (+34934893000, fagreda.germanstrias@gencat.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of symptoms assessed by International Prostate Symptom Score (IPSS) (time frame: Baseline to 6 months after procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jan 2020.