Prostatic Hyperplasia, BenignNCT03653117
Transperineal Laser Ablation for Treatment of Benign Prostatic Obstruction
A study testing Transperineal laser ablation in people with Prostatic Hyperplasia, Benign, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
Rationale: With age a large group of men experience lower urinary tract symptoms (LUTS) due to benign prostatic obstruction (BPO). Standard treatment is a transurethral resection of the prostate or laser vaporization. Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Prostatic Hyperplasia, Benign
- What is being tested?
- Transperineal laser ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- 18 Oct 2018to 23 May 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 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male
- ≥ 40 years of age
- Peak urinary flow rate (Qmax): ≥ 5 mL/sec to ≤ 15 mL/sec, with a minimum voided volume of ≥ 125 mL, measured with uroflowmetry or urodynamic investigation
- Post-void residual (PVR): ≤ 250 mL
- Prostate volume: ≥ 30 and ≤ 120 cc, measured by transrectal ultrasound
- Urodynamic investigation proven bladder outlet obstruction
- Signed informed consent
Who cannot join
- Previous invasive prostate intervention (TURP, laser, ablation, etc.)
- History of prostate or bladder cancer
- Indwelling Foley catheter or clean intermittent catheterization (CIC)
- PSA of ≥ 3.0 ng/mL without negative biopsies
- Inability or unwillingness to tolerate temporary discontinuation of anticoagulation or anti-platelet therapy
- Other conditions / status
Show all 16Show fewer
- Active urinary tract infection / prostatitis
- Macroscopic haematuria without a known contributing factor
- Poor detrusor muscle function or other neurological disorder that would impact bladder function (eg, multiple sclerosis, Parkinson's disease, spinal cord injuries, (diabetic) polyneuropathy)
- Concurrent malignancy except basal skin cancer
- History of lower urinary tract surgery (eg, TURP, laser, urinary diversion, artificial urinary sphincter, penile prosthesis)
- History of pelvic radiation therapy or radical pelvic surgery
- History of bladder neck contracture and/or urethral strictures within the 5 years prior to the informed consent date
- Bladder stones
- Medical contraindication for undergoing TPLA surgery (eg, infection, coagulopathy, significant cardiac or other medical risk factors for surgery)
- Diagnosed or suspected bleeding disorder
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Academic Medical Center
Amsterdam, North Holland, 1105AZ
About this study
Official title: Transperineal Laser Ablation for Treatment of LUTS Due to Benign Prostatic Obstruction
Rationale: With age a large group of men experience lower urinary tract symptoms (LUTS) due to benign prostatic obstruction (BPO). Standard treatment is a transurethral resection of the prostate or laser vaporization. As these techniques enter the prostate via the urethra, are invasive and require general or spinal anaesthesia. Transperineal laser ablation (TPLA) is a minimal invasive procedure, that can be performed under local anaesthesia.
Objective: The primary objective of this study is to prove feasibility and safety of TPLA for LUTS due to BPO in healthy men.
Secondary objectives: The secondary objectives are to determine functional voiding, erectile outcomes and changes on imaging.
Read the detailed description
This study is set up as a prospective, single centre, interventional pilot study.
Eligible patients are diagnosed with LUTS due to BPO at the outpatient clinic of the department of Urology at the Academic Medical Center (AMC) and have an indication for surgical treatment. The investigators aim to include 20 patients.
Eligible patients will be informed about this study by the urologist in the outpatient clinic. Information about the study will be provided both orally and in written form.
The TPLA procedure is performed with the Echolaser X4 system. The system uses a diode laser source that operates at the 1064nm wavelength. The maximum energy delivered is 10 watts per laser source. The system works with the concept of thermoablation, resulting in coagulative necrosis of tissue. Two to four fibers are introduced in the prostate under untrasound vision. Ablation will be performed with 3 watts power per fibre and a total of 1200 - 1800 J will be delivered per fibre in 400 - 600 s.
Follow-up will exist of four visits following surgery at 4 weeks, three, six and 12 months. The visits imply medical history, adverse event registration, physical examination (on indication) and uroflowmetry. Patient-reported outcome measures (PROMs) are used to measure functional outcomes. Used PROMs are the International Prostate Symptom Score (IPSS), International Index of Erectile Function 15 (IIEF-15), Visual Analogue Scale (VAS) and hematuria grading scale (HGS). In addition to this, imaging will exist of a contrast enhanced ultrasound (CEUS) at four weeks and 12 months.
- Conditions
- Prostatic Hyperplasia, Benign
- Being tested
- Transperineal laser ablation
- Keywords
- Transperineal laser ablation, LUTS, BPO, Laser ablation
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transperineal laser ablationDevice
Also called Echolaser X4
Minimal invasive coagulation of prostatic tissue by laser
| Study group | Role | What they receive |
|---|---|---|
| TPLA | Experimental | TPLA procedure Receives: Device: Transperineal laser ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of technical successful TPLA treatments
Number of technical successful performed TPLA treatments without failures related to the machine or procedure.
Measured: 24 hours following TPLA treatment
Incidence of TPLA treatment-emergent adverse events
Number of adverse events using the CTCAE v5.0. Procedural safety is shown when there are no adverse events of grade 3 or higher.
Measured: 30 days following TPLA treatment
Secondary outcomes (4)
Functional outcomes of TPLA
Functional outcomes of TPLA measured by uroflowmetry, expressed in change of Qmax.
Measured: 12 months following TPLA treatment
Spontaneous voiding post TPLA
The presence of spontaneous voiding following TPLA treatment
Measured: 24 hours following TPLA treatment
Erectile function
To evaluate erectile function after TPLA treatment, measured by the International Index of Erectile function 15 (IIEF-15) IIEF is a self-administered scale designed to assess erectile functioning: includes 15 questions on 5 relevant domains of male sexual function; Erectile function: Q1-5 Score range 0-5 + Q15 score range 1-5, total score 1-30, higher indicates better outcome; Orgasmic function: Q9-10 Score range 0-5, total score 0-10, higher indicates better outcome; Sexual desire: Q11-12 Score range 1-5, total score 2-10, higher indicates better outcome; Intercourse satisfaction: Q6-8 Score range 0-5, total score 0-15, higher indicates better outcome; Overall satisfaction: Q13-14 Score range 1-5, total score 2-10, higher indicates better outcome; All subscale are summed to combine them to a total IIEF-15 score.
Measured: 12 months following TPLA treatment
Antegrade ejaculation
To evaluate antegrade ejaculation after TPLA treatment, measured by patient reporting.
Measured: 12 months following TPLA treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start18 Oct 2018
- Primary completion23 May 2022
- Study completion23 May 2022
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 Prostatic Hyperplasia, BenignStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- This study is a prospective, single centre, interventional pilot study.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Elesta S.R.L.
- Responsible party
- Principal investigator, Prof.dr. H.P. Beerlage, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03653117
- Sponsor's protocol ID
- 2018_149
- Status last verified
- Jun 2022
- First submitted
- 22 Aug 2018
- Last updated
- 21 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
van Kollenburg RAA, van Riel LAMJG, Oddens JR, de Reijke TM, van Leeuwen TG, de Bruin DM. Contrast-enhanced Ultrasound Imaging Following Transperineal Laser Ablation for Lower Urinary Tract Symptoms. Urology. 2025 Apr;198:141-147. doi: 10.1016/j.urology.2024.11.043. Epub 2024 Nov 26.
PubMed 39603354
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transperineal Laser Ablation for Treatment of LUTS Due to Benign Prostatic Obstruction
- ClinicalTrials.gov ID
- NCT03653117
- Acronym / sponsor ID
- 2018_149
- Conditions
- Prostatic Hyperplasia, Benign
- Keywords
- Transperineal laser ablation, LUTS, BPO, Laser ablation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- Elesta S.R.L.
- Study start
- 18 Oct 2018 (actual)
- Primary completion
- 23 May 2022 (actual)
- Study completion
- 23 May 2022 (actual)
- First posted
- 31 Aug 2018 (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.
Rationale: With age a large group of men experience lower urinary tract symptoms (LUTS) due to benign prostatic obstruction (BPO). Standard treatment is a transurethral resection of the prostate or laser vaporization. As these techniques enter the prostate via the urethra, are invasive and require general or spinal anaesthesia. Transperineal laser ablation (TPLA) is a minimal invasive procedure, that can be performed under local anaesthesia.
Objective: The primary objective of this study is to prove feasibility and safety of TPLA for LUTS due to BPO in healthy men.
Secondary objectives: The secondary objectives are to determine functional voiding, erectile outcomes and changes on imaging.
Detailed description
This study is set up as a prospective, single centre, interventional pilot study.
Eligible patients are diagnosed with LUTS due to BPO at the outpatient clinic of the department of Urology at the Academic Medical Center (AMC) and have an indication for surgical treatment. The investigators aim to include 20 patients.
Eligible patients will be informed about this study by the urologist in the outpatient clinic. Information about the study will be provided both orally and in written form.
The TPLA procedure is performed with the Echolaser X4 system. The system uses a diode laser source that operates at the 1064nm wavelength. The maximum energy delivered is 10 watts per laser source. The system works with the concept of thermoablation, resulting in coagulative necrosis of tissue. Two to four fibers are introduced in the prostate under untrasound vision. Ablation will be performed with 3 watts power per fibre and a total of 1200 - 1800 J will be delivered per fibre in 400 - 600 s.
Follow-up will exist of four visits following surgery at 4 weeks, three, six and 12 months. The visits imply medical history, adverse event registration, physical examination (on indication) and uroflowmetry. Patient-reported outcome measures (PROMs) are used to measure functional outcomes. Used PROMs are the International Prostate Symptom Score (IPSS), International Index of Erectile Function 15 (IIEF-15), Visual Analogue Scale (VAS) and hematuria grading scale (HGS). In addition to this, imaging will exist of a contrast enhanced ultrasound (CEUS) at four weeks and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study is a prospective, single centre, interventional pilot study.
| Arm | Type | Receives |
|---|---|---|
| TPLA | Experimental | Device: Transperineal laser ablationTPLA procedure |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male
- ≥ 40 years of age
- Peak urinary flow rate (Qmax): ≥ 5 mL/sec to ≤ 15 mL/sec, with a minimum voided volume of ≥ 125 mL, measured with uroflowmetry or urodynamic investigation
- Post-void residual (PVR): ≤ 250 mL
- Prostate volume: ≥ 30 and ≤ 120 cc, measured by transrectal ultrasound
Key exclusion criteria (16 listed)
- Previous invasive prostate intervention (TURP, laser, ablation, etc.)
- History of prostate or bladder cancer
- Indwelling Foley catheter or clean intermittent catheterization (CIC)
- PSA of ≥ 3.0 ng/mL without negative biopsies
- Inability or unwillingness to tolerate temporary discontinuation of anticoagulation or anti-platelet therapy
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 |
|---|---|---|
| Transperineal laser ablationAlso: Echolaser X4Minimal invasive coagulation of prostatic tissue by laser | Device | TPLA |
Primary outcome
Incidence of technical successful TPLA treatments
Time frame: 24 hours following TPLA treatment
Number of technical successful performed TPLA treatments without failures related to the machine or procedure.
Incidence of TPLA treatment-emergent adverse events
Time frame: 30 days following TPLA treatment
Number of adverse events using the CTCAE v5.0. Procedural safety is shown when there are no adverse events of grade 3 or higher.
4 secondary outcomes
Functional outcomes of TPLA
Time frame: 12 months following TPLA treatment
Spontaneous voiding post TPLA
Time frame: 24 hours following TPLA treatment
Erectile function
Time frame: 12 months following TPLA treatment
Antegrade ejaculation
Time frame: 12 months following TPLA treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2022.
- Derived from this study: PubMed 39603354van Kollenburg RAA, van Riel LAMJG, Oddens JR, de Reijke TM, van Leeuwen TG, de Bruin DM. Contrast-enhanced Ultrasound Imaging Following Transperineal Laser Ablation for Lower Urinary Tract Symptoms. Urology. 2025 Apr;198:141-147. doi: 10.1016/j.urology.2024.11.043. Epub 2024 Nov 26.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transperineal laser ablation in people with Prostatic Hyperplasia, Benign, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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 16 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: finished, as of the sponsor's last update on 21 Jun 2022. 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 Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of technical successful TPLA treatments (time frame: 24 hours following TPLA treatment). The study lists 2 primary outcomes in all. 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 NCT03653117, 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 21 Jun 2022.