Lower Urinary Tract SymptomsNCT03776006
Registry: TPLA for LUTS
An observational study of Lower Urinary Tract Symptoms and Benign Prostate Hyperplasia, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).
Trial summary
Rationale: The treatment of lower urinary tract symptoms (LUTS) due to benign prostatic enlargement in men with transperineal laser ablation (TPLA) may offer advantages in functional outcomes and safety over current standard therapies. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Lower Urinary Tract Symptoms, Benign Prostate Hyperplasia, Benign Prostatic Hypertrophy With Outflow Obstruction
- What is being tested?
- Transperineal Laser Ablation
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2019to 1 Feb 2029
- How long will I take part?
- 5 Years
- Phase
- Observational
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population comprises those patients presenting with lower urinary tract symptoms due to benign prostatic enlargement and are planned to undergo transperineal laser ablation in the participating centres.
Who may be able to join
- Male
- Presenting with lower urinary tract symptoms
- Indication for transperineal laser ablation
- Signed informed consent form
Who cannot join
- Age < 18 years
- Previous or active treatment for prostate cancer (active surveillance is not seen as active treatment)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Registry of Transperineal Laser Ablation for Treatment of Lower Urinary Tract Symptoms With Use of the Echolaser® Device: A Multicentre, International Registry to Evaluate the Treatment of LUTS in Terms of Long-term Efficacy, Functional Outcomes and Safety
Rationale: The treatment of lower urinary tract symptoms (LUTS) due to benign prostatic enlargement in men with transperineal laser ablation (TPLA) may offer advantages in functional outcomes and safety over current standard therapies. As the technique is relatively new, indications and outcomes for this treatment are subject of investigation. However, the technique is already applied outside clinical studies. Clinical information from these treatments can be useful for future research. The aim of this study is to collect data on patients treated with transperineal laser ablation of the prostate outside clinical trials and to provide data on safety and functional outcomes in these patients in order to improve treatment.
Objective: To assess long-term efficacy of transperineal laser ablation for lower urinary tract symptoms, to assess functional outcomes, to assess safety, to determine baseline patient characteristics, to collect information on possible differences between centres applying treatment of transperineal laser ablation and to explore the optimal treatment indications and possible limitations.
Read more
Study design: This is an international prospective observational study in which data is recorded of patients who are treated with transperineal laser ablation for lower urinary tract symptoms.
Study population: Male patients treated with transperineal laser ablation for lower urinary tract symptoms due to benign prostatic enlargement.
Main study parameters/endpoints: The primary endpoint of this study is long-term efficacy of transperineal laser ablation for lower urinary tract symptoms measured by the time until surgical retreatment.
- Conditions
- Lower Urinary Tract Symptoms, Benign Prostate Hyperplasia, Benign Prostatic Hypertrophy With Outflow Obstruction
- Being tested
- Transperineal Laser Ablation
- Keywords
- Transperineal laser ablation, LUTS
- Medical subject headings
- Lower Urinary Tract Symptoms, Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transperineal Laser AblationProcedure or surgery
Also called Echolaser X4
Transperineal Laser Ablation of the Prostate
| Study group | Role | What they receive |
|---|---|---|
| TPLA | Not described Receives: Procedure: Transperineal Laser Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term treatment efficacy measured by the time until surgical retreatment.
The treatment effectiveness is measured by the time until the need for surgical retreatment. This is measured by the time between the TPLA treatment and retreatment indicated due to new micturion problems. The time is expressed in years.
Measured: 5 years following TPLA treatment
Secondary outcomes (5)
Experienced functional efficacy measured by change in International Prostate Symptom Score
The experienced functional efficacy is measured by change in the International Prostate Symptom Score (IPSS). The IPSS is a is a self-administered scale of 7 questions concerning urinary symptoms plus one question concerning quality of life (QoL). Each of the seven symptoms includes the assignment of scores from 0 to 5. The total score can therefore range from 0 to 35 points (asymptomatic to very symptomatic). The patient's quality of life (QoL) will be evaluated separately.
Measured: 12 months following TPLA treatment
Objectified functional efficacy measured by change of maximum flow by uroflowmetry.
Change in maximum urinary flow rate after 12 months compared to baseline.
Measured: 12 months following TPLA treatment
Long-term treatment efficacy measured by the time until restart of urological medication.
The treatment effectiveness is measured by the time until the need for medical treatment due to new miction symptoms. This is measured by the time between the TPLA treatment and start of medical treatment for LUTS. The time is expressed in years.
Measured: 5 years following TPLA treatment
Procedural safety measuered by the incidence of TPLA procedure related adverse events, reported by the CTCAE v5.0..
Number of intraoperative adverse events using the CTCAE v5.0. Procedural safety is shown when no adverse events of grade 3 or higher.
Measured: 1 day following TPLA treatment
Treatment safety measured by adverse event incidence at 30 days, reported by the CTCAE v5.0
Number of adverse events using the CTCAE v5.0. Treatment safety is shown when no adverse events of grade 3b or higher are reported at 30 days post-TPLA treatment.
Measured: 30 days 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 posted14 Dec 2018
- Study start1 Feb 2019 (estimated)
- Primary completion1 Feb 2029 (estimated)
- Study completion1 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Urinary Tract SymptomsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. T.M. de Reijke, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03776006
- Sponsor's protocol ID
- W18_316
- Status last verified
- Jan 2019
- First submitted
- 13 Dec 2018
- Last updated
- 18 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- 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 18 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry of Transperineal Laser Ablation for Treatment of Lower Urinary Tract Symptoms With Use of the Echolaser® Device: A Multicentre, International Registry to Evaluate the Treatment of LUTS in Terms of Long-term Efficacy, Functional Outcomes and Safety
- ClinicalTrials.gov ID
- NCT03776006
- Acronym / sponsor ID
- W18_316
- Conditions
- Lower Urinary Tract Symptoms, Benign Prostate Hyperplasia, Benign Prostatic Hypertrophy With Outflow Obstruction
- Keywords
- Transperineal laser ablation, LUTS
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 1 Feb 2019 (estimated)
- Primary completion
- 1 Feb 2029 (estimated)
- Study completion
- 1 Feb 2029 (estimated)
- First posted
- 14 Dec 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: The treatment of lower urinary tract symptoms (LUTS) due to benign prostatic enlargement in men with transperineal laser ablation (TPLA) may offer advantages in functional outcomes and safety over current standard therapies. As the technique is relatively new, indications and outcomes for this treatment are subject of investigation. However, the technique is already applied outside clinical studies. Clinical information from these treatments can be useful for future research. The aim of this study is to collect data on patients treated with transperineal laser ablation of the prostate outside clinical trials and to provide data on safety and functional outcomes in these patients in order to improve treatment.
Objective: To assess long-term efficacy of transperineal laser ablation for lower urinary tract symptoms, to assess functional outcomes, to assess safety, to determine baseline patient characteristics, to collect information on possible differences between centres applying treatment of transperineal laser ablation and to explore the optimal treatment indications and possible limitations.
Study design: This is an international prospective observational study in which data is recorded of patients who are treated with transperineal laser ablation for lower urinary tract symptoms.
Study population: Male patients treated with transperineal laser ablation for lower urinary tract symptoms due to benign prostatic enlargement.
Main study parameters/endpoints: The primary endpoint of this study is long-term efficacy of transperineal laser ablation for lower urinary tract symptoms measured by the time until surgical retreatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TPLA | – | Procedure: Transperineal Laser Ablation |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population comprises those patients presenting with lower urinary tract symptoms due to benign prostatic enlargement and are planned to undergo transperineal laser ablation in the participating centres.
Key inclusion criteria (4 listed)
- Male
- Presenting with lower urinary tract symptoms
- Indication for transperineal laser ablation
- Signed informed consent form
Key exclusion criteria (2 listed)
- Age < 18 years
- Previous or active treatment for prostate cancer (active surveillance is not seen as active treatment)
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 X4Transperineal Laser Ablation of the Prostate | Procedure or surgery | TPLA |
Primary outcome
Long-term treatment efficacy measured by the time until surgical retreatment.
Time frame: 5 years following TPLA treatment
The treatment effectiveness is measured by the time until the need for surgical retreatment. This is measured by the time between the TPLA treatment and retreatment indicated due to new micturion problems. The time is expressed in years.
5 secondary outcomes
Experienced functional efficacy measured by change in International Prostate Symptom Score
Time frame: 12 months following TPLA treatment
Objectified functional efficacy measured by change of maximum flow by uroflowmetry.
Time frame: 12 months following TPLA treatment
Long-term treatment efficacy measured by the time until restart of urological medication.
Time frame: 5 years following TPLA treatment
Procedural safety measuered by the incidence of TPLA procedure related adverse events, reported by the CTCAE v5.0..
Time frame: 1 day following TPLA treatment
Treatment safety measured by adverse event incidence at 30 days, reported by the CTCAE v5.0
Time frame: 30 days following TPLA treatment
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 18 Jan 2019.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Lower Urinary Tract Symptoms and Benign Prostate Hyperplasia, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).
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 4 inclusion and 2 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: opening soon, as of the sponsor's last update on 18 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact H Beerlage, Prof. (+31 20 5664776, h.p.beerlage@amc.uva.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long-term treatment efficacy measured by the time until surgical retreatment. (time frame: 5 years following TPLA treatment). 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 18 Jan 2019.