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Registry: TPLA for LUTS

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ClinicalTrials.gov Identifier: NCT03776006
Recruitment Status : Not yet recruiting
First Posted : December 14, 2018
Last Update Posted : January 18, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. T.M. de Reijke, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief 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. 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.


Condition or disease Intervention/treatment
Lower Urinary Tract Symptoms Benign Prostate Hyperplasia Benign Prostatic Hypertrophy With Outflow Obstruction Procedure: Transperineal Laser Ablation

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
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
Estimated Study Start Date : February 1, 2019
Estimated Primary Completion Date : February 1, 2029
Estimated Study Completion Date : February 1, 2029

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
TPLA Procedure: Transperineal Laser Ablation
Transperineal Laser Ablation of the Prostate
Other Name: Echolaser X4




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Experienced functional efficacy measured by change in International Prostate Symptom Score [ Time Frame: 12 months following TPLA treatment ]
    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.

  2. Objectified functional efficacy measured by change of maximum flow by uroflowmetry. [ Time Frame: 12 months following TPLA treatment ]
    Change in maximum urinary flow rate after 12 months compared to baseline.

  3. Long-term treatment efficacy measured by the time until restart of urological medication. [ Time Frame: 5 years following TPLA treatment ]
    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.

  4. 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 ]
    Number of intraoperative adverse events using the CTCAE v5.0. Procedural safety is shown when no adverse events of grade 3 or higher.

  5. Treatment safety measured by adverse event incidence at 30 days, reported by the CTCAE v5.0 [ Time Frame: 30 days following TPLA treatment ]
    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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • Male
  • Presenting with lower urinary tract symptoms
  • Indication for transperineal laser ablation
  • Signed informed consent form

Exclusion Criteria:

  • Age < 18 years
  • Previous or active treatment for prostate cancer (active surveillance is not seen as active treatment)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03776006


Contacts
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Contact: H Beerlage, Prof. +31 20 5664776 h.p.beerlage@amc.uva.nl

Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Additional Information:

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Responsible Party: Dr. T.M. de Reijke, Principal Investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT03776006     History of Changes
Other Study ID Numbers: W18_316
First Posted: December 14, 2018    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr. T.M. de Reijke, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
Transperineal laser ablation
LUTS

Additional relevant MeSH terms:
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Prostatic Hyperplasia
Hyperplasia
Hypertrophy
Lower Urinary Tract Symptoms
Pathologic Processes
Pathological Conditions, Anatomical
Urological Manifestations
Signs and Symptoms
Prostatic Diseases
Genital Diseases, Male