Thuflep/SOLEP : Initial Experience and Results of Prostate Laser Enucleation With Thulium-fiber Laser (TFL)

March 8, 2022 updated by: MALVAL Benoit, Clinique Saint-Hilaire
Thuflep TLF: initial experience and results of prostate laser enucleation with fibrous thulium laser (TLF)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

While prostate laser enucleation is being confirmed as the new gold standard for surgical management of benign prostate hypertrophy, the holmium:Yag laser is currently the most widely used. A new laser technology, the fibrous thulium laser (TFL), has recently appeared with clearly superior results for lithotripsy. The question therefore arises of the surgical and functional results of the use of fibrous thulium for prostate enucleation.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Rouen, France, 76000
        • Clinique Saint Hilaire

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

all patients treated at clinique saint hilaire Rouen with Thuflep, who consent

Description

Inclusion Criteria:

  • Patients superior or equal to 18 years old
  • Benign Prostate Hypertrophy ( more than 30cc.)
  • Indication to surgical treatment
  • No contraindication for surgery
  • No opposition to participating in the study

Exclusion Criteria:

  • Evidence of urethral stenosis
  • Evidence of a bladder tumour
  • Evidence of prostate cancer known or confirmed by prostate biopsies if suspected
  • Known neurological bladder
  • Refusal to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Measuring the evolution of Urinary Symptoms Rated by the IPSS Score after prostate laser enucleation with TFL
Time Frame: MONTH 12
self reported International Prostate Symptom Score (IPSS) From 0 (no symptom) to 35 (maximum symptoms)
MONTH 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rate of post-operative complications
Time Frame: MONTH 6
post operative complications : urethral stenosis, prostate bed sclerosis, overactive bladder, urinary incontinence, erectile dysfunction
MONTH 6
duration of intervention
Time Frame: POST SURGERY HOUR 24
in minutes
POST SURGERY HOUR 24
bloodloss assessment
Time Frame: Day 1
measurement of haemoglobinemia
Day 1
max flow assessment
Time Frame: MONTH 12
measured with urinary flowmeter in ml/sec
MONTH 12
max flow assessment
Time Frame: MONTH 6
measured with urinary flowmeter
MONTH 6
max flow assessment
Time Frame: MONTH 3
measured with urinary flowmeter
MONTH 3
max flow assessment
Time Frame: MONTH 1
measured with urinary flowmeter
MONTH 1
post-void residual (PVR) urine test
Time Frame: MONTH 12
ml
MONTH 12
post-void residual (PVR) urine test
Time Frame: MONTH 6
ml
MONTH 6
post-void residual (PVR) urine test
Time Frame: MONTH 3
ml
MONTH 3
post-void residual (PVR) urine test
Time Frame: MONTH 1
ml
MONTH 1
erectile dysfunction assessment
Time Frame: MONTH 12
self reported International Index of Erectile Function 5 score(IIEF-5) from 5 : severe erectil dysfunction to 25 : no erectile dysfunction
MONTH 12
erectile dysfunction assessment
Time Frame: MONTH 6
self reported International Index of Erectile Function 5 score(IIEF-5) from 5 : severe erectil dysfunction to 25 : no erectile dysfunction
MONTH 6
erectile dysfunction assessment
Time Frame: MONTH 3
self reported International Index of Erectile Function 5 score(IIEF-5) from 5 : severe erectil dysfunction to 25 : no erectile dysfunction
MONTH 3
erectile dysfunction assessment
Time Frame: MONTH 1
self reported International Index of Erectile Function 5 score(IIEF-5) from 5 : severe erectil dysfunction to 25 : no erectile dysfunction
MONTH 1
quality of life assessment
Time Frame: MONTH 12
self reported Short Form (36) Health Survey score(SF-36) from 0 to 100 (good health)
MONTH 12
quality of life assessment
Time Frame: MONTH 6
self reported Short Form (36) Health Survey score(SF-36) from 0 to 100 (good health)
MONTH 6
quality of life assessment
Time Frame: MONTH 3
self reported Short Form (36) Health Survey score(SF-36) from 0 to 100 (good health)
MONTH 3
quality of life assessment
Time Frame: MONTH 1
self reported Short Form (36) Health Survey score(SF-36) from 0 to 100 (good health)
MONTH 1
urinary incontinence Assessment
Time Frame: MONTH 12
self reported International Consultation on Incontinence: short questionary score (ICIQ) from 0 : no leaks, to 19 : major leaks
MONTH 12
urinary incontinence Assessment
Time Frame: MONTH 6
self reported International Consultation on Incontinence: short questionary score (ICIQ) from 0 : no leaks, to 19 : major leaks
MONTH 6
urinary incontinence Assessment
Time Frame: MONTH 3
self reported International Consultation on Incontinence: short questionary score (ICIQ) from 0 : no leaks, to 19 : major leaks
MONTH 3
urinary incontinence Assessment
Time Frame: MONTH 1
self reported International Consultation on Incontinence: short questionary score (ICIQ) from 0 : no leaks, to 19 : major leaks
MONTH 1
prostatic specific antigen in ng/mL level evolution
Time Frame: MONTH 1
ng/ml
MONTH 1
Measuring the evolution of Urinary Symptoms Rated by the IPSS Score after prostate laser enucleation with TFL
Time Frame: MONTH 1
self reported International Prostate Symptom Score (IPSS) From 0 (no symptom) to 35 (maximum symptoms)
MONTH 1
Measuring the evolution of Urinary Symptoms Rated by the IPSS Score after prostate laser enucleation with TFL
Time Frame: MONTH 3
self reported International Prostate Symptom Score (IPSS) From 0 (no symptom) to 35 (maximum symptoms)
MONTH 3
Measuring the evolution of Urinary Symptoms Rated by the IPSS Score after prostate laser enucleation with TFL
Time Frame: MONTH 6
self reported International Prostate Symptom Score (IPSS) From 0 (no symptom) to 35 (maximum symptoms)
MONTH 6
PATIENT GLOBAL IMPRESSION OF IMPROVEMENT
Time Frame: MONTH 1
SELF REPORT SATISFACTION QUESTIONARY FROM 1 (better condition ) to 7 ( worse condition)
MONTH 1
PATIENT GLOBAL IMPRESSION OF SEVERITY
Time Frame: MONTH 1
SELF REPORT SATISFACTION QUESTIONARY FROM 1( normal )to 4 (severe )
MONTH 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Clinique Saint-Hilaire

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: BENOIT MALVAL, Clinique Saint-Hilaire

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 19, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 7, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 8, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 22, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 8, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 202000549

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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