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

Clinique Saint-Hilaire50 enrolled

Overview

Thuflep TLF: initial experience and results of prostate laser enucleation with fibrous thulium laser (TLF)

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

OBSERVATIONAL

Enrollment

Conditions

Prostate Hyperplasia

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Clinique Saint Hilaire

Rouen, France

Outcomes

Primary Outcomes

Measuring the evolution of Urinary Symptoms Rated by the IPSS Score after prostate laser enucleation with TFL

self reported International Prostate Symptom Score (IPSS) From 0 (no symptom) to 35 (maximum symptoms)

Time frame: MONTH 12

Secondary Outcomes

Rate of post-operative complications

post operative complications : urethral stenosis, prostate bed sclerosis, overactive bladder, urinary incontinence, erectile dysfunction

Time frame: MONTH 6

duration of intervention

in minutes

Time frame: POST SURGERY HOUR 24

bloodloss assessment

measurement of haemoglobinemia

Time frame: Day 1

max flow assessment

measured with urinary flowmeter in ml/sec

Time frame: MONTH 12

max flow assessment

measured with urinary flowmeter

Time frame: MONTH 6

max flow assessment

measured with urinary flowmeter

Time frame: MONTH 3

max flow assessment

measured with urinary flowmeter

Time frame: MONTH 1

post-void residual (PVR) urine test

Data from ClinicalTrials.gov

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Time frame: MONTH 12

post-void residual (PVR) urine test

Time frame: MONTH 6

post-void residual (PVR) urine test

Time frame: MONTH 3

post-void residual (PVR) urine test

Time frame: MONTH 1

erectile dysfunction assessment

self reported International Index of Erectile Function 5 score(IIEF-5) from 5 : severe erectil dysfunction to 25 : no erectile dysfunction

Time frame: MONTH 12

erectile dysfunction assessment

self reported International Index of Erectile Function 5 score(IIEF-5) from 5 : severe erectil dysfunction to 25 : no erectile dysfunction

Time frame: MONTH 6

erectile dysfunction assessment

self reported International Index of Erectile Function 5 score(IIEF-5) from 5 : severe erectil dysfunction to 25 : no erectile dysfunction

Time frame: MONTH 3

erectile dysfunction assessment

self reported International Index of Erectile Function 5 score(IIEF-5) from 5 : severe erectil dysfunction to 25 : no erectile dysfunction

Time frame: MONTH 1

quality of life assessment

self reported Short Form (36) Health Survey score(SF-36) from 0 to 100 (good health)

Time frame: MONTH 12

quality of life assessment

self reported Short Form (36) Health Survey score(SF-36) from 0 to 100 (good health)

Time frame: MONTH 6

quality of life assessment

self reported Short Form (36) Health Survey score(SF-36) from 0 to 100 (good health)

Time frame: MONTH 3

quality of life assessment

self reported Short Form (36) Health Survey score(SF-36) from 0 to 100 (good health)

Time frame: MONTH 1

urinary incontinence Assessment

self reported International Consultation on Incontinence: short questionary score (ICIQ) from 0 : no leaks, to 19 : major leaks

Time frame: MONTH 12

urinary incontinence Assessment

self reported International Consultation on Incontinence: short questionary score (ICIQ) from 0 : no leaks, to 19 : major leaks

Time frame: MONTH 6

urinary incontinence Assessment

self reported International Consultation on Incontinence: short questionary score (ICIQ) from 0 : no leaks, to 19 : major leaks

Time frame: MONTH 3

urinary incontinence Assessment

self reported International Consultation on Incontinence: short questionary score (ICIQ) from 0 : no leaks, to 19 : major leaks

Time frame: MONTH 1

prostatic specific antigen in ng/mL level evolution

ng/ml

Time frame: MONTH 1

Measuring the evolution of Urinary Symptoms Rated by the IPSS Score after prostate laser enucleation with TFL

self reported International Prostate Symptom Score (IPSS) From 0 (no symptom) to 35 (maximum symptoms)

Time frame: MONTH 1

Measuring the evolution of Urinary Symptoms Rated by the IPSS Score after prostate laser enucleation with TFL

self reported International Prostate Symptom Score (IPSS) From 0 (no symptom) to 35 (maximum symptoms)

Time frame: MONTH 3

Measuring the evolution of Urinary Symptoms Rated by the IPSS Score after prostate laser enucleation with TFL

self reported International Prostate Symptom Score (IPSS) From 0 (no symptom) to 35 (maximum symptoms)

Time frame: MONTH 6

PATIENT GLOBAL IMPRESSION OF IMPROVEMENT

SELF REPORT SATISFACTION QUESTIONARY FROM 1 (better condition ) to 7 ( worse condition)

Time frame: MONTH 1

PATIENT GLOBAL IMPRESSION OF SEVERITY

SELF REPORT SATISFACTION QUESTIONARY FROM 1( normal )to 4 (severe )

Time frame: MONTH 1