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

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

Detailed Description
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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.

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

Conditions
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Prostate Hyperplasia

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | MONTH 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of post-operative complications | post operative complications : urethral stenosis, prostate bed sclerosis, overactive bladder, urinary incontinence, erectile dysfunction | MONTH 6 | 
| duration of intervention | in minutes | POST SURGERY HOUR 24 | 
| bloodloss assessment | measurement of haemoglobinemia | Day 1 | 
| max flow assessment | measured with urinary flowmeter in ml/sec | MONTH 12 | 
| max flow assessment | measured with urinary flowmeter | MONTH 6 | 
| max flow assessment | measured with urinary flowmeter | MONTH 3 | 
| max flow assessment | measured with urinary flowmeter | MONTH 1 | 
| post-void residual (PVR) urine test | ml | MONTH 12 | 
| post-void residual (PVR) urine test | ml | MONTH 6 | 
| post-void residual (PVR) urine test | ml | MONTH 3 | 
| post-void residual (PVR) urine test | ml | 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 | 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 | 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 | 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 | MONTH 1 | 
| quality of life assessment | self reported Short Form (36) Health Survey score(SF-36) from 0 to 100 (good health) | MONTH 12 | 
| quality of life assessment | self reported Short Form (36) Health Survey score(SF-36) from 0 to 100 (good health) | MONTH 6 | 
| quality of life assessment | self reported Short Form (36) Health Survey score(SF-36) from 0 to 100 (good health) | MONTH 3 | 
| quality of life assessment | self reported Short Form (36) Health Survey score(SF-36) from 0 to 100 (good health) | MONTH 1 | 
| urinary incontinence Assessment | self reported International Consultation on Incontinence: short questionary score (ICIQ) from 0 : no leaks, to 19 : major leaks | MONTH 12 | 
| urinary incontinence Assessment | self reported International Consultation on Incontinence: short questionary score (ICIQ) from 0 : no leaks, to 19 : major leaks | MONTH 6 | 
| urinary incontinence Assessment | self reported International Consultation on Incontinence: short questionary score (ICIQ) from 0 : no leaks, to 19 : major leaks | MONTH 3 | 
| urinary incontinence Assessment | 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 | ng/ml | 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) | 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) | 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) | MONTH 6 | 
| PATIENT GLOBAL IMPRESSION OF IMPROVEMENT | SELF REPORT SATISFACTION QUESTIONARY FROM 1 (better condition ) to 7 ( worse condition) | MONTH 1 | 
| PATIENT GLOBAL IMPRESSION OF SEVERITY | SELF REPORT SATISFACTION QUESTIONARY FROM 1( normal )to 4 (severe ) | MONTH 1 |