An observational study in Prostate Hyperplasia, sponsored by Clinique Saint-Hilaire. Completed at 1 site in France. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-22.
Sponsored by Clinique Saint-Hilaire · Observational
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.
783 studies on the registry are indexed under Prostatic Hyperplasia; 174 are open to participants now.
This study's enrollment of 50 is below the median of 214 across 167 observational studies indexed under Prostatic Hyperplasia.
Browse Prostatic Hyperplasia studies →This is the only study on the registry with Clinique Saint-Hilaire as lead sponsor.
Counted across the registry records on this site, refreshed daily.
all patients treated at clinique saint hilaire Rouen with Thuflep, who consent
Exclusion Criteria:
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
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
ml
Time frame: MONTH 12
post-void residual (PVR) urine test
ml
Time frame: MONTH 6
post-void residual (PVR) urine test
ml
Time frame: MONTH 3
post-void residual (PVR) urine test
ml
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
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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