Clinical trial NCT04580628: Thuflep/SOLEP : Initial Experience and Results of Prostate Laser Enucleation With Thulium-fiber Laser (TFL)
Official title: Thuflep/SOLEP : Initial Experience and Results of Prostate Laser Enucleation With Thulium-fiber Laser (TFL)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Hyperplasia
Lead sponsor: Clinique Saint-Hilaire
Sponsor class: OTHER
First posted: 2020-10-08
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patients treated at clinique saint hilaire Rouen with Thuflep, who consent

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Measuring the evolution of Urinary Symptoms Rated by the IPSS Score after prostate laser enucleation with TFL
timeFrame: MONTH 12
Secondary outcomes:
measure: Rate of post-operative complications
timeFrame: MONTH 6
measure: duration of intervention
timeFrame: POST SURGERY HOUR 24
measure: bloodloss assessment
timeFrame: Day 1
measure: max flow assessment
timeFrame: MONTH 12
measure: max flow assessment
timeFrame: MONTH 6
measure: max flow assessment
timeFrame: MONTH 3
measure: max flow assessment
timeFrame: MONTH 1
measure: post-void residual (PVR) urine test
timeFrame: MONTH 12
measure: post-void residual (PVR) urine test
timeFrame: MONTH 6
measure: post-void residual (PVR) urine test
timeFrame: MONTH 3
measure: post-void residual (PVR) urine test
timeFrame: MONTH 1
measure: erectile dysfunction assessment
timeFrame: MONTH 12
measure: erectile dysfunction assessment
timeFrame: MONTH 6
measure: erectile dysfunction assessment
timeFrame: MONTH 3
measure: erectile dysfunction assessment
timeFrame: MONTH 1
measure: quality of life assessment
timeFrame: MONTH 12
measure: quality of life assessment
timeFrame: MONTH 6
measure: quality of life assessment
timeFrame: MONTH 3
measure: quality of life assessment
timeFrame: MONTH 1
measure: urinary incontinence Assessment
timeFrame: MONTH 12
measure: urinary incontinence Assessment
timeFrame: MONTH 6
measure: urinary incontinence Assessment
timeFrame: MONTH 3
measure: urinary incontinence Assessment
timeFrame: MONTH 1
measure: prostatic specific antigen in ng/mL level evolution
timeFrame: MONTH 1
measure: Measuring the evolution of Urinary Symptoms Rated by the IPSS Score after prostate laser enucleation with TFL
timeFrame: MONTH 1
measure: Measuring the evolution of Urinary Symptoms Rated by the IPSS Score after prostate laser enucleation with TFL
timeFrame: MONTH 3
measure: Measuring the evolution of Urinary Symptoms Rated by the IPSS Score after prostate laser enucleation with TFL
timeFrame: MONTH 6
measure: PATIENT GLOBAL IMPRESSION OF IMPROVEMENT
timeFrame: MONTH 1
measure: PATIENT GLOBAL IMPRESSION OF SEVERITY
timeFrame: MONTH 1
Other outcomes:
Locations:
city: Rouen
country: France
facility: Clinique Saint Hilaire
Study officials:
affiliation: Clinique Saint-Hilaire
name: BENOIT MALVAL
role: PRINCIPAL_INVESTIGATOR
References: