Thuflep/SOLEP : Initial Experience and Results of Prostate Laser Enucleation With Thulium-fiber Laser (TFL)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prostate Hyperplasia
- Sponsor
- Clinique Saint-Hilaire
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Measuring the evolution of Urinary Symptoms Rated by the IPSS Score after prostate laser enucleation with TFL
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
MALVAL Benoit
Principal Investigator, Doctor in urology department
Clinique Saint-Hilaire
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
Outcomes
Primary Outcomes
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)
Secondary Outcomes
- duration of intervention(POST SURGERY HOUR 24)
- max flow assessment(MONTH 1)
- quality of life assessment(MONTH 1)
- bloodloss assessment(Day 1)
- Rate of post-operative complications(MONTH 6)
- erectile dysfunction assessment(MONTH 1)
- prostatic specific antigen in ng/mL level evolution(MONTH 1)
- Measuring the evolution of Urinary Symptoms Rated by the IPSS Score after prostate laser enucleation with TFL(MONTH 6)
- PATIENT GLOBAL IMPRESSION OF SEVERITY(MONTH 1)
- post-void residual (PVR) urine test(MONTH 1)
- PATIENT GLOBAL IMPRESSION OF IMPROVEMENT(MONTH 1)
- urinary incontinence Assessment(MONTH 1)