Prostate Hyperplasia
Conditions
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.
Interventions
None listed
Sponsors
Clinique Saint-Hilaire
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measuring the evolution of Urinary Symptoms Rated by the IPSS Score after prostate laser enucleation with TFL | MONTH 12 | self reported International Prostate Symptom Score (IPSS) From 0 (no symptom) to 35 (maximum symptoms) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| duration of intervention | POST SURGERY HOUR 24 | in minutes |
| bloodloss assessment | Day 1 | measurement of haemoglobinemia |
| max flow assessment | MONTH 12 | measured with urinary flowmeter in ml/sec |
| post-void residual (PVR) urine test | MONTH 12 | ml |
| erectile dysfunction assessment | MONTH 12 | self reported International Index of Erectile Function 5 score(IIEF-5) from 5 : severe erectil dysfunction to 25 : no erectile dysfunction |
| Rate of post-operative complications | MONTH 6 | post operative complications : urethral stenosis, prostate bed sclerosis, overactive bladder, urinary incontinence, erectile dysfunction |
| urinary incontinence Assessment | MONTH 12 | self reported International Consultation on Incontinence: short questionary score (ICIQ) from 0 : no leaks, to 19 : major leaks |
| prostatic specific antigen in ng/mL level evolution | MONTH 1 | ng/ml |
| Measuring the evolution of Urinary Symptoms Rated by the IPSS Score after prostate laser enucleation with TFL | MONTH 1 | self reported International Prostate Symptom Score (IPSS) From 0 (no symptom) to 35 (maximum symptoms) |
| PATIENT GLOBAL IMPRESSION OF IMPROVEMENT | MONTH 1 | SELF REPORT SATISFACTION QUESTIONARY FROM 1 (better condition ) to 7 ( worse condition) |
| PATIENT GLOBAL IMPRESSION OF SEVERITY | MONTH 1 | SELF REPORT SATISFACTION QUESTIONARY FROM 1( normal )to 4 (severe ) |
| quality of life assessment | MONTH 12 | self reported Short Form (36) Health Survey score(SF-36) from 0 to 100 (good health) |
Countries
France
Outcome results
None listed