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

Completed

• Conditions: Prostate Hyperplasia

• Registration Number: NCT04580628
• Lead Sponsor: Clinique Saint-Hilaire

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.

Study Timeline

• Study Start: 2020-07-01
• Study First Submitted: 2020-09-19
• Study First Submitted QC: 2020-10-07
• Study First Posted: 2020-10-08
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-08
• Last Update Posted: 2022-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
duration of intervention	POST SURGERY HOUR 24	in minutes
max flow assessment	MONTH 1	measured with urinary flowmeter
quality of life assessment	MONTH 1	self reported Short Form (36) Health Survey score(SF-36) from 0 to 100 (good health)
bloodloss assessment	Day 1	measurement of haemoglobinemia
Rate of post-operative complications	MONTH 6	post operative complications : urethral stenosis, prostate bed sclerosis, overactive bladder, urinary incontinence, erectile dysfunction
erectile dysfunction assessment	MONTH 1	self reported International Index of Erectile Function 5 score(IIEF-5) from 5 : severe erectil dysfunction to 25 : no erectile dysfunction
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 6	self reported International Prostate Symptom Score (IPSS) From 0 (no symptom) to 35 (maximum symptoms)
PATIENT GLOBAL IMPRESSION OF SEVERITY	MONTH 1	SELF REPORT SATISFACTION QUESTIONARY FROM 1( normal )to 4 (severe )
post-void residual (PVR) urine test	MONTH 1	ml
PATIENT GLOBAL IMPRESSION OF IMPROVEMENT	MONTH 1	SELF REPORT SATISFACTION QUESTIONARY FROM 1 (better condition ) to 7 ( worse condition)
urinary incontinence Assessment	MONTH 1	self reported International Consultation on Incontinence: short questionary score (ICIQ) from 0 : no leaks, to 19 : major leaks

Trial Locations

Locations (1)

Clinique Saint Hilaire; 🇫🇷 Rouen, France