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

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

Study Overview

• Status: Completed
• Conditions: Prostate Hyperplasia

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 Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• France
  • Rouen, France, 76000
    • Clinique Saint Hilaire

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

all patients treated at clinique saint hilaire Rouen with Thuflep, who consent

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	MONTH 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of post-operative complications	post operative complications : urethral stenosis, prostate bed sclerosis, overactive bladder, urinary incontinence, erectile dysfunction	MONTH 6
duration of intervention	in minutes	POST SURGERY HOUR 24
bloodloss assessment	measurement of haemoglobinemia	Day 1
max flow assessment	measured with urinary flowmeter in ml/sec	MONTH 12
max flow assessment	measured with urinary flowmeter	MONTH 6
max flow assessment	measured with urinary flowmeter	MONTH 3
max flow assessment	measured with urinary flowmeter	MONTH 1
post-void residual (PVR) urine test	ml	MONTH 12
post-void residual (PVR) urine test	ml	MONTH 6
post-void residual (PVR) urine test	ml	MONTH 3
post-void residual (PVR) urine test	ml	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	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	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	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	MONTH 1
quality of life assessment	self reported Short Form (36) Health Survey score(SF-36) from 0 to 100 (good health)	MONTH 12
quality of life assessment	self reported Short Form (36) Health Survey score(SF-36) from 0 to 100 (good health)	MONTH 6
quality of life assessment	self reported Short Form (36) Health Survey score(SF-36) from 0 to 100 (good health)	MONTH 3
quality of life assessment	self reported Short Form (36) Health Survey score(SF-36) from 0 to 100 (good health)	MONTH 1
urinary incontinence Assessment	self reported International Consultation on Incontinence: short questionary score (ICIQ) from 0 : no leaks, to 19 : major leaks	MONTH 12
urinary incontinence Assessment	self reported International Consultation on Incontinence: short questionary score (ICIQ) from 0 : no leaks, to 19 : major leaks	MONTH 6
urinary incontinence Assessment	self reported International Consultation on Incontinence: short questionary score (ICIQ) from 0 : no leaks, to 19 : major leaks	MONTH 3
urinary incontinence Assessment	self reported International Consultation on Incontinence: short questionary score (ICIQ) from 0 : no leaks, to 19 : major leaks	MONTH 1
prostatic specific antigen in ng/mL level evolution	ng/ml	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)	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)	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)	MONTH 6
PATIENT GLOBAL IMPRESSION OF IMPROVEMENT	SELF REPORT SATISFACTION QUESTIONARY FROM 1 (better condition ) to 7 ( worse condition)	MONTH 1
PATIENT GLOBAL IMPRESSION OF SEVERITY	SELF REPORT SATISFACTION QUESTIONARY FROM 1( normal )to 4 (severe )	MONTH 1

Collaborators and Investigators

• Sponsor: Clinique Saint-Hilaire
• Investigators: Principal Investigator: BENOIT MALVAL, Clinique Saint-Hilaire

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: September 19, 2020
• First Submitted That Met QC Criteria: October 7, 2020
• First Posted (Actual): October 8, 2020

Study Record Updates

• Last Update Posted (Actual): March 22, 2022
• Last Update Submitted That Met QC Criteria: March 8, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia
• Other Study ID Numbers: 202000549

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No