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

Prostate Hyperplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04580628
• Other study ID #: 202000549
• Status: Completed
• Start date: July 1, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: March 2022
• Source: Clinique Saint-Hilaire
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hyperplasia
• Prostate Hyperplasia
• Prostatic Hyperplasia

Locations

Country	Name	City	State
France	Clinique Saint Hilaire	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
Clinique Saint-Hilaire

Country where clinical trial is conducted

France, 

Outcome

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