Thulium Fiber Laser Enucleation of the Prostate (TFLEP) vs HoLEP With Moses Technology (m-HoLEP)

Benign Prostatic Hyperplasia Clinical Trial

Official title:

Thulium Fiber Laser Compared to Holmium:YAG Laser With Moses Technology for Enucleation of the Prostate: A Prospective Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04807296
• Other study ID #: MP-02-2021-9505
• Status: Recruiting
• Phase: N/A
• Start date: September 8, 2021
• Est. completion date: September 2024

Study information

• Verified date: October 2023
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Enucleation of the prostate equips technology (usually laser) to effectively treat lower urinary tract symptoms associated with benign prostate hyperplasia (BPH). The holmium: yttrium-aluminum-garnet (Ho: YAG) laser is considered the gold standard laser used to perform enucleation of the prostate. Holmium laser enucleation of the prostate (HoLEP) reduces hospital stay and hemoglobin drop while improving International Prostate Symptom Score (IPSS) and quality of life, as well as other postoperative outcomes. HoLEP has been found to have a better enucleation efficiency rate and may have better hemostatic properties when combined with the modulated pulsed laser energy featured associated with Moses technology (m-HoLEP).

A novel laser technology called thulium fiber laser (TFL) delivers a pulsed laser at a more optimal wavelength and a shallower depth of tissue penetration leading to better hemostatic properties. However, the differences in clinical outcomes between TFL enucleation of the prostate (TFLEP) and m-HoLEP have yet to be described. This prospective study aims to compare the safety profile and clinical outcomes, peri-operatively up to one year post-operatively, between m-HoLEP and TFLEP with BPH and evidence of bladder obstruction.

Description:

Enucleation of the prostate equips technology (usually laser) to effectively treat lower urinary tract symptoms associated with benign prostate hyperplasia (BPH). The holmium: yttrium-aluminum-garnet (Ho: YAG) laser is the longest running and most studied laser used to perform this minimally invasive procedure.

Holmium laser enucleation of the prostate (HoLEP) reduces hospital stay and hemoglobin drop while improving IPSS and quality of life, as well as other positive postoperative outcomes. HoLEP has been found to have a better enucleation efficiency rate and may have better hemostatic properties when combined with the modulated pulsed laser energy featured associated with Moses technology (m-HoLEP).

A novel laser technology called thulium fiber laser (TFL) delivers a pulsed laser at a more optimal wavelength and a shallower depth of tissue penetration leading to better hemostatic properties. However, the differences in clinical outcomes between TFL enucleation of the prostate (TFLEP) and m-HoLEP, to our knowledge, have yet to be described.

This prospective study aims to compare the safety profile and clinical outcomes, peri-operatively up to one year post-operatively, between m-HoLEP and TFLEP with BPH and evidence of bladder obstruction. Variables of particular interest include the length of hospital stay and the need for blood transfusion, which are benefits of both techniques compared to transurethral resection of the prostate, the current gold standard of BPH treatment according to American Urological Association (AUA) guidelines. The results of this study will guide urologists in selecting the most appropriate procedure from the growing armamentarium of treatments for BPH.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with symptomatic benign prostate hyperplasia : urinary retention, acute renal failure (post-renal), refractory hematuria, repeated urinary tract infections, refractory symptoms.

• Prostates between 50-300 grams,

• IPSS = 8,

• Inadequate response to previous medical treatments,

• Qmax < 15 ml/sec and

• Providing informed consent

Exclusion Criteria:

• History of prostatic surgery,

• History of prostate or bladder cancer,

• Neurogenic bladder,

• Urethral stricture,

• Anticoagulant therapy (aspirin permitted), not ceased during surgery

• Patients unfit for surgery

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

Intervention

Procedure:
• TFLEP
Thulium fiber laser (TFL) is a novel laser technology that delivers a pulsed laser at a more optimal wavelength and a shallower depth of tissue penetration leading to better hemostatic properties. Patients will undergo thulium fiber laser enucleation of the prostate (TFLEP) at the Centre Hospitalier de l'Université de Montréal (CHUM) as a treatment for benign prostate hyperplasia. The surgeon performing TFLEP is experienced in TFLEP procedures. Fifty (50) patients will undergo TFLEP.
• m-HoLEP
The holmium: yttrium-aluminum-garnet (Ho: YAG) laser is the longest running and most studied laser used to perform this minimally invasive procedure. Holmium laser enucleation of the prostate reduces hospital stay and hemoglobin drop while improving IPSS and quality of life, as well as other positive postoperative outcomes compared to the historical gold standard, transurethral resection of the prostate (TURP). HoLEP has been found to have a better enucleation efficiency rate and may have better hemostatic properties when combined with the modulated pulsed laser energy featured associated with Moses technology (m-HoLEP). Patients will undergo m-HoLEP at the Centre intégré universitaire de santé et de services sociaux (CIUSSS) du Nord-de-l'Île-de-Montréal as a treatment for benign prostate hyperplasia. The surgeon performing m-HoLEP is experienced in m-HoLEP procedures. Fifty (50) patients will undergo m-HoLEP

Locations

Country	Name	City	State
Canada	Centre hospitalier de l'Université de Montréal	Montréal

Sponsors (1)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare the hospital stay between the thulium fiber laser enucleation of the prostate (TFLEP) and the holmium:YAG laser enucleation of the prostate with Moses technology (m-HoLEP).	Length of hospital stay following surgery, measured in hours and minutes.	1 day post-operatively
Secondary	To compare intraoperative adverse events between cohorts	Incidence of bleeding and blood transfusion, injury or perforation of the bladder or urinary tract	During surgery
Secondary	To compare enucleation and morcellation time between cohorts	Enucleation time and morcellation time, measured in minutes.	During surgery
Secondary	To compare enucleation rate of instrumentation between cohorts	Enucleation rate, measured in enucleated tissue (mL) / time (minutes)	During surgery
Secondary	To compare operative time between cohorts	Operative time, measured in hours	During surgery
Secondary	To compare catheterization time between cohorts	Time until catheter was removed from participant post-surgery, measured in hours and minutes	Up to 7-days post-operatively
Secondary	To compare drop in International Prostate Symptom Score (I-PSS) between cohorts	The International Prostate Symptom Score (I-PSS) is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic).	Up to 1-year post-operatively
Secondary	To measure increase of Quality of life (QoL) between cohorts	IPSS includes one question pertaining to QoL which asks: "If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that? Scored from 0-6 with 0 being "delighted" and 6 being "terrible". Higher the score, the lower the quality of life.	Up to 1-year post-operatively
Secondary	To compare peak urine flow rates (Qmax) between cohorts	Indicates the maximum urine flow rate. In men peak flow rates (Qmax) less than 15 ml/second are considered abnormal. This is measured by uroflowmetry, which measures the flow and force of urine stream during urination.	Up to 1-year post-operatively
Secondary	To compare change in erectile function (IIEF) between cohorts	The International Index of Erectile Function (IIEF) is standardised and validated 15-item self-evaluation scale provides pre-post treatment clinic evaluations of erectile function, orgasmic function, sexual desire, satisfaction in sexual intercourse and general satisfaction.	Up to 1-year post-operatively
Secondary	To compare post-void residual urine volume (PVR) between cohorts	Amount of urine retained in the bladder after a voluntary void.	Up to 1-year post-operatively
Secondary	To compare the impact of incontinence (ICIQ-short form) between cohorts	The International Consultation on Incontinence Modular Questionnaire - Short Form (ICIQ-SF) reflects the impact of urinary incontinence on QoL. Three (3) items are summed up (frequency of urinary incontinence, amount of leakage, overall impact of urinary incontinence) to provide a score between 0 & 21. Higher scores reflect increased urinary incontinence and poorer QoL.	Up to 1-year post-operatively
Secondary	To compare prostate-specific antigen (PSA) levels between cohorts	PSA levels	Up to 1-year post-operatively
Secondary	To compare postoperative complications levels between cohorts	Incidence of urinary tract infection and stress or urge incontinence	Up to 1-year post-operatively