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

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM) (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04807296

Collaborator

(none)

100

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Benign Prostatic Hyperplasia	Procedure: TFLEP Procedure: m-HoLEP	N/A

Detailed Description

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).

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Each arm will consist of 50 patients: one undergoing Thulium Fiber Laser Enucleation of the Prostate (TFLEP) and the other undergoing Holmium:YAG Laser Enucleation of the Prostate with Moses Technology (m-HoLEP).Two surgeons will be involved in this study. One surgeon with experience with TFLEP will perform all 50 TFLEP procedures and one surgeon with experience with m-HoLEP will perform all 50 m-HoLEP procedures.Each arm will consist of 50 patients: one undergoing Thulium Fiber Laser Enucleation of the Prostate (TFLEP) and the other undergoing Holmium:YAG Laser Enucleation of the Prostate with Moses Technology (m-HoLEP).Two surgeons will be involved in this study. One surgeon with experience with TFLEP will perform all 50 TFLEP procedures and one surgeon with experience with m-HoLEP will perform all 50 m-HoLEP procedures.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2021

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Sep 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	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.
Active Comparator: 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.	Procedure: 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

Arm

Intervention/Treatment

Active Comparator: 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.

Procedure: TFLEP

Active Comparator: 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.

Procedure: m-HoLEP

Outcome Measures

Primary Outcome Measures

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). [1 day post-operatively]
Length of hospital stay following surgery, measured in hours and minutes.

Secondary Outcome Measures

To compare intraoperative adverse events between cohorts [During surgery]
Incidence of bleeding and blood transfusion, injury or perforation of the bladder or urinary tract
To compare enucleation and morcellation time between cohorts [During surgery]
Enucleation time and morcellation time, measured in minutes.
To compare enucleation rate of instrumentation between cohorts [During surgery]
Enucleation rate, measured in enucleated tissue (mL) / time (minutes)
To compare operative time between cohorts [During surgery]
Operative time, measured in hours
To compare catheterization time between cohorts [Up to 7-days post-operatively]
Time until catheter was removed from participant post-surgery, measured in hours and minutes
To compare drop in International Prostate Symptom Score (I-PSS) between cohorts [Up to 1-year post-operatively]
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).
To measure increase of Quality of life (QoL) between cohorts [Up to 1-year post-operatively]
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.
To compare peak urine flow rates (Qmax) between cohorts [Up to 1-year post-operatively]
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.
To compare change in erectile function (IIEF) between cohorts [Up to 1-year post-operatively]
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.
To compare post-void residual urine volume (PVR) between cohorts [Up to 1-year post-operatively]
Amount of urine retained in the bladder after a voluntary void.
To compare the impact of incontinence (ICIQ-short form) between cohorts [Up to 1-year post-operatively]
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.
To compare prostate-specific antigen (PSA) levels between cohorts [Up to 1-year post-operatively]
PSA levels
To compare postoperative complications levels between cohorts [Up to 1-year post-operatively]
Incidence of urinary tract infection and stress or urge incontinence

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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