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

Primary Purpose

Benign Prostatic Hyperplasia

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
TFLEP
m-HoLEP
Sponsored by
Centre hospitalier de l'Université de Montréal (CHUM)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Prostatic Hyperplasia focused on measuring Lasers, Solid-State, Lower Urinary Tract Symptoms, Hyperplasia, Urological Manifestations, Prostatic Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept 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

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

Sites / Locations

  • Centre hospitalier de l'Université de MontréalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

TFLEP

m-HoLEP

Arm Description

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.

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.

Outcomes

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).
Length of hospital stay following surgery, measured in hours and minutes.

Secondary Outcome Measures

To compare intraoperative adverse events between cohorts
Incidence of bleeding and blood transfusion, injury or perforation of the bladder or urinary tract
To compare enucleation and morcellation time between cohorts
Enucleation time and morcellation time, measured in minutes.
To compare enucleation rate of instrumentation between cohorts
Enucleation rate, measured in enucleated tissue (mL) / time (minutes)
To compare operative time between cohorts
Operative time, measured in hours
To compare catheterization time between cohorts
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
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
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
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
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
Amount of urine retained in the bladder after a voluntary void.
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.
To compare prostate-specific antigen (PSA) levels between cohorts
PSA levels
To compare postoperative complications levels between cohorts
Incidence of urinary tract infection and stress or urge incontinence

Full Information

First Posted
March 17, 2021
Last Updated
November 10, 2022
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
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1. Study Identification

Unique Protocol Identification Number
NCT04807296
Brief Title
Thulium Fiber Laser Enucleation of the Prostate (TFLEP) vs HoLEP With Moses Technology (m-HoLEP)
Official Title
Thulium Fiber Laser Compared to Holmium:YAG Laser With Moses Technology for Enucleation of the Prostate: A Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 8, 2021 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hyperplasia
Keywords
Lasers, Solid-State, Lower Urinary Tract Symptoms, Hyperplasia, Urological Manifestations, Prostatic Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TFLEP
Arm Type
Active Comparator
Arm Description
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.
Arm Title
m-HoLEP
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
TFLEP
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
m-HoLEP
Intervention Description
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
Primary Outcome Measure Information:
Title
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).
Description
Length of hospital stay following surgery, measured in hours and minutes.
Time Frame
1 day post-operatively
Secondary Outcome Measure Information:
Title
To compare intraoperative adverse events between cohorts
Description
Incidence of bleeding and blood transfusion, injury or perforation of the bladder or urinary tract
Time Frame
During surgery
Title
To compare enucleation and morcellation time between cohorts
Description
Enucleation time and morcellation time, measured in minutes.
Time Frame
During surgery
Title
To compare enucleation rate of instrumentation between cohorts
Description
Enucleation rate, measured in enucleated tissue (mL) / time (minutes)
Time Frame
During surgery
Title
To compare operative time between cohorts
Description
Operative time, measured in hours
Time Frame
During surgery
Title
To compare catheterization time between cohorts
Description
Time until catheter was removed from participant post-surgery, measured in hours and minutes
Time Frame
Up to 7-days post-operatively
Title
To compare drop in International Prostate Symptom Score (I-PSS) between cohorts
Description
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).
Time Frame
Up to 1-year post-operatively
Title
To measure increase of Quality of life (QoL) between cohorts
Description
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.
Time Frame
Up to 1-year post-operatively
Title
To compare peak urine flow rates (Qmax) between cohorts
Description
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.
Time Frame
Up to 1-year post-operatively
Title
To compare change in erectile function (IIEF) between cohorts
Description
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.
Time Frame
Up to 1-year post-operatively
Title
To compare post-void residual urine volume (PVR) between cohorts
Description
Amount of urine retained in the bladder after a voluntary void.
Time Frame
Up to 1-year post-operatively
Title
To compare the impact of incontinence (ICIQ-short form) between cohorts
Description
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.
Time Frame
Up to 1-year post-operatively
Title
To compare prostate-specific antigen (PSA) levels between cohorts
Description
PSA levels
Time Frame
Up to 1-year post-operatively
Title
To compare postoperative complications levels between cohorts
Description
Incidence of urinary tract infection and stress or urge incontinence
Time Frame
Up to 1-year post-operatively

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Centre hospitalier de l'Université de Montréal
City
Montréal
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Naeem Bhojani
Phone
514-890-8000

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We do not plan to share individual data. We do plan to present our findings at conferences however all patient information will be anonymized.

Learn more about this trial

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

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