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

NCT04807296 | Unknown

• 1 other identifier: MP-02-2021-9505
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Benign Prostatic Hyperplasia

Keywords

Lasers, Solid-State; Lower Urinary Tract Symptoms; Hyperplasia; Urological Manifestations; Prostatic Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• To compare intraoperative adverse events between cohorts

  During surgery

• To compare enucleation and morcellation time between cohorts

  During surgery

• To compare enucleation rate of instrumentation between cohorts

  During surgery

• To compare operative time between cohorts

  During surgery

• To compare catheterization time between cohorts

  Up to 7-days post-operatively

Study Arms (2)

TFLEP

ACTIVE COMPARATOR

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

m-HoLEP

ACTIVE COMPARATOR

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

Interventions

TFLEP PROCEDURE

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.

TFLEP

m-HoLEP PROCEDURE

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

m-HoLEP

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (1)

Centre hospitalier de l'Université de Montréal

Montreal, Canada

RECRUITING

MeSH Terms

Conditions

Prostatic Hyperplasia; Lower Urinary Tract Symptoms; Hyperplasia; Urological Manifestations; Prostatic Diseases

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 17, 2021
• First Posted: March 19, 2021
• Study Start: September 8, 2021
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: October 26, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)