Clinical trial NCT04807296: 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
Overall status: RECRUITING
Phase: NA
Conditions: Benign Prostatic Hyperplasia
Keywords: Lasers, Solid-State
Lower Urinary Tract Symptoms
Hyperplasia
Urological Manifestations
Prostatic Disease
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
First posted: 2021-03-19
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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).
timeFrame: 1 day post-operatively
Secondary outcomes:
measure: To compare intraoperative adverse events between cohorts
timeFrame: During surgery
measure: To compare enucleation and morcellation time between cohorts
timeFrame: During surgery
measure: To compare enucleation rate of instrumentation between cohorts
timeFrame: During surgery
measure: To compare operative time between cohorts
timeFrame: During surgery
measure: To compare catheterization time between cohorts
timeFrame: Up to 7-days post-operatively
measure: To compare drop in International Prostate Symptom Score (I-PSS) between cohorts
timeFrame: Up to 1-year post-operatively
measure: To measure increase of Quality of life (QoL) between cohorts
timeFrame: Up to 1-year post-operatively
measure: To compare peak urine flow rates (Qmax) between cohorts
timeFrame: Up to 1-year post-operatively
measure: To compare change in erectile function (IIEF) between cohorts
timeFrame: Up to 1-year post-operatively
measure: To compare post-void residual urine volume (PVR) between cohorts
timeFrame: Up to 1-year post-operatively
measure: To compare the impact of incontinence (ICIQ-short form) between cohorts
timeFrame: Up to 1-year post-operatively
measure: To compare prostate-specific antigen (PSA) levels between cohorts
timeFrame: Up to 1-year post-operatively
measure: To compare postoperative complications levels between cohorts
timeFrame: Up to 1-year post-operatively
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Centre hospitalier de l'Université de Montréal
Study officials:
References: