Benign Prostatic HyperplasiaNCT04807296
Thulium Fiber Laser Enucleation of the Prostate (TFLEP) vs HoLEP With Moses Technology (m-HoLEP)
A study testing TFLEP and m-HoLEP in people with Benign Prostatic Hyperplasia, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- TFLEP and m-HoLEP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 8 Sep 2021to Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Centre hospitalier de l'Université de Montréal
Montreal
Naeem Bhojani, 514-890-8000
About this study
Official title: Thulium Fiber Laser Compared to Holmium:YAG Laser With Moses Technology for Enucleation of the Prostate: A Prospective Study
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.
Read the 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.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- TFLEP, m-HoLEP
- Keywords
- Lasers, Solid-State, Lower Urinary Tract Symptoms, Hyperplasia, Urological Manifestations, Prostatic Disease
- Medical subject headings
- Prostatic Hyperplasia, Lower Urinary Tract Symptoms, Hyperplasia, Urological Manifestations, Prostatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TFLEPProcedure or surgery
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-HoLEPProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: m-HoLEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day post-operatively
Secondary outcomes (13)
To compare intraoperative adverse events between cohorts
Incidence of bleeding and blood transfusion, injury or perforation of the bladder or urinary tract
Measured: During surgery
To compare enucleation and morcellation time between cohorts
Enucleation time and morcellation time, measured in minutes.
Measured: During surgery
To compare enucleation rate of instrumentation between cohorts
Enucleation rate, measured in enucleated tissue (mL) / time (minutes)
Measured: During surgery
To compare operative time between cohorts
Operative time, measured in hours
Measured: During surgery
To compare catheterization time between cohorts
Time until catheter was removed from participant post-surgery, measured in hours and minutes
Measured: Up to 7-days post-operatively
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).
Measured: Up to 1-year post-operatively
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.
Measured: Up to 1-year post-operatively
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.
Measured: Up to 1-year post-operatively
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.
Measured: Up to 1-year post-operatively
To compare post-void residual urine volume (PVR) between cohorts
Amount of urine retained in the bladder after a voluntary void.
Measured: Up to 1-year post-operatively
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.
Measured: Up to 1-year post-operatively
To compare prostate-specific antigen (PSA) levels between cohorts
PSA levels
Measured: Up to 1-year post-operatively
To compare postoperative complications levels between cohorts
Incidence of urinary tract infection and stress or urge incontinence
Measured: Up to 1-year post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start8 Sep 2021
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04807296
- Sponsor's protocol ID
- MP-02-2021-9505
- Status last verified
- Oct 2023
- First submitted
- 17 Mar 2021
- Last updated
- 26 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not plan to share individual data. We do plan to present our findings at conferences however all patient information will be anonymized.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thulium Fiber Laser Compared to Holmium:YAG Laser With Moses Technology for Enucleation of the Prostate: A Prospective Study
- ClinicalTrials.gov ID
- NCT04807296
- Acronym / sponsor ID
- MP-02-2021-9505
- Conditions
- Benign Prostatic Hyperplasia
- Keywords
- Lasers, Solid-State, Lower Urinary Tract Symptoms, Hyperplasia, Urological Manifestations, Prostatic Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- 8 Sep 2021 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 19 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| TFLEP | Active comparator | Procedure: TFLEPThulium 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. |
| m-HoLEP | Active comparator | Procedure: m-HoLEPThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- History of prostatic surgery,
- History of prostate or bladder cancer,
- Neurogenic bladder,
- Urethral stricture,
- Anticoagulant therapy (aspirin permitted), not ceased during surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TFLEPThulium 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. | Procedure or surgery | TFLEP |
| m-HoLEPThe 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 | Procedure or surgery | m-HoLEP |
Primary outcome
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).
Time frame: 1 day post-operatively
Length of hospital stay following surgery, measured in hours and minutes.
13 secondary outcomes
To compare intraoperative adverse events between cohorts
Time frame: During surgery
To compare enucleation and morcellation time between cohorts
Time frame: During surgery
To compare enucleation rate of instrumentation between cohorts
Time frame: During surgery
To compare operative time between cohorts
Time frame: During surgery
To compare catheterization time between cohorts
Time frame: Up to 7-days post-operatively
To compare drop in International Prostate Symptom Score (I-PSS) between cohorts
Time frame: Up to 1-year post-operatively
To measure increase of Quality of life (QoL) between cohorts
Time frame: Up to 1-year post-operatively
To compare peak urine flow rates (Qmax) between cohorts
Time frame: Up to 1-year post-operatively
To compare change in erectile function (IIEF) between cohorts
Time frame: Up to 1-year post-operatively
To compare post-void residual urine volume (PVR) between cohorts
Time frame: Up to 1-year post-operatively
To compare the impact of incontinence (ICIQ-short form) between cohorts
Time frame: Up to 1-year post-operatively
To compare prostate-specific antigen (PSA) levels between cohorts
Time frame: Up to 1-year post-operatively
To compare postoperative complications levels between cohorts
Time frame: Up to 1-year post-operatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
- Individual participant dataSharing planned: No. We do not plan to share individual data. We do plan to present our findings at conferences however all patient information will be anonymized.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TFLEP and m-HoLEP in people with Benign Prostatic Hyperplasia, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). (time frame: 1 day post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2023.