Benign Prostatic HyperplasiaNCT05240001
Thulium Fiber Laser (TFL) vs Holmium MOSES for Treatment of Benign Prostatic Hyperplasia (BPH)
A study testing Thulium Fibre Laser and MOSES Holmium Laser in people with Benign Prostatic Hyperplasia, run by Thunder Bay Regional Health Research Institute at 1 site in Canada.
Trial summary
Benign prostatic hyperplasia (BPH), the non-cancerous enlargement of the prostate, places pressure on the urethra and causes urination and bladder problems. Transurethral Resection of the Prostate (TURP) remains the gold standard treatment in most centres for BPH. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- Thulium Fibre Laser and MOSES Holmium Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteCanada
- Study dates
- 20 Apr 2022to Dec 2025
- 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 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males over 50 years of age at the time of enrollment
- Referred to urology for refractory LUTS or urinary retention secondary to BPH
- Failed medical (non-surgical) treatment
- Prostate size on preoperative TRUS of≥80 ml
- IPSS >15 and QOL score ≥3 and Qmax <15 ml/sec
- Written informed consent to participate in the study
- Ability to comply with the requirements of the study procedures
Who cannot join
- Previous surgical treatment for BPH
- History of prostate cancer
- Prostate size < 80 mL
- History of urethral stenosis or its management
- Known or suspected neurogenic bladder
- Participants with active urinary tract infection until appropriately treated
- Participants with preexisting conditions, which, in the opinion of the investigator, interfere with the conduct of the study
- Participants who lack the capacity, or cannot speak English, in order to provide free and informed written consent
Trial locations and contacts
1 site in 1 country.
Hazem Elmansy, MD contact
Canada1 site, 1 recruiting
- Recruiting
Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, P7B 6V4
Rabail Siddiqui, MPH, MHSc, siddiqur@tbh.net
About this study
Official title: Thulium Fiber Laser (TFL) Versus Holmium MOSES Laser Enucleation of the Prostate for Treatment of Benign Prostatic Hyperplasia (BPH): A Randomized Prospective Clinical Study
Benign prostatic hyperplasia (BPH), the non-cancerous enlargement of the prostate, places pressure on the urethra and causes urination and bladder problems. Transurethral Resection of the Prostate (TURP) remains the gold standard treatment in most centres for BPH. However, morbidity after TURP is high, especially bleeding requiring blood transfusion and late postoperative bleeding.
Holmium laser enucleation of the prostate (HoLEP) is a safe and effective procedure which has demonstrated comparable results to TURP. HOLEP also offers patients the alternative of being treated endoscopically with minimal blood loss, short catheterization time, and decreased hospital stay. The main reason HoLEP has yet to become the new standard for treatment of symptomatic BPH is due the complexity of this procedure as compared to TURP. Furthermore, the HoLEP can be used with the MOSESTM system, a system that allows for more efficiency and ease of use of the HoLEP.
Read more
Thulium fiber laser (TFL) enucleation of the prostate is an emerging technology for endoscopic prostate enucleation that is notable for its high wavelength and pulsed mode of action. Recent studies have shown TFL enucleation of the prostate to be a safe and highly efficacious treatment modality for the management of large volume (> 80 cm3) glands in BPH. Due to its novelty, further studies are needed to broaden the investigators' understanding of the TFL and comprehend the full implications and benefits of this new technology, as well its limitations.
The aim of this study is to whether Thulium Fiber laser enucleation of the prostate (ThuFLEP) and Holmium laser enucleation using MOSES™ (M-HoLEP) have comparable length of hospital stay, as well as intraoperative and postoperative outcomes.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- Thulium Fibre Laser, MOSES Holmium Laser
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thulium Fibre LaserDevice
Participants will undergo treatment using the TFL
MOSES Holmium LaserDevice
Participants will undergo treatment using the MOSES Holmium laser.
| Study group | Role | What they receive |
|---|---|---|
| Thulium Fibre Laser (TFL) | Experimental | Patients randomized to this arm will undergo treatment using the TFL. Receives: Device: Thulium Fibre Laser |
| MOSES Holmium Laser | Experimental | Patients randomized to this arm will undergo treatment using the MOSES Holmium laser. Receives: Device: MOSES Holmium Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of stay in the hospital
Measured: within 6 hours
Secondary outcomes (10)
Incidence of bleeding
Measured: Intra-Op
Incidence of blood transfusion
Measured: Intra-Op
Operative time
Including laser use time
Measured: Intra-Op
International Prostate Symptom Score
Eight questions (seven concerning urinary symptoms and one concerning quality of life), responses range from 0 (better outcome) to 5 (worse outcome), with total score ranging from 0 to 35.
Measured: 1,3,6,12 months post-op
Quality of Life (QOL) as scored on the International Prostate Symptom Score (IPSS)
Response to the last question on the IPSS:
"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?" Response ranging from 'Delighted' to 'Terrible'.
Measured: 1,3,6,12 months post-op
Peak flow rate
Qmax
Measured: 1,3,6,12 months post-op
Post-void residual
PVR
Measured: 1,3,6,12 months post-op
Prostate specific antigen
PSA
Measured: 1,3,6,12 months post-op
Change in size
Assessed by TRUS
Measured: 6 months
Time to Catheter Removal
Measured: within 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2022
- Study start20 Apr 2022
- Primary completionApr 2025 (estimated)
- Study completionDec 2025 (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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thunder Bay Regional Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hazem Elmansy, Thunder Bay Regional Health Research Institute
- Investigators
- Hazem Elmansy, MD, Principal investigator, Thunder Bay Regional Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05240001
- Sponsor's protocol ID
- RP-775
- Status last verified
- Aug 2024
- First submitted
- 7 Jan 2022
- Last updated
- 16 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thulium Fiber Laser (TFL) Versus Holmium MOSES Laser Enucleation of the Prostate for Treatment of Benign Prostatic Hyperplasia (BPH): A Randomized Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT05240001
- Acronym / sponsor ID
- RP-775
- Conditions
- Benign Prostatic Hyperplasia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Thunder Bay Regional Health Research InstituteUniversity, hospital or other
- Study start
- 20 Apr 2022 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 15 Feb 2022 (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.
Benign prostatic hyperplasia (BPH), the non-cancerous enlargement of the prostate, places pressure on the urethra and causes urination and bladder problems. Transurethral Resection of the Prostate (TURP) remains the gold standard treatment in most centres for BPH. However, morbidity after TURP is high, especially bleeding requiring blood transfusion and late postoperative bleeding.
Holmium laser enucleation of the prostate (HoLEP) is a safe and effective procedure which has demonstrated comparable results to TURP. HOLEP also offers patients the alternative of being treated endoscopically with minimal blood loss, short catheterization time, and decreased hospital stay. The main reason HoLEP has yet to become the new standard for treatment of symptomatic BPH is due the complexity of this procedure as compared to TURP. Furthermore, the HoLEP can be used with the MOSESTM system, a system that allows for more efficiency and ease of use of the HoLEP.
Thulium fiber laser (TFL) enucleation of the prostate is an emerging technology for endoscopic prostate enucleation that is notable for its high wavelength and pulsed mode of action. Recent studies have shown TFL enucleation of the prostate to be a safe and highly efficacious treatment modality for the management of large volume (> 80 cm3) glands in BPH. Due to its novelty, further studies are needed to broaden the investigators' understanding of the TFL and comprehend the full implications and benefits of this new technology, as well its limitations.
The aim of this study is to whether Thulium Fiber laser enucleation of the prostate (ThuFLEP) and Holmium laser enucleation using MOSES™ (M-HoLEP) have comparable length of hospital stay, as well as intraoperative and postoperative outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thulium Fibre Laser (TFL) | Experimental | Device: Thulium Fibre LaserPatients randomized to this arm will undergo treatment using the TFL. |
| MOSES Holmium Laser | Experimental | Device: MOSES Holmium LaserPatients randomized to this arm will undergo treatment using the MOSES Holmium laser. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males over 50 years of age at the time of enrollment
- Referred to urology for refractory LUTS or urinary retention secondary to BPH
- Failed medical (non-surgical) treatment
- Prostate size on preoperative TRUS of≥80 ml
- IPSS >15 and QOL score ≥3 and Qmax <15 ml/sec
Key exclusion criteria (8 listed)
- Previous surgical treatment for BPH
- History of prostate cancer
- Prostate size < 80 mL
- History of urethral stenosis or its management
- Known or suspected neurogenic bladder
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 |
|---|---|---|
| Thulium Fibre LaserParticipants will undergo treatment using the TFL | Device | Thulium Fibre Laser (TFL) |
| MOSES Holmium LaserParticipants will undergo treatment using the MOSES Holmium laser. | Device | MOSES Holmium Laser |
Primary outcome
Length of stay in the hospital
Time frame: within 6 hours
10 secondary outcomes
Incidence of bleeding
Time frame: Intra-Op
Incidence of blood transfusion
Time frame: Intra-Op
Operative time
Time frame: Intra-Op
International Prostate Symptom Score
Time frame: 1,3,6,12 months post-op
Quality of Life (QOL) as scored on the International Prostate Symptom Score (IPSS)
Time frame: 1,3,6,12 months post-op
Peak flow rate
Time frame: 1,3,6,12 months post-op
Post-void residual
Time frame: 1,3,6,12 months post-op
Prostate specific antigen
Time frame: 1,3,6,12 months post-op
Change in size
Time frame: 6 months
Time to Catheter Removal
Time frame: within 4 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
- Individual participant dataSharing planned: No
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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.
Hazem Elmansy, MD contact
Hazem Elmansy, MD principal investigator
Thunder Bay Regional Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thulium Fibre Laser and MOSES Holmium Laser in people with Benign Prostatic Hyperplasia, run by Thunder Bay Regional Health Research Institute 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 7 inclusion and 8 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 16 Aug 2024. 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?
Contact Rabail Siddiqui, MPH, MHSc ((807) 684-6608, siddiqur@tbh.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of stay in the hospital (time frame: within 6 hours). 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 16 Aug 2024.