Thulium Fiber Laser (TFL) vs Holmium MOSES for Treatment of Benign Prostatic Hyperplasia (BPH)

August 15, 2024 updated by: Hazem Elmansy, Thunder Bay Regional Health Research Institute

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.

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

104

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Rabail Siddiqui, MPH, MHSc
  • Phone Number: (807) 684-6608
  • Email: siddiqur@tbh.net

Study Contact Backup

  • Name: Hazem Elmansy, MD

Study Locations

  • Canada
    • Ontario
      • Thunder Bay, Ontario, Canada, P7B 6V4
        • Recruiting
        • Thunder Bay Regional Health Sciences Centre
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Males over 50 years of age at the time of enrollment
  2. Referred to urology for refractory LUTS or urinary retention secondary to BPH
  3. Failed medical (non-surgical) treatment
  4. Prostate size on preoperative TRUS of≥80 ml
  5. IPSS >15 and QOL score ≥3 and Qmax <15 ml/sec
  6. Written informed consent to participate in the study
  7. Ability to comply with the requirements of the study procedures

Exclusion Criteria:

  1. Previous surgical treatment for BPH
  2. History of prostate cancer
  3. Prostate size < 80 mL
  4. History of urethral stenosis or its management
  5. Known or suspected neurogenic bladder
  6. Participants with active urinary tract infection until appropriately treated
  7. Participants with preexisting conditions, which, in the opinion of the investigator, interfere with the conduct of the study
  8. Participants who lack the capacity, or cannot speak English, in order to provide free and informed written consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Thulium Fibre Laser (TFL)
Patients randomized to this arm will undergo treatment using the TFL.
Device: Thulium Fibre Laser
Participants will undergo treatment using the TFL
Experimental: MOSES Holmium Laser
Patients randomized to this arm will undergo treatment using the MOSES Holmium laser.
Device: MOSES Holmium Laser
Participants will undergo treatment using the MOSES Holmium laser.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Length of stay in the hospital
Time Frame: within 6 hours
within 6 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of bleeding
Time Frame: Intra-Op
Intra-Op
Incidence of blood transfusion
Time Frame: Intra-Op
Intra-Op
Operative time
Time Frame: Intra-Op
Including laser use time
Intra-Op
International Prostate Symptom Score
Time Frame: 1,3,6,12 months post-op
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.
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

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'.
1,3,6,12 months post-op
Peak flow rate
Time Frame: 1,3,6,12 months post-op
Qmax
1,3,6,12 months post-op
Post-void residual
Time Frame: 1,3,6,12 months post-op
PVR
1,3,6,12 months post-op
Prostate specific antigen
Time Frame: 1,3,6,12 months post-op
PSA
1,3,6,12 months post-op
Change in size
Time Frame: 6 months
Assessed by TRUS
6 months
Time to Catheter Removal
Time Frame: within 4 hours
within 4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thunder Bay Regional Health Research Institute

Investigators

  • Principal Investigator: Hazem Elmansy, MD, Thunder Bay Regional Health Sciences Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2022

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

January 7, 2022

First Submitted That Met QC Criteria

February 14, 2022

First Posted (Actual)

February 15, 2022

Study Record Updates

Last Update Posted (Actual)

August 16, 2024

Last Update Submitted That Met QC Criteria

August 15, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RP-775

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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