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NCT Number: NCT05240001

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

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.

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Key information

Age range

50 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Thunder Bay Regional Health Sciences Centre

Thunder Bay, Ontario, P7B 6V4, Canada

Location status: Recruiting

Location contact

Rabail Siddiqui, MPH, MHSc

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Thulium Fibre Laser

Device

Participants will undergo treatment using the TFL

MOSES holmium laser

Device

Participants will undergo treatment using the MOSES Holmium laser.

Primary outcomes

  1. Length of stay in the hospital

    Time frame: within 6 hours

Secondary outcomes

  1. Incidence of bleeding

    Time frame: Intra-Op

  2. Incidence of blood transfusion

    Time frame: Intra-Op

  3. Operative time

    Time frame: Intra-Op

    Including laser use time

  4. 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.

  5. 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'.

  6. Peak flow rate

    Time frame: 1,3,6,12 months post-op

    Qmax

  7. Post-void residual

    Time frame: 1,3,6,12 months post-op

    PVR

  8. Prostate specific antigen

    Time frame: 1,3,6,12 months post-op

    PSA

  9. Change in size

    Time frame: 6 months

    Assessed by TRUS

  10. Time to Catheter Removal

    Time frame: within 4 hours

Study contacts

Contact information is provided by the study sponsor or research team.

Hazem Elmansy, MD

CONTACT

Rabail Siddiqui, MPH, MHSc

CONTACT

[email protected]

(807) 684-6608

Sponsors and collaborators

Lead sponsor

Thunder Bay Regional Health Research Institute

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Feb 15, 2022
Registry last updated
Aug 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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