Thulium Fiber Laser Compared to Holmium:YAG Laser With Moses Technology for Enucleation of the Prostate: A Prospective Study

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Canada
Centre hospitalier de l'Université de Montréal
RECRUITING
Montreal
Time Frame
Start Date: 2021-09-08
Estimated Completion Date: 2024-09
Participants
Target number of participants: 100
Treatments
Active_comparator: TFLEP
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.
Active_comparator: m-HoLEP
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.
Related Therapeutic Areas
Sponsors
Leads: Centre hospitalier de l'Université de Montréal (CHUM)

This content was sourced from clinicaltrials.gov