TFLEP vs m-HoLEP for Enlarged Prostate

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial compares two laser treatments for men with enlarged prostates causing urinary problems. It aims to see which laser method, holmium with Moses technology or thulium fiber, is safer and more effective. The study will help doctors choose the best treatment for their patients.

Eligibility Criteria

Men with bothersome urinary symptoms due to an enlarged prostate (BPH), who haven't improved with medication, can join. They should have a prostate size between 50-300 grams and a urine flow rate of less than 15 ml/sec. Men who've had previous prostate/bladder surgery, cancer in these areas, or certain bladder conditions cannot participate.

Inclusion Criteria

My previous treatments did not work well.

I have severe symptoms from an enlarged prostate, like difficulty urinating or kidney issues.

Qmax < 15 ml/sec and

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Exclusion Criteria

I have had surgery on my prostate.

I am on blood thinners, but I can't stop them for surgery.

I am not a candidate for surgery due to my health condition.

See 3 more

Treatment Details

Interventions

m-HoLEP (Procedure)
TFLEP (Procedure)

Trial OverviewThe study compares two laser technologies for treating BPH: m-HoLEP uses the Ho: YAG laser with Moses technology for better blood control; TFLEP uses thulium fiber laser which may offer similar benefits. The trial will assess safety and effectiveness up to one year after treatment.

Participant Groups

2Treatment groups

Active Control

Group I: m-HoLEPActive Control1 Intervention

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.

Group II: TFLEPActive Control1 Intervention

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.