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Procedure

TFLEP vs m-HoLEP for Enlarged Prostate

N/A
Recruiting
Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Inadequate response to previous medical treatments,
Patients with symptomatic benign prostate hyperplasia : urinary retention, acute renal failure (post-renal), refractory hematuria, repeated urinary tract infections, refractory symptoms.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1-year post-operatively
Awards & highlights

Study Summary

This trialis comparing two types of laser technology to treat BPH and bladder obstruction, to see which is more effective in improving quality of life, reducing hospital stay and hemoglobin drop.

Who is the study for?
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.Check my eligibility
What is being tested?
The 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.See study design
What are the potential side effects?
Potential side effects from both procedures include bleeding, infection risk, temporary difficulty urinating or need for catheterization post-surgery, irritation during urination, erectile dysfunction, and rare cases of urinary incontinence.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My previous treatments did not work well.
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I have severe symptoms from an enlarged prostate, like difficulty urinating or kidney issues.
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My prostate weighs between 50-300 grams.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1-year post-operatively
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1-year post-operatively for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To compare the hospital stay between the thulium fiber laser enucleation of the prostate (TFLEP) and the holmium:YAG laser enucleation of the prostate with Moses technology (m-HoLEP).
Secondary outcome measures
To compare catheterization time between cohorts
To compare change in erectile function (IIEF) between cohorts
To compare drop in International Prostate Symptom Score (I-PSS) between cohorts
+10 more

Trial Design

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.

Find a Location

Who is running the clinical trial?

Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
365 Previous Clinical Trials
129,209 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still openings available in this research endeavor?

"Yes, the clinical trial is currently recruiting volunteers. The initial post was made on September 8th 2021 and it was recently updated on November 10th 2022 according to information found through clinicaltrials.gov."

Answered by AI

How many individuals have volunteered to be part of this clinical experiment?

"Affirmative. The information hosted on clinicaltrials.gov indicates that the trial is currently recruiting participants, with initial posting occuring on September 8th 2021 and most recent editing done November 10th 2022. 100 individuals are required to join this study from 1 medical centre."

Answered by AI
~14 spots leftby Sep 2024