All > Congenital Adrenal Hyperplasia

m-HoLEP for Enlarged Prostate

Centre hospitalier de l'Université de Montréal, Montréal, Canada
Enlarged ProstateTFLEP - Procedure
Eligibility
18+
Male
What conditions do you have?
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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.

Eligible Conditions
  • Enlarged Prostate

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
N/A

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Loop Diuretic (Furosemide)
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Flexible diuretic regimen
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Holmium laser with thulium lasers

Study Objectives

1 Primary · 13 Secondary · Reporting Duration: Up to 1-year post-operatively

1 day post-operatively
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).
During surgery
To compare enucleation and morcellation time between cohorts
To compare enucleation rate of instrumentation between cohorts
To compare intraoperative adverse events between cohorts
To compare operative time between cohorts
Up to 1-year post-operatively
To compare change in erectile function (IIEF) between cohorts
To compare drop in International Prostate Symptom Score (I-PSS) between cohorts
To compare peak urine flow rates (Qmax) between cohorts
To compare post-void residual urine volume (PVR) between cohorts
To compare postoperative complications levels between cohorts
To compare prostate-specific antigen (PSA) levels between cohorts
To compare the impact of incontinence (ICIQ-short form) between cohorts
To measure increase of Quality of life (QoL) between cohorts
Up to 7-days post-operatively
To compare catheterization time between cohorts

Trial Safety

Phase-Based Safety

1 of 3

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3
Loop Diuretic (Furosemide)
3
Flexible diuretic regimen
3
Holmium laser with thulium lasers

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

m-HoLEP
1 of 2
TFLEP
1 of 2

Active Control

100 Total Participants · 2 Treatment Groups

Primary Treatment: m-HoLEP · No Placebo Group · N/A

m-HoLEP
Procedure
ActiveComparator Group · 1 Intervention: m-HoLEP · Intervention Types: Procedure
TFLEP
Procedure
ActiveComparator Group · 1 Intervention: TFLEP · Intervention Types: Procedure

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 1-year post-operatively

Who is running the clinical trial?

Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
340 Previous Clinical Trials
116,784 Total Patients Enrolled

Eligibility Criteria

Age 18+ · Male Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Previous medical treatments have not been effective.
You have an enlarged prostate gland that is causing troublesome urinary symptoms or other complications such as kidney problems or recurrent infections.
You have a high score on the International Prognostic Scoring System (IPSS), which helps predict the likelihood of developing a blood disorder.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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