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Laser Therapy
Thulium Fiber vs MOSES Holmium Laser for Enlarged Prostate
N/A
Recruiting
Led By Hazem Elmansy, MD
Research Sponsored by Thunder Bay Regional Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1,3,6,12 months post-op
Awards & highlights
Study Summary
This trial is testing two procedures for benign prostatic hyperplasia (BPH), a non-cancerous enlargement of the prostate. The procedures being tested are transurethral resection of the prostate (TURP) and holmium laser enucleation of the prostate (HoLEP). The study will compare the two procedures in terms of length of hospital stay, intraoperative outcomes, and postoperative outcomes.
Who is the study for?
This trial is for men over 50 with severe urinary symptoms from an enlarged prostate (BPH) who haven't improved with medication. They must have a prostate size of ≥80 ml, be able to follow study procedures, and give informed consent in English. Men with urethral stenosis history, prostate cancer, active infections or previous BPH surgery are excluded.Check my eligibility
What is being tested?
The study compares two laser treatments for BPH: Thulium Fiber Laser (TFL) enucleation and Holmium MOSES Laser enucleation. It aims to see if they're equally effective in reducing hospital stay time and improving intraoperative and postoperative outcomes.See study design
What are the potential side effects?
Potential side effects may include bleeding requiring blood transfusion, late postoperative bleeding similar to TURP complications but expected less due to the nature of laser treatments which typically result in minimal blood loss.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1,3,6,12 months post-op
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1,3,6,12 months post-op
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Length of stay in the hospital
Secondary outcome measures
Change in size
Incidence of bleeding
Incidence of blood transfusion
+7 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Thulium Fibre Laser (TFL)Experimental Treatment1 Intervention
Patients randomized to this arm will undergo treatment using the TFL.
Group II: MOSES Holmium LaserExperimental Treatment1 Intervention
Patients randomized to this arm will undergo treatment using the MOSES Holmium laser.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Thulium Fibre Laser
2022
N/A
~190
Find a Location
Who is running the clinical trial?
Thunder Bay Regional Research InstituteLead Sponsor
8 Previous Clinical Trials
730 Total Patients Enrolled
Thunder Bay Regional Health Research InstituteLead Sponsor
9 Previous Clinical Trials
830 Total Patients Enrolled
Hazem Elmansy, MDPrincipal InvestigatorThunder Bay Regional Health Sciences Centre
4 Previous Clinical Trials
450 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had urethral stenosis or treatment for it.I can understand and consent to the study in English.My prostate is smaller than 80 mL.I am a man over 50 years old.I have had surgery for an enlarged prostate.I have a history of prostate cancer.My prostate was measured to be 80 ml or larger before surgery.I have bladder control issues due to nerve problems.I do not have an active urinary tract infection, or it is being treated.I have been referred to a urologist for ongoing urinary problems due to an enlarged prostate.My condition did not improve with medication alone.
Research Study Groups:
This trial has the following groups:- Group 1: Thulium Fibre Laser (TFL)
- Group 2: MOSES Holmium Laser
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any open recruitment opportunities for this clinical trial?
"Affirmative. According to clinicaltrials.gov, this clinical trial is actively accepting applicants with the initial post and last update both occurring on April 20th 2022. 104 patients need to be recruited from 1 site for participation in the trial."
Answered by AI
How many individuals are currently engaged in this medical experiment?
"Affirmative. According to the records on clinicaltrials.gov, this research is currently recruiting participants. It was originally posted on April 20th 2022 and has been updated recently on the same day. The research requires 104 individuals from one specific centre for enrollment."
Answered by AI
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