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CO2 Laser Therapy for Peyronie's Disease
N/A
Waitlist Available
Led By Ryan Flannigan, MD
Research Sponsored by University of British Columbia
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 change in penile measurements (baseline vs. week 18, 24, & 52).
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a laser therapy to treat men with Peyronie's Disease by breaking down scar tissue in the penis, aiming to improve its shape and function without invasive procedures. Laser therapy has been proposed with success in the treatment of Induratio Penis Plastica (IPP), also called Peyronie's Syndrome.
Who is the study for?
This trial is for healthy males aged 18 or older, diagnosed with Peyronie's Disease for at least a year and have stable disease. They must be in a stable relationship, able to read and understand English, and willing to sign consent forms. Men with penile curvature between 30º-90º are eligible.
What is being tested?
The study tests Fractional Carbon Dioxide Laser Therapy as a treatment for Peyronie's Disease. Participants will receive this therapy at a laser density coverage of 10-15%. It's designed to see if the laser can help reduce symptoms of the disease.
What are the potential side effects?
Potential side effects may include discomfort during the procedure, redness, swelling, burning sensation on treated areas, changes in skin pigmentation, and scarring.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change in penile measurements (baseline vs. week 18, 24, & 52).
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change in penile measurements (baseline vs. week 18, 24, & 52).
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Measured reduction in penile curvature
Secondary study objectives
International Index of Erectile Function Questionnaire
Peyronie's Disease Questionnaire
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Fractional CO2 Laser Therapy at 10-15% Laser Density CoverageExperimental Treatment1 Intervention
Study participants with Peyronies Disease will be treated with a Fractional Carbon Dioxide Laser set at a 10-15% laser density. The patient will receive three laser therapy sessions over 12 weeks (one session every four weeks). Following each session, topical triamcinolone will be applied to the treated area.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fractional Carbon Dioxide Laser Therapy at 10-15% Laser Density Coverage
2021
N/A
~10
Find a Location
Who is running the clinical trial?
University of British ColumbiaLead Sponsor
1,472 Previous Clinical Trials
2,489,615 Total Patients Enrolled
Ryan Flannigan, MDPrincipal InvestigatorUBC Faculty of Medicine - Department of Urologic Sciences
1 Previous Clinical Trials
12 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are willing to have vaginal intercourse with a female partner/spousePenile curvature of 30º-90º in the dorsal, lateral, or dorsal/lateral plane.You have Peyronie's disease for at least 12 months with evidence of stable disease as determined by the investigator.You have signed an informed consent agreement and an authorization form to allow disclosure of protected information.You are able to read, complete, and understand the various rating instruments in English.
Research Study Groups:
This trial has the following groups:- Group 1: Fractional CO2 Laser Therapy at 10-15% Laser Density Coverage
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.