RecruitingPHASE1INTERVENTIONAL

Title Fractioned CO2 Laser in the Treatment of Chronic Phase Peyronie's Disease

This study is exploring a new way to treat Peyronie's disease, a condition where scar tissue forms in the penis, causing it to bend or curve. This can lead to pain, difficulty with sex, and emotional distress. Current treatments have their drawbacks, so we're looking at a different option: a special laser that uses light to reduce the scar tissue on the skin's surface. This study is an early stage (Phase 1) trial. Our main goal is to find out if this laser treatment is safe for chronic Peyronie's disease and whether it's practical to use. We'll also check if it helps reduce the penis curve. We hope this research can lead to a new, effective treatment for men affected by this condition.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Ottawa Hospital Research Institute

Enrolment target

Start

01 Oct 2025

Estimated completion

01 Oct 2027

Peyronies Disease

What is this study about?

Peyronie's disease is a condition that affects the penis. It's caused by a build-up of scar tissue, like a tough patch, inside the penis. This scar tissue can make the penis bend, shorten, or have dents when it’s erect. For many men, this can cause pain during sex, make it difficult to have intercourse, and significantly impact their confidence and well-being. Current treatments for Peyronie's disease, whether they are medications or surgery, have some limitations. For example, some proven treatments are not available everywhere, and surgery can sometimes lead to new problems like issues with erections or changes in feeling.

This study is looking into a new treatment called Fractional CO2 Laser Therapy. This laser treatment is applied to the surface of the skin and uses light to break down and reduce the abnormal scar tissue. It's a non-invasive treatment, meaning it doesn't involve needles or cuts. It's already been tried in a small study where it helped reduce the penis curve safely for all men involved. We want to investigate this option further because it has the potential to offer a less invasive and more widely available treatment for men living with Peyronie's disease.

This is an early-stage (Phase 1) study. Our main goals are to check if the Fractional CO2 Laser is safe to use for men with Peyronie's disease that has been stable for a while, and to see if it's practical to give this treatment. We'll also be carefully looking to see if the treatment helps to reduce the bending or curving of the penis. Participants will have several check-ups, receive three laser treatments, and then have follow-up appointments to see how they're doing both in the short and longer term.

Key takeaways

Exploring a new, non-invasive laser treatment for Peyronie's disease.
This is an early-stage study focused on safety and feasibility.
Aims to reduce penile curvature and improve quality of life.
Requires three laser sessions over six weeks, and follow-up for a year.
Eligibility includes stable Peyronie's for at least 12 months with a specific curve angle.

Who may be eligible?

To join this study, you need to be a man aged 18 or older with Peyronie's disease. Your condition must have been present for at least 12 months and stable for at least 6 months, meaning the bend in your penis hasn't changed and you're not experiencing pain related to it anymore. Your penis should have a bend or curve between 30 and 90 degrees when erect, and you must be able to understand and complete forms in English.

There are certain reasons why you might not be able to join. For example, if your penis curve is less than 30 or more than 90 degrees, or if you have other penis conditions not related to Peyronie's. You also can't have solid, very hard calcium deposits (calcification) in the scar tissue, as this would prevent the laser from working. If you've recently had other treatments for Peyronie's disease, such as surgery, injections, or special shockwave therapy within the last few months, you might not be eligible.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a man aged 18 or older?
Has your Peyronie's disease been stable (unchanged curve, no pain) for at least 6 months?
Is your penile curve between 30 and 90 degrees?
Do you not have hard calcification in your penis scar tissue?
Have you not had other Peyronie's treatments (like surgery or injections) recently?

Answer every question to see your result.

What does participation involve?

If you join this study, you will first have a health check-up for your Peyronie's disease. This will involve measuring your penis and checking the curve with a special ultrasound scan. You'll also be asked to fill out questionnaires about your sexual function and how Peyronie's disease affects you. You will then receive three laser treatment sessions, which will be spaced out every six weeks. After your treatments, you'll have follow-up appointments to see how you're getting on, both 24 weeks (about 6 months) and 52 weeks (about a year) after your first treatment. The total duration of the study for you will be about a year.

Potential risks and benefits

Participating in this study might offer a potential benefit if the laser treatment helps reduce the curve in your penis, which could improve your quality of life and make sexual activity easier. However, as this is an early-stage study for a new treatment, there's always a chance it might not work for you, or it could cause side effects. Possible risks of laser treatment might include temporary redness, swelling, or discomfort in the treated area, similar to other skin laser procedures. All procedures carry some level of risk. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

The Ottawa Hospital
Verified postcode
Ottawa, Canada· Recruiting

Common questions

What is fractional CO2 laser therapy?

It's a skin surface treatment that uses light to gently break down scar tissue. It's non-invasive, meaning no needles or cuts.

What is Peyronie's disease?

It's a condition where scar tissue forms in the penis, causing it to bend or curve, which can lead to pain and make sex difficult.

Is this a new treatment?

This laser technology has been used for other conditions, but its use for Peyronie's disease is still in early research stages (Phase 1 clinical trial).

How long does the study last?

If you take part, you'll be involved for about a year, including treatments and follow-up visits.

Will I receive actual treatment or a 'no treatment' approach?

The information provided only mentions Fractional CO2 laser and 'Sham (No Treatment)' as interventions. The summary states 'Enrolled study participants will undergo an initial clinical assessment… They will then undergo 3 laser therapy sessions'. This means that all participants in this study would be receiving the active laser treatment, not the 'sham' or 'no treatment' option.

How to find out more

Amanda Ross

amanross@toh.ca 6137985555 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.