Microneedle Treatment of Chronic Phase Peyronie's Disease: A Pilot Clinical Trial
This study is investigating a new treatment called microneedling for men with Peyronie's disease. Peyronie's disease causes scar tissue on the penis, leading to bending, shortening, or pain during sex. Microneedling involves making very tiny pokes in the scarred areas to encourage natural healing. This initial study, called a 'pilot trial,' will check how safe and practical this microneedle treatment is for men who have had stable Peyronie's disease for at least a year. Participants will have assessments of their penis, fill out questionnaires, and receive 3-4 microneedling sessions. The researchers will then follow up on their progress for nearly a year to see the results.
At a glance
What is this study about?
Peyronie's disease is a condition where scar tissue, often called a 'plaque,' forms under the skin of the penis. This scar tissue isn't like a normal scar; it can be quite firm and cause the penis to bend or curve when erect. For some men, this bending can be significant, leading to issues like a shorter penis, narrowing, or even pain during sex. It can also significantly impact a man's confidence and overall well-being. This study is focusing on men who have had Peyronie's disease for a while, where the condition has become stable and isn't actively changing.
The research team is exploring a new approach called 'microneedling.' This involves using a device that creates very small, shallow punctures in the skin and scar tissue. The idea behind microneedling is that these tiny injuries can help stimulate the body's natural healing processes and encourage the scar tissue to become softer or more flexible. It's a 'minimally invasive' treatment, meaning it doesn't involve major surgery.
This particular study is a 'pilot clinical trial,' which means it's an early-stage study designed to understand the basics. The main goals are to find out if microneedling is safe to use for Peyronie's disease and if it's a practical treatment to give in a clinic setting. The results will help researchers decide if this treatment shows enough promise to be studied further in larger trials.
Key takeaways
- This study is testing a new, minimally invasive treatment called microneedling for Peyronie's disease.
- It's a pilot study, focused on safety and how practical the treatment is for men with stable, long-term Peyronie's.
- Participation involves assessments, 3-4 treatment sessions, and follow-ups for about a year.
- It's an opportunity to try a new approach, but there's no guarantee of improvement.
- You can withdraw from the study at any time if you wish.
Who may be eligible?
To join this study, you need to be a healthy man aged 18 or older. You must have been diagnosed with Peyronie's disease for at least 12 months, and importantly, your condition must be stable, meaning the bend in your penis hasn't changed in the last six months, and you're not experiencing pain from it. The bend in your penis needs to be between 30 and 90 degrees.
There are also some reasons why you wouldn't be able to join. For example, if your penis has problems other than Peyronie's, such as certain birth defects, infections, or other types of growths. Men whose penis doesn't get firm enough to measure the bend accurately, or who have very hard, calcified scar tissue that couldn't be treated with microneedling, would also not be eligible. If you've recently had other treatments for Peyronie's disease, like surgery, injections, or certain medications, you'll need to wait for a specific period before you can consider joining this study.
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?
- Have you had Peyronie's disease for at least one year?
- Has your Peyronie's disease been stable (no changes in bend, no pain) for the last six months?
- Is the bend in your penis typically between 30 and 90 degrees when erect?
- Have you waited the required time after any previous Peyronie's treatments (e.g., injections, surgery)?
- Are you able to get an erection firm enough for measurements?
What does participation involve?
If you join this study, you will first have a detailed check-up. This includes measuring your penis both when it's soft and when it's erect, and using an ultrasound scan to get a better look at the bend. You'll also be asked to complete questionnaires about your sexual health and how Peyronie's disease affects you.
Following these initial checks, you will undergo 3 to 4 microneedle treatment sessions. These sessions will be spaced out, happening every 6 to 8 weeks. After your treatments are complete, the study team will follow up with you. There will be a shorter follow-up around 24 weeks after the start of the study, and a longer one approximately 52 to 54 weeks (about a year) later, to see how you're doing in the long term. The total duration of your involvement in the study, from your first visit to your final follow-up, will be just over a year.
Potential risks and benefits
Locations (1)
- The Ottawa HospitalVerified postcodeOttawa, Canada
Common questions
What is Peyronie's disease?
It's a condition where scar tissue forms inside the penis, causing it to bend or curve, often leading to pain or difficulty during sex.
What is microneedling?
It's a procedure that uses very fine needles to make tiny punctures in the skin and scar tissue, aiming to encourage natural healing.
Will I get better if I join this study?
This is a pilot study, meaning it's an early test. There's no guarantee the treatment will work for everyone, but researchers hope to see if it's safe and practical.
How long will the study last for me?
From your first visit to your final check-up, your involvement in the study will be for about a year.
Can I leave the study once I start?
Yes, you can choose to leave the study at any point, and your decision will not affect your future medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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