Active not recruitingNAINTERVENTIONAL

Efficacy of High Intensity Laser for Provoked Vestibulodynia

This research is investigating a new treatment for women who experience long-lasting pain around the opening of the vagina, a condition called provoked vestibulodynia. This pain often occurs during sex or when pressure is applied. Many women with this condition find that current treatments don't fully help, so new options are needed. We are testing a treatment called High Intensity Laser Therapy (HILT). In this study, some women will receive the active laser treatment, while others will get a 'dummy' laser treatment that looks and feels similar but isn't active. This helps us understand if the real laser is effective. The aim is to see if this laser can reduce pain and improve overall well-being and quality of life for those affected.

At a glance

Status

Active not recruiting

Phase

Sponsor

Université de Sherbrooke

Enrolment target

142

Start

26 Oct 2022

Estimated completion

01 Nov 2025

Vulvodynia

What is this study about?

Imagine feeling a sharp or burning pain around the opening of your vagina, especially when there's touch or an attempt at sex. This is called provoked vestibulodynia (say: vul-voh-din-ee-uh), and it's a type of persistent pain that affects many women. It can make everyday life and relationships difficult, and for some, the treatments available don't always fully resolve the pain.

Because many women still struggle with this pain, doctors are always looking for new and better ways to help. We've done some smaller studies that suggest a treatment called High Intensity Laser Therapy (HILT) might be helpful for chronic pain, including this type of vaginal pain. This laser doesn't cut or burn the skin; instead, it uses light to try and reduce pain and inflammation beneath the surface. Now, we need to do a bigger study to confirm if it really works.

This study will compare the active laser treatment to a 'sham' (or dummy) laser treatment. This helps us to truly understand if the laser itself is making a difference, rather than other factors. By doing this, we hope to find a new, effective way to help women living with provoked vestibulodynia to reduce their pain and improve their quality of life.

Key takeaways

The study explores a new laser treatment for specific vaginal pain.
It compares an active laser to a 'dummy' treatment.
Participation involves 12 short treatment sessions over 6 weeks, plus follow-up.
The aim is to reduce pain and improve quality of life.
You won't know if you're getting the active or dummy treatment.
You can withdraw from the study at any time.

Who may be eligible?

To join this study, you must be a woman between 18 and 45 years old. You need to have been experiencing moderate to severe pain around the opening of your vagina during sex or when touch is applied, for at least three months. This pain should also happen at least 90% of the time during these activities. A doctor will confirm your specific diagnosis through a special gynaecological exam.

There are also some reasons why you might not be able to join. For example, if your vaginal pain is caused by something else, like a skin condition, an infection, or certain other medical issues, then this study might not be suitable for you. If you've been pregnant in the last year, are currently pregnant, or have gone through menopause, you wouldn't be able to participate.

Also, if you've had certain surgeries in the vaginal or pelvic area, or if you've already had laser treatment for vaginal pain before, this study isn't for you. It's important that we check for any other medical conditions or medications you're taking that could affect your pain or the study results.

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 woman between 18 and 45 years old?
Do you have regular moderate to severe pain around the vaginal opening, most often during sex or touch, for at least 3 months?
Have you *not* had laser treatment for vaginal pain before?
Are you *not* currently pregnant or have you been pregnant in the last year?
Do you *not* have other major conditions like active infections or certain surgeries that could explain your pain?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll first have a gynaecological examination to make sure the study is right for you. Then, you'll complete some questionnaires about your pain and how you're feeling. After this, you'll be randomly placed into one of two groups: either the active laser group or the dummy laser group.

Both groups will have 12 treatment sessions over six weeks, meaning you'll come in twice a week for about 30 minutes each time. If you're in the active laser group, you'll get the real High Intensity Laser Therapy. If you're in the dummy laser group, you'll have a device that looks and feels like the real one but doesn't deliver any active treatment. You won't know which group you're in.

After your treatments are finished, you'll fill out the questionnaires again two weeks later, and then again six months after that, to see if there have been any changes or improvements. The total duration of your active involvement in the study, including follow-up, will be around 6 months and 2 weeks.

Potential risks and benefits

Participating in this study might offer some potential benefits. If you receive the active laser treatment, your pain might improve, leading to a better quality of life and reduced distress. Even if you receive the dummy treatment, your regular check-ups and attention from the study team might be beneficial. However, there's no guarantee the treatment will work for you, and it's also possible you could receive the dummy treatment which is not expected to have a direct health benefit. Potential risks of the laser treatment are generally considered low, but could include temporary mild skin irritation or discomfort, which will be monitored closely. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (4)

Centre Hospitalier Universitaire de Québec - Université Laval
Verified postcode
Québec, Canada
Kinatex l'Ormière
Verified postcode
Québec, Canada
Centre hospitalier universitaire de Sherbrooke
Verified postcode
Sherbrooke, Canada
Exogenia
Verified postcode
Sherbrooke, Canada

Common questions

What is provoked vestibulodynia?

It's a type of ongoing pain around the opening of the vagina that usually happens when there's touch, pressure, or during sex.

What is High Intensity Laser Therapy (HILT) exactly?

It's a treatment that uses a special type of light energy. It's non-invasive, meaning it doesn't involve needles or surgery, and aims to reduce pain and inflammation.

Will I know if I'm getting the real laser or the dummy treatment?

No, you won't know which group you're in. This helps us fairly test the treatment without your expectations influencing the results.

How long will my appointments be?

Each treatment session will be about 30 minutes long, and you'll have two sessions per week for six weeks.

What if I decide I don't want to continue the study?

You are completely free to leave the study at any point, and your decision will not affect your medical care in any way.