What side effects are associated with this type of intervention?

Common treatments for vulvodynia similar to High Intensity Laser Therapy (HILT) include low-level laser therapy (LLLT) and physical therapy. Known side effects of these treatments are generally minimal but can include temporary discomfort or pain at the treatment site, redness, and swelling. In rare cases, patients may experience burns or skin irritation. Overall, these treatments are considered safe with a low risk of serious adverse effects.

What prior FDA approvals exist?

As of now, there are no specific FDA-approved treatments for Vulvodynia that directly align with the mechanisms of High Intensity Laser Therapy (HILT). However, treatments for Vulvodynia generally include medications such as topical anesthetics, anticonvulsants, and antidepressants to manage pain. Non-pharmacologic treatments like physical therapy and cognitive-behavioral therapy are also commonly used. While laser therapies are being studied for their potential benefits, they have not yet received FDA approval specifically for Vulvodynia.

What other types of research exist?

Promising, novel alternatives to High Intensity Laser Therapy (HILT) for Vulvodynia patients include: 1) Low-Level Laser Therapy (LLLT), which uses lower energy levels to achieve similar therapeutic effects; 2) Photodynamic Therapy (PDT), which combines light with photosensitizing agents to target and treat affected tissues; and 3) Platelet-Rich Plasma (PRP) therapy, which uses concentrated platelets from the patient's own blood to promote healing and reduce inflammation.

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High Intensity Laser Therapy for Vulvodynia (Laser_RCT Trial)

N/A

Recruiting

Led By Mélanie Morin, PT, PhD

Research Sponsored by Université de Sherbrooke

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2-week post-treatment evaluation, 6-months follow-up assessment

Summary

This trial is testing a powerful laser treatment to help women with a specific type of chronic vaginal pain. The laser aims to reduce pain and improve their quality of life by using focused light energy. Laser therapy has shown promise in treating similar conditions, with benefits lasting for an extended period.

Who is the study for?

This trial is for women who've had provoked vestibulodynia, a type of vulvar pain, for at least 3 months. They should feel moderate to severe pain during sexual activities most of the time. Women with certain urogynecological conditions, other causes of vulvovaginal pain, recent pregnancies or surgeries in the area, or those using medications affecting pain perception are not eligible.

What is being tested?

The study compares High Intensity Laser Therapy (HILT) with a sham treatment to see which is more effective for reducing vulvar pain. Participants will be randomly assigned to receive either real laser therapy or a placebo-like inactive laser in biweekly sessions over six weeks.

What are the potential side effects?

While specific side effects are not detailed here, HILT may cause discomfort at the site of application and potential skin irritation. The sham procedure should have no side effects as it's inactive; however, participants might experience placebo effects.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2-week post-treatment evaluation, 6-months follow-up assessment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2-week post-treatment evaluation, 6-months follow-up assessment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2-week post-treatment evaluation, 6-months follow-up assessment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pain

Secondary study objectives

Keratoplasty, Penetrating

Pain

Change in intercourse self-efficacy

+7 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: High Intensity Laser Therapy (HILT)Active Control1 Intervention

Active high intensity laser therapy for 12 biweekly sessions (6 consecutive weeks of biweekly treatments)

Group II: Sham High Intensity Laser TherapyPlacebo Group1 Intervention

Sham high-intensity laser therapy for 12 biweekly sessions (6 consecutive weeks of biweekly treatments)

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

High Intensity Laser Therapy (HILT) for Vulvodynia works by using concentrated light energy to reduce pain and inflammation, promote tissue repair, and improve blood circulation. This is crucial for Vulvodynia patients as it directly addresses the chronic pain and inflammation associated with the condition, potentially providing significant relief and improving quality of life. Enhanced tissue repair and blood circulation further aid in healing and reducing symptom recurrence.

The use of vaginal lasers in the treatment of urinary incontinence and overactive bladder, systematic review.Update: The Clinical Role of Vaginal Lasers for the Treatment of the Genitourinary Syndrome of Menopause.A systematic review of laser therapy for vulvovaginal atrophy/genitourinary syndrome of menopause in breast cancer survivors.