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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
Awards & highlights

Laser_RCT Trial Summary

This trial investigates if laser treatment can help women suffering from provoked vestibulodynia. Participants will receive either active laser treatment or a deactivated laser treatment and will be assessed before and after treatment.

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.Check my eligibility
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.See study design
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.

Laser_RCT Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pain
Secondary outcome measures
Keratoplasty, Penetrating
Pain
Change in intercourse self-efficacy
+7 more

Laser_RCT 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)

Find a Location

Who is running the clinical trial?

Université de SherbrookeLead Sponsor
292 Previous Clinical Trials
69,299 Total Patients Enrolled
6 Trials studying Vulvodynia
456 Patients Enrolled for Vulvodynia
Centre de recherche du Centre hospitalier universitaire de SherbrookeOTHER
58 Previous Clinical Trials
31,023 Total Patients Enrolled
3 Trials studying Vulvodynia
126 Patients Enrolled for Vulvodynia
ExogeniaUNKNOWN
1 Previous Clinical Trials
41 Total Patients Enrolled
1 Trials studying Vulvodynia
41 Patients Enrolled for Vulvodynia

Media Library

High Intensity Laser Therapy (HILT) (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05597358 — N/A
Vulvodynia Research Study Groups: Sham High Intensity Laser Therapy, High Intensity Laser Therapy (HILT)
Vulvodynia Clinical Trial 2023: High Intensity Laser Therapy (HILT) Highlights & Side Effects. Trial Name: NCT05597358 — N/A
High Intensity Laser Therapy (HILT) (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05597358 — N/A
Vulvodynia Patient Testimony for trial: Trial Name: NCT05597358 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To which demographic is participation in this trial open?

"This clinical trial requires participants to have vulvodynia and be aged between 18 and 45. The study is currently seeking 142 patients in total."

Answered by AI

Are individuals aged 40 or above able to participate in this clinical examination?

"This medical trial has a minimum age of consent and a maximum age limit for participants, 18 years old and 45 years old respectively."

Answered by AI

Are enrollees being sought at present for this medical trial?

"Evidently, this specific clinical trial is not currently accepting patients. Initially posted on November 7th 2022 and last updated on October 24th 2022, the study is inactive for now. However, there are 10 other studies that have open recruitment at present time."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
3+
What state do they live in?
Ontario
Florida
What site did they apply to?
Exogenia
Centre Hospitalier Universitaire de Québec - Université Laval

Why did patients apply to this trial?

I want to collaborate with the Vulvodynia Community to find a treatment that be accessible to many patients.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

Who is responsible for the expenses?
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Efficacy of High Intensity Laser for Provoked Vestibulodynia
2022. "Efficacy of High Intensity Laser for Provoked Vestibulodynia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05597358.
All > Vulvodynia
~71 spots leftby Nov 2025
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