VulvodyniaLaser_RCTNCT05597358
Efficacy of High Intensity Laser for Provoked Vestibulodynia
A study testing High Intensity Laser Therapy (HILT) in people with Vulvodynia, run by Université de Sherbrooke at 4 sites in Canada.
Trial summary
This is a multicenter randomized controlled trial (RCT) investigating the effects of laser treatments in women suffering from provoked vestibulodynia compared to a sham-laser treatment. Following their enrollment in the study, participants will undergo a gynecological examination for confirmation of their diagnoses. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Vulvodynia
- What is being tested?
- High Intensity Laser Therapy (HILT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 145 participants
- Where
- 4 sitesCanada
- Study dates
- 26 Oct 2022to 16 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Moderate to severe pain (≥ 5/10) at least 90% of the time during sexual intercourse or attempted sexual intercourse for at least 3 months
- Provoked vestibulodynia of at least 3 months duration prior to the study and diagnosed by a standardized gynaecologic exam
Who cannot join
- Other causes of vulvovaginal pain (e.g., spontaneous vulvovaginal pain not related to sexual intercourse/contact, dermatological condition, herpes, vulvovaginal atrophy)
- Post-menopausal state
- Current pregnancy or pregnancy in the last year
- Urogynecological condition (e.g., pelvic organ prolapse (POP) ≥ 3, urinary/vaginal infection active or in the last 3 months)
- Anterior vulvar, vaginal or pelvic surgery (e.g., vestibulectomy, corrective pelvic organ prolapse surgery)
- Prior use of laser treatments for vulvar pain
- Expected changes of medication that could influence pain perception (e.g., analgesic, antidepressant)
- Other medical conditions that could interfere with the study
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
Centre Hospitalier Universitaire de Québec - Université Laval
Québec, Quebec, G1V 4G2
Kinatex l'Ormière
Québec, Quebec, G2B 3K3
Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec, J1H 5N4
Exogenia
Sherbrooke, Quebec, J1L 1C6
About this study
Official title: Efficacy of High Intensity Laser Therapy for Reducing Pain During Intercourse in Women With Provoked Vestibulodynia: A Multicenter Randomized Controlled Trial
This is a multicenter randomized controlled trial (RCT) investigating the effects of laser treatments in women suffering from provoked vestibulodynia compared to a sham-laser treatment. Following their enrollment in the study, participants will undergo a gynecological examination for confirmation of their diagnoses. Eligible participants will then be asked to complete a consent form and the baseline assessment. The baseline assessment consists of the completion of validated questionnaires (outcome measures). Participants will be randomized into the laser group or sham-laser group. The laser group will receive 12 sessions of active high intensity laser therapy (HILT) (30 minutes biweekly for 6 consecutive weeks). The sham-laser group will receive 12 sessions (30 minutes biweekly for 6 consecutive weeks) of laser therapy using a deactivated probe. Outcome measures (validated questionnaires) will also be assessed 2 weeks post-treatment as well as 6 months post-treatment (follow-up assessment).
Read the detailed description
Vulvodynia, a chronic vulvar pain condition, affects between 8 and 18% of reproductive-aged women. The main subtype of vulvodynia is provoked vestibulodynia (PVD), which is characterized by a sharp or burning pain at the vaginal opening while applying pressure to the vulvar vestibule or attempting vaginal penetration. Women suffering from PVD experience greater psychological distress, a worsened quality of life and overall well-being as well as sexual dysfunctions for both the women and their intimate partners. Women suffering from PVD have limited treatment options, and some women have persistent pain despite the available treatment options. Therefore, a new therapeutic avenue needs to be explored. High intensity laser therapy (HILT), a non-invasive and non-ablative laser technique, was found to be effective in several chronic pain conditions. Our randomized pilot study confirmed that HILT is feasible for treating PVD. The promising findings obtained provided support for conducting this large multicenter randomized controlled trial.
- Conditions
- Vulvodynia
- Being tested
- High Intensity Laser Therapy (HILT), Sham High Intensity Laser Therapy
- Keywords
- Laser, Provoked vestibulodynia, Pain, Sexual dysfunctions
- Medical subject headings
- Vulvodynia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity Laser Therapy (HILT)Radiation
Also called Nd:Yag laser
Nd:Yag 1064 nm pulsed high intensity laser will be applied to the vulvar area.
Sham High Intensity Laser TherapyRadiation
Also called Sham, Control, Deactivated probe
Nd:Yag 1064 pulsed high intensity laser deactivated probe will be applied to the vulvar area.
| Study group | Role | What they receive |
|---|---|---|
| High Intensity Laser Therapy (HILT) | Active comparator | Active high intensity laser therapy for 12 biweekly sessions (6 consecutive weeks of biweekly treatments) Receives: Radiation: High Intensity Laser Therapy (HILT) |
| Sham High Intensity Laser Therapy | Sham comparator | Sham high-intensity laser therapy for 12 biweekly sessions (6 consecutive weeks of biweekly treatments) Receives: Radiation: Sham High Intensity Laser Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain intensity during intercourse
To explore changes in pain intensity during intercourse (Numerical Rating Scale (NRS), ranging from 0 to 10, where 0 is no pain at all, and 10 is the worst pain ever)
Measured: Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment
Secondary outcomes (10)
Change in pain quality
To explore changes in the sensory, affective, and evaluative components of pain (McGill-Melzack Questionnaire). Minimum value: 0, Maximum value: 78, higher scores indicate a worse outcome (higher pain).
Measured: Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment
Change in sexual function
To explore changes in sexual function (Female Sexual Function Index - FSFI). Minimum value: 2, Maximum value: 36, lower scores indicate a worse outcome (low sexual function).
Measured: Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment
Change in sexual distress
To explore changes in sexual distress (Female Sexual Distress Scale - FSDS). Minimum value: 0, Maximum value: 52, higher scores indicate a worse outcome (higher sexually-related distress).
Measured: Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment
Change in pain catastrophizing
To explore changes in pain catastrophizing (Pain Catastrophizing Scale - PCS). Minimum value: 0, Maximum value: 52, higher scores indicate a worse outcome (higher pain catastrophizing).
Measured: Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment
Change in fear of pain
To explore changes in fear of pain (Pain Anxiety Symptoms Scale - PASS-20). Minimum value: 0, Maximum value: 100, higher scores indicate a worse outcome (higher fear of pain).
Measured: Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment
Change in cognitions regarding vaginal penetration
To explore the cognitions of women towards vaginal penetration (Vaginal penetration cognition questionnaire (VPCQ)). Minimum value: 0, Maximum value: 240, higher scores show higher levels of perceived penetration control.
Measured: Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment
Change in the life impact of pelvic pain
To explore the change in the life impact of pelvic pain (Pelvic Pain Impact Questionnaire). Minimum value: 0, Maximum value: 32, higher scores indicate that the pelvic pain of the participants has a strong impact on their life.
Measured: Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment
Change in intercourse self-efficacy
To explore the change self-efficacy regarding painful intercourse (Painful Intercourse Self-Efficacy Scale). Minimum value: 20, Maximum value: 100, higher scores indicate higher self-efficacy.
Measured: Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment
Level of satisfaction with treatment
To determine acceptability by measuring the participants' satisfaction with the treatment on a Numeric Rating Scale (NRS) ranging from 0 (completely dissatisfied) to 10 (completely satisfied).
Measured: 2-week post-treatment evaluation, 6-months follow-up assessment
Patient's global impression of change
To examine patient self-reported improvement (Patient's Global Impression of Change - PGIC) ranging from "very much worse" to "very much improved" on a 7-point scale.
Measured: 2-week post-treatment evaluation, 6-months follow-up assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2022
- Study start26 Oct 2022
- Primary completion16 Nov 2025
- Study completion16 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VulvodyniaStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- * Baseline evaluation * Randomization to active laser or sham laser (12 sessions in 6 consecutive weeks) Post-treatment evaluation (2 weeks post-treatment) * Follow-up evaluation (6 months post-treatment)
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Collaborators
- Centre de recherche du Centre hospitalier universitaire de Sherbrooke, Exogenia, CHU de Quebec-Universite Laval, Kinatex l'Ormière
- Responsible party
- Sponsor
- Investigators
- Mélanie Morin, PT, PhD, Principal investigator, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05597358
- Sponsor's protocol ID
- MP-31-2023-4770
- Acronym
- Laser_RCT
- Status last verified
- Jun 2026
- First submitted
- 24 Oct 2022
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Deidentified data will be made available upon approval by the principal investigator and study team.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of High Intensity Laser Therapy for Reducing Pain During Intercourse in Women With Provoked Vestibulodynia: A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05597358
- Acronym / sponsor ID
- Laser_RCT / MP-31-2023-4770
- Conditions
- Vulvodynia
- Keywords
- Laser, Provoked vestibulodynia, Pain, Sexual dysfunctions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Collaborators
- Centre de recherche du Centre hospitalier universitaire de Sherbrooke, Exogenia, CHU de Quebec-Universite Laval, Kinatex l'Ormière
- Study start
- 26 Oct 2022 (actual)
- Primary completion
- 16 Nov 2025 (actual)
- Study completion
- 16 Nov 2025 (actual)
- First posted
- 28 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter randomized controlled trial (RCT) investigating the effects of laser treatments in women suffering from provoked vestibulodynia compared to a sham-laser treatment. Following their enrollment in the study, participants will undergo a gynecological examination for confirmation of their diagnoses. Eligible participants will then be asked to complete a consent form and the baseline assessment. The baseline assessment consists of the completion of validated questionnaires (outcome measures). Participants will be randomized into the laser group or sham-laser group. The laser group will receive 12 sessions of active high intensity laser therapy (HILT) (30 minutes biweekly for 6 consecutive weeks). The sham-laser group will receive 12 sessions (30 minutes biweekly for 6 consecutive weeks) of laser therapy using a deactivated probe. Outcome measures (validated questionnaires) will also be assessed 2 weeks post-treatment as well as 6 months post-treatment (follow-up assessment).
Detailed description
Vulvodynia, a chronic vulvar pain condition, affects between 8 and 18% of reproductive-aged women. The main subtype of vulvodynia is provoked vestibulodynia (PVD), which is characterized by a sharp or burning pain at the vaginal opening while applying pressure to the vulvar vestibule or attempting vaginal penetration. Women suffering from PVD experience greater psychological distress, a worsened quality of life and overall well-being as well as sexual dysfunctions for both the women and their intimate partners. Women suffering from PVD have limited treatment options, and some women have persistent pain despite the available treatment options. Therefore, a new therapeutic avenue needs to be explored. High intensity laser therapy (HILT), a non-invasive and non-ablative laser technique, was found to be effective in several chronic pain conditions. Our randomized pilot study confirmed that HILT is feasible for treating PVD. The promising findings obtained provided support for conducting this large multicenter randomized controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- * Baseline evaluation * Randomization to active laser or sham laser (12 sessions in 6 consecutive weeks) Post-treatment evaluation (2 weeks post-treatment) * Follow-up evaluation (6 months post-treatment)
| Arm | Type | Receives |
|---|---|---|
| High Intensity Laser Therapy (HILT) | Active comparator | Radiation: High Intensity Laser Therapy (HILT)Active high intensity laser therapy for 12 biweekly sessions (6 consecutive weeks of biweekly treatments) |
| Sham High Intensity Laser Therapy | Sham comparator | Radiation: Sham High Intensity Laser TherapySham high-intensity laser therapy for 12 biweekly sessions (6 consecutive weeks of biweekly treatments) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Moderate to severe pain (≥ 5/10) at least 90% of the time during sexual intercourse or attempted sexual intercourse for at least 3 months
- Provoked vestibulodynia of at least 3 months duration prior to the study and diagnosed by a standardized gynaecologic exam
Key exclusion criteria (8 listed)
- Other causes of vulvovaginal pain (e.g., spontaneous vulvovaginal pain not related to sexual intercourse/contact, dermatological condition, herpes, vulvovaginal atrophy)
- Post-menopausal state
- Current pregnancy or pregnancy in the last year
- Urogynecological condition (e.g., pelvic organ prolapse (POP) ≥ 3, urinary/vaginal infection active or in the last 3 months)
- Anterior vulvar, vaginal or pelvic surgery (e.g., vestibulectomy, corrective pelvic organ prolapse surgery)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Intensity Laser Therapy (HILT)Also: Nd:Yag laserNd:Yag 1064 nm pulsed high intensity laser will be applied to the vulvar area. | Radiation | High Intensity Laser Therapy (HILT) |
| Sham High Intensity Laser TherapyAlso: Sham, Control, Deactivated probeNd:Yag 1064 pulsed high intensity laser deactivated probe will be applied to the vulvar area. | Radiation | Sham High Intensity Laser Therapy |
Primary outcome
Change in pain intensity during intercourse
Time frame: Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment
To explore changes in pain intensity during intercourse (Numerical Rating Scale (NRS), ranging from 0 to 10, where 0 is no pain at all, and 10 is the worst pain ever)
10 secondary outcomes
Change in pain quality
Time frame: Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment
Change in sexual function
Time frame: Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment
Change in sexual distress
Time frame: Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment
Change in pain catastrophizing
Time frame: Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment
Change in fear of pain
Time frame: Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment
Change in cognitions regarding vaginal penetration
Time frame: Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment
Change in the life impact of pelvic pain
Time frame: Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment
Change in intercourse self-efficacy
Time frame: Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment
Level of satisfaction with treatment
Time frame: 2-week post-treatment evaluation, 6-months follow-up assessment
Patient's global impression of change
Time frame: 2-week post-treatment evaluation, 6-months follow-up assessment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: Undecided. Deidentified data will be made available upon approval by the principal investigator and study team.
Related trials for Vulvodynia
Active, not recruitingPhase 2
A Phase 2 Study to Evaluate the Efficacy and Safety of Pudafensine in Vulvodynia (Provoked Vestibulodynia)
Vulvodynia
Not yet recruiting
Integrated Care Pathway for Hormonally Mediated Vestibulodynia: a Feasibility and Acceptability Pilot
Vestibulodynia, Vulvodynia
Active, not recruiting
Vestibulectomy Surgical Techniques Comparison Study
Vulvar Pain, Vulvodynia
Not yet recruiting
Transcutaneous Genital Nerves Stimulation for the Treatment of Refractory Chronic Pelvic and Genital Pain in Women.
Refractory Visceral Pelvic Pain, Refractory Genital Pain
Not yet recruitingPhase 2
A Pilot Study on the Efficacy of Oral Low Dose Naltrexone for Vulvodynia
Vulvodynia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mélanie Morin, PT, PhD principal investigator
Université de Sherbrooke
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Intensity Laser Therapy (HILT) in people with Vulvodynia, run by Université de Sherbrooke at 4 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain intensity during intercourse (time frame: Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.