VulvodyniaNCT04502810
High-level Laser for Provoked Vestibulodynia
A study testing High-level laser therapy in people with Vulvodynia, run by Université de Sherbrooke at 1 site in Canada.
Trial summary
This is a randomized feasibility and acceptability study investigating the effects of laser treatment in women suffering from provoked vestibulodynia compared to a sham-laser treatment. Participants will be randomized into the laser group or sham-laser group. 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-level laser therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2020to 4 May 2021
- 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) during sexual intercourse for at least 3 months
- Moderate to severe pain (≥5/10) in at least 90% of sexual intercourses or attempted sexual intercourse for at least 3 months
- Provoked vestibulodynia lasting at least 3 months prior to the study and diagnosed by a standardised gynaecologic exam
Who cannot join
- Other causes of vulvo-vaginal pain (e.g. spontaneous vulvovaginal pain not related to sexual intercourse/contact, dermatological condition, herpes, vulvo-vaginal atrophy)
- Post-menopausal state
- Actual or past pregnancy in the last year
- Urogynecological condition (e.g. pelvic organs prolapse ≥3, urinary/vaginal infection active or in the last 3 months)
- Anterior vulvar, vaginal or pelvic surgery (e.g. vestibulectomy, corrective pelvic organs prolapses 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
1 site in 1 country.
Canada1 site
Centre hospitalier Universitaire de Sherbroke
Sherbrooke, Quebec, J1H 5N4
About this study
Official title: A Feasibility and Acceptability Study of High-level Laser for Women With Provoked Vestibulodynia
This is a randomized feasibility and acceptability study investigating the effects of laser treatment in women suffering from provoked vestibulodynia compared to a sham-laser treatment. Participants will be randomized into the laser group or sham-laser group. The laser group will receive 12 sessions of real high-level 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. Outcomes measures will be assessed at baseline and at post-treatment and will include: feasibility and acceptability variables, pain, sexual function, sexual distress, psychological variables and perceived improvement after the treatment.
- Conditions
- Vulvodynia
- Being tested
- High-level 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-level laser therapyRadiation
Also called Nd:Yag laser
Nd:Yag 1064 nm pulsed high-level Laser will be applied to the vulvar area.
| Study group | Role | What they receive |
|---|---|---|
| High-level laser therapy | Experimental | Real high-level laser therapy laser 12 biweekly sessions (6 consecutive weeks of biweekly treatments) Receives: Radiation: High-level laser therapy |
| Sham High-level laser therapy | Sham comparator | Sham high-level laser therapy laser 12 biweekly sessions (6 consecutive weeks of biweekly treatments) Receives: Radiation: High-level laser therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence rate
To determine acceptability by assessing adherence to treatment sessions
Measured: 2-week post-treatment evaluation
Level of satisfaction with the treatment
To determine acceptability by measuring the participants' satisfaction with the treatment on a numeric rating scale ranging from 0 (completely dissatisfied) to 10 (completely satisfied)
Measured: 2-week post-treatment evaluation
Willingness to recommend the treatment
To determine acceptability by assessing whether the participant would recommend the treatment.
Measured: 2-week post-treatment evaluation
Rate of adverse events
To document any adverse events.
Measured: 2-week post-treatment evaluation
Blinding effectiveness
To assess the feasibility of maintaining blinding to group allocation for the therapists, assessors and therapists. Evaluated by asking the question: ''What treatment do you think you have received / given? ''
Measured: 2-week post-treatment evaluation
Recruitment rate
To assess the recruitment rate including the barriers and reasons for refusing to participate as well as the reasons for exclusion
Measured: Baseline to 2-week post-treatment evaluation
Completion and dropout rates
To evaluate completion and dropout rates based on the completion of the post-treatment evaluation.
Measured: 2-week post-treatment evaluation
Completeness of data
To examine the percentage of completed outcome measures.
Measured: Baseline to 2-week post-treatment evaluation
Secondary outcomes (9)
Change in pain intensity during intercourse
To explore changes in pain intensity during intercourse (Numerical Rating Scale, ranging from 0 to 10, where 0 is no pain at all, and 10 is the worst pain ever)
Measured: Baseline to 2-week post-treatment evaluation
Change in sexual function
To explore changes in sexual function (Female Sexual Function Index). Minimum value: 2, Maximum value: 36 and lower scores mean worst outcome (low sexual function).
Measured: Baseline to 2-week post-treatment evaluation
Change in sexual distress
To explore changes in sexual distress (Female Sexual Distress Scale ). Minimum value: 0, Maximum value: 52, higher scores mean worst outcome (higher sexually related distress).
Measured: Baseline to 2-week post-treatment evaluation
Change in pain quality
To explore changes on the sensory, affective and evaluative components of pain (McGill-Melzack Questionnaire). Minimum value: 0, Maximum value: 78, higher scores mean worst outcome (higher pain).
Measured: Baseline to 2-week post-treatment evaluation
Patient's global impression of change
To examine patient self-reported improvement (Patient's Global Impression of Change ranging from "very much worse" to "very much improved" on a 7-point scale.
Measured: Baseline to 2-week post-treatment evaluation
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 mean worst outcome (higher fear of pain).
Measured: Baseline to 2-week post-treatment evaluation
Change in pain catastrophization
To explore changes in pain catastrophization (Pain Catastrophizing Scale (PCS)). Minimum value: 0, Maximum value: 52, higher scores mean worse outcome (higher pain catastrophization)
Measured: Baseline to 2-week post-treatment evaluation
Change in vulvar pain sensitivity
To explore changes in vulvar pain sensitivity (algometer)
Measured: Baseline to 2-week post-treatment evaluation
Change in vulvar blood circulation
To explore changes in vulvar blood circulation using the laser speckle. Vulvar vestibule blood perfusion is expressed in arbitrary perfusion units (APUs).
Measured: Baseline to 2-week post-treatment evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2020
- Study start1 Aug 2020
- Primary completion4 May 2021
- Study completion4 May 2021
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 real laser or sham laser (12 sessions in 6 consecutive weeks) - Post-treatment evaluation
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 41 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
- Responsible party
- Principal investigator, Mélanie Morin, Université de Sherbrooke
- Investigators
- Mélanie Morin, PT, PhD, Principal investigator, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04502810
- Sponsor's protocol ID
- #2020-3535
- Status last verified
- Jan 2022
- First submitted
- 27 Jul 2020
- Last updated
- 10 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility and Acceptability Study of High-level Laser for Women With Provoked Vestibulodynia
- ClinicalTrials.gov ID
- NCT04502810
- Acronym / sponsor ID
- #2020-3535
- Conditions
- Vulvodynia
- Keywords
- Laser, Provoked vestibulodynia, Pain, Sexual dysfunctions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Collaborators
- Centre de recherche du Centre hospitalier universitaire de Sherbrooke, Exogenia
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 4 May 2021 (actual)
- Study completion
- 4 May 2021 (actual)
- First posted
- 6 Aug 2020 (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 randomized feasibility and acceptability study investigating the effects of laser treatment in women suffering from provoked vestibulodynia compared to a sham-laser treatment. Participants will be randomized into the laser group or sham-laser group. The laser group will receive 12 sessions of real high-level 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. Outcomes measures will be assessed at baseline and at post-treatment and will include: feasibility and acceptability variables, pain, sexual function, sexual distress, psychological variables and perceived improvement after the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Baseline evaluation - Randomization to real laser or sham laser (12 sessions in 6 consecutive weeks) - Post-treatment evaluation
| Arm | Type | Receives |
|---|---|---|
| High-level laser therapy | Experimental | Radiation: High-level laser therapyReal high-level laser therapy laser 12 biweekly sessions (6 consecutive weeks of biweekly treatments) |
| Sham High-level laser therapy | Sham comparator | Radiation: High-level laser therapySham high-level laser therapy laser 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 (3 listed)
- Moderate to severe pain (≥5/10) during sexual intercourse for at least 3 months
- Moderate to severe pain (≥5/10) in at least 90% of sexual intercourses or attempted sexual intercourse for at least 3 months
- Provoked vestibulodynia lasting at least 3 months prior to the study and diagnosed by a standardised gynaecologic exam
Key exclusion criteria (8 listed)
- Other causes of vulvo-vaginal pain (e.g. spontaneous vulvovaginal pain not related to sexual intercourse/contact, dermatological condition, herpes, vulvo-vaginal atrophy)
- Post-menopausal state
- Actual or past pregnancy in the last year
- Urogynecological condition (e.g. pelvic organs prolapse ≥3, urinary/vaginal infection active or in the last 3 months)
- Anterior vulvar, vaginal or pelvic surgery (e.g. vestibulectomy, corrective pelvic organs prolapses 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-level laser therapyAlso: Nd:Yag laserNd:Yag 1064 nm pulsed high-level Laser will be applied to the vulvar area. | Radiation | High-level laser therapy, Sham High-level laser therapy |
Primary outcome
Adherence rate
Time frame: 2-week post-treatment evaluation
To determine acceptability by assessing adherence to treatment sessions
Level of satisfaction with the treatment
Time frame: 2-week post-treatment evaluation
To determine acceptability by measuring the participants' satisfaction with the treatment on a numeric rating scale ranging from 0 (completely dissatisfied) to 10 (completely satisfied)
Willingness to recommend the treatment
Time frame: 2-week post-treatment evaluation
To determine acceptability by assessing whether the participant would recommend the treatment.
Rate of adverse events
Time frame: 2-week post-treatment evaluation
To document any adverse events.
Blinding effectiveness
Time frame: 2-week post-treatment evaluation
To assess the feasibility of maintaining blinding to group allocation for the therapists, assessors and therapists. Evaluated by asking the question: ''What treatment do you think you have received / given? ''
Recruitment rate
Time frame: Baseline to 2-week post-treatment evaluation
To assess the recruitment rate including the barriers and reasons for refusing to participate as well as the reasons for exclusion
Completion and dropout rates
Time frame: 2-week post-treatment evaluation
To evaluate completion and dropout rates based on the completion of the post-treatment evaluation.
Completeness of data
Time frame: Baseline to 2-week post-treatment evaluation
To examine the percentage of completed outcome measures.
9 secondary outcomes
Change in pain intensity during intercourse
Time frame: Baseline to 2-week post-treatment evaluation
Change in sexual function
Time frame: Baseline to 2-week post-treatment evaluation
Change in sexual distress
Time frame: Baseline to 2-week post-treatment evaluation
Change in pain quality
Time frame: Baseline to 2-week post-treatment evaluation
Patient's global impression of change
Time frame: Baseline to 2-week post-treatment evaluation
Change in fear of pain
Time frame: Baseline to 2-week post-treatment evaluation
Change in pain catastrophization
Time frame: Baseline to 2-week post-treatment evaluation
Change in vulvar pain sensitivity
Time frame: Baseline to 2-week post-treatment evaluation
Change in vulvar blood circulation
Time frame: Baseline to 2-week post-treatment evaluation
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 10 Feb 2022.
- Individual participant dataSharing planned: No
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-level laser therapy in people with Vulvodynia, run by Université de Sherbrooke at 1 site 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 3 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 10 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Adherence rate (time frame: 2-week post-treatment evaluation). The study lists 8 primary outcomes in all. 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 10 Feb 2022.