Vulvodynia (Chronic Vulvar Pain)PVDNCT06999395
Does a Virtual Program for Pelvic Pain Improve Pain and Sexual Outcomes in Individuals With Provoked Vestibulodynia?
A study testing Virtual online pelvic health program in people with Vulvodynia (Chronic Vulvar Pain) and Vulvar Vestibulitis, run by Queen's University at 1 site in Canada.
Trial summary
The goal of this clinical trial is to learn if a 3-month online pelvic health program works to improve pain and sexual wellbeing in adult women with chronic genital pain. The main research questions it aims to answer are: How well does the program work to improve pain and sexual wellbeing? How well does the program… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vulvodynia (Chronic Vulvar Pain), Vulvar Vestibulitis, Vestibulodynia
- What is being tested?
- Virtual online pelvic health program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteCanada
- Study dates
- 17 Dec 2025to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Self-reported physician diagnosis of provoked vestibulodynia (PVD)
- PVD duration of at least 3 months
- PVD pain intensity rating of at least 3 on a scale from 0 (no pain) to 10 (extreme pain)
- Resides in North America (Canada or the United States)
- Fluent in English
Who cannot join
- Less than 18 years old
- Pregnancy or suspected pregnancy
- Breastfeeding
- Up to one year postpartum
- Physical or mental health conditions that significantly interfere with activities of daily living
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Sexual Health Research Laboratory
Kingston, Ontario, K7L 3N6
About this study
Official title: Examining the Efficacy of a Multimodal Virtual Program on Pain and Sexual Outcomes in Individuals With Provoked Vestibulodynia: A Randomized Clinical Trial
The goal of this clinical trial is to learn if a 3-month online pelvic health program works to improve pain and sexual wellbeing in adult women with chronic genital pain. The main research questions it aims to answer are:
- How well does the program work to improve pain and sexual wellbeing?
- How well does the program work to improve pain anxiety and pain interference?
- How do participants rate their improvement after completing the program?
- How satisfied are participants with the program?
Read more
Researchers will compare participants who receive the program right away to those who wait for the program. Participants who receive the program right away will
- Progress through the program at their own pace
- Learn about pain science, do pelvic health exercises, and use information to be more mindful and less anxious about the pain
- Answer questions about their pain experiences and sexual wellbeing before and after the 3-month program, as well as 3 months after the end of the program
- Provide information about their experiences with the program and progress through the program during and after the program
Read the detailed description
The primary aim of the proposed single-centre randomized controlled trial is to examine the efficacy of a virtual multimodal 12-week program for individuals with provoked vestibulodynia (PVD, diagnosed by a healthcare provider) compared with a waitlist control group (i.e., participants who are on the waitlist to receive treatment). We hypothesize that participation in the program will result in greater improvements in our primary outcomes of pain and sexual wellbeing for persons with PVD immediately post-treatment and at 3-month follow-up compared to the control group. Our secondary aim is to compare outcomes of the program versus control group on secondary measures of pain catastrophizing, pain self-efficacy, interference (on sexual life and life in general), perceived improvement, and treatment satisfaction. We hypothesize that participants in the program will report greater improvements in these outcomes compared to participants on the waitlist . We will also collect information on adverse events, progress through the program, and thoughts about the program.
- Conditions
- Vulvodynia (Chronic Vulvar Pain), Vulvar Vestibulitis, Vestibulodynia, Provoked Vestibulodynia, Provoked Localized Vulvodynia
- Being tested
- Virtual online pelvic health program
- Keywords
- vulvodynia, provoked vestibulodynia, virtual pelvic health program, pain and sexual wellbeing outcomes, randomized controlled trial, intervention
- Medical subject headings
- Vulvodynia, Vulvar Vestibulitis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual online pelvic health programBehavioural
The program offers a multimodal approach to self-guided treatment for PVD. Its multimodal approach is exemplified by pain education focusing on pelvic health and neuroplasticity to provide the foundation for strategies strengthening the mind-body connection to the pelvis; mindful breathing and relaxation exercises to reduce nervous system overactivation and enhance mood; and gradual progression of exercises encouraging awareness, stretching, and strengthening to promote relaxation of the pelvic floor muscles and reduction of accessory muscle tension resulting from protective guarding. The program uses 3 separate yet interconnected modules: Learn (20 modules of pain science education and skills), Rewire (11 modules featuring mindfulness and relaxation), and Move (45 pelvic and other exercises).
| Study group | Role | What they receive |
|---|---|---|
| Active treatment | Experimental | Participants in the active treatment arm will receive access to the program once determined eligible. Receives: Behavioral: Virtual online pelvic health program |
| Waitlist control | No intervention | Participants in the waitlist control group will wait 3 months for access to the program. As the wait, they will receive the same surveys at the same timepoints as the active treatment group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sexual insertional pain
0 (no pain) to 10 (extreme pain) rating for pain experienced during sexual activities involving vaginal insertion. Higher scores indicate higher pain intensity (worse outcomes).
Measured: Baseline, 12 weeks (immediate post-treatment), 3-month follow-up
Nonsexual insertional pain
0 (no pain) to 10 (extreme pain) rating for pain experienced during nonsexual activities involving vaginal insertion. Higher scores indicate higher pain intensity (worse outcomes).
Measured: Baseline, 12 weeks (immediate post-treatment), 3-month follow-up
Provoked vulvar pain by pressure/contact
0 (no pain) to 10 (extreme pain) rating for pain experienced during activities (sexual or nonsexual) involving pressure or contact to the vaginal opening. Higher scores indicate higher pain intensity (worse outcomes).
Measured: Baseline, 12 weeks (immediate post-treatment), 3-month follow-up
Sexual function
Female Sexual Function Index. Range of scores is 2 to 36, with higher scores indicating better sexual function (better outcomes). A score of 26.55 and lower indicates possible sexual dysfunction.
Measured: Baseline, 12 weeks (immediate post-treatment), 3-month follow-up
Pain interference on sexual life
The Sexual Function Interference subscale of the Vulvar Pain Assessment Questionnaire-Screening version will be used. Range of scores is 0-24, with higher scores indicating more interference (worse outcome).
Measured: Baseline, 12 weeks (immediate post-treatment), 3-month follow-up
Pain related interference on one's life
The activity engagement subscale of the Chronic Pain Acceptance Questionnaire (range 0-66, higher scores indicate higher levels of acceptance, which suggest better outcomes) and the Life Interference subscale of the Vulvar Pain Assessment Questionnaire-Screening version (range 0-24, higher scores indicate more interference, which suggest worse outcomes) will be used.
Measured: Baseline, 12 weeks (immediate post-treatment), 3-month follow-up
Participant global ratings of improvement
Scale of 0 (deterioration) to 5 (complete recovery) will be used. Range 0-5, with higher scores indicating more improvement.
Measured: 12 weeks (immediate post-treatment), 3-month follow-up
Treatment satisfaction
Scale of 0 (completely dissatisfied) to 10 (completely satisfied) will be used. Range of scores, 0-10, with higher scores indicating higher treatment satisfaction.
Measured: 12 weeks (immediate post-treatment), 3-month follow-up
Secondary outcomes (3)
Pain Catastrophizing
The Pain Catastrophizing Scale will be used. Total scores range from 0-52, with higher scores indicating higher catastrophizing (worse outcomes).
Measured: Baseline, 12 weeks (immediate post-treatment), 3-month follow-up
Pain Self-efficacy
The Pain Self-Efficacy Scale will be used. Total scores range from 0-60, with higher scores indicating greater pain self-efficacy (better outcomes).
Measured: Baseline, 12 weeks (immediate post-treatment), 3-month follow-up
Sexual distress
The 5 item Sexual Distress Scale will be used. Total scores range from 5-25, with higher scores indicating greater sexual distress (worse outcomes).
Measured: Baseline, 12 weeks (immediate post-treatment), 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start17 Dec 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vulvodynia (Chronic Vulvar Pain)Studies of the same condition, open and under way.
- 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Caroline Pukall, Queen's University
- Investigators
- Caroline Pukall, PhD, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06999395
- Sponsor's protocol ID
- QueensU-196214
- Other IDs
- 196214
- Acronym
- PVD
- Status last verified
- Feb 2026
- First submitted
- 9 May 2025
- Last updated
- 12 Feb 2026
- 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 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Efficacy of a Multimodal Virtual Program on Pain and Sexual Outcomes in Individuals With Provoked Vestibulodynia: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06999395
- Acronym / sponsor ID
- PVD / QueensU-196214
- Conditions
- Vulvodynia (Chronic Vulvar Pain), Vulvar Vestibulitis, Vestibulodynia, Provoked Vestibulodynia, Provoked Localized Vulvodynia
- Keywords
- vulvodynia, provoked vestibulodynia, virtual pelvic health program, pain and sexual wellbeing outcomes, randomized controlled trial, intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Study start
- 17 Dec 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 31 May 2025 (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.
The goal of this clinical trial is to learn if a 3-month online pelvic health program works to improve pain and sexual wellbeing in adult women with chronic genital pain. The main research questions it aims to answer are:
- How well does the program work to improve pain and sexual wellbeing?
- How well does the program work to improve pain anxiety and pain interference?
- How do participants rate their improvement after completing the program?
- How satisfied are participants with the program?
Researchers will compare participants who receive the program right away to those who wait for the program. Participants who receive the program right away will
- Progress through the program at their own pace
- Learn about pain science, do pelvic health exercises, and use information to be more mindful and less anxious about the pain
- Answer questions about their pain experiences and sexual wellbeing before and after the 3-month program, as well as 3 months after the end of the program
- Provide information about their experiences with the program and progress through the program during and after the program
Detailed description
The primary aim of the proposed single-centre randomized controlled trial is to examine the efficacy of a virtual multimodal 12-week program for individuals with provoked vestibulodynia (PVD, diagnosed by a healthcare provider) compared with a waitlist control group (i.e., participants who are on the waitlist to receive treatment). We hypothesize that participation in the program will result in greater improvements in our primary outcomes of pain and sexual wellbeing for persons with PVD immediately post-treatment and at 3-month follow-up compared to the control group. Our secondary aim is to compare outcomes of the program versus control group on secondary measures of pain catastrophizing, pain self-efficacy, interference (on sexual life and life in general), perceived improvement, and treatment satisfaction. We hypothesize that participants in the program will report greater improvements in these outcomes compared to participants on the waitlist . We will also collect information on adverse events, progress through the program, and thoughts about the program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active treatment | Experimental | Behavioral: Virtual online pelvic health programParticipants in the active treatment arm will receive access to the program once determined eligible. |
| Waitlist control | No intervention | –Participants in the waitlist control group will wait 3 months for access to the program. As the wait, they will receive the same surveys at the same timepoints as the active treatment group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Self-reported physician diagnosis of provoked vestibulodynia (PVD)
- PVD duration of at least 3 months
- PVD pain intensity rating of at least 3 on a scale from 0 (no pain) to 10 (extreme pain)
- Resides in North America (Canada or the United States)
- Fluent in English
Key exclusion criteria (5 listed)
- Less than 18 years old
- Pregnancy or suspected pregnancy
- Breastfeeding
- Up to one year postpartum
- Physical or mental health conditions that significantly interfere with activities of daily living
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 |
|---|---|---|
| Virtual online pelvic health programThe program offers a multimodal approach to self-guided treatment for PVD. Its multimodal approach is exemplified by pain education focusing on pelvic health and neuroplasticity to provide the foundation for strategies strengthening the mind-body connection to the pelvis; mindful breathing and relaxation exercises to reduce nervous system overactivation and enhance mood; and gradual progression of exercises encouraging awareness, stretching, and strengthening to promote relaxation of the pelvic floor muscles and reduction of accessory muscle tension resulting from protective guarding. The program uses 3 separate yet interconnected modules: Learn (20 modules of pain science education and skills), Rewire (11 modules featuring mindfulness and relaxation), and Move (45 pelvic and other exercises). | Behavioural | Active treatment |
Primary outcome
Sexual insertional pain
Time frame: Baseline, 12 weeks (immediate post-treatment), 3-month follow-up
0 (no pain) to 10 (extreme pain) rating for pain experienced during sexual activities involving vaginal insertion. Higher scores indicate higher pain intensity (worse outcomes).
Nonsexual insertional pain
Time frame: Baseline, 12 weeks (immediate post-treatment), 3-month follow-up
0 (no pain) to 10 (extreme pain) rating for pain experienced during nonsexual activities involving vaginal insertion. Higher scores indicate higher pain intensity (worse outcomes).
Provoked vulvar pain by pressure/contact
Time frame: Baseline, 12 weeks (immediate post-treatment), 3-month follow-up
0 (no pain) to 10 (extreme pain) rating for pain experienced during activities (sexual or nonsexual) involving pressure or contact to the vaginal opening. Higher scores indicate higher pain intensity (worse outcomes).
Sexual function
Time frame: Baseline, 12 weeks (immediate post-treatment), 3-month follow-up
Female Sexual Function Index. Range of scores is 2 to 36, with higher scores indicating better sexual function (better outcomes). A score of 26.55 and lower indicates possible sexual dysfunction.
Pain interference on sexual life
Time frame: Baseline, 12 weeks (immediate post-treatment), 3-month follow-up
The Sexual Function Interference subscale of the Vulvar Pain Assessment Questionnaire-Screening version will be used. Range of scores is 0-24, with higher scores indicating more interference (worse outcome).
Pain related interference on one's life
Time frame: Baseline, 12 weeks (immediate post-treatment), 3-month follow-up
The activity engagement subscale of the Chronic Pain Acceptance Questionnaire (range 0-66, higher scores indicate higher levels of acceptance, which suggest better outcomes) and the Life Interference subscale of the Vulvar Pain Assessment Questionnaire-Screening version (range 0-24, higher scores indicate more interference, which suggest worse outcomes) will be used.
Participant global ratings of improvement
Time frame: 12 weeks (immediate post-treatment), 3-month follow-up
Scale of 0 (deterioration) to 5 (complete recovery) will be used. Range 0-5, with higher scores indicating more improvement.
Treatment satisfaction
Time frame: 12 weeks (immediate post-treatment), 3-month follow-up
Scale of 0 (completely dissatisfied) to 10 (completely satisfied) will be used. Range of scores, 0-10, with higher scores indicating higher treatment satisfaction.
3 secondary outcomes
Pain Catastrophizing
Time frame: Baseline, 12 weeks (immediate post-treatment), 3-month follow-up
Pain Self-efficacy
Time frame: Baseline, 12 weeks (immediate post-treatment), 3-month follow-up
Sexual distress
Time frame: Baseline, 12 weeks (immediate post-treatment), 3-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Vulvodynia (Chronic Vulvar Pain)
Active, not recruiting
Vulvodynia Intervention: the Effect of Multimodal Treatment for Provoked Vulvodynia
Vulvodynia (Chronic Vulvar Pain)
Recruiting
VIBRating vs Traditional Therapy for Treatment of ENTry Dyspareunia
Genito-Pelvic Pain/Penetration Disorder, Dyspareunia
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.
Caroline Pukall, PhD principal investigator
Queen's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual online pelvic health program in people with Vulvodynia (Chronic Vulvar Pain) and Vulvar Vestibulitis, run by Queen's University 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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 12 Feb 2026. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shannon Research Coordinator, MA (613 533 3276, qshrl@queensu.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sexual insertional pain (time frame: Baseline, 12 weeks (immediate post-treatment), 3-month follow-up). 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 12 Feb 2026; AzTrials last refreshed its copy on 29 Oct 2026.