12-week online pelvic health program for provoked vestibulodynia
Official title: Examining the Efficacy of a Multimodal Virtual Program on Pain and Sexual Outcomes in Individuals With Provoked Vestibulodynia: A Randomized Clinical Trial
Run by Queen's University · NCT06999395 · Data updated 2026-11-12
This project will try a 12-week online pelvic health program to see if it reduces pain and improves sexual wellbeing for adults in North America with provoked vestibulodynia.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 250 (estimated) |
| Sponsor | Queen's University Academic / other |
| Locations | 1 site (Kingston, Ontario) |
| Status | Recruiting |
| Started | December 17, 2025 |
| Main results expected | December 2027 |
| Study ends | December 2028 |
| Registry record updated | February 12, 2026 |
| Trial ID | NCT06999395 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) in Canada or the United States with a physician diagnosis of provoked vestibulodynia lasting at least 3 months and average pain of at least 3/10 who are fluent in English are ideal candidates.
✕Probably not a fit
People who are pregnant, breastfeeding, within one year postpartum, have significant physical or mental health conditions that limit daily activities, or who do not have provoked vestibulodynia or are not fluent in English may not benefit from this program.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This single-centre randomized controlled trial at Queen's University compares a 12-week multimodal virtual pelvic health program to a waitlist control for people with clinician-diagnosed provoked vestibulodynia. Participants who start the program progress at their own pace through pain-science education, pelvic health exercises, and strategies to reduce pain-related anxiety and interference. Outcomes measured include pain intensity, sexual wellbeing, pain catastrophizing, self-efficacy, interference, perceived improvement, and treatment satisfaction at baseline, immediately post-program, and at 3-month follow-up. Adverse events, program engagement, and participant feedback will also be collected.
Why it matters
Potential benefit: If successful, the program could provide an accessible, non-invasive option to reduce vulvar pain and improve sexual wellbeing for people with provoked vestibulodynia.
How similar studies have gone: In-person multimodal pelvic health and pain-science programs have shown promising results for vulvodynia, but fully virtual programs for provoked vestibulodynia are less well-studied.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where it's running
-
Sexual Health Research Laboratory
Kingston, Ontario, Canada Recruiting
Study contacts
- Principal investigator: Caroline Pukall, PhD — Queen's University
- Study coordinator: Shannon Research Coordinator, MA
- Email: qshrl@queensu.ca
- Phone: 613 533 3276
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Comparing a vibrating pelvic floor device to traditional vaginal dilators for treating entry dyspareunia
This study is testing whether a new vibrating pelvic floor device can help women with pain during sex feel better compared to using traditional vaginal dilators.
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Dry needling to reduce pain during intercourse for provoked vestibulodynia
This trial will test whether dry needling can reduce pain during intercourse in women with provoked vestibulodynia.
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IncobotulinumtoxinA (botulinum toxin) injections for provoked vestibulodynia with overactive pelvic floor muscles
This trial will test whether injections of incobotulinumtoxinA reduce pain during standardized dilator testing in premenopausal women with provoked vestibulodynia and hypertonic pelvic floor muscles.
-
Topical ketotifen 0.25% for secondary vestibulodynia
This Phase 2 trial will test whether applying ketotifen 0.25% cream to the vulvar vestibule reduces pain in adult women with secondary provoked vestibulodynia.
-
Interventions for managing pelvic health issues in women
This study is testing whether light therapy and physical therapy can help women with vulvar pain feel better over 14 weeks.
-
Improving diagnosis of vestibulodynia using omics approaches
This study is trying to find better ways to diagnose vestibulodynia in women aged 18 to 50 by looking at biological samples to see if there are specific markers that can help identify this painful condition.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.