12-week online pelvic health program for provoked vestibulodynia
Examining the Efficacy of a Multimodal Virtual Program on Pain and Sexual Outcomes in Individuals With Provoked Vestibulodynia: A Randomized Clinical Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Queen's University Academic / other |
| Locations | 1 site (Kingston, Ontario) |
| Trial ID | NCT06999395 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Kingston, Ontario
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.