Virtual online pelvic health program: 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 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 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
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Sexual insertional pain — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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