PVD
Examining the Efficacy of a Multimodal Virtual Program on Pain and Sexual Outcomes in Individuals With Provoked Vestibulodynia: A Randomized Clinical Trial
Sponsor study identifier
Secondary identifiers
OTHER_GRANT · Canadian Intitutes of Health Research
interventional
250
1 country
1
Study Start
December 17, 2025
Actual (reported)Primary Completion
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 9, 2025
Actual (reported)May 31, 2025
Actual (reported)December 17, 2025
Actual (reported)December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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).
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).
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).
Participants in the active treatment arm will receive access to the program once determined eligible.
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.
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).
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Sexual Health Research Laboratory
Kingston, Ontario, K7L 3N6, Canada
Caroline Pukall, PhD
Queen's University
First Submitted
May 9, 2025
First Posted
May 31, 2025
Study Start
December 17, 2025
Actual (reported)Primary Completion
December 2027
EstimatedBiomodulation and Rehabilitation Interventions to tarGet Pelvic Health
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.
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).
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.
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.
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.
12 weeks (immediate post-treatment), 3-month follow-up
Pain Catastrophizing
Baseline, 12 weeks (immediate post-treatment), 3-month follow-up
Pain Self-efficacy
Baseline, 12 weeks (immediate post-treatment), 3-month follow-up
Sexual distress
Baseline, 12 weeks (immediate post-treatment), 3-month follow-up
Adverse events
At 3, 6, and 9 weeks during intervention, 12 weeks (immediate post-treatment), 3-month follow-up
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
February 12, 2026
Record last verified: 2026-02
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Source: ClinicalTrials.gov.
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