Clinical trial NCT06999395: Does a Virtual Program for Pelvic Pain Improve Pain and Sexual Outcomes in Individuals With 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Lead sponsor: Queen's University
Sponsor class: OTHER
First posted: 2025-05-31
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

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.

Eligibility 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

Primary outcomes:
measure: Sexual insertional pain
timeFrame: Baseline, 12 weeks (immediate post-treatment), 3-month follow-up
measure: Nonsexual insertional pain
timeFrame: Baseline, 12 weeks (immediate post-treatment), 3-month follow-up
measure: Provoked vulvar pain by pressure/contact
timeFrame: Baseline, 12 weeks (immediate post-treatment), 3-month follow-up
measure: Sexual function
timeFrame: Baseline, 12 weeks (immediate post-treatment), 3-month follow-up
measure: Pain interference on sexual life
timeFrame: Baseline, 12 weeks (immediate post-treatment), 3-month follow-up
measure: Pain related interference on one's life
timeFrame: Baseline, 12 weeks (immediate post-treatment), 3-month follow-up
measure: Participant global ratings of improvement
timeFrame: 12 weeks (immediate post-treatment), 3-month follow-up
measure: Treatment satisfaction
timeFrame: 12 weeks (immediate post-treatment), 3-month follow-up
Secondary outcomes:
measure: Pain Catastrophizing
timeFrame: Baseline, 12 weeks (immediate post-treatment), 3-month follow-up
measure: Pain Self-efficacy
timeFrame: Baseline, 12 weeks (immediate post-treatment), 3-month follow-up
measure: Sexual distress
timeFrame: Baseline, 12 weeks (immediate post-treatment), 3-month follow-up
Other outcomes:
measure: Adverse events
timeFrame: At 3, 6, and 9 weeks during intervention, 12 weeks (immediate post-treatment), 3-month follow-up
Locations:
Study officials:
affiliation: Queen's University
name: Caroline Pukall, PhD
role: PRINCIPAL_INVESTIGATOR
References: