Does a Virtual Program for Pelvic Pain Improve Pain and Sexual Outcomes in Individuals With Provoked Vestibulodynia?

NCT06999395 | Recruiting

• 2 other identifiers: QueensU-196214196214
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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

Conditions

Vulvar Vestibulitis; Vestibulodynia; Provoked Vestibulodynia; Vulvodynia (Chronic Vulvar Pain); Provoked Localized Vulvodynia

Keywords

vulvodynia; provoked vestibulodynia; virtual pelvic health program; pain and sexual wellbeing outcomes; randomized controlled trial; intervention

Outcome Measures

Primary Outcomes (8)

• 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).

  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

Secondary Outcomes (3)

• 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

Other Outcomes (1)

• Adverse events

  At 3, 6, and 9 weeks during intervention, 12 weeks (immediate post-treatment), 3-month follow-up

Study Arms (2)

Active treatment

EXPERIMENTAL

Participants in the active treatment arm will receive access to the program once determined eligible.

Behavioral: Virtual online pelvic health program

Waitlist control

NO INTERVENTION

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.

Interventions

Virtual online pelvic health program BEHAVIORAL

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).

Active treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Queen's University: lead

Study Sites (1)

Sexual Health Research Laboratory

Kingston, Ontario, K7L 3N6, Canada

RECRUITING

MeSH Terms

Conditions

Vulvodynia; Vulvar Vestibulitis; Pain

Condition Hierarchy (Ancestors)

Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Vulvitis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Caroline Pukall, PhD

  Queen's University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shannon Research Coordinator, MA

CONTACT

613 533 3276; qshrl@queensu.ca

Marilyn Post-doctoral fellow, PhD

CONTACT

613 533 3276; qshrl@queensu.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Collaborators and statistician.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 9, 2025
• First Posted: May 31, 2025
• Study Start: December 17, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)