Recruiting

Pelvic Health Program

Sponsor:

Queen's University

Code:

NCT06999395

Conditions

Vulvodynia (Chronic Vulvar Pain)

Vulvar Vestibulitis

Vestibulodynia

Provoked Vestibulodynia

Provoked Localized Vulvodynia

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Virtual online pelvic health program

Study Details

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

Vulvodynia (Chronic Vulvar Pain)

Vulvar Vestibulitis

Vestibulodynia

Provoked Vestibulodynia

Provoked Localized Vulvodynia

Study ID

NCT06999395

Start date

Dec 17, 2025

Status verified date

Feb, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

250 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Active treatment

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

no intervention: Waitlist control

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

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).

Primary outcome measure

  • Sexual insertional pain [ Time Frame: Baseline, 12 weeks (immediate post-treatment), 3-month follow-up ]
  • Nonsexual insertional pain [ Time Frame: Baseline, 12 weeks (immediate post-treatment), 3-month follow-up ]
  • Provoked vulvar pain by pressure/contact [ Time Frame: Baseline, 12 weeks (immediate post-treatment), 3-month follow-up ]
  • Sexual function [ Time Frame: Baseline, 12 weeks (immediate post-treatment), 3-month follow-up ]
  • Pain interference on sexual life [ Time Frame: Baseline, 12 weeks (immediate post-treatment), 3-month follow-up ]
  • Pain related interference on one's life [ Time Frame: Baseline, 12 weeks (immediate post-treatment), 3-month follow-up ]
  • Participant global ratings of improvement [ Time Frame: 12 weeks (immediate post-treatment), 3-month follow-up ]
  • Treatment satisfaction [ Time Frame: 12 weeks (immediate post-treatment), 3-month follow-up ]

Central Contacts and Locations

Central contacts

Shannon Research Coordinator, MA

613 533 3276qshrl@queensu.ca

Marilyn Post-doctoral fellow, PhD

613 533 3276qshrl@queensu.ca

Locations

Sexual Health Research Laboratory

Recruiting

Kingston, Ontario, Canada, K7L 3N6

More Information

Sponsor

Queen's University

Last update posted

Feb 12, 2026

Last verified

Feb, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Queen's University on 2026-02-12.