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

Queen's University

Status: Not yet enrolling

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

Treatments: Behavioral: Virtual online pelvic health program

Study type: Interventional

Funder types: Other

Identifiers

NCT06999395

196214 (Other Grant/Funding Number)

QueensU-196214

Details and patient eligibility

About

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

Full 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.

Enrollment: 250 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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250 participants in 2 patient groups

Active treatment

Experimental group

Description:

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

Treatment:

Behavioral: Virtual online pelvic health program

Waitlist control

No Intervention group

Description:

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.