PelvicSense Study: a Virtual Skills-Based Program to Manage Pelvic Pain
Patients with provoked vestibulodynia (PVD) are needed to test the efficacy of PelvicSense, a virtual skills-based program to manage pelvic pain and possibly vulvodynia. In this randomized controlled trial, the control group waits six months to do the program. It is our hope that PelvicSense will help vulvodynia patients manage their pain at home.
Study Overview
- Potential participants complete a brief online eligibility screener (approximately 5 minutes)
- Eligible participants are invited to complete a phone screening interview (20–30 minutes)
- Participants then complete a baseline survey (approximately 30 minutes) and are randomized to receive the program either immediately or after a 6‑month wait period
- Participants complete three brief check‑in surveys (weeks 3, 6, and 9; 5–10 minutes each), as well as two longer surveys (approximately 30 minutes each) at the end of the program and three months later
Eligibility Criteria
Participants must:
- Have a healthcare provider diagnosis of provoked vestibulodynia
- Be 18 years of age or older
- Be able to read, speak, and write in English
- Currently reside in Canada or the United States
- Be willing to answer questions about PVD, sexual wellbeing, and their experience with the program
For more information please visit www.sexlab.ca/participate or email qshrl@queensu.ca.
This study has received ethical approval from the Queen’s University Health Sciences and Affiliated Teaching Hospitals Research Ethics Board (HSREB).
Clinical Trial investigating IncobotulinumtoxinA a New Treatment for Pelvic Floor Muscle Dysfunction
IncobotulinumtoxinA is an approved injected medication for several conditions that involve muscle overactivity, but its use for vulvar pain (vulvodynia) is experimental. This is a research study to learn whether this drug can safely and effectively reduce vulvar pain in people with provoked vestibular pain that may be caused by tight pelvic floor muscles.
Study Overview:
The study will include 5 visits over 26-30 weeks, including the following:
- 2-week screening period
- 12-week treatment phase with 2 injection/treatment visits and 2 follow-up visits
Participants will initially be randomly assigned to receive either IncobotulinumtoxinA or placebo injections. The placebo injection does not contain any active medication. However, those women who initailly received placebo will later be given the opportunity to receive the study medication at no cost while being monitored by the study physician.
This trial is taking place at the Centers for Vulvovaginal Disorders at the NY and DC locations only. There are no other locations that are offering the ability to participate in this study.
Eligibility Criteria:
- Female participants ≥ 18 years of age who are premenopausal
- Have pelvic floor muscle pain for at least 3 months and for no more than 15 years
- Have not received injections of botulinum toxin (Botox, Dysport, Jeuveau, or Xeomin)
in the pelvic floor muscles within the last 12 months prior to starting study - Are willing to attend all study visits and feel comfortable receiving 2 rounds of injections
with our office
If you are interested in participating, please email research.cvvd@gmail.com.