Virtual Program for Vulvodynia

(PVD Trial)

Overseen By Marilyn Post-doctoral fellow, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Queen's University

Disqualifiers: Pregnancy, Breastfeeding, Postpartum, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a 3-month online program can help women with chronic genital pain feel better and improve their sexual well-being. The researchers aim to determine if the program can reduce pain anxiety and interference in daily life. Participants will be divided into two groups; one will start the program immediately, while the other will wait. Women diagnosed with provoked vestibulodynia (a type of genital pain) for at least three months and residing in North America are suitable candidates for the trial. As an unphased trial, this study offers participants the chance to contribute to valuable research that could enhance treatment options for women with similar conditions.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this virtual program is safe for improving pelvic health?

Research has shown that digital health programs for pelvic health are generally safe. Participants in studies have tolerated these programs well, with few reports of negative side effects. For example, a similar program included weekly online sessions with a pelvic health expert and exercises. Participants in these studies did not report significant negative effects, suggesting that this approach is safe.

This trial's virtual pelvic health program aims to help with ongoing genital pain through education and exercises. While the trial does not involve testing a drug or physical treatment, past research supports the safety of participation. These types of programs have proven to be safe and manageable for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial for a virtual online pelvic health program for vulvodynia because it offers a unique, accessible approach that could potentially reach more patients than traditional in-person therapies. Unlike standard treatments, which often include medication or physical therapy requiring clinic visits, this virtual program can be accessed from the comfort of one's home, reducing barriers to treatment such as travel and scheduling. Additionally, the program may incorporate a combination of education, exercises, and self-management strategies specifically tailored for vulvodynia, which might empower participants to take an active role in managing their symptoms.

What evidence suggests that this virtual program is effective for vulvodynia?

Research has shown that online pelvic health programs may help treat vulvodynia, a type of long-lasting genital pain. In this trial, participants in the active treatment arm will access a virtual online pelvic health program. One study found that internet-based treatment reduced pain during sex. Another study showed that a similar treatment helped with muscle tightness in the pelvic area. These virtual programs can also make it easier for people to access care. Overall, early evidence suggests these programs might help with pain and improve sexual well-being. ^{2 4 6 7 8}

Who Is on the Research Team?

Caroline Pukall, PhD

Principal Investigator

Queen's University

Are You a Good Fit for This Trial?

This trial is for adult women in North America who have been diagnosed with provoked vestibulodynia (PVD), a type of chronic genital pain, and have experienced it for at least 3 months. Participants must rate their pain as 3 or higher on a scale to 10 and be fluent in English.

Inclusion Criteria

I have been diagnosed with provoked vestibulodynia.

My pain level is at least a 3 out of 10.

I live in North America (Canada or the US).

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 12-week virtual multimodal program focusing on pelvic health exercises, pain science education, and mindfulness to improve pain and sexual wellbeing

12 weeks

Progress through the program at their own pace

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments of pain and sexual wellbeing

3 months

Assessments at 3-month post-treatment

What Are the Treatments Tested in This Trial?

Interventions

• Virtual online pelvic health program

Trial Overview

The study tests if a virtual pelvic health program can improve pain and sexual wellbeing over three months. It compares immediate access to the program against delayed entry, tracking participants' progress, pain anxiety, interference, satisfaction, and overall improvement.

How Is the Trial Designed?

Group I: Active treatment Experimental Treatment 1 Intervention

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

Group II: Waitlist control Active Control 1 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.

Who Is Running the Clinical Trial?

Queen's University

Lead Sponsor

Trials

382

Recruited

122,000+

Citations

1.

researchgate.net

researchgate.net/publication/357391035_Internet-based_Treatment_for_Vulvodynia_EMBLA_-_A_Randomized_Controlled_Study

Internet-based Treatment for Vulvodynia (EMBLA)

Data were collected at baseline, 6 weeks after baseline, and approximately 10 months after baseline. Outcomes Pain-related (pain during intercourse, tampon test ...

2.

mdpi.com

mdpi.com/2079-9721/12/8/174

Evaluation of the Effectiveness of Combined Treatment ...

This pilot study demonstrates that the suggested treatment improves the hypertonicity of the pelvic floor, as measured by ultrasound parameters.

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10798054/

A Scoping Review of the Literature from 2010 to 2023 - PMC

There is, however, promising research in virtual delivery of vulvar pain programs making programs, if effective, more accessible.,. One ...

4.

journals.sagepub.com

journals.sagepub.com/doi/10.1177/20552076251382088

A pelvic health eRehabilitation program to address ...

The Program includes twelve weekly small-group online educational sessions with a pelvic health physiotherapist, five individual exercise ...

5.

journals.lww.com

journals.lww.com/greenjournal/fulltext/2022/04000/digital_therapeutic_device_for_urinary.17.aspx

Digital Therapeutic Device for Urinary Incontinence

Pelvic floor muscle training guided by a motion-based digital therapeutic device resulted in significantly improved UI symptoms and reduction of UI episodes.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12608623/

Digital Health Technologies in the Treatment of Chronic Pelvic ...

Objective: To comprehensively examine the qualitative results of current studies reporting the efficacy of digital health (DH) technologies ...

7.

mdpi.com

mdpi.com/resolver?pii=ijerph19031506

Online Information on Painful Sexual Dysfunction in Women

The objective of this study was to evaluate the content, quality, and readability of websites containing information on dyspareunia, vaginismus, ...

8.

aptapelvichealth.org

aptapelvichealth.org/events/call-for-proposals-sexual-pain-dysfunction

Virtual Pop-Up on Interdisciplinary Approaches to Sexual ...

Emphasis is placed on collaborative care, effective screening and communication, appropriate referral pathways, and trauma-informed, patient-centered strategies ...