Multimodal treatment for provoked vulvodynia in young women
Young Vulvodynia: Effect and Efficacy of a Multimodal Treatment for Young Women With Vulvar Pain
This project will try a combined treatment (including cognitive behavioral therapy and other approaches) to see if it reduces pain and improves sexual and emotional health in young women aged 15–23 with provoked vulvodynia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 15 Years to 23 Years |
| Sex | Female |
| Sponsor | Region Örebro County Academic / other |
| Locations | 1 site (Örebro) |
| Trial ID | NCT07092332 on ClinicalTrials.gov |
What this trial studies
This is a sequential single-case experimental AB design conducted at a youth guidance center in Örebro, Sweden, using randomized baseline lengths of 4, 5, or 6 weeks followed by a 25-week treatment period. Participants complete brief self-assessments twice weekly via the m-Path app during baseline and treatment, plus comprehensive questionnaires before, after, and at six months. Inclusion requires biological females aged 15–23 with a diagnosis of provoked vulvodynia and excludes those with prioritized severe psychological issues, recent childbirth, ongoing pregnancy, PTSD related to sexual trauma, insufficient Swedish, or no experience of vaginal sex. Outcomes align with the Core Outcome Set in vulvodynia and focus on pain as the primary measure alongside psychological, sexual, and relational health.
Who should consider this trial
Good fit: Ideal candidates are biological females aged 15 to 23, diagnosed with provoked vulvodynia, who have experience of vaginal sex and can communicate in Swedish and attend the Örebro youth clinic.
Not a fit: Patients with severe mental-health problems that need priority treatment, current pregnancy or childbirth within the past year, PTSD related to sexual trauma, insufficient Swedish language skills, or no experience of vaginal sex may not benefit or be eligible for this program.
Why it matters
Potential benefit: If successful, the multimodal approach could reduce provoked vulvar pain and improve sexual and psychological well‑being in young women.
How similar studies have performed: Multimodal programs combining CBT and pelvic health approaches have shown promising but mixed results in adults, and applying a randomized single-case design to young women is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Biological sex female * 15-23 years of age * Diagnosed with Provoked vulvodynia Exclusion Criteria: * Severe psychological issues that should be prioritized before vulvodynia treatment (e.g., substance abuse, psychosis) * Ongoing pregnancy * Childbirth within the last year * Post-traumatic stress disorder (PTSD) related to sexual trauma * Insufficient mastery of the Swedish language * No experience of vaginal sex, as vaginismus might be suspected, which requires different treatment
Where this trial is running
Örebro
- Ungdomsmottagningen — Örebro, Sweden (Recruiting)
Study contacts
- Study coordinator: Rebecca Lennartsson, MSc
- Email: rebecca.lennartsson@regionorebrolan.se
- Phone: +46733690524
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.