Young Vulvodynia: Effect and Efficacy of Multimodal Treatment.

NCT07092332 · tracked via the Priya Life Science Sweden tracker

Sponsor

Region Örebro County

Phase

Not applicable

Started

2025-06-10

Last updated

2026-08-12

Condition(s) studied

Vulvodynia

Investigational drug(s) / intervention(s)

Multimodal treatment

Multimodal treatment: Vulvodynia Intervention adapted for late adolescents and young adults. A multimodal treatment for provoked vulvodynia The treatment consists of 11 treatment sessions. Working with goal-directed behavior change that has both physiological and psychosocial components. The treatment sessions will be conducted with various professionals, bot simultaneously and separately. The intervention is based on physiological and psychosocial components working with goal-directed behavioral change; both educational and practical elements, examples of these are vulva care, lubrication exercises, pelvic floor relaxation, work with thoughts, feelings, and behaviors related to the pain, as well as thoughts, feelings and behaviors related to sex and desire, and educational and practical elements focusing on open communication and validation. The treatment sessions are between 60 to 90 minutes each. There is a possibility for the participants to involve partner during two of the treatment sessions.

Study summary

The aim of this SCED-study is to evaluate a multimodal treatment for vulvodynia in young women. The main questions it aims to answer are:

Is multimodal treatment effective for provoked vulvodynia in young women? How is multimodal treatment experienced by young women with vulvodynia?

Participants will respond to frequent questionnaires (two times a week) during a baseline period of 4,5 or 6 weeks, as well as during their treatment period ( a total of 25 weeks). In addition they will respond to pre-, post-treatment and 6 month follow-up questionnaires.

Eligibility

Sex

FEMALE

Min age

15 Years

Max age

23 Years

Healthy volunteers

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

Primary outcome measure(s)

Genital Pain Intensity — Pre, post treatment (25 weeks after the baseline measurement started) and at 6 month follow-up. Repeated measures twice a week during baseline (4, 5 or 6 weeks) and treatment period, for 25 weeks.
Provoked pain during sexual and non-sexual activities. Seven activities where pain is rated on a scale from 0 to 10. Higher scoring indicates higher degree of pain. There are also subsequent questions regarding whether they have performed the described activity or not within a specific time frame.

Trial sites (1)

Facility	City	Region	Status
Ungdomsmottagningen	Örebro	Sweden

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07092332 on ClinicalTrials.gov ↗ ← All trials in Sweden