Young Vulvodynia: Effect and Efficacy of Multimodal Treatment.

NCT07092332 | Recruiting

• 3 other identifiers: 282171RFR-1010966OLL-1013529
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vulvodynia

Keywords

Vulvodynia; Provoked Vulvodynia; Multimodal Treatment; Cognitive Behavior Therapy; Single-Case Experimental Design; Chronic Pain; Adolescent; Emerging Adulthood

Outcome Measures

Primary Outcomes (1)

• Genital Pain Intensity

  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.

  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.

Secondary Outcomes (10)

• Sexual Function

  FSFI: Pre, post treatment (25 weeks after the baseline measurement started) and at 6 month follow-up. FSFI-6 Repeated measures twice a week during baseline (4, 5 or 6 weeks) and treatment period, for 25 weeks.

• Participant Identified Treatment Goal

  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.

• Pelvic Floor Tension

  Pre, post treatment (25 weeks after the baseline measurement started) and at a 6 month follow-up. During baseline and treatment period measured twice a week, for 25 weeks.

• Sexual Satisfaction

  Pre and post treatment (25 weeks after the baseline measurement started) and at 6 months follow-up

• Sexual Pain Coping

  Pre, post treatment (25 weeks after the baseline measurement started) and at 6 month follow-up, during baseline (4, 5 or 6 weeks) and treatment period measured twice a week for 25 weeks´.

Other Outcomes (6)

• Demographic

  Pre treatment. Questions about partner/-s are measured pre and post treatment and at 6 month follow-up.

• Experiences of sexual and physical abuse

  Pre-treatment

• Treatment expectations

  Pre-treatment

Study Arms (2)

Baseline period

NO INTERVENTION

During a 4, 5 or 6 week waiting period, participants respond to a short questionnaire twice a week.

Multimodal Treatment

EXPERIMENTAL

Multimodal Treatment.

Behavioral: Multimodal treatment

Interventions

Multimodal treatment BEHAVIORAL

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.

Multimodal Treatment

Eligibility Criteria

• Age: 15 Years - 23 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Biological sex female
• years of age
• Diagnosed with Provoked vulvodynia

You may not qualify if:

• 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

Sponsors & Collaborators

• Region Örebro County: lead
• Örebro University, Sweden: collaborator

Study Sites (1)

Ungdomsmottagningen

Örebro, Sweden

RECRUITING

MeSH Terms

Conditions

Vulvodynia; Chronic Pain

Interventions

Combined Modality Therapy

Condition Hierarchy (Ancestors)

Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Rebecca Lennartsson, MSc

CONTACT

+46733690524; rebecca.lennartsson@regionorebrolan.se

Ida Flink, Professor

CONTACT

+46721564449; ida.flink@kau.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will be blinded to baseline length allocations.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctoral Student

Model Details: The study utilises a sequential single-case experimental AB design with randomized waiting period length (4, 5 or 6 weeks). Included in the design is also a pre-, post- and 6 month follow up measurement allowing for single group analysis of change. In addition, we collect qualitative data from patients, to explore experiences of participation in the study and the treatment.

Study Record Dates

• First Submitted: June 10, 2025
• First Posted: July 29, 2025
• Study Start: June 10, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)