VulvodyniaUVNCT07092332
Young Vulvodynia: Effect and Efficacy of Multimodal Treatment.
A study testing Multimodal treatment in people with Vulvodynia, run by Region Örebro County at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 to 23 years, women only
- Conditions the study is for
- Vulvodynia
- What is being tested?
- Multimodal treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSweden
- Study dates
- 10 Jun 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 23 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Biological sex female
- 15-23 years of age
- Diagnosed with Provoked vulvodynia
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Young Vulvodynia: Effect and Efficacy of a Multimodal Treatment for Young Women With Vulvar Pain
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.
Read the detailed description
The current study is an effectiveness evaluation, applying a sequential single case experimental AB design (SCED) with randomized baseline length, implemented at a youth guidance center. Potential participants will be informed about the study and answer a few questions digitally to ensure that participation in the study is appropriate for them. An assessment will then be conducted and questions will be asked about the pain, psychological, sexual and relational health, and a diagnostic interview will be conducted to exclude other psychological issues that needs to be prioritized before vulvodynia treatment.
After the assessment interview and inclusion, participants will be randomized in tiers to a 4, 5, or 6 week baseline period. Thereafter, the treatment will begin. During the baseline and treatment period, participants will complete a short self-assessment questionnaire, twice a week, to measure pain (primary outcome) and other key variables. To facilitate the repeated assessments, we will use the m-Path app, which was developed by KU Leuven University in Belgium to easily evaluate treatment for both patients and therapists. In addition to the repeated assessments, the treatment will be evaluated through a comprehensive web-based self-assessment questionnaire before and after the intervention and at a six-month follow-up. The outcome measures are in line with Core Outcome set in Vulvodynia.
- Conditions
- Vulvodynia
- Being tested
- Multimodal treatment
- Keywords
- Vulvodynia, Provoked Vulvodynia, Multimodal Treatment, Cognitive Behavior Therapy, Single-Case Experimental Design, Chronic Pain, Adolescent, Emerging Adulthood
- Medical subject headings
- Vulvodynia, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal treatmentBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Multimodal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The Female Sexual Function Index (FSFI) is a self-report measure of female sexual function that assesses six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. It consists of 19 questions, rated on a 5-point scale, with a higher score indicating a better sexual function. The short version, FSFI-6 contains 6 questions.
Measured: 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
All participants identify one own primary goal. Participants chose an individual treatment goal and rate treatment goal attainment, from 0-10, 0= the goal is not at all achieved, 10= the goal is achieved.
Measured: 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
Self-report assessment of pelvic floor tension and pelvic floor relaxation. Two items rated on a 11-point scale, from 0-10, higher scores indicate greater tension and more difficulty relaxing the pelvic floor, and physiotherapeutic examination.
Measured: 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
Sexual Satisfaction as measured with Global Measure of Sexual Satisfaction (GMSEX), 5 items rated on a 7 point scale. Higher scores indicate a higher degree of sexual function.
Measured: Pre and post treatment (25 weeks after the baseline measurement started) and at 6 months follow-up
Sexual Pain Coping
Avoidance and Endurance Coping strategies related to sexual pain. Measured with CHAMP Sexual Pain Coping Scale. 12 items assess coping strategies for sexual pain: avoidance and endurance, rated on a 7 point-scale from 1 to 7, where higher scoring indicating a higher degree of avoidance and/or endurance.
For repeated measure: Two items from the CHAMP Sexual Pain Coping Scale (CSPCS), rated on a 7-point scale, with higher scores indicating a higher degree of avoidance and endurance.
Measured: 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´.
Pain Catastrophizing
Pain Catastrophizing, as measured by the CSQ-CAT. 7 items rated on a 5-point scale from 0 (not at all) to 4 (all the time). Higher scores indicating greater levels of pain catastrophizing.
Measured: Pre and post treatment (25 weeks after the baseline measurement started) and at 6 months follow-up
Depressive symptoms
Using the patient health questionnaire (PHQ-9), 9 items are rated on a 4-point scale, from 0 to 3. Higher scores indicating higher degree of depression symtoms.
Measured: Pre and post treatment, and at 6 months follow-up
Anxiety symptoms
Using the Generalized Anxiety Disorder questionnaire (GAD-7), 7 items rated on a 4-point scale from 0 to 3, higher scoring indicating a higher degree of anxiety symptoms.
Measured: Pre- and post treatment and at 6 month follow-up.
Change in quality of life
World Health Organization Quality of Life-BREF, 1 item where participants rates their quality of life, on a 5-point scale from 1 to 5, higher scoring indicating greater quality of life.
Measured: Pre and post treatment, and at 6 months follow-up
Change in life interference, sexual function interference and communication.
Vulvar pain assessment questionnaire (VPAQ)-short Inventory is a disease-specific set of measurement scales to capture the biopsychosocial nature of vulvodynia. We are using the parts from the questionnaire that evaluates life interference, sexual function interference, impact on relationship and sexual communication.
Life interference:6 items rated on a 6-point scale from 0 (not at all) to 4 (avoid because of pain). Higher scores indicating greater life interference.
Sexual function interference: 5 items rated on a 6-point scale from 0 (not at all) to 4 (avoid because of pain)
6 items about communication with partner rated on a 5-point scale from 0 (largely uncomfortable) to 4 (largely comfortable). Higher scoring indicates
Measured: Pre and post treatment (25 weeks after the baseline measurement started) and at 6 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start10 Jun 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VulvodyniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Örebro County
- Sponsor type
- University, hospital or other
- Collaborators
- Örebro University, Sweden
- Responsible party
- Principal investigator, Rebecca Lennartsson, Region Örebro County
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07092332
- Sponsor's protocol ID
- 282171
- Other IDs
- RFR-1010966, OLL-1013529
- Acronym
- UV
- Status last verified
- Aug 2026
- First submitted
- 10 Jun 2025
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Because of the sensitive nature of the data. Data can be provided by request.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Young Vulvodynia: Effect and Efficacy of a Multimodal Treatment for Young Women With Vulvar Pain
- ClinicalTrials.gov ID
- NCT07092332
- Acronym / sponsor ID
- UV / 282171
- Conditions
- Vulvodynia
- Keywords
- Vulvodynia, Provoked Vulvodynia, Multimodal Treatment, Cognitive Behavior Therapy, Single-Case Experimental Design, Chronic Pain, Adolescent, Emerging Adulthood
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Region Örebro CountyUniversity, hospital or other
- Collaborators
- Örebro University, Sweden
- Study start
- 10 Jun 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 29 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The current study is an effectiveness evaluation, applying a sequential single case experimental AB design (SCED) with randomized baseline length, implemented at a youth guidance center. Potential participants will be informed about the study and answer a few questions digitally to ensure that participation in the study is appropriate for them. An assessment will then be conducted and questions will be asked about the pain, psychological, sexual and relational health, and a diagnostic interview will be conducted to exclude other psychological issues that needs to be prioritized before vulvodynia treatment.
After the assessment interview and inclusion, participants will be randomized in tiers to a 4, 5, or 6 week baseline period. Thereafter, the treatment will begin. During the baseline and treatment period, participants will complete a short self-assessment questionnaire, twice a week, to measure pain (primary outcome) and other key variables. To facilitate the repeated assessments, we will use the m-Path app, which was developed by KU Leuven University in Belgium to easily evaluate treatment for both patients and therapists. In addition to the repeated assessments, the treatment will be evaluated through a comprehensive web-based self-assessment questionnaire before and after the intervention and at a six-month follow-up. The outcome measures are in line with Core Outcome set in Vulvodynia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Multimodal treatmentMultimodal Treatment. |
Who may qualify
- Ages
- 15 to 23 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Biological sex female
- 15-23 years of age
- Diagnosed with Provoked vulvodynia
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multimodal treatmentVulvodynia 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. | Behavioural | Multimodal Treatment |
Primary outcome
Genital Pain Intensity
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.
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.
10 secondary outcomes
Sexual Function
Time frame: 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
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.
Pelvic Floor Tension
Time frame: 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
Time frame: Pre and post treatment (25 weeks after the baseline measurement started) and at 6 months follow-up
Sexual Pain Coping
Time frame: 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´.
Pain Catastrophizing
Time frame: Pre and post treatment (25 weeks after the baseline measurement started) and at 6 months follow-up
Depressive symptoms
Time frame: Pre and post treatment, and at 6 months follow-up
Anxiety symptoms
Time frame: Pre- and post treatment and at 6 month follow-up.
Change in quality of life
Time frame: Pre and post treatment, and at 6 months follow-up
Change in life interference, sexual function interference and communication.
Time frame: Pre and post treatment (25 weeks after the baseline measurement started) and at 6 months follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: No. Because of the sensitive nature of the data. Data can be provided by request.
Related trials for Vulvodynia
Active, not recruitingPhase 2
A Phase 2 Study to Evaluate the Efficacy and Safety of Pudafensine in Vulvodynia (Provoked Vestibulodynia)
Vulvodynia
Not yet recruiting
Integrated Care Pathway for Hormonally Mediated Vestibulodynia: a Feasibility and Acceptability Pilot
Vestibulodynia, Vulvodynia
Active, not recruiting
Vestibulectomy Surgical Techniques Comparison Study
Vulvar Pain, Vulvodynia
Not yet recruiting
Transcutaneous Genital Nerves Stimulation for the Treatment of Refractory Chronic Pelvic and Genital Pain in Women.
Refractory Visceral Pelvic Pain, Refractory Genital Pain
Not yet recruitingPhase 2
A Pilot Study on the Efficacy of Oral Low Dose Naltrexone for Vulvodynia
Vulvodynia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal treatment in people with Vulvodynia, run by Region Örebro County at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genital Pain Intensity (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.