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Not Yet Recruiting NCT07908901

Integrated Care Pathway for Hormonally Mediated Vestibulodynia: a Feasibility and Acceptability Pilot

Conditions: Vestibulodynia, Vulvodynia, Vulvar Vestibulitis

Sex: Female
Ages: 18 Years – 45 Years
Healthy volunteers: No
Phase: NA
Enrollment: 35
Sponsor: HerAccess ApS

Location: OsteoMedica Copenhagen Nørrebro

Summary

This single-arm pilot study evaluates whether an integrated six-month care pathway for women with persistent vestibular vulvar pain and suspected hormonally mediated vestibulodynia can be delivered as planned, and how participants and clinicians experience it. The pathway brings existing clinical and supportive elements together in one coordinated sequence: a digital symptom questionnaire whose answers are organised by topic for clinician review, specialist pre-screening by a gynaecologist with expertise in vulvar pain, pelvic floor screening by an authorised pelvic floor physiotherapist, gynaecological assessment by the responsible investigator, individual clinical management, pharmacy coordination, optional home videos and psychosexual support, and follow-up. Up to 35 women aged 18-45 in Denmark are followed for 24 weeks. The study measures pathway feasibility (consent, completion of pathway steps, handover times, retention, deviations) and acceptability (participant and clinician experience). It does not measure symptom change or treatment effect.

Eligibility Criteria

Inclusion Criteria: * Age 18-45 years * Resident in Denmark throughout the 24-week follow-up period * Provoked, unprovoked or mixed vestibular vulvar pain for at least three months * Able to participate in Danish or English * Able to attend the required clinical assessments in Copenhagen * Able to provide informed consent and complete the study questionnaires * Symptom history considered relevant, at specialist clinical pre-screening, for assessment within the pathway Exclusion Criteria: * Pregnancy or breastfeeding where the responsible investigator considers participation clinically inappropriate * Active infection, unexplained bleeding, suspected malignancy or another condition requiring assessment outside the pathway * A clinical condition that makes the planned examination unsafe or inappropriate * Predominant hypertonic pelvic floor dysfunction, absence of an indicated hormonal component at specialist review, or another mechanism requiring a different principal care pathway (these participants receive guidance on appropriate next steps) * Concurrent participation in another study that conflicts with the pathway * Inability to provide informed consent

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07908901). StuddyBuddy aggregates publicly available trial information.