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Integrated Care Pathway for Hormonally Mediated Vestibulodynia: a Feasibility and Acceptability Pilot
Sponsor: HerAccess ApS
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.
Official title: HerAccess Pilot Study: Feasibility and Acceptability of an Integrated Care Pathway for Hormonally Mediated Vestibulodynia
Key Details
Gender
FEMALE
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
35
Start Date
2027-01
Completion Date
2027-12
Last Updated
2026-11-02
Healthy Volunteers
No
Interventions
HerAccess integrated care pathway
Coordination of existing clinical and supportive elements into one pathway: (1) digital symptom questionnaire presenting the participant's own answers by topic for clinician review, with no scoring or classification; (2) specialist pre-screening by a gynaecologist with vulvar pain expertise; (3) pelvic floor screening by an authorised pelvic floor physiotherapist; (4) gynaecological and vestibular examination and individual care plan by the responsible investigator; (5) individual clinical management decided by the responsible investigator, which may include a named-patient compounded topical estradiol 0.01%/testosterone 0.1% preparation where clinically indicated; (6) pharmacy coordination; (7) optional movement and pelvic floor relaxation videos; (8) optional clinical sexologist consultation; (9) experience questionnaires and a final interview. The object of study is the delivery and experience of the pathway, not the effect of any individual treatment.
Locations (2)
OsteoMedica
Copenhagen, Nørrebro, Denmark
Klinik Hormony
Frederiksberg, Denmark