Feasibility Study for Provoked Vestibulodynia
Condition: Vestibulodynia
MeSH terms: Vulvodynia; Vulvar Vestibulitis
Study type: Interventional

Summary: 
      The feasibility and acceptability of a somatosensory rehabilitation program and an
      educational pain management program will be investigated in women with provoked
      vestibulodynia. Forty-four women will be randomized into the two groups. The secondary
      objective is to explore the effects of the somatosensory rehabilitation program compared to
      the pain management program. Each participant will receive 12 weekly sessions with a
      physiotherapist.

      The somatosensory rehabilitation program includes minimizing contact with the painful zone of
      the vulva and uses repeated tactile stimulation at a tolerated distance, proximal to the
      vulva. The pain management program includes teaching participants about vulvar hygiene,
      chronic pain mechanisms, relaxation techniques, and approaches to reduce skin irritations in
      painful regions. Participants in both groups will also receive advice on sexual function and
      steps toward resuming sexual activities with vaginal penetration.

      Feasibility and acceptability outcomes will be assessed and analyzed using descriptive
      statistics for the adherence rates to treatment sessions and home exercises, the recruitment
      rate, retention rate, satisfaction, and adverse effects. The results will be compared to
      predetermined thresholds to determine the feasibility and acceptability of a future clinical
      trial.

      Secondary measures will be assessed at baseline, two weeks after the treatment, and at three
      months follow-up. These outcomes will be assessed using validated questionnaires (pain,
      sexual function, global impression of change, psychological variables, quality of life) as
      well as evaluations of tactile and pressure sensitivity in vulvar regions using
      monofilaments, a 2-point aesthesiometer and an algometer. Linear mixed models for repeated
      measurements (2 groups, 3 measurement times) will be used to explore the treatment effects
      and will contribute to determining the feasibility of a future clinical trial.

      Hypothesis and expected results: It is expected that both programs will meet the
      pre-determined criteria for acceptability and feasibility in women with provoked
      vestibulodynia. This study will provide guidance for a future randomized clinical trial.
    


Intervention name(s): Somatosensory Rehabilitation Program; Educational Pain Management Program
Intervention type(s): Other; Other
Intervention description(s): Somatosensory rehabilitation program includes minimizing contact with the painful zone of the vulva and uses tactile stimulation at a tolerated distance from the vulva. Each participant will also receive advice on resuming sexual activities with vaginal penetration.; Educational Pain Management Program includes education on decreasing irritative contacts with the vulva and relaxation techniques. Each participant will also receive advice on resuming sexual activities with vaginal penetration.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Baseline evaluation - Randomization to Somatosensory Rehabilitation Program or Educational Pain Management Program (12 sessions within 12 weeks) - 2 weeks post-treatment evaluation - 3 months follow-up
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Provoked Vestibulodynia; Pain; Allodynia; Somatosensory Rehabilitation