Feasibility Study for Provoked Vestibulodynia

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.

Conditions

• Vestibulodynia

Interventions

OTHER

Somatosensory Rehabilitation Program

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.

OTHER

Educational Pain Management Program

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.

Sponsors & Collaborators

• Canadian Institutes of Health Research (CIHR)

  collaborator OTHER_GOV

• Centre de recherche du Centre hospitalier universitaire de Sherbrooke

  collaborator OTHER

• Centre de Recherche du Centre Hospitalier de l'Université de Montréal

  collaborator OTHER

• Université de Sherbrooke

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-05-16

Primary Completion

2023-07-31

Completion

2023-07-31

Countries

• Canada

Study Locations