Feasibility Study for Provoked Vestibulodynia

Université de Sherbrooke

Status: Completed

Conditions: Vestibulodynia

Treatments: Other: Educational Pain Management Program; Other: Somatosensory Rehabilitation Program

Study type: Interventional

Funder types: Other

Identifiers

NCT05342402

#2022-4357

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosis of provoked vestibulodynia according to a standardized gynaecologic exam
2. Moderate to severe pain (≥5/10) located in the vulvar vestibule for at least 90% of vaginal penetrations or attempted vaginal penetrations or activities with pressure on the vagina for at least 3 months

Exclusion criteria

1. Other causes of vulvo-vaginal pain (e.g. spontaneous vulvovaginal pain not related to sexual intercourse/contact, dermatological condition, herpes, vulvo-vaginal atrophy)
2. Prior vulvo-vaginal surgery or radiotherapy
3. Post-menopausal status
4. Participant refusal to not use other treatments for the provoked vestibulodynia during the entire study (until 3 months post-treatment);
5. Other urogynecological condition (e.g. pelvic organs prolapse ≥3, current urinary/vaginal infection or in the last 3 months)
6. Prior use of Somatosensory Rehabilitation Program or Educational Pain Management Program
7. Current or past pregnancy in the last year;
8. Changes of medication that could influence pain perception (e.g. analgesic, antidepressant) in the last 3 months
9. Major psychological condition (e.g. depressive symptoms, anxiety) which can present a security issue for the participant
10. Other medical conditions that could interfere with the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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45 participants in 2 patient groups

Somatosensory Rehabilitation Program

Experimental group

Description:

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.

Treatment:

Other: Somatosensory Rehabilitation Program

Educational Pain Management Program (PMP)

Active Comparator group

Description:

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.

Treatment:

Other: Educational Pain Management Program