Clinical trial NCT05342402: Feasibility Study for Provoked Vestibulodynia
Official title: Assessing the Feasibility of Somatosensory Rehabilitation and Pain Management Programs in Women With Provoked Vestibulodynia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vestibulodynia
Keywords: Provoked Vestibulodynia
Pain
Allodynia
Somatosensory Rehabilitation
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
name: Centre de Recherche du Centre Hospitalier de l'Université de Montréal
First posted: 2022-04-22
Enrollment: 45
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Adherence rate to home exercises
timeFrame: From first to last session (baseline to 12th week)
measure: Patients' adherence rate to treatment sessions
timeFrame: From first to last session (baseline to 12th week)
measure: Adherence rate to assessment sessions
timeFrame: Baseline to 3 months post-treatment evaluation
measure: Retention rate
timeFrame: Baseline to 3 months post-treatment evaluation
measure: Recruitment rate
timeFrame: At baseline only (during the recruitement period)
measure: Therapists treatment adherence
timeFrame: From first to last session (baseline to 12th week)
Secondary outcomes:
measure: Intervention Acceptability Questionnaire
timeFrame: At 2-week post-treatment and at 3 months post-treatment
measure: Credibility and Expectancy Questionnaire
timeFrame: At baseline only (before the initiation of the treatment)
measure: Patients' Global Impression of Change and Satisfaction
timeFrame: At 2-week post-treatment and 3 months post-treatment
measure: Self-Efficacy Question
timeFrame: At baseline, 6 week after the initiation of treatment, and at the last treatment (12th week)
measure: Adverse events
timeFrame: 2-week and 3 months post-treatment
measure: Pain intensity during intercourse (Numerical Rating Scale)
timeFrame: Changes from pre- to 2-week post-treatment, from 2-week post-treatment to 3-month post-treatment, and from pre-treatment to 3-month post-treatment
measure: Pain quality (McGill-Melzack questionnaire-short form)
timeFrame: Change in the scores from pre- to 2-week post-treatment, from 2-week post-treatment to 3-month post-treatment, and from pre-treatment to 3-month post-treatment
measure: Vulvar sensitivity
timeFrame: Change in the scores from pre- to 2-week post-treatment, from 2-week post-treatment to 3-month post-treatment, and from pre-treatment to 3-month post-treatment
measure: Vulvar tactile allodynia area
timeFrame: Change in the surface from pre- to 2-week post-treatment, from 2-week post-treatment to 3-month post-treatment, and from pre-treatment to 3-month post-treatment
measure: Vulvar tactile alllodynia severity
timeFrame: Change in the surface from pre- to 2-week post-treatment, from 2-week post-treatment to 3-month post-treatment, and from pre-treatment to 3-month post-treatment
measure: Vulvar tactile sensibility
timeFrame: Change in the surface from pre- to 2-week post-treatment, from 2-week post-treatment to 3-month post-treatment, and from pre-treatment to 3-month post-treatment
measure: Two-point discrimination test
timeFrame: Change in the surface from pre- to 2-week post-treatment, from 2-week post-treatment to 3-month post-treatment, and from pre-treatment to 3-month post-treatment
measure: Female Sexual Function Index (FSFI)
timeFrame: Change in the scores from pre- to 2-week post-treatment, from 2-week post-treatment to 3-month post-treatment, and from pre-treatment to 3-month post-treatment
measure: Female Sexual Distress Scale (FSDS)
timeFrame: Change in the scores from pre- to 2-week post-treatment, from 2-week post-treatment to 3-month post-treatment, and from pre-treatment to 3-month post-treatment
measure: Pain Anxiety Symptoms Scale (PASS-20)
timeFrame: Change in the scores from pre- to 2-week post-treatment, from 2-week post-treatment to 3-month post-treatment, and from pre-treatment to 3-month post-treatment
measure: Pain Catastrophizing Scale (PCS)
timeFrame: Change in the scores from pre- to 2-week post-treatment, from 2-week post-treatment to 3-month post-treatment, and from pre-treatment to 3-month post-treatment
measure: Beck Depression Inventory questionnaire (BDI-II)
timeFrame: Change in the scores from pre- to 2-week post-treatment, from 2-week post-treatment to 3-month post-treatment, and from pre-treatment to 3-month post-treatment
measure: Vaginal Penetration Cognition Questionnaire (VPCQ)
timeFrame: Change in the scores from pre- to 2-week post-treatment, and from pre-treatment to 3-month post-treatment
measure: 12-item Short Form Survey (SF-12 v2)
timeFrame: Change in the scores from pre- to 2-week post-treatment, from 2-week post-treatment to 3-month post-treatment, and from pre-treatment to 3-month post-treatment
Other outcomes:
measure: Short-Leeds Assessment for Neuropathic Symptoms and Signs (S-LANSS)
timeFrame: At baseline only (before the initiation of the treatment)
Locations:
city: Sherbrooke
country: Canada
facility: Centre Hospitalier Universitaire de Sherbrooke
state: Quebec
Study officials:
References: