Feasibility Study for Provoked Vestibulodynia

NCT05342402 | Completed

• 1 other identifier: #2022-4357
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Vestibulodynia

Keywords

Provoked Vestibulodynia; Pain; Allodynia; Somatosensory Rehabilitation

Outcome Measures

Primary Outcomes (6)

• Adherence rate to home exercises

  The adherence rate to home exercises for each treatment group will be assessed using a daily diary. The participants will record the frequency and duration of the exercises completed.

  From first to last session (baseline to 12th week)

• Patients' adherence rate to treatment sessions

  The patients' adherence to treatment sessions will be recorded in the participants' treatment files (present vs absent).

  From first to last session (baseline to 12th week)

• Adherence rate to assessment sessions

  The adherence to assessment sessions (present vs absent) will be recorded in the participants' assessment files. The reasons for absences will be documented.

  Baseline to 3 months post-treatment evaluation

• Retention rate

  The retention rate will be assessed by calculating the ratio of participants who stay in the study until the post-intervention and 3-month follow-up assessments. Reasons for dropouts will be collected.

  Baseline to 3 months post-treatment evaluation

• Recruitment rate

  The recruitment rate will be recorded as the average number of participants recruited per month as well as the participant accrual rate (participants enrolled / participants screened for diagnosis). Reasons for refusing to participate will be documented if the participant consents to inform the study's research team.

  At baseline only (during the recruitement period)

• Therapists treatment adherence

  The therapists' treatment adherence will be assessed within the therapists' files to verify that all the interventions' key components were applied and respected.

  From first to last session (baseline to 12th week)

Secondary Outcomes (19)

• Intervention Acceptability Questionnaire

  At 2-week post-treatment and at 3 months post-treatment

• Credibility and Expectancy Questionnaire

  At baseline only (before the initiation of the treatment)

• Patients' Global Impression of Change and Satisfaction

  At 2-week post-treatment and 3 months post-treatment

• Self-Efficacy Question

  At baseline, 6 week after the initiation of treatment, and at the last treatment (12th week)

• Adverse events

  2-week and 3 months post-treatment

Other Outcomes (1)

• Short-Leeds Assessment for Neuropathic Symptoms and Signs (S-LANSS)

  At baseline only (before the initiation of the treatment)

Study Arms (2)

Somatosensory Rehabilitation Program

EXPERIMENTAL

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: Somatosensory Rehabilitation Program

Educational Pain Management Program (PMP)

ACTIVE COMPARATOR

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.

Other: Educational Pain Management Program

Interventions

Somatosensory Rehabilitation Program OTHER

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.

Somatosensory Rehabilitation Program

Educational Pain Management Program OTHER

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.

Educational Pain Management Program (PMP)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosis of provoked vestibulodynia according to a standardized gynaecologic exam
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Université de Sherbrooke: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Centre de recherche du Centre hospitalier universitaire de Sherbrooke: collaborator
• Centre de Recherche du Centre Hospitalier de l'Université de Montréal: collaborator

Study Sites (1)

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Related Links

• Facebook page
• Laboratory Web page

MeSH Terms

Conditions

Vulvodynia; Pain; Hyperalgesia

Condition Hierarchy (Ancestors)

Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Somatosensory Disorders; Sensation Disorders; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher and Full Professor

Model Details: 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

Study Record Dates

• First Submitted: April 16, 2022
• First Posted: April 22, 2022
• Study Start: May 16, 2022
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: September 28, 2023

Record last verified: 2023-09

Locations

CA (1)