Vulvodynia
Conditions
Keywords
Laser, Provoked vestibulodynia, Pain, Sexual dysfunctions
Brief summary
This is a randomized feasibility and acceptability study investigating the effects of laser treatment in women suffering from provoked vestibulodynia compared to a sham-laser treatment. Participants will be randomized into the laser group or sham-laser group. The laser group will receive 12 sessions of real high-level laser therapy (HILT) (30-minutes biweekly for 6 consecutive weeks). The sham-laser group will receive 12 sessions (30-minutes biweekly for 6 consecutive weeks) of laser therapy using a deactivated probe. Outcomes measures will be assessed at baseline and at post-treatment and will include: feasibility and acceptability variables, pain, sexual function, sexual distress, psychological variables and perceived improvement after the treatment.
Interventions
RADIATIONHigh-level laser therapy
Nd:Yag 1064 nm pulsed high-level Laser will be applied to the vulvar area.
Sponsors
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Exogenia
Université de Sherbrooke
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Baseline evaluation - Randomization to real laser or sham laser (12 sessions in 6 consecutive weeks) - Post-treatment evaluation
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Moderate to severe pain (≥5/10) during sexual intercourse for at least 3 months * Moderate to severe pain (≥5/10) in at least 90% of sexual intercourses or attempted sexual intercourse for at least 3 months * Provoked vestibulodynia lasting at least 3 months prior to the study and diagnosed by a standardised gynaecologic exam
Exclusion criteria
* Other causes of vulvo-vaginal pain (e.g. spontaneous vulvovaginal pain not related to sexual intercourse/contact, dermatological condition, herpes, vulvo-vaginal atrophy) * Post-menopausal state * Actual or past pregnancy in the last year * Urogynecological condition (e.g. pelvic organs prolapse ≥3, urinary/vaginal infection active or in the last 3 months) * Anterior vulvar, vaginal or pelvic surgery (e.g. vestibulectomy, corrective pelvic organs prolapses surgery) * Prior use of laser treatments for vulvar pain * Expected changes of medication that could influence pain perception (e.g. analgesic, antidepressant) * Other medical conditions that could interfere with the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Completion and dropout rates | 2-week post-treatment evaluation | To evaluate completion and dropout rates based on the completion of the post-treatment evaluation. |
| Completeness of data | Baseline to 2-week post-treatment evaluation | To examine the percentage of completed outcome measures. |
| Adherence rate | 2-week post-treatment evaluation | To determine acceptability by assessing adherence to treatment sessions |
| Level of satisfaction with the treatment | 2-week post-treatment evaluation | To determine acceptability by measuring the participants' satisfaction with the treatment on a numeric rating scale ranging from 0 (completely dissatisfied) to 10 (completely satisfied) |
| Willingness to recommend the treatment | 2-week post-treatment evaluation | To determine acceptability by assessing whether the participant would recommend the treatment. |
| Rate of adverse events | 2-week post-treatment evaluation | To document any adverse events. |
| Blinding effectiveness | 2-week post-treatment evaluation | To assess the feasibility of maintaining blinding to group allocation for the therapists, assessors and therapists. Evaluated by asking the question: ''What treatment do you think you have received / given? '' |
| Recruitment rate | Baseline to 2-week post-treatment evaluation | To assess the recruitment rate including the barriers and reasons for refusing to participate as well as the reasons for exclusion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain intensity during intercourse | Baseline to 2-week post-treatment evaluation | To explore changes in pain intensity during intercourse (Numerical Rating Scale, ranging from 0 to 10, where 0 is no pain at all, and 10 is the worst pain ever) |
| Change in vulvar blood circulation | Baseline to 2-week post-treatment evaluation | To explore changes in vulvar blood circulation using the laser speckle. Vulvar vestibule blood perfusion is expressed in arbitrary perfusion units (APUs). |
| Change in sexual function | Baseline to 2-week post-treatment evaluation | To explore changes in sexual function (Female Sexual Function Index). Minimum value: 2, Maximum value: 36 and lower scores mean worst outcome (low sexual function). |
| Change in sexual distress | Baseline to 2-week post-treatment evaluation | To explore changes in sexual distress (Female Sexual Distress Scale ). Minimum value: 0, Maximum value: 52, higher scores mean worst outcome (higher sexually related distress). |
| Change in pain quality | Baseline to 2-week post-treatment evaluation | To explore changes on the sensory, affective and evaluative components of pain (McGill-Melzack Questionnaire). Minimum value: 0, Maximum value: 78, higher scores mean worst outcome (higher pain). |
| Patient's global impression of change | Baseline to 2-week post-treatment evaluation | To examine patient self-reported improvement (Patient's Global Impression of Change ranging from very much worse to very much improved on a 7-point scale. |
| Change in fear of pain | Baseline to 2-week post-treatment evaluation | To explore changes in fear of pain (Pain Anxiety Symptoms Scale (PASS-20)). Minimum value: 0, Maximum value: 100, higher scores mean worst outcome (higher fear of pain). |
| Change in pain catastrophization | Baseline to 2-week post-treatment evaluation | To explore changes in pain catastrophization (Pain Catastrophizing Scale (PCS)). Minimum value: 0, Maximum value: 52, higher scores mean worse outcome (higher pain catastrophization) |
| Change in vulvar pain sensitivity | Baseline to 2-week post-treatment evaluation | To explore changes in vulvar pain sensitivity (algometer) |
Countries
Canada
Outcome results
None listed