High-level Laser for Provoked Vestibulodynia

Vulvodynia Clinical Trial

Official title:

A Feasibility and Acceptability Study of High-level Laser for Women With Provoked Vestibulodynia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04502810
• Other study ID #: #2020-3535
• Status: Completed
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: May 4, 2021

Study information

• Verified date: January 2022
• Source: Université de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: May 4, 2021
• Est. primary completion date: May 4, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Vulvar Vestibulitis
• Vulvodynia

Intervention

Radiation:
• High-level laser therapy
Nd:Yag 1064 nm pulsed high-level Laser will be applied to the vulvar area.

Locations

Country	Name	City	State
Canada	Centre hospitalier Universitaire de Sherbroke	Sherbrooke	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
Université de Sherbrooke	Centre de recherche du Centre hospitalier universitaire de Sherbrooke, Exogenia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence rate	To determine acceptability by assessing adherence to treatment sessions	2-week post-treatment evaluation
Primary	Level of satisfaction with the treatment	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)	2-week post-treatment evaluation
Primary	Willingness to recommend the treatment	To determine acceptability by assessing whether the participant would recommend the treatment.	2-week post-treatment evaluation
Primary	Rate of adverse events	To document any adverse events.	2-week post-treatment evaluation
Primary	Blinding effectiveness	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? ''	2-week post-treatment evaluation
Primary	Recruitment rate	To assess the recruitment rate including the barriers and reasons for refusing to participate as well as the reasons for exclusion	Baseline to 2-week post-treatment evaluation
Primary	Completion and dropout rates	To evaluate completion and dropout rates based on the completion of the post-treatment evaluation.	2-week post-treatment evaluation
Primary	Completeness of data	To examine the percentage of completed outcome measures.	Baseline to 2-week post-treatment evaluation
Secondary	Change in pain intensity during intercourse	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)	Baseline to 2-week post-treatment evaluation
Secondary	Change in sexual function	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).	Baseline to 2-week post-treatment evaluation
Secondary	Change in sexual distress	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).	Baseline to 2-week post-treatment evaluation
Secondary	Change in pain quality	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).	Baseline to 2-week post-treatment evaluation
Secondary	Patient's global impression of change	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.	Baseline to 2-week post-treatment evaluation
Secondary	Change in fear of pain	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).	Baseline to 2-week post-treatment evaluation
Secondary	Change in pain catastrophization	To explore changes in pain catastrophization (Pain Catastrophizing Scale (PCS)). Minimum value: 0, Maximum value: 52, higher scores mean worse outcome (higher pain catastrophization)	Baseline to 2-week post-treatment evaluation
Secondary	Change in vulvar pain sensitivity	To explore changes in vulvar pain sensitivity (algometer)	Baseline to 2-week post-treatment evaluation
Secondary	Change in vulvar blood circulation	To explore changes in vulvar blood circulation using the laser speckle. Vulvar vestibule blood perfusion is expressed in arbitrary perfusion units (APUs).	Baseline to 2-week post-treatment evaluation