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Efficacy of High Intensity Laser for Provoked Vestibulodynia (Laser_RCT)

Primary Purpose

Vulvodynia

Status

Recruiting

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

High Intensity Laser Therapy (HILT)

Sham High Intensity Laser Therapy

About this trial

This is an interventional treatment trial for Vulvodynia focused on measuring Laser, Provoked vestibulodynia, Pain, Sexual dysfunctions

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Moderate to severe pain (≥ 5/10) at least 90% of the time during sexual intercourse or attempted sexual intercourse for at least 3 months
Provoked vestibulodynia of at least 3 months duration prior to the study and diagnosed by a standardized gynaecologic exam

Exclusion Criteria:

Other causes of vulvovaginal pain (e.g., spontaneous vulvovaginal pain not related to sexual intercourse/contact, dermatological condition, herpes, vulvovaginal atrophy)
Post-menopausal state
Current pregnancy or pregnancy in the last year
Urogynecological condition (e.g., pelvic organ prolapse (POP) ≥ 3, urinary/vaginal infection active or in the last 3 months)
Anterior vulvar, vaginal or pelvic surgery (e.g., vestibulectomy, corrective pelvic organ prolapse 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

Sites / Locations

Centre hospitalier universitaire de SherbrookeRecruiting
ExogeniaRecruiting
Centre Hospitalier Universitaire de Québec - Université Laval
Kinatex l'Ormière

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

High Intensity Laser Therapy (HILT)

Sham High Intensity Laser Therapy

Arm Description

Active high intensity laser therapy for 12 biweekly sessions (6 consecutive weeks of biweekly treatments)

Sham high-intensity laser therapy for 12 biweekly sessions (6 consecutive weeks of biweekly treatments)

Outcomes

Primary Outcome Measures

Change in pain intensity during intercourse

To explore changes in pain intensity during intercourse (Numerical Rating Scale (NRS), ranging from 0 to 10, where 0 is no pain at all, and 10 is the worst pain ever)

Secondary Outcome Measures

Change in pain quality

To explore changes in the sensory, affective, and evaluative components of pain (McGill-Melzack Questionnaire). Minimum value: 0, Maximum value: 78, higher scores indicate a worse outcome (higher pain).

Change in sexual function

To explore changes in sexual function (Female Sexual Function Index - FSFI). Minimum value: 2, Maximum value: 36, lower scores indicate a worse outcome (low sexual function).

Change in sexual distress

To explore changes in sexual distress (Female Sexual Distress Scale - FSDS). Minimum value: 0, Maximum value: 52, higher scores indicate a worse outcome (higher sexually-related distress).

Change in pain catastrophizing

To explore changes in pain catastrophizing (Pain Catastrophizing Scale - PCS). Minimum value: 0, Maximum value: 52, higher scores indicate a worse outcome (higher pain catastrophizing).

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 indicate a worse outcome (higher fear of pain).

Change in cognitions regarding vaginal penetration

To explore the cognitions of women towards vaginal penetration (Vaginal penetration cognition questionnaire (VPCQ)). Minimum value: 0, Maximum value: 240, higher scores show higher levels of perceived penetration control.

Change in the life impact of pelvic pain

To explore the change in the life impact of pelvic pain (Pelvic Pain Impact Questionnaire). Minimum value: 0, Maximum value: 32, higher scores indicate that the pelvic pain of the participants has a strong impact on their life.

Change in intercourse self-efficacy

To explore the change self-efficacy regarding painful intercourse (Painful Intercourse Self-Efficacy Scale). Minimum value: 20, Maximum value: 100, higher scores indicate higher self-efficacy.

Level of satisfaction with treatment

To determine acceptability by measuring the participants' satisfaction with the treatment on a Numeric Rating Scale (NRS) ranging from 0 (completely dissatisfied) to 10 (completely satisfied).

Patient's global impression of change

To examine patient self-reported improvement (Patient's Global Impression of Change - PGIC) ranging from "very much worse" to "very much improved" on a 7-point scale.

Full Information

NCT ID

NCT05597358

First Posted

October 24, 2022

Last Updated

January 16, 2023

Sponsor

Université de Sherbrooke

Collaborators

Centre de recherche du Centre hospitalier universitaire de Sherbrooke, Exogenia, CHU de Quebec-Universite Laval, Kinatex l'Ormière

1. Study Identification

Unique Protocol Identification Number

NCT05597358

Brief Title

Efficacy of High Intensity Laser for Provoked Vestibulodynia

Acronym

Laser_RCT

Official Title

Efficacy of High Intensity Laser Therapy for Reducing Pain During Intercourse in Women With Provoked Vestibulodynia: A Multicenter Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 26, 2022 (Actual)

Primary Completion Date

November 1, 2025 (Anticipated)

Study Completion Date

November 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Université de Sherbrooke

Collaborators

Centre de recherche du Centre hospitalier universitaire de Sherbrooke, Exogenia, CHU de Quebec-Universite Laval, Kinatex l'Ormière

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This is a multicenter randomized controlled trial (RCT) investigating the effects of laser treatments in women suffering from provoked vestibulodynia compared to a sham-laser treatment. Following their enrollment in the study, participants will undergo a gynecological examination for confirmation of their diagnoses. Eligible participants will then be asked to complete a consent form and the baseline assessment. The baseline assessment consists of the completion of validated questionnaires (outcome measures). Participants will be randomized into the laser group or sham-laser group. The laser group will receive 12 sessions of active high intensity 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. Outcome measures (validated questionnaires) will also be assessed 2 weeks post-treatment as well as 6 months post-treatment (follow-up assessment).

Detailed Description

Vulvodynia, a chronic vulvar pain condition, affects between 8 and 18% of reproductive-aged women. The main subtype of vulvodynia is provoked vestibulodynia (PVD), which is characterized by a sharp or burning pain at the vaginal opening while applying pressure to the vulvar vestibule or attempting vaginal penetration. Women suffering from PVD experience greater psychological distress, a worsened quality of life and overall well-being as well as sexual dysfunctions for both the women and their intimate partners. Women suffering from PVD have limited treatment options, and some women have persistent pain despite the available treatment options. Therefore, a new therapeutic avenue needs to be explored. High intensity laser therapy (HILT), a non-invasive and non-ablative laser technique, was found to be effective in several chronic pain conditions. Our randomized pilot study confirmed that HILT is feasible for treating PVD. The promising findings obtained provided support for conducting this large multicenter randomized controlled trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vulvodynia

Keywords

Laser, Provoked vestibulodynia, Pain, Sexual dysfunctions

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Baseline evaluation Randomization to active laser or sham laser (12 sessions in 6 consecutive weeks) Post-treatment evaluation (2 weeks post-treatment) Follow-up evaluation (6 months post-treatment)

Masking

ParticipantInvestigatorOutcomes Assessor

Masking Description

Participants, investigators, outcomes assessors and data analysts will be masked to group assignation.

Allocation

Randomized

Enrollment

142 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

High Intensity Laser Therapy (HILT)

Arm Type

Active Comparator

Arm Description

Active high intensity laser therapy for 12 biweekly sessions (6 consecutive weeks of biweekly treatments)

Arm Title

Sham High Intensity Laser Therapy

Arm Type

Sham Comparator

Arm Description

Sham high-intensity laser therapy for 12 biweekly sessions (6 consecutive weeks of biweekly treatments)

Intervention Type

Radiation

Intervention Name(s)

High Intensity Laser Therapy (HILT)

Other Intervention Name(s)

Nd:Yag laser

Intervention Description

Nd:Yag 1064 nm pulsed high intensity laser will be applied to the vulvar area.

Intervention Type

Radiation

Intervention Name(s)

Sham High Intensity Laser Therapy

Other Intervention Name(s)

Sham, Control, Deactivated probe

Intervention Description

Nd:Yag 1064 pulsed high intensity laser deactivated probe will be applied to the vulvar area.

Primary Outcome Measure Information:

Title

Change in pain intensity during intercourse

Description

To explore changes in pain intensity during intercourse (Numerical Rating Scale (NRS), ranging from 0 to 10, where 0 is no pain at all, and 10 is the worst pain ever)

Time Frame