High-level Laser for Provoked Vestibulodynia

January 26, 2022 updated by: Mélanie Morin, Université de Sherbrooke

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
41

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Centre hospitalier Universitaire de Sherbroke

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: High-level laser therapy
Real high-level laser therapy laser 12 biweekly sessions (6 consecutive weeks of biweekly treatments)
Radiation: High-level laser therapy
Nd:Yag 1064 nm pulsed high-level Laser will be applied to the vulvar area.
Other Names:
  • Nd:Yag laser
Sham Comparator: Sham High-level laser therapy
Sham high-level laser therapy laser 12 biweekly sessions (6 consecutive weeks of biweekly treatments)
Radiation: High-level laser therapy
Nd:Yag 1064 nm pulsed high-level Laser will be applied to the vulvar area.
Other Names:
  • Nd:Yag laser

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Adherence rate
Time Frame: 2-week post-treatment evaluation
To determine acceptability by assessing adherence to treatment sessions
2-week post-treatment evaluation
Level of satisfaction with the treatment
Time Frame: 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)
2-week post-treatment evaluation
Willingness to recommend the treatment
Time Frame: 2-week post-treatment evaluation
To determine acceptability by assessing whether the participant would recommend the treatment.
2-week post-treatment evaluation
Rate of adverse events
Time Frame: 2-week post-treatment evaluation
To document any adverse events.
2-week post-treatment evaluation
Blinding effectiveness
Time Frame: 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? ''
2-week post-treatment evaluation
Recruitment rate
Time Frame: 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
Baseline to 2-week post-treatment evaluation
Completion and dropout rates
Time Frame: 2-week post-treatment evaluation
To evaluate completion and dropout rates based on the completion of the post-treatment evaluation.
2-week post-treatment evaluation
Completeness of data
Time Frame: Baseline to 2-week post-treatment evaluation
To examine the percentage of completed outcome measures.
Baseline to 2-week post-treatment evaluation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in pain intensity during intercourse
Time Frame: 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)
Baseline to 2-week post-treatment evaluation
Change in sexual function
Time Frame: 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).
Baseline to 2-week post-treatment evaluation
Change in sexual distress
Time Frame: 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).
Baseline to 2-week post-treatment evaluation
Change in pain quality
Time Frame: 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).
Baseline to 2-week post-treatment evaluation
Patient's global impression of change
Time Frame: 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.
Baseline to 2-week post-treatment evaluation
Change in fear of pain
Time Frame: 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).
Baseline to 2-week post-treatment evaluation
Change in pain catastrophization
Time Frame: 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)
Baseline to 2-week post-treatment evaluation
Change in vulvar pain sensitivity
Time Frame: Baseline to 2-week post-treatment evaluation
To explore changes in vulvar pain sensitivity (algometer)
Baseline to 2-week post-treatment evaluation
Change in vulvar blood circulation
Time Frame: 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).
Baseline to 2-week post-treatment evaluation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Université de Sherbrooke

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Exogenia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mélanie Morin, PT, PhD, Université de Sherbrooke

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 4, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 4, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 27, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 6, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 10, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • #2020-3535

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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