search
Back to results

High-level Laser for Provoked Vestibulodynia

Primary Purpose

Vulvodynia

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
High-level laser therapy
Sponsored by
Université de Sherbrooke
About
Eligibility
Locations
Arms
Outcomes
Full info

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) 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

Sites / Locations

  • Centre hospitalier Universitaire de Sherbroke

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

High-level laser therapy

Sham High-level laser therapy

Arm Description

Real high-level laser therapy laser 12 biweekly sessions (6 consecutive weeks of biweekly treatments)

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

Outcomes

Primary Outcome Measures

Adherence rate
To determine acceptability by assessing adherence to treatment sessions
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)
Willingness to recommend the treatment
To determine acceptability by assessing whether the participant would recommend the treatment.
Rate of adverse events
To document any adverse events.
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? ''
Recruitment rate
To assess the recruitment rate including the barriers and reasons for refusing to participate as well as the reasons for exclusion
Completion and dropout rates
To evaluate completion and dropout rates based on the completion of the post-treatment evaluation.
Completeness of data
To examine the percentage of completed outcome measures.

Secondary Outcome Measures

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)
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).
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).
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).
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.
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).
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)
Change in vulvar pain sensitivity
To explore changes in vulvar pain sensitivity (algometer)
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).

Full Information

First Posted
July 27, 2020
Last Updated
January 26, 2022
Sponsor
Université de Sherbrooke
Collaborators
Centre de recherche du Centre hospitalier universitaire de Sherbrooke, Exogenia
search

1. Study Identification

Unique Protocol Identification Number
NCT04502810
Brief Title
High-level Laser for Provoked Vestibulodynia
Official Title
A Feasibility and Acceptability Study of High-level Laser for Women With Provoked Vestibulodynia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
May 4, 2021 (Actual)
Study Completion Date
May 4, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université de Sherbrooke
Collaborators
Centre de recherche du Centre hospitalier universitaire de Sherbrooke, Exogenia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

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 real laser or sham laser (12 sessions in 6 consecutive weeks) - Post-treatment evaluation
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High-level laser therapy
Arm Type
Experimental
Arm Description
Real high-level laser therapy laser 12 biweekly sessions (6 consecutive weeks of biweekly treatments)
Arm Title
Sham High-level laser therapy
Arm Type
Sham Comparator
Arm Description
Sham high-level laser therapy laser 12 biweekly sessions (6 consecutive weeks of biweekly treatments)
Intervention Type
Radiation
Intervention Name(s)
High-level laser therapy
Other Intervention Name(s)
Nd:Yag laser
Intervention Description
Nd:Yag 1064 nm pulsed high-level Laser will be applied to the vulvar area.
Primary Outcome Measure Information:
Title
Adherence rate
Description
To determine acceptability by assessing adherence to treatment sessions
Time Frame
2-week post-treatment evaluation
Title
Level of satisfaction with the treatment
Description
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)
Time Frame
2-week post-treatment evaluation
Title
Willingness to recommend the treatment
Description
To determine acceptability by assessing whether the participant would recommend the treatment.
Time Frame
2-week post-treatment evaluation
Title
Rate of adverse events
Description
To document any adverse events.
Time Frame
2-week post-treatment evaluation
Title
Blinding effectiveness
Description
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? ''
Time Frame
2-week post-treatment evaluation
Title
Recruitment rate
Description
To assess the recruitment rate including the barriers and reasons for refusing to participate as well as the reasons for exclusion
Time Frame
Baseline to 2-week post-treatment evaluation
Title
Completion and dropout rates
Description
To evaluate completion and dropout rates based on the completion of the post-treatment evaluation.
Time Frame
2-week post-treatment evaluation
Title
Completeness of data
Description
To examine the percentage of completed outcome measures.
Time Frame
Baseline to 2-week post-treatment evaluation
Secondary Outcome Measure Information:
Title
Change in pain intensity during intercourse
Description
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)
Time Frame
Baseline to 2-week post-treatment evaluation
Title
Change in sexual function
Description
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).
Time Frame
Baseline to 2-week post-treatment evaluation
Title
Change in sexual distress
Description
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).
Time Frame
Baseline to 2-week post-treatment evaluation
Title
Change in pain quality
Description
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).
Time Frame
Baseline to 2-week post-treatment evaluation
Title
Patient's global impression of change
Description
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.
Time Frame
Baseline to 2-week post-treatment evaluation
Title
Change in fear of pain
Description
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).
Time Frame
Baseline to 2-week post-treatment evaluation
Title
Change in pain catastrophization
Description
To explore changes in pain catastrophization (Pain Catastrophizing Scale (PCS)). Minimum value: 0, Maximum value: 52, higher scores mean worse outcome (higher pain catastrophization)
Time Frame
Baseline to 2-week post-treatment evaluation
Title
Change in vulvar pain sensitivity
Description
To explore changes in vulvar pain sensitivity (algometer)
Time Frame
Baseline to 2-week post-treatment evaluation
Title
Change in vulvar blood circulation
Description
To explore changes in vulvar blood circulation using the laser speckle. Vulvar vestibule blood perfusion is expressed in arbitrary perfusion units (APUs).
Time Frame
Baseline to 2-week post-treatment evaluation

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mélanie Morin, PT, PhD
Organizational Affiliation
Université de Sherbrooke
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre hospitalier Universitaire de Sherbroke
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

High-level Laser for Provoked Vestibulodynia

We'll reach out to this number within 24 hrs