Ignite Creation Date:
2024-05-06 @ 3:02 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04502810
Status:
COMPLETED
Last Update Posted:
2022-02-10
First Post:
2020-07-27
Brief Title:
High-level Laser for Provoked Vestibulodynia
Sponsor:
Université de Sherbrooke
Organization:
Université de Sherbrooke
Study Overview
Official Title:
A Feasibility and Acceptability Study of High-level Laser for Women With Provoked Vestibulodynia
Status:
COMPLETED
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None