Laser Vaginal Treatment for GSM
Primary Purpose
Menopausal Urethral Atrophy, Vulvar Atrophy
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
laser vaginal treatment
Sponsored by
About this trial
This is an interventional treatment trial for Menopausal Urethral Atrophy
Eligibility Criteria
Inclusion Criteria:
- Females aged 45-70 years;
- 2 or more years since last natural menstrual period, or surgical menopause (bilateral oophorectomy);
- at least 1 vaginal symptom reported from the following list, experienced for the past 30 days which is moderate or severe at least once a week: dryness | itching | irritation | soreness/pain | dyspareunia;
- no concurrent or new planned treatment for GSM during the treatment period and the 3 months following it;
- vaginal anatomy allows for laser therapy; 6) willing and able to comply with the study protocol.
Exclusion Criteria:
- Patient is pregnant/lactating
- unexplained abnormal genital bleeding
- current acute vaginal/ bladder infection
- antibiotic use the past 30 days;
- women under age 55 with endometrial ablation/ hysterectomy/ at least one ovary;
- concurrent use of any other new GSM treatment
- pelvic surgery <3 months
- current treatment for chronic pelvic pain
Sites / Locations
- Sunnybrook Health Sciences Centre, University of TorontoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
laser treatment
sham treatment
Arm Description
Outcomes
Primary Outcome Measures
subjective measure of change in: the patient's most bothersome symptom
The most bothersome symptom of GSM (vaginal dryness, discomfort, itching, dyspareunia, urinary urgency, dysuria) will be identified and its severity rated on a standardized 4-point scale: 0=none, 1=mild, 2=moderate, 3=severe
Secondary Outcome Measures
Full Information
NCT ID
NCT04042766
First Posted
July 31, 2019
Last Updated
April 12, 2023
Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Innovation Fund of the Alternative Funding Plan from the Academic Health Sciences Centres of Ontario
1. Study Identification
Unique Protocol Identification Number
NCT04042766
Brief Title
Laser Vaginal Treatment for GSM
Official Title
Laser Vaginal Treatment for GSM
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Innovation Fund of the Alternative Funding Plan from the Academic Health Sciences Centres of Ontario
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Genitourinary Syndrome of Menopause (GSM) due to low estrogen levels affects about half of post-menopausal women and may have a dramatic impact on women's quality of life. Women complain of vaginal dryness, itching, discomfort, malodour, painful intercourse and may have urinary urgency, irritation, bladder/urethral pain and recurring bladder infections. First-line therapies include vaginal moisturizers, lubricants and estrogen (either oral or with vaginal cream/tablets). While these therapies are effective, the ongoing costs and the resistance to the indefinite use of vaginal creams/inserts is a challenge to the continued use of these therapies. Recently, an innovative laser therapy has been used to treat women with GSM. A randomized controlled trial (RCT) to study how effective the laser is to treat women with GSM is planned.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Menopausal Urethral Atrophy, Vulvar Atrophy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
laser treatment
Arm Type
Active Comparator
Arm Title
sham treatment
Arm Type
Sham Comparator
Intervention Type
Procedure
Intervention Name(s)
laser vaginal treatment
Intervention Description
Er:YAG laser
Primary Outcome Measure Information:
Title
subjective measure of change in: the patient's most bothersome symptom
Description
The most bothersome symptom of GSM (vaginal dryness, discomfort, itching, dyspareunia, urinary urgency, dysuria) will be identified and its severity rated on a standardized 4-point scale: 0=none, 1=mild, 2=moderate, 3=severe
Time Frame
Baseline and 3 months after treatment start
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Females aged 45-70 years;
2 or more years since last natural menstrual period, or surgical menopause (bilateral oophorectomy);
at least 1 vaginal symptom reported from the following list, experienced for the past 30 days which is moderate or severe at least once a week: dryness | itching | irritation | soreness/pain | dyspareunia;
no concurrent or new planned treatment for GSM during the treatment period and the 3 months following it;
vaginal anatomy allows for laser therapy; 6) willing and able to comply with the study protocol.
Exclusion Criteria:
Patient is pregnant/lactating
unexplained abnormal genital bleeding
current acute vaginal/ bladder infection
antibiotic use the past 30 days;
women under age 55 with endometrial ablation/ hysterectomy/ at least one ovary;
concurrent use of any other new GSM treatment
pelvic surgery <3 months
current treatment for chronic pelvic pain
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joanne Lawrence, BSc
Phone
4164806100
Ext
2309
Email
joanne.lawrence@sunnybrook.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia Lee, MD
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre, University of Toronto
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joanne Lawrence, BSc
12. IPD Sharing Statement
Plan to Share IPD
No
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Laser Vaginal Treatment for GSM
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