Laser Vaginal Treatment for GSM

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable

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.

Participation Requirements
Sex: Female
Minimum Age: 45
Maximum Age: 70
Healthy Volunteers: Accepts Healthy Volunteers

• 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.

Other Locations
Sunnybrook Health Sciences Centre, University of Toronto
Contact Information
Joanne Lawrence, BSc
Time Frame
Start Date: August 1, 2019
Estimated Completion Date: September 1, 2023
Target number of participants: 60
Active Comparator: laser treatment
Sham Comparator: sham treatment
Patricia Lee
Leads: Sunnybrook Health Sciences Centre
Collaborators: Innovation Fund of the Alternative Funding Plan from the Academic Health Sciences Centres of Ontario

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