Laser Vaginal Treatment for GSM (NCT04042766) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Laser Vaginal Treatment for GSM
Canada60 participantsStarted 2019-08-01
Plain-language 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.
Who can participate
Age range45 Years – 70 Years
SexFEMALE
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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;
✕
What they're measuring
1
subjective measure of change in: the patient's most bothersome symptom
Timeframe: Baseline and 3 months after treatment start