Laser Vaginal Treatment for GSM

Launched by SUNNYBROOK HEALTH SCIENCES CENTRE · Jul 31, 2019

Keywords

ClinConnect Summary

This clinical trial is studying a new laser treatment for women experiencing symptoms of Genitourinary Syndrome of Menopause (GSM), which can occur after menopause due to lower estrogen levels. About half of post-menopausal women may face issues like vaginal dryness, itching, discomfort, and painful intercourse. Traditional treatments, such as vaginal creams and moisturizers, can be effective but may not be suitable for everyone due to ongoing costs or personal preferences. The trial aims to see how well the laser therapy works in relieving these symptoms.

To participate, women aged 45 to 70 who have not had a menstrual period for at least two years and are experiencing at least one moderate or severe vaginal symptom are encouraged to join. It’s important that potential participants are not currently receiving other treatments for GSM and have no recent infections or certain medical conditions. Those who join the trial can expect to undergo the laser treatment and will be monitored for their symptoms over time. If you're looking for relief from GSM symptoms, this trial could be an opportunity to explore a new treatment option.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Females aged 45-70 years;
• • 2. 2 or more years since last natural menstrual period, or surgical menopause (bilateral oophorectomy);
• • 3. 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;
• • 4. no concurrent or new planned treatment for GSM during the treatment period and the 3 months following it;
• • 5. vaginal anatomy allows for laser therapy; 6) willing and able to comply with the study protocol.
• Exclusion Criteria:
• • 1. Patient is pregnant/lactating
• • 2. unexplained abnormal genital bleeding
• • 3. current acute vaginal/ bladder infection
• • 4. antibiotic use the past 30 days;
• • 5. women under age 55 with endometrial ablation/ hysterectomy/ at least one ovary;
• • 6. concurrent use of any other new GSM treatment
• • 7. pelvic surgery \<3 months
• • 8. current treatment for chronic pelvic pain