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Laser Vaginal Treatment for GSM

Laser Vaginal Treatment for GSM

Recruiting
45-70 years
Female
Phase N/A

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Overview

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.

Eligibility

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

Study details
    Menopausal Urethral Atrophy
    Vulvar Atrophy

NCT04042766

Sunnybrook Health Sciences Centre

23 February 2024

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FAQs

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