Laser Vaginal Treatment for GSM

Study Overview
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Brief Summary
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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.

Official Title
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Laser Vaginal Treatment for GSM

Conditions
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Menopausal Urethral Atrophy, Vulvar Atrophy

Intervention / Treatment
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* Procedure: laser vaginal treatment


Participation Criteria
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Eligibility Criteria
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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; 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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: laser treatment<br> | Procedure: laser vaginal treatment<br>* Er:YAG laser<br>|
| Sham Comparator: sham treatment<br> | Procedure: laser vaginal treatment<br>* Er:YAG laser<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline and 3 months after treatment start |