Menopausal Urethral Atrophy, Vulvar Atrophy
Conditions
Brief 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.
Interventions
PROCEDURElaser vaginal treatment
Er:YAG laser
Sponsors
Sunnybrook Health Sciences Centre
Innovation Fund of the Alternative Funding Plan from the Academic Health Sciences Centres of Ontario
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| subjective measure of change in: the patient's most bothersome symptom | Baseline and 3 months after treatment start | 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 |
Countries
Canada
Contacts
PRINCIPAL_INVESTIGATORPatricia Lee, MD
Sunnybrook Health Sciences Centre
Outcome results
None listed