Laser Vaginal Treatment for GSM

Sunnybrook Health Sciences Centre

Status: Enrolling

Conditions: Menopausal Urethral Atrophy; Vulvar Atrophy

Treatments: Procedure: laser vaginal treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT04042766

094-2019

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 45 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

laser treatment

Active Comparator group

Treatment:

Procedure: laser vaginal treatment

sham treatment

Sham Comparator group

Treatment:

Procedure: laser vaginal treatment