Laser Vaginal Treatment for GSM

Vulvar Atrophy Clinical Trial

Official title:

Laser Vaginal Treatment for GSM

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04042766
• Other study ID #: 094-2019
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: March 1, 2026

Study information

• Verified date: April 2023
• Source: Sunnybrook Health Sciences Centre
• Contact: Razia Sultana, MD
• Phone: 4164806100
• Email: razia.sultana[@]sri.utoronto.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 1, 2026
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 70 Years

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

Related Conditions & MeSH terms

• Atrophy
• Menopausal Urethral Atrophy
• Vulvar Atrophy

Intervention

Procedure:
• laser vaginal treatment
Er:YAG laser

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre, University of Toronto	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre	Innovation Fund of the Alternative Funding Plan from the Academic Health Sciences Centres of Ontario

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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