Laser Vaginal Treatment for GSM

NCT ID: NCT04042766

Last Updated: 2024-02-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-01
• Study Completion Date: 2026-03-01

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.

Conditions

Menopausal Urethral Atrophy; Vulvar Atrophy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

laser treatment

Group Type: ACTIVE_COMPARATOR

laser vaginal treatment

Intervention Type: PROCEDURE

Er:YAG laser

sham treatment

Group Type: SHAM_COMPARATOR

laser vaginal treatment

Intervention Type: PROCEDURE

Er:YAG laser

Interventions

laser vaginal treatment

Er:YAG laser

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Innovation Fund of the Alternative Funding Plan from the Academic Health Sciences Centres of Ontario

UNKNOWN

Sponsor Role: collaborator

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patricia Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Centre

Locations

Sunnybrook Health Sciences Centre, University of Toronto

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Razia Sultana, MD

Role: CONTACT

razia.sultana@sri.utoronto.ca

4164806100 ext. 87776

Facility Contacts

Razia Sultana, MD

Role: primary

Other Identifiers

094-2019

Identifier Type: -

Identifier Source: org_study_id