NCT04042766

Laser Vaginal Treatment for GSM

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Sunnybrook Health Sciences Centre · Academic / Other
• Sex: Female
• Age: 45 Years – 70 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
PROCEDURE	laser vaginal treatment	Er:YAG laser

Timeline

• Start date: 2019-08-01
• Primary completion: 2024-03-01
• Completion: 2026-03-01
• First posted: 2019-08-02
• Last updated: 2024-02-15

Locations

1 site across 1 country: Canada