Laser Vaginal Treatment for GSM

NCT04042766 | Active Not Recruiting

• 1 other identifier: 094-2019
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

laser treatment

ACTIVE COMPARATOR

Procedure: laser vaginal treatment

sham treatment

SHAM COMPARATOR

Procedure: laser vaginal treatment

Interventions

laser vaginal treatment PROCEDURE

Er:YAG laser

laser treatment; sham treatment

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females aged 45-70 years;
• or more years since last natural menstrual period, or surgical menopause (bilateral oophorectomy);
• 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;
• no concurrent or new planned treatment for GSM during the treatment period and the 3 months following it;
• vaginal anatomy allows for laser therapy; 6) willing and able to comply with the study protocol.

You may not qualify if:

• Patient is pregnant/lactating
• unexplained abnormal genital bleeding
• current acute vaginal/ bladder infection
• antibiotic use the past 30 days;
• women under age 55 with endometrial ablation/ hysterectomy/ at least one ovary;
• concurrent use of any other new GSM treatment
• pelvic surgery \<3 months
• current treatment for chronic pelvic pain

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• Innovation Fund of the Alternative Funding Plan from the Academic Health Sciences Centres of Ontario: collaborator

Study Sites (1)

Sunnybrook Health Sciences Centre, University of Toronto

Toronto, Ontario, M4N 3M5, Canada

Location

Study Officials

• Patricia Lee, MD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2019
• First Posted: August 2, 2019
• Study Start: August 1, 2019
• Primary Completion: March 24, 2025
• Study Completion (Estimated): October 31, 2027
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)