Laser Vaginal Treatment for GSM

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.

Study Overview

• Status: Recruiting
• Conditions: Vulvar Atrophy; Menopausal Urethral Atrophy
• Intervention / Treatment: Procedure: laser vaginal treatment

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Razia Sultana, MD; Phone Number: 87776 4164806100; Email: razia.sultana@sri.utoronto.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
      • Recruiting
      • Sunnybrook Health Sciences Centre, University of Toronto
      • Contact: Razia Sultana, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: sham treatment	Procedure: laser vaginal treatment; Er:YAG laser
Active Comparator: laser treatment	Procedure: laser vaginal treatment; Er:YAG laser

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Sunnybrook Health Sciences Centre
• Collaborators: Innovation Fund of the Alternative Funding Plan from the Academic Health Sciences Centres of Ontario
• Investigators: Principal Investigator: Patricia Lee, MD, Sunnybrook Health Sciences Centre

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: July 31, 2019
• First Submitted That Met QC Criteria: July 31, 2019
• First Posted (Actual): August 2, 2019

Study Record Updates

• Last Update Posted (Estimated): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 14, 2024
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Atrophy
• Other Study ID Numbers: 094-2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No