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Laser Vaginal Treatment for GSM

Primary Purpose

Menopausal Urethral Atrophy, Vulvar Atrophy

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
laser vaginal treatment
Sponsored by
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Menopausal Urethral Atrophy

Eligibility Criteria

45 Years - 70 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Sunnybrook Health Sciences Centre, University of TorontoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

laser treatment

sham treatment

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 31, 2019
Last Updated
April 12, 2023
Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Innovation Fund of the Alternative Funding Plan from the Academic Health Sciences Centres of Ontario
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1. Study Identification

Unique Protocol Identification Number
NCT04042766
Brief Title
Laser Vaginal Treatment for GSM
Official Title
Laser Vaginal Treatment for GSM
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Innovation Fund of the Alternative Funding Plan from the Academic Health Sciences Centres of Ontario

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Menopausal Urethral Atrophy, Vulvar Atrophy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
laser treatment
Arm Type
Active Comparator
Arm Title
sham treatment
Arm Type
Sham Comparator
Intervention Type
Procedure
Intervention Name(s)
laser vaginal treatment
Intervention Description
Er:YAG laser
Primary Outcome Measure Information:
Title
subjective measure of change in: the patient's most bothersome symptom
Description
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
Time Frame
Baseline and 3 months after treatment start

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Females aged 45-70 years; 2 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. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joanne Lawrence, BSc
Phone
4164806100
Ext
2309
Email
joanne.lawrence@sunnybrook.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia Lee, MD
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre, University of Toronto
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joanne Lawrence, BSc

12. IPD Sharing Statement

Plan to Share IPD
No

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Laser Vaginal Treatment for GSM

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