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Laser Vaginal Treatment for GSM

Sponsor
Sunnybrook Health Sciences Centre (Other)
Overall Status
Recruiting
CT.gov ID
NCT04042766
Collaborator
Innovation Fund of the Alternative Funding Plan from the Academic Health Sciences Centres of Ontario (Other)
60
Enrollment
1
Location
2
Arms
49
Anticipated Duration (Months)
1.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: laser vaginal treatment
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Laser Vaginal Treatment for GSM
Actual Study Start Date :
Aug 1, 2019
Anticipated Primary Completion Date :
Nov 1, 2021
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: laser treatment

Procedure: laser vaginal treatment
Er:YAG laser
Sham Comparator: sham treatment

Procedure: laser vaginal treatment
Er:YAG laser

Outcome Measures

Primary Outcome Measures

  1. subjective measure of change in: the patient's most bothersome symptom [Baseline and 3 months after treatment start]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years to 70 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sunnybrook Health Sciences Centre, University of Toronto Toronto Ontario Canada M4N 3M5

Sponsors and Collaborators

  • Sunnybrook Health Sciences Centre
  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT04042766
Other Study ID Numbers:
  • 094-2019
First Posted:
Aug 2, 2019
Last Update Posted:
Nov 4, 2020
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Atrophy

Study Results

No Results Posted as of Nov 4, 2020