Laser Vaginal Treatment for GSM

  • STATUS
    Recruiting
  • End date
    Sep 1, 2023
  • participants needed
    60
  • sponsor
    Sunnybrook Health Sciences Centre
Updated on 27 October 2022
Accepts healthy volunteers

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.

Details
Condition Menopausal Urethral Atrophy, Vulvar Atrophy
Treatment laser vaginal treatment
Clinical Study IdentifierNCT04042766
SponsorSunnybrook Health Sciences Centre
Last Modified on27 October 2022

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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