Laser Therapy for Treatment of Urogenital Symptoms in Women
NCT ID: NCT03681678
Last Updated: 2025-12-23
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
100 participants
OBSERVATIONAL
2018-10-08
2025-06-10
Brief Summary
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Detailed Description
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Case report and case series data suggest that laser treatment of the vaginal tissues is well tolerated by patients and does not pose serious risks to the patient. Several case series demonstrate improvements in vulvovaginal and urinary symptoms, and in sexual function. However, these studies are from a select few centers, are small, and are also biased in that the laser treatment is only available to patients who are able to pay for it. Additionally, most studies report only on vulvovaginal symptoms, despite increasing use of laser for urinary symptoms. Several recent editorials have called for larger studies with longer follow-up and high quality outcome measures. This study has been designed to address these needs.
This is a prospective observational study of women undergoing vaginal treatment with the fCO2 laser for a wide range of patients with vulvovaginal, sexual and/or urologic complaints. The effects of fCO2 therapy will be evaluated by various physical assessments and patient questionnaires.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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fCO2 Laser Therapy Group
Women treated with the fCO2 laser
fCO2 Laser Therapy Group
Women enrolled in the study will receive three treatments with the fractional carbon dioxide (fCO2) laser. The interval between treatments is approximately six weeks. Intra-vaginal laser treatments will be delivered at 8 points at each level of the vaginal wall.
Interventions
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fCO2 Laser Therapy Group
Women enrolled in the study will receive three treatments with the fractional carbon dioxide (fCO2) laser. The interval between treatments is approximately six weeks. Intra-vaginal laser treatments will be delivered at 8 points at each level of the vaginal wall.
Eligibility Criteria
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Inclusion Criteria
2. 18 years of age or greater and 90 years of age or less
3. One or more of the following indications for fCO2 laser treatment:
1. Genitourinary symptoms of menopause, including after natural, medical- induced or surgical menopause
2. Vaginal dryness, burning, itching or dyspareunia not related to menopause
3. Stress urinary incontinence
4. Recurrent urinary tract infections (UTIs), defined as 4 or more in a year
5. Overactive bladder
4. Must sign the informed consent
5. Must be willing to comply with the study protocol
Exclusion Criteria
1. Currently implanted synthetic pelvic mesh, sling or tape
2. Current or previous genital cancers
3. Radiation to the vaginal or colo-rectal tissue
4. Currently pregnant or less than 3 months following pregnancy
5. Undiagnosed vaginal or cervical lesions
2. Patients who have received vaginal fCO2 laser treatment within the past 12 months
3. Patients treated with vaginal estrogen within the past 3 months
4. Patients with undiagnosed vaginal bleeding
5. Active vulvar or vaginal infection, including herpes, candidiasis, etc.
6. Current urinary tract infection (UTI), confirmed by positive urine culture and patient-reported symptoms
7. Pelvic or vaginal surgery with the past 9 months
8. Pelvic organ prolapse beyond the introitus
9. Patient possesses any other characteristics that, per the investigator's judgment, deems them unsuitable (i.e. may increase the patient's risk, may affect the conduct of the study etc.) for the treatment and/or study
10. Participation in an investigational trial that used a study treatment, medication and/or biologic within 6 months or less prior to the date of the screening visit
18 Years
90 Years
FEMALE
No
Sponsors
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Corewell Health East
OTHER
Responsible Party
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Kenneth M Peters, MD
Chief Urology
Principal Investigators
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Kenneth Peters, MD
Role: PRINCIPAL_INVESTIGATOR
Corewell Health William Beaumont University Hospital
Locations
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Corewell Health William Beaumont University Hospital
Royal Oak, Michigan, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2018-142
Identifier Type: -
Identifier Source: org_study_id