CompletedNot Applicable

Laser Therapy for Treatment of Urogenital Symptoms in Women

United States100 participantsStarted 2018-10-08

Plain-language summary

This is a prospective observational study of women undergoing vaginal treatment with the fractional carbon dioxide (fCO2) laser for various urogenital symptoms.

Who can participate

Age range18 Years – 90 Years

SexFEMALE

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Inclusion criteria

✓. Female
✓. 18 years of age or greater and 90 years of age or less
✓. One or more of the following indications for fCO2 laser treatment:
✓. Genitourinary symptoms of menopause, including after natural, medical- induced or surgical menopause
✓. Vaginal dryness, burning, itching or dyspareunia not related to menopause
✓. Stress urinary incontinence
✓. Recurrent urinary tract infections (UTIs), defined as 4 or more in a year
✓. Overactive bladder

Exclusion criteria

✕. Contraindications to fCO2 laser treatment, such as:
✕. Currently implanted synthetic pelvic mesh, sling or tape
✕. Current or previous genital cancers
✕. Radiation to the vaginal or colo-rectal tissue
✕. Currently pregnant or less than 3 months following pregnancy
✕. Undiagnosed vaginal or cervical lesions
✕. Patients who have received vaginal fCO2 laser treatment within the past 12 months
✕. Patients treated with vaginal estrogen within the past 3 months

What they're measuring

Patient Global Impression of Improvement (PGI-I) Score at 4 Weeks After Initial Treatment

Timeframe: 4 weeks post-initial treatment

Trial details

NCT IDNCT03681678

SponsorCorewell Health East

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-12-15

Results submitted2023-12-14

View on ClinicalTrials.gov More Genitourinary System; Disorder, Female trials