Laser Therapy for Treatment of Urogenital Symptoms in Women

What this trial studies

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

Conditions in scope

• Genitourinary System; Disorder, Female
• Burning Vagina
• Dyspareunia
• Irritation; Vagina
• Menopause Related Conditions
• Urinary Incontinence
• Urinary Bladder, Overactive
• Urinary Tract Infections

Interventions

• fCO2 Laser Therapy Group (Device) — 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.

Who can join

Women only · Ages 18 Years to 90 Years

Inclusion criteria

• Female
• 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

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Completed
• Study type: Observational
• Phase: N/A
• Start date: 2018-10-08
• Primary completion: 2022-12-15
• Last update posted: 2025-12-23
• First posted: 2018-09-24

Sponsor & contact

Lead sponsor: Corewell Health East (Other)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Patient Global Impression of Improvement (PGI-I) Score at 4 Weeks After Initial Treatment (4 weeks post-initial treatment)
  PGI-I score is recorded 4 weeks after initial treatment completion. The PGI-I asks the patient to "check the box that best describes how your urinary and/or vaginal symptoms are now, compared with how you symptoms were before you began this study." There are 7 possible responses ranging from 1 to 7, where 1 is "Very Much Better", 2 is "Much…

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.