NCT03681678

Laser Therapy for Treatment of Urogenital Symptoms in Women

Fractional Carbon Dioxide Laser Therapy of the Vagina for Treatment of Urogenital Symptoms in Women

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: Corewell Health East · Academic / Other
• Sex: Female
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Fractional carbon dioxide (fCO2) laser treatment of the vaginal tissue has been proposed as a treatment for various genitourinary symptoms, including vaginal itching, burning, dryness, dyspareunia (difficult or painful sexual intercourse), dysuria (painful or difficult urination), nocturia (waking at night to urinate), incontinence (the involuntary loss of urine), urine frequency, urine urgency, and urinary tract infection (UTI). 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

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

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2018-10-08
• Primary completion: 2022-12-15
• Completion: 2025-06-10
• First posted: 2018-09-24
• Last updated: 2025-12-23
• Results posted: 2024-10-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study