N/A
N=100
Laser Therapy for Treatment of Urogenital Symptoms in Women
Genitourinary System; Disorder, Female · Burning Vagina · Dyspareunia · Irritation; Vagina · Menopause Related Conditions
Bottom Line
View on ClinicalTrials.gov: NCT03681678 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Patient Global Impression of Improvement (PGI-I) Score at 4 Weeks After Initial Treatment — 2.66 score on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- fCO2 Laser Therapy Group (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Corewell Health East
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient Global Impression of Improvement (PGI-I) Score at 4 Weeks After Initial Treatment |
2.66 | — |
| SECONDARY Change in Patient Global Impression of Improvement (PGI-I) Score |
— | — |
| SECONDARY Change in Vaginal pH and Overall Vaginal Health on Physical Exam as Measured by the Vaginal Health Inventory Score (VHIS). |
— | — |
| SECONDARY Change in Urinary Symptoms as Measured by the Questionnaire for Urinary Incontinence Diagnosis (QUID). |
— | — |
| SECONDARY Change in Overactive Bladder (OAB) Symptoms as Measured by the Overactive Bladder Questionnaire-Short Form (OAB-q SF). |
— | — |
| SECONDARY Change in Voiding Diaries. |
— | — |
| SECONDARY Change in Sexual Function, Including Dyspareunia Symptoms, as Measured by the Female Sexual Function Inventory (FSFI). |
— | — |
| SECONDARY Change in Frequency of UTI Occurrences, as Measured by a Positive Urine Culture Test. |
— | — |
| SECONDARY Change in Mental Health Status as Measured by the Generalized Anxiety Disorder Questionnaire (GAD-7). |
— | — |
| SECONDARY Change in Mental Health Status as Measured by the Patient Health Questionnaire (PHQ-8). |
— | — |
| SECONDARY Change in Life and Sexual Impact of Vulvovaginal Skin Symptoms. |
— | — |
| SECONDARY Change in the Presence of Lactobacillus, Assessed by Vaginal Swab. |
— | — |
Summary
This is a prospective observational study of women undergoing vaginal treatment with the fractional carbon dioxide (fCO2) laser for various urogenital symptoms.
Eligibility Criteria
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
- Must sign the informed consent
- Must be willing to comply with the study protocol
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
- Patients with undiagnosed vaginal bleeding
- Active vulvar or vaginal infection, including herpes, candidiasis, etc.
- Current urinary tract infection (UTI), confirmed by positive urine culture and patient-reported symptoms
- Pelvic or vaginal surgery with the past 9 months
- Pelvic organ prolapse beyond the introitus
- 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
- 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
Data sourced from ClinicalTrials.gov (NCT03681678). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.