Laser Therapy for Treatment of Urogenital Symptoms in Women

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.

Inclusion Criteria:

1. Female

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. Contraindications to fCO2 laser treatment, such as:

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