Laser Therapy for Treatment of Urogenital Symptoms in Women

Corewell Health East100 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Genitourinary System; Disorder, Female Burning Vagina Dyspareunia

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Patient Global Impression of Improvement (PGI-I) Score at 4 Weeks After 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 Better, 3 is "A Little Bit Better", 4 is "No Change", 5 is "A Little Worse", 6 is "Much Worse", and 7 is "Very Much Worse". A score from 1 to 3 would indicate improvement.

Time frame: 4 weeks post-initial treatment

Secondary Outcomes

Change in Patient Global Impression of Improvement (PGI-I) Score

The average change in patients' PGI-I scores from baseline to 6 months and 36 months post-treatment. The PGI-I asks the patient to "check the one number that best describes how your urinary tract condition is now compared with how it was before your treatment." There are 7 possible responses ranging from 1 to 7, where 1 is "Very Much Better" and 7 is "Very Much Worse". A lower score would represent improvement and a favorable outcome.