Clinical trial NCT03681678: Laser Therapy for Treatment of Urogenital Symptoms in Women
Official title: Fractional Carbon Dioxide Laser Therapy of the Vagina for Treatment of Urogenital Symptoms in Women
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Genitourinary System; Disorder, Female
Burning Vagina
Dyspareunia
Irritation; Vagina
Menopause Related Conditions
Urinary Incontinence
Urinary Bladder, Overactive
Urinary Tract Infections
Stress Urinary Incontinence
Keywords: Laser Therapy
Lead sponsor: William Beaumont Hospitals
Sponsor class: OTHER
First posted: 2018-09-24
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women meeting all of the inclusion criteria and non of the exclusion criteria may be enrolled in the study.

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient Global Impression of Improvement (PGI-I) Score at 4 Weeks After Initial Treatment
timeFrame: 4 weeks post-initial treatment
Secondary outcomes:
measure: Change in Patient Global Impression of Improvement (PGI-I) Score
timeFrame: 6 months and 36 months post-initial treatment
measure: Change in Vaginal pH and Overall Vaginal Health on Physical Exam as Measured by the Vaginal Health Inventory Score (VHIS).
timeFrame: 6 months and 36 months post-initial treatment
measure: Change in Urinary Symptoms as Measured by the Questionnaire for Urinary Incontinence Diagnosis (QUID).
timeFrame: 6 months and 36 months post-initial treatment
measure: Change in Overactive Bladder (OAB) Symptoms as Measured by the Overactive Bladder Questionnaire-Short Form (OAB-q SF).
timeFrame: 6 months and 36 months post-initial treatment
measure: Change in Voiding Diaries.
timeFrame: 6 months and 36 months post-initial treatment
measure: Change in Sexual Function, Including Dyspareunia Symptoms, as Measured by the Female Sexual Function Inventory (FSFI).
timeFrame: 6 months and 36 months post-initial treatment
measure: Change in Frequency of UTI Occurrences, as Measured by a Positive Urine Culture Test.
timeFrame: 6 months and 36 months post-initial treatment
measure: Change in Mental Health Status as Measured by the Generalized Anxiety Disorder Questionnaire (GAD-7).
timeFrame: 6 months and 36 months post-initial treatment
measure: Change in Mental Health Status as Measured by the Patient Health Questionnaire (PHQ-8).
timeFrame: 6 months and 36 months post-initial treatment
measure: Change in Life and Sexual Impact of Vulvovaginal Skin Symptoms.
timeFrame: 6 months and 36 months post-initial treatment
measure: Change in the Presence of Lactobacillus, Assessed by Vaginal Swab.
timeFrame: 6 months and 36 months post-initial treatment
Other outcomes:
Locations:
city: Royal Oak
country: United States
facility: Beaumont Hospital
state: Michigan
Study officials:
affiliation: William Beaumont Hospitals
name: Kenneth Peters, MD
role: PRINCIPAL_INVESTIGATOR
References: