A Single-Blind, Randomized Study to Compare fCO2 Laser Therapy Versus Sham for Treatment of SUI in Women

A Single-Blind, Randomized Study to Compare the Efficacy and Safety of Fractional Carbon Dioxide Laser Therapy Versus Sham for Treatment of Stress Urinary Incontinence Symptoms in Women

This is a prospective randomized sham-controlled study of patients undergoing vaginal treatment with a fractional carbon dioxide (fCO2) laser for stress urinary incontinence (SUI) symptoms. Eligible participants will be randomized (like a flip of a coin) to receive active or sham fCO2 laser treatments. Three treatments with the fCO2 laser or sham to the vagina will be performed, approximately four weeks apart.

Stress urinary incontinence (SUI) is a common problem that affects 35-40% of women worldwide. SUI occurs when a woman experiences involuntary leakage of urine with physical activities such as exercise, coughing and sneezing that increases intra-abdominal pressure. Vaginal laser therapy offers a potential novel treatment for SUI, however there is limited scientific evidence to show benefits to treatment. A sham controlled study will further add to the literature and evidence to support or oppose the use of the fCO2 laser for SUI.

The purpose of this study is to compare active therapy to sham treatment to determine if a true benefit to treatment exists. Eligible participants will be randomized 1:1, to receive active or sham fCO2 laser treatments. Three treatments, active or sham, to the vagina will be performed approximately four weeks apart. The primary efficacy endpoint is four weeks after completing all treatments. Treatment durability and safety will be assessed eight weeks after the primary endpoint.

Inclusion Criteria:

1. Female
2. Age ≥18 years and ≤75 of age
3. Mild to moderate SUI defined by Stamey Grade 1 and 2
4. Positive bladder stress test at screening
5. Negative urinary tract infection (UTI) at the time of study enrollment. If a patient does have a UTI, they may be rescreened after treatment
6. No additional SUI therapy in the past 2 months such as pelvic floor physical therapy, medications, or participation in another SUI study
7. No prior history of midurethral sling or fascial sling for SUI
8. No prior history of urethral bulking procedure for SUI
9. No prior history of autologous muscle derived stem cell injection in the urethra
10. Must sign the informed consent form
11. Must be willing to comply with the study protocol

Exclusion Criteria:

1. Contraindications to fCO2 laser treatment, such as:

   1. previous pelvic mesh surgery
   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. active infections (candidiasis, herpes genitalis, etc.)
   6. vaginal or cervical lesions noted on initial exam

2. Patients with undiagnosed vaginal bleeding not related to menses

3. Active vulvar or vaginal infection, including herpes

4. Current UTI, confirmed by positive urine culture and patient-reported UTI symptoms

5. Recurrent UTI defined as 3 UTIs in the past 6 months or 4 UTIs in the past 1 year

6. Pelvic or vaginal surgery within the past 9 months

7. Pelvic organ prolapse beyond the introitus

8. Patient possesses any other characteristics that, per the investigator's judgment, deems them unsuitable (i.e. may increase patient's risk, may affect the conduct of the study, etc.) for the treatment and/or study.

9. Participation in an investigational trial that used a study treatment, medication and/or biologic within 30 days or less prior to the date of the screening visit.

Deferral

Patients may be deferred and rescreened at a later date under the following conditions:

• Patients with active vulvar or vaginal infections may be rescreened after treatment
• Patients with an active UTI may be rescreened after treatment
• Patients with undiagnosed vaginal bleeding may be rescreened after complete work-up, treatment and resolution of vaginal bleeding
• Patients pregnant within the past 3 months
• Patients with recent vaginal or uterine surgery within the 9 months

Note: To preserve the scientific integrity of the study some inclusion and exclusion criteria are not listed. At the conclusion of the study all items will be posted.