Hybrid Fractional Laser Treatment for Symptoms of Urinary Incontinence

Both 2940 nm Er:YAG (Erbium-doped yttrium aluminium garnet) and 1470 nm diode lasers are
cleared by the Food and Drug Administration (FDA) for ablation, vaporization, coagulation of
soft tissue and for skin resurfacing. Fractional delivery of laser is a well-established
method that stimulates tissue remodeling in the dermis while leaving the surrounding tissue
intact in order to decrease healing time. The layers of skin and vaginal mucosal tissue
exhibit similarities that suggest the clinical results seen with skin resurfacing may be
translated to the vaginal tissue. Improved vaginal tissue tone and increased collagen
formation in the lamina propria beneath the urethra may lead to improved urinary control.
This multi-centered, 18-month prospective clinical trial will determine the safety and
long-term effectiveness of hybrid fractional 2940 nm and 1470 nm lasers (Hybrid Fractional
Laser) as an alternative non-surgical, non-hormonal treatment for improvement of symptoms of
urinary incontinence.

Inclusion Criteria:

1. Healthy biological female aged between 30 to 75 years

2. Is experiencing at least one or a combination of the following symptoms of urinary
incontinence (UI)

1. involuntary urine leakage on effort, exertion, sneezing, coughing

2. sudden intense urge to urinate followed by involuntary loss of urine

3. Has been experiencing symptoms of UI for greater than 3 months

4. Normal urinalysis

5. Has indicated willingness to participate in the study by signing an informed consent
form

6. Can read, understand and sign informed consent form

7. Agree to adhere to the treatment and follow-up schedule and post treatment care
instructions

Exclusion Criteria:

1. Undiagnosed abnormal genital bleeding

2. Has history of pelvic surgery or other energy-based vaginal therapy within 6 months
prior to enrollment

3. Is pregnant or planning to get pregnant within the study period

4. Is currently breastfeeding

5. Has an active sexually transmitted infection (STI)

6. Has equal to or greater than stage III prolapse, according to pelvic organ prolapse
quantification system (POP-Q test)

7. Has signs or symptoms of vaginitis/vulvitis

8. Has signs or symptoms of acute urinary tract infection (UTI)

9. Has voiding dysfunction or urinary retention

10. Has predominantly overactive bladder (OAB) as proven by urodynamics

11. Is currently taking medication for treating urinary incontinence

12. Has a known history of neurologic disease

13. Has history of heart failure

14. Any medical conditions that might interfere with wound healing

15. Has history of abnormal wound healing

16. Has participated in any clinical trial involving an investigational drug or procedure
within past 30 days

17. The investigator feels that for any reason the subject is not eligible to participate
in the study.