The Effect Of Fractional CO2 Laser Therapy On Cancer Survivors With Genitourinary Syndrome Of Menopause (GSM)

Inclusion Criteria:

• Women who have had non-metastatic (M0, ≤Stage IIIA) cancer with any hormone receptorand her2 neu status who have completed cancer-related treatment>=6 months prior toenrollment with no evidence of metastasis or currently active disease
• Women currently on endocrine therapy, single agent Herceptin, or observation
• Patient-reported dyspareunia and/or vaginal dryness with the severity of >=4 on ascale from 0 (none) to 10 (most severe) that has been persistent for over >= 4 weeksand/or the inability to be sexually active due to pain
• Age 21 to 70 years
• Subjects seeking treatment of GSM
• Objective evidence of menopause: percentage of superficial vaginal epithelial cells ofvaginal smear (MI) ≤ 5% and Vaginal fluid pH > 4.5 (for women within the first 3 yearspost-menopause)
• Normal Papanicolaou (PAP) test smear last performed as a standard of care
• Negative urine analysis
• Sexually active (having sexual intercourse at least once a month) or desire tomaintain sexual activity
• Informed consent process completed and subject signed a consent form.
• Able and willing to comply with the treatment/follow-up schedule and requirements
• Patient is willing to use non-hormonal contraception method during the course of thestudy.

Exclusion Criteria:

• Active genital infection.
• Acute or (recurring) Urinary Tract Infection (UTI) or genital infection (e.g. Herpesor candida or (condyloma ) defined as > 2 episodes in the recent year.
• Hormonal replacement therapies (local or systemic) within the last 6 weeks.
• Pelvic Organ Prolapse (POP ≥ 2) according to the pelvic organ prolapse quantificationsystem (may be relative).
• Prior reconstructive pelvic mesh surgery.
• Previous surgery in the treated area in the last 6 months.
• Participation in a study of another device or drug within 6 months prior to enrollmentor during this study, if treatments of the vagina were involved.
• Any other reason that, in the opinion of the investigator, prevents the subject fromparticipating in the study or compromise the subject safety.
• Patient is pregnant or planning to become pregnant within the next six months.