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

Launched by LUMENIS BE LTD. · Mar 12, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the use of a special type of laser treatment called fractional CO2 laser therapy to help women who are cancer survivors and are experiencing symptoms of Genitourinary Syndrome of Menopause (GSM). GSM can cause problems like vaginal dryness and pain during sex, which can significantly affect a woman's quality of life. Many women who have undergone cancer treatments face these issues but cannot use traditional hormone treatments for relief. The goal of this study is to see if this laser therapy is safe and effective for these women.

To be eligible for the trial, participants need to be women between the ages of 21 and 70 who have completed their cancer treatment at least six months ago and are not currently experiencing active cancer. They should also have reported moderate to severe vaginal dryness or pain during sex that has lasted for more than four weeks. Participants will undergo the laser treatment and will be monitored for safety and effectiveness. It’s important to note that women who have certain infections, are currently using hormone treatments, or are pregnant cannot participate in this study. If you think this trial could be right for you or someone you know, it could be a valuable opportunity to find relief from GSM symptoms.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Women who have had non-metastatic (M0, ≤Stage IIIA) cancer with any hormone receptor and her2 neu status who have completed cancer-related treatment\>=6 months prior to enrollment 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 a scale from 0 (none) to 10 (most severe) that has been persistent for over \>= 4 weeks and/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 of vaginal smear (MI) ≤ 5% and Vaginal fluid pH \> 4.5 (for women within the first 3 years post-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 to maintain 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 the study.
• Exclusion Criteria:
• • Active genital infection.
• • Acute or (recurring) Urinary Tract Infection (UTI) or genital infection (e.g. Herpes or 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 quantification system (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 enrollment or during this study, if treatments of the vagina were involved.
• • Any other reason that, in the opinion of the investigator, prevents the subject from participating in the study or compromise the subject safety.
• • Patient is pregnant or planning to become pregnant within the next six months.