Fractional CO2 laser for postmenopausal vaginal symptoms - a follow-up study
A prospective study of fractional CO2 laser for postmenopausal vaginal symptoms - investigating the placebo effect
GRACE Unit - School of Women's and Children's Health, UNSW Sydney, Australia
30 participants
Jun 23, 2021
Interventional
Conditions
Summary
We have performed a double blind placebo-controlled randomised trial investigating the efficacy of fractional CO2 laser for postmenopausal vaginal symptoms. At completion of study (data collection and analysis), participants have been contacted individually to unblind and reveal their randomisation allocation, and as offered at recruitment, participants from both the laser and sham groups will be offered the opportunity to undergo one laser treatment course (three treatments, four weeks apart). Participants who opt for the treatment course will attend the clinic for treatment which will be performed at the laser treatment settings as aforementioned. Prior to each of their three treatments, participants will complete the same questionnaires as during the study assessing symptom severity. Participants will be asked to report adverse events at every visit. The aim of the study is to further evaluate the efficacy of this treatment and investigate the role of placebo effect.
Eligibility
Inclusion Criteria6
- Symptomatic women with 1 AND 2 or 3
- Previously participated in the double blind placebo-controlled randomised trial of fractional CO2 laser
- AND
- Post-menopausal women who have not had a menstrual period for at least 12 months (with an intact uterus) and/or have vulvovaginal symptoms substantial enough for them to present to their health care provider due to symptoms
- OR
- Women who have previously had a hysterectomy and have vaginal atrophy symptoms and have an elevation of FSH (>30) consistent with a post-menopausal state.
Exclusion Criteria6
- Current urinary tract infection.
- Active genital infections.
- Current genital herpes infection.
- Pelvic organ prolapse (most substantial prolapse) POPQ system stage 2.
- Previous vaginal prolapse surgery where there is mesh repair in the pelvis.
- Chronic disease states which will interfere with compliance to study
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Interventions
Fractional CO2 laser is used as a treatment for postmenopausal vaginal symtpoms. Energy is applied to the vaginal mucosa by a specifically designed vaginal probe. The 5 minute treatment claims to 'rejuvenate' the mucosa and reverse postmenopausal vulvovaginal symptoms. However, no placebo-controlled trials had been performed until recently. Our group has performed a placebo controlled randomised trial which found no difference between intervention and sham treatment groups. Participants have been informed of the results and have been offered one course of the interventional treatment, consisting of 3 treatments, each at least 4 weeks apart. These treatments will be performed by a suitably qualified medical practitioner. Complicance to treatment will be monitored by the research coordinator who will operate the schedule/timetable. The treatment involves slow insertion of the vaginal probe into the vagina until it reaches the cervix or vaginal vault. The laser is set at dot power 40 watt, dwell time 1000 microseconds, dot spacing 1000 micrometres, smart stack parameter 2 and emission mode DP. The laser will then be activated as it is withdrawn to provide complete treatment of the vaginal walls. Energy is applied to vaginal walls in a pattern pre-determined by perforations in the probe matrix which covers the laser probe, allowing for even-spacing of energy and preventing treatment of confluent areas. Furthermore, a mirror at the end of the probe angled at 45 degrees protects the cervix from treatment. The duration of the procedure is anticipated to be approximately 5 minutes.
Locations(1)
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ACTRN12621000361808