RecruitingACTRN12621000361808

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

Sponsor

GRACE Unit - School of Women's and Children's Health, UNSW Sydney, Australia

Enrollment

30 participants

Start Date

Jun 23, 2021

Study Type

Interventional

Conditions

Atrophic vaginitis Postmenopausal vaginal symptoms

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

Sex: FemalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

After menopause, declining oestrogen levels can cause vaginal dryness, discomfort during sex, and urinary symptoms — a cluster of issues sometimes called genitourinary syndrome of menopause. Fractional CO2 laser treatment is a relatively new option that uses gentle laser pulses to stimulate the vaginal lining and encourage its renewal. This follow-up study is offering treatment to women who participated in an earlier double-blind randomised trial (where neither they nor the doctors knew who received real laser treatment and who received a sham), now that the trial results are complete. Participants from both the laser group and the sham (placebo) group from the original trial are being offered the opportunity to receive one full course of laser treatment — three sessions, four weeks apart. Before each session, they complete questionnaires assessing their symptom severity. Adverse events are reported at every visit. This follow-up study will provide additional long-term data on whether the laser treatment is effective, and also helps explore the extent of any placebo effect observed in the original trial. It offers all previous trial participants the potential benefit of the treatment while contributing valuable scientific knowledge.

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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)

Royal Hospital for Women - Randwick

NSW, Australia

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ACTRN12621000361808