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Trial registered on ANZCTR
Registration number
ACTRN12621000361808
Ethics application status
Approved
Date submitted
23/02/2021
Date registered
30/03/2021
Date last updated
14/03/2022
Date data sharing statement initially provided
30/03/2021
Type of registration
Prospectively registered
Titles & IDs
Public title
Fractional CO2 laser for postmenopausal vaginal symptoms - a follow-up study
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Scientific title
A prospective study of fractional CO2 laser for postmenopausal vaginal symptoms - investigating the placebo effect
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Secondary ID [1]
303523
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Nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Postmenopausal vaginal symptoms
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Postmenopausal symptoms
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Genitourinary syndrome of menopause
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Atrophic vaginitis
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Condition category
Condition code
Reproductive Health and Childbirth
318671
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0
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Menstruation and menopause
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Renal and Urogenital
318672
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0
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Normal development and function of male and female renal and urogenital system
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
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.
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Intervention code [1]
319806
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Treatment: Devices
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Comparator / control treatment
Comparison with results from placebo controlled randomised trial (data collection from Aug 2016 to June 2020; registration number ACTRN12616001403426).
Access to individual participant data is available.
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Control group
Historical
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Outcomes
Primary outcome [1]
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Visual analogue scale (VAS) score of the most bothersome postmenopausal symptoms at baseline (including vaginal itching, burning, dryness, dyspareunia and dysuria)
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Assessment method [1]
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Timepoint [1]
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Participants will be assessed before treatment 1 (0 months), before treatment 2 (1 month), before treatment 3 (2 months), 6 months from treatment 1 (6 months), and 12 months from treatment 1 (12 months).
Timepoint 12 months from treatment will be considered the primary endpoint.
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Secondary outcome [1]
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Visual analogue scale (VAS) score of severity of postmenopausal symptom of vaginal itching at baseline
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Assessment method [1]
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Timepoint [1]
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Participants will be assessed before treatment 1 (0 months), before treatment 2 (1 month), before treatment 3 (2 months), 6 months from treatment 1 (6 months), and 12 months from treatment 1 (12 months)
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Secondary outcome [2]
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Visual analogue scale (VAS) score of severity of postmenopausal symptom of vaginal burning at baseline
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Assessment method [2]
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Timepoint [2]
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Participants will be assessed before treatment 1 (0 months), before treatment 2 (1 month), before treatment 3 (2 months), 6 months from treatment 1 (6 months), and 12 months from treatment 1 (12 months)
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Secondary outcome [3]
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Visual analogue scale (VAS) score of severity of postmenopausal symptom of vaginal dryness at baseline
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Assessment method [3]
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Timepoint [3]
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Participants will be assessed before treatment 1 (0 months), before treatment 2 (1 month), before treatment 3 (2 months), 6 months from treatment 1 (6 months), and 12 months from treatment 1 (12 months)
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Secondary outcome [4]
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Visual analogue scale (VAS) score of severity of postmenopausal symptom of dyspareunia at baseline
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Assessment method [4]
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Timepoint [4]
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Participants will be assessed before treatment 1 (0 months), before treatment 2 (1 month), before treatment 3 (2 months), 6 months from treatment 1 (6 months), and 12 months from treatment 1 (12 months)
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Secondary outcome [5]
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Visual analogue scale (VAS) score of severity of postmenopausal symptom of dysuria at baseline
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Assessment method [5]
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Timepoint [5]
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Participants will be assessed before treatment 1 (0 months), before treatment 2 (1 month), before treatment 3 (2 months), 6 months from treatment 1 (6 months), and 12 months from treatment 1 (12 months)
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Secondary outcome [6]
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Vulvovaginal Symptom Questionnaire (VSQ)
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Assessment method [6]
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Timepoint [6]
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Participants will be assessed before treatment 1 (0 months), before treatment 2 (1 month), before treatment 3 (2 months), 6 months from treatment 1 (6 months), and 12 months from treatment 1 (12 months)
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Secondary outcome [7]
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Assessment of Quality of Life - 6D (AQoL-6D) Scores - 6 dimensions
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Assessment method [7]
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Timepoint [7]
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Participants will be assessed before treatment 1 (0 months), 6 months from treatment 1 (6 months), and 12 months from treatment 1 (12 months)
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Secondary outcome [8]
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Adverse events as reported by participants
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Assessment method [8]
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Timepoint [8]
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Participants will be asked regarding adverse events before treatment 2 (1 month), before treatment 3 (2 months), 6 months from treatment 1 (6 months), and 12 months from treatment 1 (12 months)
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Eligibility
Key inclusion criteria
Symptomatic women with 1 AND 2 or 3
1. Previously participated in the double blind placebo-controlled randomised trial of fractional CO2 laser
AND
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2. 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
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3. 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Current urinary tract infection.
2. Active genital infections.
3. Current genital herpes infection.
4. Pelvic organ prolapse (most substantial prolapse) POPQ system stage 2.
5. Previous vaginal prolapse surgery where there is mesh repair in the pelvis.
6. Chronic disease states which will interfere with compliance to study
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Nil
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Nil
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
19/04/2021
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Actual
23/06/2021
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Date of last participant enrolment
Anticipated
15/04/2022
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Actual
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Date of last data collection
Anticipated
1/03/2023
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Actual
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Sample size
Target
30
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Accrual to date
26
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Royal Hospital for Women - Randwick
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Recruitment postcode(s) [1]
33256
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2031 - Randwick
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Funding & Sponsors
Funding source category [1]
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Hospital
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Name [1]
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Royal Hospital for Women
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Address [1]
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Barker St
Randwick NSW 2031
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Country [1]
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Australia
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Primary sponsor type
University
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Name
GRACE Unit - School of Women's and Children's Health, UNSW Sydney, Australia
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Address
Locked bag 2000
Barker St
Randwick, 2031 NSW
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Nil
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Address [1]
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Nil
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Country [1]
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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South Eastern Sydney Local Health District EC00134
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Ethics committee address [1]
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Room G71 East Wing
Edmund Blackett Building
Prince of Wales Hospital
High St
RANDWICK NSW 2031
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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22/02/2021
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Approval date [1]
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07/06/2021
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Ethics approval number [1]
307937
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Summary
Brief 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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Fiona Li
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Address
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School of Women's and Children's Health
Royal Hospital for Women Level 1
Barker St, Randwick NSW 2031
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Country
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Australia
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Phone
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+61 2 9382 6248
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Fiona Li
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Address
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School of Women's and Children's Health
Royal Hospital for Women Level 1
Barker St, Randwick NSW 2031
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Country
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Australia
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Phone
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+61 2 9382 6248
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Fiona Li
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Address
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School of Women's and Children's Health
Royal Hospital for Women Level 1
Barker St, Randwick NSW 2031
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Country
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Australia
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Phone
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+61 2 9382 6248
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Fax
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
All de-identified data will be shared
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When will data be available (start and end dates)?
Undefined
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Available to whom?
Public access
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Available for what types of analyses?
All
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How or where can data be obtained?
Online - will be published on Research Data Australia when completed
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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