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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
Scientific title
A prospective study of fractional CO2 laser for postmenopausal vaginal symptoms - investigating the placebo effect
Secondary ID [1] 303523 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postmenopausal vaginal symptoms 320847 0
Postmenopausal symptoms 320849 0
Genitourinary syndrome of menopause 320850 0
Atrophic vaginitis 320851 0
Condition category
Condition code
Reproductive Health and Childbirth 318671 318671 0 0
Menstruation and menopause
Renal and Urogenital 318672 318672 0 0
Normal development and function of male and female renal and urogenital system

Intervention/exposure
Study type
Interventional
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 The laser will then be activated as it is withdrawn to provide complete treatment of the vaginal walls.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.
Intervention code [1] 319806 0
Treatment: Devices
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.
Control group
Historical

Outcomes
Primary outcome [1] 326617 0
Visual analogue scale (VAS) score of the most bothersome postmenopausal symptoms at baseline (including vaginal itching, burning, dryness, dyspareunia and dysuria)
Timepoint [1] 326617 0
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.
Secondary outcome [1] 392146 0
Visual analogue scale (VAS) score of severity of postmenopausal symptom of vaginal itching at baseline
Timepoint [1] 392146 0
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)
Secondary outcome [2] 392147 0
Visual analogue scale (VAS) score of severity of postmenopausal symptom of vaginal burning at baseline
Timepoint [2] 392147 0
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)
Secondary outcome [3] 392148 0
Visual analogue scale (VAS) score of severity of postmenopausal symptom of vaginal dryness at baseline
Timepoint [3] 392148 0
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)
Secondary outcome [4] 393265 0
Visual analogue scale (VAS) score of severity of postmenopausal symptom of dyspareunia at baseline
Timepoint [4] 393265 0
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)
Secondary outcome [5] 393266 0
Visual analogue scale (VAS) score of severity of postmenopausal symptom of dysuria at baseline
Timepoint [5] 393266 0
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)
Secondary outcome [6] 393267 0
Vulvovaginal Symptom Questionnaire (VSQ)
Timepoint [6] 393267 0
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)
Secondary outcome [7] 393268 0
Assessment of Quality of Life - 6D (AQoL-6D) Scores - 6 dimensions
Timepoint [7] 393268 0
Participants will be assessed before treatment 1 (0 months), 6 months from treatment 1 (6 months), and 12 months from treatment 1 (12 months)
Secondary outcome [8] 393269 0
Adverse events as reported by participants
Timepoint [8] 393269 0
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)

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
---
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
OR
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.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Nil
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Nil
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
19/04/2021
Actual
23/06/2021
Date of last participant enrolment
Anticipated
15/04/2022
Actual
Date of last data collection
Anticipated
1/03/2023
Actual
Sample size
Target
30
Accrual to date
26
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 18808 0
Royal Hospital for Women - Randwick
Recruitment postcode(s) [1] 33256 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 307944 0
Hospital
Name [1] 307944 0
Royal Hospital for Women
Country [1] 307944 0
Australia
Primary sponsor type
University
Name
GRACE Unit - School of Women's and Children's Health, UNSW Sydney, Australia
Address
Locked bag 2000
Barker St
Randwick, 2031 NSW
Country
Australia
Secondary sponsor category [1] 308662 0
None
Name [1] 308662 0
Nil
Address [1] 308662 0
Nil
Country [1] 308662 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307937 0
South Eastern Sydney Local Health District EC00134
Ethics committee address [1] 307937 0
Room G71 East Wing
Edmund Blackett Building
Prince of Wales Hospital
High St
RANDWICK NSW 2031
Ethics committee country [1] 307937 0
Australia
Date submitted for ethics approval [1] 307937 0
22/02/2021
Approval date [1] 307937 0
07/06/2021
Ethics approval number [1] 307937 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 108982 0
Dr Fiona Li
Address 108982 0
School of Women's and Children's Health
Royal Hospital for Women Level 1
Barker St, Randwick NSW 2031
Country 108982 0
Australia
Phone 108982 0
+61 2 9382 6248
Fax 108982 0
Email 108982 0
fiona.li@unsw.edu.au
Contact person for public queries
Name 108983 0
Dr Fiona Li
Address 108983 0
School of Women's and Children's Health
Royal Hospital for Women Level 1
Barker St, Randwick NSW 2031
Country 108983 0
Australia
Phone 108983 0
+61 2 9382 6248
Fax 108983 0
Email 108983 0
fiona.li@unsw.edu.au
Contact person for scientific queries
Name 108984 0
Dr Fiona Li
Address 108984 0
School of Women's and Children's Health
Royal Hospital for Women Level 1
Barker St, Randwick NSW 2031
Country 108984 0
Australia
Phone 108984 0
+61 2 9382 6248
Fax 108984 0
Email 108984 0
fiona.li@unsw.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All de-identified data will be shared
When will data be available (start and end dates)?
Undefined
Available to whom?
Public access
Available for what types of analyses?
All
How or where can data be obtained?
Online - will be published on Research Data Australia when completed


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.