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Trial registered on ANZCTR


Registration number
ACTRN12617001466336p
Ethics application status
Not yet submitted
Date submitted
25/09/2017
Date registered
17/10/2017
Date last updated
17/10/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The effectiveness of Thermiva monopolar radiofrequency device in treating symptoms of vaginal laxity in women who have had vaginal births.
Scientific title
The effectiveness of Thermiva monopolar radiofrequency device in treating symptoms of vaginal laxity in parous women.
Secondary ID [1] 292967 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
TTS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vaginal Laxity 304866 0
Condition category
Condition code
Renal and Urogenital 304179 304179 0 0
Other renal and urogenital disorders
Reproductive Health and Childbirth 304310 304310 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Thermiva is a TGA approved device being utilised for the management of various vulvovaginal disorders including vaginal laxity. The Thermiva is a monopolar radiofrequency device which consists of a small generator, a probe and a grounding pad. The active aspect of the probe is only thumbprint sized and constant movement of the probe allows for tissue cooling to occur. Although, the optimal temperature is 47 degrees Celsius, feedback from the patient determines the maximum temperature achieved. Automated feedback from the machine prevents the clinician from reaching an unsafe temperature range. The device can be moved faster to reduce temperature and more slowly to increase it.

Treatment for the trial will include internal (vaginal canal) and external (labial) treatment. Internal treatment will target each quadrant of the vagina for 2 minutes and bilateral labia for 2 minutes each. The ThermiVA group and placebo group will undergo the same treatment regimens. The only difference being in the placebo group sub therapeutic temperature of maximum 30 degrees Celsius will be maintained. Generally, patients receive a new probe at each visit. However, in our pilot study we have used one probe per patient. The probe is cleaned after each treatment (it does not need sterilisation) and given to the patient to bring back at subsequent treatments.

Patients will undergo three treatments at one month intervals.

The intervention will be delivered by an experienced Obstetrician and Gynecologist Fellow who has previous experience in delivering Thermiva treatment.

The intervention will occur at a specialised Thermiva clinic at the Townsville Hospital.
Intervention code [1] 299205 0
Treatment: Devices
Comparator / control treatment
The Thermi Tight study will be a single blinded randomized placebo controlled trial. It will be conducted at the Townsville Hospital. The enrolled subjects will be randomised (1:1) to treatment or a sham group. The study personnel initiating the study will not be blinded. However, the physical examination at the follow-up visits will be conducted by a study doctor who will be blinded. This will help prevent bias. The analysis will be intention to treat.

The Thermiva group and the placebo group will undergo the same treatment regimes. The only significant difference being in the placebo group sub therapeutic temperature of maximum 30 degrees Celsius will be maintained.
Control group
Placebo

Outcomes
Primary outcome [1] 303488 0
Change in vaginal laxity as assessed by the vaginal laxity questionnaire.
Timepoint [1] 303488 0
24 month period post randomisation.
Secondary outcome [1] 339059 0
Change in vaginal laxity as assessed by vaginal laxity bother score (VLBS)
Timepoint [1] 339059 0
24 month period post randomisation
Secondary outcome [2] 339468 0
Change in vaginal flatus as assessed by vaginal flatus score (VFS)
Timepoint [2] 339468 0
24 month period post randomisation
Secondary outcome [3] 339469 0
Change in sexual function as measured by female sexual function index (FSFI)
Timepoint [3] 339469 0
24 month period post randomisation
Secondary outcome [4] 339470 0
Change in genital hiatus as assessed via genital hiatus measurement.
Timepoint [4] 339470 0
24 month period post randomisation
Secondary outcome [5] 339471 0
Change in pelvic floor muscle strength as assessed via modified oxford score.
Timepoint [5] 339471 0
24 month period post randomisation.
Secondary outcome [6] 339472 0
To establish if there is a difference between treatment related adverse events in the treatment and sham group.

Most common side effect is lower abdominal pain which occurs at the time of the treatment.
Burns are another potential side effect.
Patients have the contact details of the Principle Investigator who will assess possible side effects.Pain will be assessed via a 1-10 pain scale.
Timepoint [6] 339472 0
24 month period post randomisation

Eligibility
Key inclusion criteria
· Women who complain of vaginal laxity (or looseness)
· Women greater than or equal to age of 18
· Patients able to and willing to give consent
· History of at least one vaginal delivery
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
· Any contraindication to radiofrequency including (women with cardiac devices, pregnancy, active sexually transmitted disease or urinary tract infections)
· Women with a greater than or equal to Stage II prolapse
· Women with body dysmorphic disorder
· Women with a history of a recto-vaginal fistula
· Non-English speaking background
· Patients unable to follow-up for a period of 12 months’ post-treatment
· Abnormal HPV DNA test and subsequent abnormal liquid based cytology
· Abnormal uterine bleeding
· Patients undergoing physiotherapy or surgical treatment for the management of their vaginal laxity

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The participants will be randomised based on the random list generated using online portal https://www.randomizer.org/ , into active or sham group. The list of randomisations will only be available to chief investigator.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size: Group sample sizes of 84 and 84 achieve 80% power to detect a difference of 0.7 between the null hypothesis that both group means are 4.2 and the alternative hypothesis that the mean of group 2 (Sham) is 3.5 with estimated group standard deviations of 1.8 and 1.4 and with a significance level (alpha) of 0.05 using a two-sided two-sample t-test based on the statistical analysis from the Viveve 1 Study.
Sample size calculation reference: Results from OpenEpi, Version 3, open source calculator.
Data will be entered into excel sheet which would be available for access only to the supervisors. Data will be stored in a safe and secure location. Data will be analysed using SPSS 23.0. Continuous variables will be tested for normality. Based on the outcome of the test parametric students’ T test or non-parametric Mann-Whitney test will be carried out to determine the significant differences in VLQ, FSFI scores. Categorical data will be analysed using the Chi-squared analysis. Factors contributing to vaginal laxity will be determined using multivariate binary logistic regression. A p value < 0.05 will be considered statistically significant.

This is the following reference for the VIVEVE study.
1. Krychman M, Rowan CG, Allan BB, DeRogatis L, Durbin S, Yacoubian A, et al. Effect of Single-Treatment, Surface-Cooled Radiofrequency Therapy on Vaginal Laxity and Female Sexual Function: The VIVEVE I Randomized Controlled Trial. The Journal of Sexual Medicine. Elsevier; 2017 Feb;14(2):215–25.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2018
Actual
Date of last participant enrolment
Anticipated
31/12/2018
Actual
Date of last data collection
Anticipated
31/12/2020
Actual
Sample size
Target
168
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 9101 0
The Townsville Hospital - Douglas
Recruitment postcode(s) [1] 17600 0
4814 - Douglas

Funding & Sponsors
Funding source category [1] 297593 0
Hospital
Name [1] 297593 0
Townsville Hospital and Health Service
Country [1] 297593 0
Australia
Primary sponsor type
Individual
Name
Dr Sapna Dilgir
Address
100 Angus Smith Dr, Douglas QLD 4814. The Townsville Hopsital, Obstetrics and Gynecology Department.
Country
Australia
Secondary sponsor category [1] 296607 0
Individual
Name [1] 296607 0
Professor Ajay Rane
Address [1] 296607 0
100 Angus Smith Dr, Douglas QLD 4814. The Townsville Hopsital, Obstetrics and Gynecology Department.
Country [1] 296607 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 298684 0
Townsville Hospital and Health Service Human Research and Ethics Committee
Ethics committee address [1] 298684 0
Ethics committee country [1] 298684 0
Australia
Date submitted for ethics approval [1] 298684 0
01/11/2017
Approval date [1] 298684 0
Ethics approval number [1] 298684 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2081 2081 0 0
/AnzctrAttachments/373707-THERMI TIGHT AGES .docx (Protocol)

Contacts
Principal investigator
Name 77886 0
Ms Sapna Dilgir
Address 77886 0
The Female Pelvic Health Unit
Mater Hospital, 21-37 Fulham Road, Pimlico, QLD, 4812
Country 77886 0
Australia
Phone 77886 0
+61 0406515809
Fax 77886 0
Email 77886 0
[email protected]
Contact person for public queries
Name 77887 0
Sapna Dilgir
Address 77887 0
The Female Pelvic Health Unit
Mater Hospital, 21-37 Fulham Road, Pimlico, QLD, 4812
Country 77887 0
Australia
Phone 77887 0
+61 0406515809
Fax 77887 0
Email 77887 0
[email protected]
Contact person for scientific queries
Name 77888 0
Sapna Dilgir
Address 77888 0
The Female Pelvic Health Unit
Mater Hospital, 21-37 Fulham Road, Pimlico, QLD, 4812
Country 77888 0
Australia
Phone 77888 0
+61 0406515809
Fax 77888 0
Email 77888 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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