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Trial registered on ANZCTR


Registration number
ACTRN12619001098123p
Ethics application status
Submitted, not yet approved
Date submitted
10/07/2019
Date registered
9/08/2019
Date last updated
9/08/2019
Date data sharing statement initially provided
9/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Vaginal Laser therapy for Treatment of Vaginal Looseness
Scientific title
Er-YAG Surgical Laser for Treatment of Vaginal Laxity – a RCT study
Secondary ID [1] 298706 0
None
Universal Trial Number (UTN)
U1111-1236-8081
Trial acronym
VITAL
Linked study record
Nil

Health condition
Health condition(s) or problem(s) studied:
Vaginal Laxity 313612 0
Condition category
Condition code
Renal and Urogenital 312045 312045 0 0
Other renal and urogenital disorders
Reproductive Health and Childbirth 312100 312100 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Er:YAG laser using the Fotona SMOOTH laser treatment versus sham randomized in equal probability. This study will not alter or interfere with any treatment or care given routinely to women as there is no routine treatment recommended currently.

Prior to Er:YAG laser, a urogynaecology nurse consultant who holds the randomization codes will inform of allocation. The doctor involved in the trial will perform the laser or sham treatment. The Fotona Er:YAG laser delivery system will be used to provide fractional treatment.
The treatment protocol using the two phase IntimaLase ® protocol with glass speculum will be following the standard parameters by the manufacturer: Firstly, treatment will be with Phase I IntimaLase laser speculum with a fluence of 3J/cm, a 7mm spot size and
SMOOTH mode frequency 2 Hz; Secondly, Phase II IntimaLase a fluence 10J/cm 2, 7mm spot size and SMOOTH mode frequency 1.6Hz.

Treatment complication and discomfort evaluation will be performed after each treatment and treatment acceptability evaluation will be performed after the first treatment only.

The study will include a screening visit, then 3 visits, four weeks apart for active or sham treatment and 3 follow up visits at 3 months and 6 months and 1 year after last treatment visit. The screening visit may be combined with the first1 treatment visit if all eligibility and consent procedures have been undertaken. Most visits will take approximately 10 minutes. The visits are detailed in the table below.

Participants will have their next appointment made before leaving to improve adherence to treatments and be contacted if they miss an appointment.
Intervention code [1] 314968 0
Treatment: Devices
Comparator / control treatment
Sham laser treatment. The patient will be blinded to the treatment but the treating doctor will not be blinded.

The sham treatment is a handpiece that will not emit any energy. The machine will be turned on as usual and make the usual sounds so that the patient is unlikely to be aware of which arm they are in.
Control group
Placebo

Outcomes
Primary outcome [1] 320677 0
To assess the subjective cure rate of laser against sham at 3months after laser treatment of vaginal laxity by participants' subjective answering of the vaginal laxity questionnaire. The primary outcome is "No vaginal laxity," which is a score of 4 or more on the vaginal laxity scale (out of 7)
Timepoint [1] 320677 0
3 months post third laser treatment
Secondary outcome [1] 372465 0
To assess subjective cure rate at 6 months and 12 months after the last treatment.
Timepoint [1] 372465 0
6 and 12 months. This secondary outcome is "No vaginal laxity," which is a score of 4 or more on the vaginal laxity scale (out of 7) on the vaginal laxity questionnaire
Secondary outcome [2] 372710 0
To assess vaginal laxity bother scores using vaginal laxity questionnaire
Timepoint [2] 372710 0
3,6 and 12 months after the last treatment.
Secondary outcome [3] 372711 0
To assess procedure-related safety, downtime, subject discomfort and subject satisfaction by asking if the patient has had any adverse effects and asking if they would recommend the treatment to a friend
Timepoint [3] 372711 0
3 months after last treatment
Secondary outcome [4] 372712 0
To determine the subjective outcomes using validated questionnaire– FSFI.
Timepoint [4] 372712 0
pre-treatment, then 3, 6 and 12 months post final treatment
Secondary outcome [5] 372713 0
To evaluate changes in vaginal prolapse (POP-Q assessment)

Timepoint [5] 372713 0
Pre-treatment and 3 months following final treatment
Secondary outcome [6] 372714 0
To evaluate changes in partner’s perception of vaginal laxity by using vaginal laxity questionnaire asking the partner's perception of vaginal looseness as "too tight, "not to tight or too loose," and "too loose."
Timepoint [6] 372714 0
Pre-treatment and 3,6 and 12 months following final treatment
Secondary outcome [7] 373465 0
To determine the subjective outcomes using validated questionnaire– FSDS-R.
Timepoint [7] 373465 0
pre-treatment, then 3, 6 and 12 months post final treatment

Eligibility
Key inclusion criteria
All participants between the ages of 18-80 with subjective vaginal laxity as defined as a score of 3 or less on the vaginal laxity scale.
Capable of providing informed consent and able to return for follow up.
Normal Cervical screening test within last five years or Papanicolau Test within 2 years.
Minimum age
18 Years
Maximum age
80 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnant subjects or women less than 12-months post-partum
Actively breastfeeding or ceased breastfeeding less than three menstrual cycles
Any previous prolapse surgery
Previous surgery in the treatment area in the last year
Active genital infection
Subject presenting with abnormal PAP result from the last three years with any of the findings according to the Bethesda (2001) system classification
Systemic steroids use within the last 3 months
Vaginal lubricants within 7 days prior to enrollment
Pelvic organ prolapse (POP) > stage 2 according to pelvic organ prolapse quantification system
Transvaginal mesh or sling implant
Serious systemic disease or any chronic condition that could interfere with study compliance
Any other reason that, in the opinion of the investigator, prevents the subject from participating in the study or compromise the subject safety
Other contraindications to laser treatment: UTI, injuries of bleeding in areas of tissue to be treated (vestibule and anterior vaginal wall), Morbid obesity (BMI>40), Diabetes, A history of Photosensivity disorder disorder or use of photosensitivity medications, abnormal scarring, scarring, excessive sun exposure, preoperative histology findings indicative of malignancy, anatomic findings consistent with the diagnosis

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)
Participants will be randomized with equal probability to Er:YAG laser or sham using a central computer-generated random allocation in blocks of 4-8. Subjects will be randomised in order of entry into the study. The nurse who informs the doctor of the results of the randomisation will not know this information prior to enrollment
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomized with equal probability to Er:YAG laser or sham using a central computer-generated random allocation in blocks of 4-8. Subjects will be randomised in order of entry into the study.
Balanced baseline characteristics would minimise influence on potential confounders. Prior to treatment, the clinician will call the central number for the allocation. A urogynaecology nurse consultant holds the randomization codes.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Intention to treat analysis

Outcomes were compared with Pearson chi squared test for categorical data and Student t test or Wilcoxon signed rank Test for continuous data as appropriate. 2 sided 95% confidence intervals will be used.

Pre-treatment & post-treatment changes in VLQ, FSFI and FDFS-R were analysed using repeated measures analysis of variance ANOVA or Friedman test as appropriate.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
21/10/2019
Actual
Date of last participant enrolment
Anticipated
28/05/2021
Actual
Date of last data collection
Anticipated
30/05/2022
Actual
Sample size
Target
76
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 14195 0
Monash Medical Centre - Moorabbin campus - East Bentleigh
Recruitment hospital [2] 14196 0
Dandenong Hospital - Dandenong
Recruitment hospital [3] 14197 0
Cabrini Hospital - Malvern - Malvern
Recruitment postcode(s) [1] 27179 0
3165 - East Bentleigh
Recruitment postcode(s) [2] 27180 0
3175 - Dandenong
Recruitment postcode(s) [3] 27181 0
3144 - Malvern

Funding & Sponsors
Funding source category [1] 303311 0
Self funded/Unfunded
Name [1] 303311 0
N/A
Country [1] 303311 0
Primary sponsor type
Individual
Name
Anna Rosamilia
Address
Monash Health, Moorabbin Hospital
823-865 Centre Rd, Bentleigh East, Vic 3165
Country
Australia
Secondary sponsor category [1] 303267 0
None
Name [1] 303267 0
Address [1] 303267 0
Country [1] 303267 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 303797 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 303797 0
Ethics committee country [1] 303797 0
Australia
Date submitted for ethics approval [1] 303797 0
30/05/2019
Approval date [1] 303797 0
Ethics approval number [1] 303797 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94842 0
A/Prof Anna Rosamilia
Address 94842 0
Monash Health
Department of Urogynaecology
Moorabbin Hospital
825-865 Centre Rd
Bentleigh East VIC 3165
Country 94842 0
Australia
Phone 94842 0
+61395096500
Fax 94842 0
Email 94842 0
annarosamilia@bigpond.com
Contact person for public queries
Name 94843 0
James Alexander
Address 94843 0
Monash Health
Department of Urogynaecology
Moorabbin Hospital
825-865 Centre Rd
Bentleigh East VIC 3165
Country 94843 0
Australia
Phone 94843 0
+61 3 9928 8111
Fax 94843 0
Email 94843 0
jwood.alexander@gmail.com
Contact person for scientific queries
Name 94844 0
James Alexander
Address 94844 0
Monash Health
Department of Urogynaecology
Moorabbin Hospital
825-865 Centre Rd
Bentleigh East VIC 3165
Country 94844 0
Australia
Phone 94844 0
+61 3 9928 8111
Fax 94844 0
Email 94844 0
jwood.alexander@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.