Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000099325
Ethics application status
Approved
Date submitted
19/12/2016
Date registered
18/01/2017
Date last updated
29/01/2019
Date data sharing statement initially provided
29/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Carbon dioxide (CO2) Surgical Laser for Treatment of Stress Urinary Incontinence in Women – a RCT study
Scientific title
CO2 Surgical Laser for Treatment of Stress Urinary Incontinence in Women – a RCT study
Secondary ID [1] 290789 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stress urinary incontinence 301349 0
Condition category
Condition code
Renal and Urogenital 301151 301151 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Fractionated CO2 surgical laser using the Lumenis Acupulse CO2 laser system and the AcuScan 120 microscanner to provide fractional treatment, delivered by a consultant urogynaecologist
Mode of delivery will be face to face and will be provided individually. Through the use of the scanner, the laser energy is delivered in a fractional manner, from 7.5-12.5 millijoule with a 5-25% density, a penetration depth of 600 micro millimeter from the 10o’clock to 2 o’clock position, starting at the top of the vagina up to 5mm from the introitus. (Lumenis protocol). This will be delivered over 3x 5minute sessions, once every 4 weeks over 3 months and be performed in an urban urogynaecological clinic.
Intervention code [1] 296674 0
Treatment: Devices
Comparator / control treatment
sham treatment - participants will attend the urban urogynaecological clinic and be seen face to face. They will have the Lumenis Acupulse CO2 microscanner inserted into the vagina but no laser energy will be delivered. They will attend for 3x5 minutes sessions, once every 4 weeks over 3 months for sham treatment. They will cross over to active treatment at the 4 month if there is no improvement in subjective symptoms of SUI.
Control group
Placebo

Outcomes
Primary outcome [1] 300518 0
To assess the subjective cure rate (positive answer to leaks when you cough or sneeze or leaks when physically active/exercising on ICIQ-UI) of the CO2 surgical laser against sham
Timepoint [1] 300518 0
3 months after laser treatment of female stress incontinence
Secondary outcome [1] 330192 0
To assess objective cure rate (negative cough stress test)
Timepoint [1] 330192 0
at 3 monthsafter the last treatment
Secondary outcome [2] 330193 0
To assess objective cure rate (negative cough stress test)
Timepoint [2] 330193 0
at 6 months after the last treatment
Secondary outcome [3] 330194 0
To assess objective cure rate (negative cough stress test)
Timepoint [3] 330194 0
at 12 months after the last treatment
Secondary outcome [4] 330195 0
To assess procedure-related safety by participant assessment of pain and discomfort that is procedure related using a visual a Pain Visual Analogue Scale (VAS)
Timepoint [4] 330195 0
3 months after last treatment
Secondary outcome [5] 330196 0
To determine the subjective outcomes of overactive bladder symptoms using ICIQ OAB questionnaire
Timepoint [5] 330196 0
at 3 months, 6 months and 12 months post last treatment
Secondary outcome [6] 330197 0
To evaluate the change in sexual function using PISQ-12, following both treatments
Timepoint [6] 330197 0
at 3 months, 6 months and 12 months post last treatment
Secondary outcome [7] 330198 0
To evaluate the effect of prolapse stage by clinical examination using the pelvic organ prolapse quantification system
Timepoint [7] 330198 0
at 3 months, 6 months and 12 months post last treatment
Secondary outcome [8] 330199 0
To compare cost effectiveness between the laser versus sham using the EQ5D
Timepoint [8] 330199 0
at 12 months post last treatment
Secondary outcome [9] 330625 0
To assess subject satisfaction using PGI-I
Timepoint [9] 330625 0
At 3, 6, 12 months post last treatment
Secondary outcome [10] 330634 0
To assess quality of life using IIQ
Timepoint [10] 330634 0
at 3 months, 6 months and 12 months post last treatment
Secondary outcome [11] 330635 0
To determine the subjective outcomes of stress incontinence symptoms using ICIQ UI SF questionnaires
Timepoint [11] 330635 0
at 3 months, 6 months and 12 months post last treatment

Eligibility
Key inclusion criteria
All participants with symptoms of stress urinary incontinence
between the ages of 18-80 years with objective stress urinary incontinence (based on one of three objective measures of either positive cough stress test or urodynamic stress incontinence or positive 24h pad weigh test (>4g))
desire conservative management
Participants will have had supervised pelvic floor muscle therapy in the last 12 months
Capable of providing informed consent and able to return for follow up.
Negative urinalysis
Normal Papanicolaou (PAP) test within the last 2 years
Minimum age
18 Years
Maximum age
80 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnant subjects
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
Recurring urinary tract infection or recurring infection of genital herpes or candida (> 2 episodes in the recent year)
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

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 CO2 laser or sham using a central computer-generated random allocation . Subjects will be randomised in order of entry into the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer-generated random allocation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Assuming an objective cure of 56% from supervised pelvic floor muscle training alone, with power of 80%, a sample size of 87 in each arm would be required to detect a clinical difference of 20%, using a one sided a of 0.05.
Allowing for attrition rate of 15%, we propose to recruit a total of 200 subjects for the trial.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/02/2017
Actual
1/04/2017
Date of last participant enrolment
Anticipated
31/12/2019
Actual
Date of last data collection
Anticipated
29/01/2021
Actual
Sample size
Target
200
Accrual to date
25
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 7135 0
Monash Medical Centre - Moorabbin campus - East Bentleigh
Recruitment hospital [2] 7136 0
Cabrini Hospital - Malvern - Malvern
Recruitment postcode(s) [1] 14897 0
3165 - East Bentleigh
Recruitment postcode(s) [2] 14898 0
3144 - Malvern

Funding & Sponsors
Funding source category [1] 295189 0
Hospital
Name [1] 295189 0
Monash Health, Pelvic floor clinic
Country [1] 295189 0
Australia
Primary sponsor type
Hospital
Name
Monash Health, Pelvic Floor Clinic
Address
823-865 Centre Road
Bentleigh East Vic 3165
Country
Australia
Secondary sponsor category [1] 294017 0
Commercial sector/Industry
Name [1] 294017 0
Lumenis
Address [1] 294017 0
Level 1 , 1 Queens Road, MElbourne Vic 3004
Country [1] 294017 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296541 0
Monash ethics committee
Ethics committee address [1] 296541 0
Ethics committee country [1] 296541 0
Australia
Date submitted for ethics approval [1] 296541 0
22/11/2016
Approval date [1] 296541 0
14/02/2017
Ethics approval number [1] 296541 0

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

Contacts
Principal investigator
Name 71198 0
Dr Lin Li Ow
Address 71198 0
Monash Health
Pelvic Floor Department
823-865 Centre Road
Bentleigh East Victoria
3165
Country 71198 0
Australia
Phone 71198 0
+613 992 88588
Fax 71198 0
+613 992 88338
Email 71198 0
[email protected]
Contact person for public queries
Name 71199 0
Alison Leitch
Address 71199 0
Monash Health
Pelvic Floor Unit
823-865 Centre Road
Bentleigh East Victoria
3165
Country 71199 0
Australia
Phone 71199 0
+613 99288588
Fax 71199 0
+613 992 88338
Email 71199 0
[email protected]
Contact person for scientific queries
Name 71200 0
Lin Li Ow
Address 71200 0
Monash Health
Pelvic Floor Unit
823-865 Centre Road
Bentleigh East Victoria
3165
Country 71200 0
Australia
Phone 71200 0
+613 99288588
Fax 71200 0
+613 992 88338
Email 71200 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
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.