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Trial registered on ANZCTR


Registration number
ACTRN12615000907549
Ethics application status
Approved
Date submitted
31/07/2015
Date registered
1/09/2015
Date last updated
19/07/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Prospective MultiCentre Randomised Controlled Trial comparing unassisted Pelvic Floor Exercises with the PeriCoach Registered Trademark system assisted Pelvic Floor Exercises in the management of female stress urinary incontinence.
Scientific title
A Prospective MultiCentre Randomised Controlled Trial comparing unassisted Pelvic Floor Exercises with the PeriCoach Registered Trademark system assisted Pelvic Floor Exercises in the management of female stress urinary incontinence.
Secondary ID [1] 286936 0
Nil
Universal Trial Number (UTN)
U1111-1171-3469
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Female Urinary Stress Incontinence 295353 0
Condition category
Condition code
Renal and Urogenital 296038 296038 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Standard Pelvic floor exercises using PeriCoach biofeedback system
The PeriCoach Sensor unit is switched on, inserted, and paired with the app on the smartphone or tablet. The accompanying smart phone application instructs users to squeeze their pelvic floor muscles at certain timepoints. The biosensors on the device measure the contraction and provide instant feedback to the participant via the app.

The PeriCoach should be used at least once a day with each session lasting 2-4 minutes for the period of the trial- 20 weeks. The app uploads the data to a web portal where it is stored and can be accessed by the user, and remotely by the treating clinician (password protected)
Intervention code [1] 292120 0
Treatment: Devices
Intervention code [2] 292526 0
Lifestyle
Intervention code [3] 292527 0
Behaviour
Comparator / control treatment
Standard Pelvic floor exercises using a combination of pulse contraction and held contraction (squeeze and lift) exercises with no device inserted for control group.
The squeeze and lift exercise should be repeated up to 8 to 12 times, holding the lift for 8 seconds if possible, resting for 8 seconds between each lift. Three sets of squeezes should be attempted with a rest between each set.
The exercises should be repeated three times a day while lying down, standing or sitting. Exercises should be continued for the 20 weeks duration of the study or as instructed by your physician. The Pericoach group will provide feedback with regards to usage. The control group will be asked to keep a diary of number of times exercises performed.
Control group
Active

Outcomes
Primary outcome [1] 295346 0
Continence as demonstrated by leakage during 24 hour pad weight test.
Timepoint [1] 295346 0
4 weeks and 20 weeks after commencement of randomisation and intervention commencing.
Secondary outcome [1] 315397 0
Number of leakage episodes, as assessed by 3 day voiding diary
Timepoint [1] 315397 0
4 weeks and 20 weeks after randomisation to study group and intervention commencing.
Secondary outcome [2] 316530 0
Global Impression of Improvement (PGI-I) Questionnaire completed by study participants.
Timepoint [2] 316530 0
4 weeks and 20 weeks following randomisation and commencement of intervention.
Secondary outcome [3] 316531 0
Assessment of adherence to treatment plan (use of PFME) using data uploaded for participants randomised to active arm. For participants randomised to control arm, a diary will be reviewed.
Timepoint [3] 316531 0
4 weeks and 20 weeks following randomisation and commencement of intervention.
Secondary outcome [4] 316532 0
Number of participants showing Improvement in vaginal resting pressure and squeeze pressure of 1 grade or more assessed by the physiotherapist or physician using standard measurements for this assessment.
Timepoint [4] 316532 0
4 weeks and 20 weeks following randomisation and commencement of intervention.
Secondary outcome [5] 316533 0
Quality of Life assessments as measured by:
*Incontinence Quality of Life (IQOL)
*International Consultation on Incontinence Questionnaire – Short Form Urinary Incontinence (ICIQ-UI-SF)
*Study Participant directed Queensland Pelvic Floor Questionnaire
*Study participant and physician Global Impression of Change Questionnaire at 4 and 20 weeks.
*PISQIR IUGA Sexual Function Questionnaire
Timepoint [5] 316533 0
4 weeks and 20 weeks following randomisation and commencement of intervention.

Eligibility
Key inclusion criteria
1. Study participant is a female and 18 years or older
2. Study participant is willing and able to sign an informed consent.
3. Study participant demonstrates stress urinary or mixed with predominantly stress, urinary incontinence of mild to moderate severity
4. Study participant willing and able to comply with follow-up activities.
5. Study participant has negative urine culture (using dipstick test) at baseline. (If leucocytes or nitrites present, send for culture. If negative or once treated, the study participant can be included).
6. Study participant has cognitive and manual capability to operate the device as determined by the investigator.
Minimum age
18 Years
Maximum age
80 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Study participant has previously failed conservative incontinence treatment for at least 6 months. Conservative treatment includes one or more of the following:
a. Pelvic exercises and bladder training
b. Drug Therapy (All anticholinergics, SUI or antidepressants prescribed for treatment of SUI).
c. Current use of Biofeedback devices in conjunction with PFT
d. Transvaginal/Transcutaneous Electrical stimulation
2. Study participant refuses or is unable to sign the informed consent.
3. Study participant is pregnant or plans to be pregnant as verified by commercially available urine pregnancy test.
4. Study participant cannot comply with study requirements, including follow-up visits and tests.
5. Study participant is currently enrolled or plans to enrol in another investigational device or drug clinical trial or who has just completed an investigational study within 2 weeks.
6. Study participant has been determined to have severe urinary incontinence as confirmed on history taking or by the use of urethral plugs, intermittent or permanent urethral catheterisation.
7. Study participant has recent surgeries within 3 months or planned surgeries during the course of the study.
8. Study participant is unable to perform PFME due to an inability to perform Pelvic floor muscle contractions.
9. Study participant has a primary urge incontinence, mixed incontinence with a predominant urgency component, or urinary incontinence caused by factors other than stress incontinence.
10. Study participant has current pelvic floor prolapse grade 4 or requiring support device.
11. Study participant has had implantation of an artificial urinary sphincter prosthesis, sling, or other urogenital implant
12. Study participant has had pelvic implant including all mesh products.
13. Study participant has neurogenic bladder dysfunction that is not treatable or controllable by pharmacological or alternative methods.
14. Study participant has uncontrolled diabetes mellitus defined as persistent blood sugar level recordings of >12mmol/l (216. mg/dl) and a glycosylated haemoglobin (HbA1C) of >9% (75mmol/mol) over the preceding 3 months which may affect voiding function.
15. Study participant has current (within last 6 months) genito urinary or gynaecological cancer.
16. Study participant needs self-intermittent catheterization.
17. Study participant has a diagnosed disease (e.g., dementia) that might preclude the study participant from being able to recall or summarize her urinary status.
18. Study participant has a diagnosed disease or medical condition (e.g., Parkinson’s) that might preclude the study participant from being physically capable of manipulating the device.
19. Study participant has known allergy to device material (silicone).
20. Study participant has active (confirmed by laboratory urinalysis) or recurrent urinary tract infections (UTIs) where recurrent is defined as > 4 times over the past year.
21. Study participant has known anatomic abnormalities of the urethra or vagina judged to prevent placement and utilisation of the Investigational Device or is assessed as having an anatomic abnormality during the physical examination at screening).

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 randomised at the completion of screening activities during Visit 2 and prior to device utilisation and training or at the commencement of Visit 3. Randomisation will be 1:1 and will be undertaking by contacting a central phone number which will issue a pre- allocated overall study specific randomisation number. A study participant will be considered enrolled and assigned a study participant ID number if they meet all eligibility criteria at visit #2. Once eligibility criteria are confirmed at this visit the participant will be randomised. Study participant IDs will be of the format “Site #, Participant#”; e.g. 01-01 for the first participant enrolled at Site 1. The Screening Log will contain the study participant number and initials but no other study participant identifiers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence has been developed by a statistician and is 1:1 - randomisation is a simple method created by computer software using a computerised sequence generation and provided by the statistician.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This is a randomised parallel group comparison of standard pelvic floor exercises with standard pelvic floor exercises and the PeriCoach device. Continuous variables will be summarized at each time using descriptive statistics including mean with a standard deviation or median with the interquartile range, the minimum and maximum, and the number of non-missing values. Categorical variables will be summarized with frequencies and proportions.

Primary Endpoints
The primary endpoint, a significant reduction in pad weight, will be compared between randomised groups using a Chi-square test and summarised as the difference in percentages with an exact 95% confidence interval.

Additionally, the mean change in the two 24-hour pad weight tests (completed at screening and 20 weeks) and averaged within a visit to provide a single 24-hour pad weight test result per visit) from baseline to 20 weeks will be compared between randomised groups using an independent t-test. The primary analysis will be based on the ITT population among study participants with two 24-hour pad weight tests at baseline and 3-months. A secondary sensitivity analysis will be conducted including pad weight results among study participants that only completed one 24-hour pad weight test at either baseline or 3-months. Analyses of the primary endpoint will also be conducted on the PP population as a further sensitivity analysis in support of the ITT analysis results. In addition, a sensitivity analysis will be performed on the ITT cohort where study participants with missing data are considered failures, i.e. did not achieve a significant reduction in pad weight. Primary endpoint rates will also be presented by radiated and irradiated study participant groups.

Secondary Endpoints
Continuous endpoints will be compared between randomised groups using independent t-tests and summarised as mean differences with 95% confidence intervals and categorical outcomes will compared with chi-square tests or fisher’s exact tests as appropriate and summarised as the difference in percentages with exact 95% confidence intervals. The secondary endpoints will be evaluated using the ITT cohort. All available data will be used for the analyses, and no imputation for missing data will be employed. Additional secondary analyses will utilise the per-protocol population.
Power was computed on the basis that the percentage successfully treated at 20 weeks in the control arm will be approximately 30% and in the Pericoach assisted arm this will be 50% or more. Using these assumptions a sample size of 90 (45:45) randomised participants will have 80% power to show this difference as statistically significant (two-sided a=0.05). The additional 10 participants included in the target sample size have been added to allow for possible participant drop out.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Other reasons/comments
Other reasons
Slow recruitment due to length of study. Interim analysis of data revealed continuation unnecessary.
Date of first participant enrolment
Anticipated
19/02/2015
Actual
24/04/2015
Date of last participant enrolment
Anticipated
30/09/2015
Actual
9/04/2016
Date of last data collection
Anticipated
16/09/2016
Actual
9/09/2016
Sample size
Target
100
Accrual to date
Final
47
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 3937 0
Calvary North Adelaide Hospital - North Adelaide
Recruitment hospital [2] 3938 0
The Royal Women's Hospital - Parkville
Recruitment hospital [3] 4115 0
Mater Hospital Pimlico - Pimlico
Recruitment postcode(s) [1] 9850 0
5006 - North Adelaide
Recruitment postcode(s) [2] 9851 0
3052 - Parkville
Recruitment postcode(s) [3] 9852 0
4812 - Hyde Park

Funding & Sponsors
Funding source category [1] 291490 0
Commercial sector/Industry
Name [1] 291490 0
Analytica Ltd
Country [1] 291490 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Analytica Ltd
Address
320 Adelaide St
Brisbane NSW 4000
Country
Australia
Secondary sponsor category [1] 290179 0
None
Name [1] 290179 0
Address [1] 290179 0
Country [1] 290179 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293032 0
Northern Sydney Local Health District
Ethics committee address [1] 293032 0
Ethics committee country [1] 293032 0
Australia
Date submitted for ethics approval [1] 293032 0
Approval date [1] 293032 0
16/01/2015
Ethics approval number [1] 293032 0
HREC/14/HAWKE/387
Ethics committee name [2] 293268 0
Bellberry HREC
Ethics committee address [2] 293268 0
Ethics committee country [2] 293268 0
Australia
Date submitted for ethics approval [2] 293268 0
22/03/2015
Approval date [2] 293268 0
30/03/2015
Ethics approval number [2] 293268 0
2015-03-222

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

Contacts
Principal investigator
Name 58162 0
Dr Ailsa Wilson Edwards
Address 58162 0
Continence Matters
Calvary Consulting Suites
Ground Floor, 89 Strangways Terrace
North Adelaide SA 5006
Country 58162 0
Australia
Phone 58162 0
+61882399109
Fax 58162 0
Email 58162 0
[email protected]
Contact person for public queries
Name 58163 0
Geoff Daly
Address 58163 0
Analytica Limited
PO Box 670
Brisbane QLD 4001
Country 58163 0
Australia
Phone 58163 0
+61-7-3278-1950
Fax 58163 0
Email 58163 0
[email protected]
Contact person for scientific queries
Name 58164 0
Geoff Daly
Address 58164 0
Analytica Limited
PO Box 670
Brisbane QLD 4001
Country 58164 0
Australia
Phone 58164 0
+61-7-3278-1950
Fax 58164 0
Email 58164 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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