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Trial registered on ANZCTR


Registration number
ACTRN12622000583741
Ethics application status
Approved
Date submitted
30/03/2022
Date registered
20/04/2022
Date last updated
20/04/2022
Date data sharing statement initially provided
20/04/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of anorectal biofeedback therapy delivered by home-based device with clinic-based anorectal manometry in patients with functional defecation disorders
Scientific title
Comparison of anorectal biofeedback therapy delivered by home-based device with clinic-based anorectal manometry in patients with functional defecation disorders
Secondary ID [1] 306863 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Functional defecation disorders 325893 0
Condition category
Condition code
Oral and Gastrointestinal 323200 323200 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An novel experimental device to aid in anorectal biofeedback therapy. The Internet-of-Medical-Things device consists of an insertable probe with sensors to collect data on anal sphincter muscle contractility and rectal lumen pressures. The probe is wirelessly connected to a mobile app to provide real-time visual feedback of muscle activities to the user. The app records and processes training session data and clinical indicators (symptoms & bowel diary) from user input. Processed data will be sent to a cloud server to allow health providers to track progress and aid in decision-making. The proposed device will allow for instrumented anorectal biofeedback training to be performed by users at a clinic or at home.

Participant involvement
The study will be conducted a GI Motility Clinic at Camden Public Hospital, NSW Australia. Participants will be randomly assigned into conventional biofeedback therapy or biofeedback therapy with the new experimental device.
The specialist nurse at the GI Motility Clinic will educate the participant on bowel function and perform the therapy (either with conventional equipment or experimental device). Training involves inserting a sensing probe into the anorectal cavity and performing a series of pulse squeeze, squeeze & hold, and push muscle maneuvers. Real-time feedback will be provided to the participant in the formal of verbal cues (conventional therapy) or visual graphics (experimental device).
Participants using experimental device may take the device home in between clinical sessions to continue with training for the duration of their therapy period. Participants will be provided with training on how to operate the device at the clinic and a physical instruction manual. Home training is recommended at one session per day, each session takes 5 - 10 minutes to complete.
Both arms of the trial will take 6 weekly clinical sessions. Each session will take approximately 30 minutes to 1 hour.
Intervention code [1] 323273 0
Treatment: Devices
Comparator / control treatment
Anorectal biofeedback therapy uses instrument-based “operant conditioning” (learning through repetition and reinforcement) to restore the normal muscle patterns for defecation. Therapy consist of muscle strength and coordination exercises with an instrument to allow users to visualize muscle activities. Biofeedback therapy is recommended as the first-line treatment of functional defecation disorders by several consensus groups including the American and European Neurogastroenterology and Motility Societies.

The control treatment is anorectal biofeedback using conventional hospital equipment. The therapy will be performed by the specialist nurse at Camden Hospital, who is well versed in anorectal biofeedback therapy having performed over 1,500 sessions.
The in clinic sessions will be conducted weekly over a period of 6 weeks and take approximately 30 mins - 1 hour to complete.
The specialist nurse will keep a track of clinical session attendance. Reminder phone calls and emails will be sent to promote adherence.
Control group
Active

Outcomes
Primary outcome [1] 330953 0
Anorectal exercise profiles generated by the experimental device compared against those from conventional anorectal manometry.

Timepoint [1] 330953 0
Baseline and weekly after intervention commencement over a period of 6 weeks.
Primary outcome [2] 331009 0
Anorectal exercise pressures generated by the experimental device compared against those from conventional anorectal manometry.
Timepoint [2] 331009 0
Baseline and weekly after intervention commencement over a period of 6 weeks.
Secondary outcome [1] 408242 0
Incontinence symptom severity using Vaizey and Wexner faecal incontinence scores

Timepoint [1] 408242 0
Baseline and weekly after intervention commencement over a period of 6 weeks.
Secondary outcome [2] 408472 0
.Incontinence episode frequency using faecal incontinent diary (days per week)
Timepoint [2] 408472 0
Baseline and weekly after intervention commencement over a period of 6 weeks.

Eligibility
Key inclusion criteria
• Males and females 18 to 65 years
• Diagnosed with urge faecal incontinence or faecal seepage
• Able to provide verbal and written consent
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Pregnant women and the human foetus
• People under the age of 18
• People with a cognitive impairment, an intellectual disability or a mental illness
• Anorectal surgery within the last 3 years
• Presence of active anal fissure and/or symptomatic haemorrhoids
• Individuals with implantable or portable electro-mechanical medical devices (e.g. pacemaker, sacral nerve stimulation impact)

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)
Random numbers generated in advance and placed into sequentially numbered opaque envelopes, sealed and used for subject assignment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization used permuted blocks of 4 with 1:1 assignment into the parallel study groups.
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 study will evaluate the capability of the experimental device to provide instrumented biofeedback (BF) therapy (create distinct BF exercise profiles and is understood by the user) and compare the data against anorectal manometry.
For the non-inferiority study, based on changes in the primary outcome measures, with n=30 per study arm, the test for non-inferiority has 0.70 power to reject, at the 0.05 significance level, the null hypothesis that the mean change due to home-BF is smaller than clinic-BF by at least 0.44 SD in favour of he alternative hypothesis that mean changes due to home-BF is no more than 0.44 SD lower than clinic-BF (i.e. Ho: delta HB-delta OB<-0.44SD vs. Ha: delta HB-delta OB=-0.44SD).
Using estimates from previous studies, we consider home-BF no worse than or better than clinic-BF if the home-BF group had at least 9 point decrease in Vaizey/Wexner faecal incontinence score (11 for clinic-BF, SD=3), 0.95 days/week decrease in faecal incontinence episodes (1.1 for clinic-BF, SD=0.25), and 19 mmHg increase in anal sphincter squeeze pressure (25 mmHg for clinic-BF, SD=10).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/05/2022
Actual
Date of last participant enrolment
Anticipated
28/04/2023
Actual
Date of last data collection
Anticipated
31/05/2023
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 22099 0
Camden Hospital - Camden
Recruitment postcode(s) [1] 37221 0
2570 - Camden

Funding & Sponsors
Funding source category [1] 311145 0
University
Name [1] 311145 0
Western Sydney University
Country [1] 311145 0
Australia
Primary sponsor type
University
Name
Western Sydney University
Address
School of Medicine, Building 30
Goldsmith Avenue
Campbelltown NSW 2560
Country
Australia
Secondary sponsor category [1] 312492 0
None
Name [1] 312492 0
Address [1] 312492 0
Country [1] 312492 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310673 0
Bellberry human research ethics committee
Ethics committee address [1] 310673 0
Ethics committee country [1] 310673 0
Australia
Date submitted for ethics approval [1] 310673 0
02/03/2022
Approval date [1] 310673 0
25/03/2022
Ethics approval number [1] 310673 0
2022/ETH00030

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

Contacts
Principal investigator
Name 118470 0
Dr Jerry Zhou
Address 118470 0
Building 30, School of Medicine
Western Sydney University
Goldsmith Avenue
Campbelltown, NSW , 2560
Country 118470 0
Australia
Phone 118470 0
+61246203865
Fax 118470 0
Email 118470 0
j.zhou@westernsydney.edu.au
Contact person for public queries
Name 118471 0
Jerry Zhou
Address 118471 0
Building 30, School of Medicine
Western Sydney University
Goldsmith Avenue
Campbelltown, NSW , 2560
Country 118471 0
Australia
Phone 118471 0
+61246203865
Fax 118471 0
Email 118471 0
j.zhou@westernsydney.edu.au
Contact person for scientific queries
Name 118472 0
Jerry Zhou
Address 118472 0
Building 30, School of Medicine
Western Sydney University
Goldsmith Avenue
Campbelltown, NSW , 2560
Country 118472 0
Australia
Phone 118472 0
+61246203865
Fax 118472 0
Email 118472 0
j.zhou@westernsydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The IPD may contain commercially sensitive information. Western Sydney University are the owners of the device's intellectual property and may wish to commercialize this device in a future date.


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.