Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001516774
Ethics application status
Approved
Date submitted
10/11/2022
Date registered
6/12/2022
Date last updated
1/06/2024
Date data sharing statement initially provided
6/12/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised controlled trial of the efficacy of biofeedback versus pelvic floor physiotherapy in patients with faecal incontinence and constipation.
Scientific title
Randomised controlled trial of the efficacy of biofeedback versus pelvic floor physiotherapy in patients with faecal incontinence and constipation.
Secondary ID [1] 307364 0
Nil
Universal Trial Number (UTN)
U1111-1284-7688
Trial acronym
BioPFIC
Linked study record
Not applicable

Health condition
Health condition(s) or problem(s) studied:
Constipation 328148 0
Faecal incontinence 328149 0
Condition category
Condition code
Oral and Gastrointestinal 325200 325200 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Physical Medicine / Rehabilitation 325348 325348 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Pelvic floor health therapy:

Patients in this arm will undergo total of six one-to-one sessions occurring every 1-2 weeks (6-12 weeks). - each session will be guided by a physiotherapist and up to 60 minutes long.

-Patients will be prescribed individualised exercises based on each patient’s presenting condition, pattern of their symptoms and clinical assessment of pelvic floor function.
-Patients will be guided through a series of pelvic floor exercises during the session and will also be given at-home exercises.
-Some examples include contraction and relaxation of pelvic floor muscles in different positions and abdomen strengthening exercises. At home exercise will be similar but at much shorter duration. Home exercises may be prescribed daily or multiple times a day.
-For sessions with physiotherapists, exercises may be assisted by an anal pressure probe or electrical stimulation if it is deemed helpful by the treating physiotherapist.

Attendance and progress will be recorded on clinical research database.
Intervention code [1] 324804 0
Treatment: Other
Comparator / control treatment
Anoretcal manometry based biofeedback:

Patients in this arm will undergo total of six one-to-one sessions occurring every 1-2 weeks (6-12 weeks) - each session will be guided by a nurse consultant and/or gastroenterologist up to 60 minutes long.

-Patients will be prescribed individualised programmes based on each patient’s presenting condition, pattern of their symptoms and clinical and physiological assessment of pelvic floor function.
-Programme will include (1) education regarding the anatomy of normal defecation, (2) advice on correct toilet positioning, (3) diaphragmatic breathing with manometric feedback to achieve adequate rectal pressure, (4) manometry and/or EMG-based biofeedback to allow anal relaxation to be synchronised with strain, (5) balloon expulsion retraining and (6) rectal sensory retraining.

Attendance and progress will be recorded on clinical research database.
Control group
Active

Outcomes
Primary outcome [1] 333033 0
Bowel satisfaction score(Visual analogue scale) change
Timepoint [1] 333033 0
At the beginning of treatment and the end of treatment course(2-3 months from the beginning of the treatment)
Primary outcome [2] 333034 0
Physician assessed post-treatment progress - Physician impression of patient's progress/changes based on symptoms and physiology as measured on anorectal manometry
Timepoint [2] 333034 0
At the beginning of treatment and the end of treatment course(2-3 months from the beginning of the treatment)
Secondary outcome [1] 416155 0
Primary outcome (Constipation arm): Constipation score change
Timepoint [1] 416155 0
At the beginning of treatment and the end of treatment course(2-3 months from the beginning of the treatment)
Secondary outcome [2] 416156 0
Primary outcome (Faecal incontinence arm) :
Faecal incontinence severity index(FISI) change
Timepoint [2] 416156 0
At the beginning of treatment and the end of treatment course(2-3 months from the beginning of the treatment)
Secondary outcome [3] 416157 0
Changes in anorectal physiology as measured by manometry and balloon expulsion test pre-and post-treatment
Timepoint [3] 416157 0
At the beginning of treatment and the end of treatment course(2-3 months from the beginning of the treatment)
Secondary outcome [4] 416177 0
Feeling of control over bowel function using patient reported visual analogue scale
Timepoint [4] 416177 0
At the beginning of treatment and the end of treatment course(2-3 months from the beginning of the treatment)

Eligibility
Key inclusion criteria
1) Patients diagnosed with constipation or faecal incontinence by referring doctor (specialist) AND has been assessed suitable for biofeedback based on the anorectal manometry and clinical profile
2) Age 20 years and above
3) Female
4) Able to speak English
5) Willingness to answer screening questionnaire
6) Willingness to give written informed consent
7) Willingness to comply with the study
Minimum age
20 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Pregnant or currently breastfeeding
2) History of a significant anorectal or distal colon surgery or radiotherapy
3) Significant rectal prolapse
4) Has a nerve stimulator for continence or gastrointestinal motility
5) Had a full course of pelvic floor health physiotherapy within last two years
6) Inability to understand and follow the procedure due to language barrier or underlying medical/mental conditions.

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)
Treatment allocation sequence will be generated prior to the commencement of the study. Treatment allocations will be inserted into a opaque envelopes. Envelopes will be handed out by the secretary during randomisation visit. Envelope will be prepared by the nurse who is not involved in the treatment or other aspects of this clinical study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generation will be done by the designated statistician. It will be done in blocks of six to ensure equal distribution of patients between two different treatment arms.
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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
12/12/2022
Actual
12/12/2022
Date of last participant enrolment
Anticipated
1/02/2026
Actual
Date of last data collection
Anticipated
1/02/2026
Actual
Sample size
Target
240
Accrual to date
120
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 23527 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 38940 0
2065 - St Leonards

Funding & Sponsors
Funding source category [1] 311647 0
Hospital
Name [1] 311647 0
Royal Northshore Hospital - Northern Sydney Local Health District
Country [1] 311647 0
Australia
Primary sponsor type
Hospital
Name
Royal Northshore Hospital - Northern Sydney Local Health District
Address
Reserve Rd, St Leonards NSW 2065
Country
Australia
Secondary sponsor category [1] 314237 0
None
Name [1] 314237 0
none
Address [1] 314237 0
none
Country [1] 314237 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311103 0
Northern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 311103 0
NSLHD Research Office, Level 13 Kolling Building, Royal North Shore Hospital, Reserve Road, St Leonards, NSW, 2065
Ethics committee country [1] 311103 0
Australia
Date submitted for ethics approval [1] 311103 0
Approval date [1] 311103 0
19/10/2022
Ethics approval number [1] 311103 0
2022ETH01164

Summary
Brief summary
When conservative treatment fails for constipation or faecal incontinence, biofeedback and pelvic floor health therapy are two different management options. These two modalities are often thought to be similar by some physicians due to both employing components of pelvic exercise. However, these two modalities have very distinct programmes and are usually delivered by different health care professionals (nurses versus physiotherapists). Despite this, no randomised controlled trial has been performed to date to compare them for both indications. This study aims to investigate any difference in outcome between the two modalities.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 119954 0
Dr Allison Malcolm
Address 119954 0
Gastroenterology Department, Level 4 Acute Service Building Royal North Shore Hospital Reserve Road, St Leonards, NSW 2065
Country 119954 0
Australia
Phone 119954 0
+61296432450
Fax 119954 0
Email 119954 0
allison.malcolm@sydney.edu.au
Contact person for public queries
Name 119955 0
Dr Allison Malcolm
Address 119955 0
Gastroenterology Department, Level 4 Acute Service Building Royal North Shore Hospital Reserve Road, St Leonards, NSW 2065
Country 119955 0
Australia
Phone 119955 0
+61296432450
Fax 119955 0
Email 119955 0
NSLHD-ngresearch@health.nsw.gov.au
Contact person for scientific queries
Name 119956 0
Dr Allison Malcolm
Address 119956 0
Gastroenterology Department, Level 4 Acute Service Building Royal North Shore Hospital Reserve Road, St Leonards, NSW 2065
Country 119956 0
Australia
Phone 119956 0
+61296432450
Fax 119956 0
Email 119956 0
NSLHD-ngresearch@health.nsw.gov.au

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.