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Trial registered on ANZCTR


Registration number
ACTRN12605000747628
Ethics application status
Approved
Date submitted
28/10/2005
Date registered
16/11/2005
Date last updated
24/09/2024
Date data sharing statement initially provided
24/09/2024
Date results information initially provided
24/09/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomized Control Trial of Biofeedback Guided Pelvic Floor Exercises in the
Treatment in Faecal Incontinence
Scientific title
Randomized Control Trial of Biofeedback Guided Pelvic Floor Exercises in the
Treatment in Faecal Incontinence
Secondary ID [1] 273328 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Faecal incontinence 899 0
Condition category
Condition code
Oral and Gastrointestinal 967 967 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Telephone support - Assessment and one biofeedback session (using real time rectal ultrasound and mannometry) with four monthly telephone treatment sessions; or Single treatment session only.
Intervention code [1] 740 0
Treatment: Other
Comparator / control treatment
Standard care - assessment and five sessions of biofeedback training using real time rectal ultrasound and mannometry.
Control group
Active

Outcomes
Primary outcome [1] 1285 0
Incontinence
Timepoint [1] 1285 0
5 months after initial visit
Secondary outcome [1] 2311 0
Quality of life
Timepoint [1] 2311 0
5 months after initial visit

Eligibility
Key inclusion criteria
1) prior assessment by a doctor, nurse specialist or physiotherapist 2) faecal incontinence.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) complete external sphincter defect, 2) obstructive defecation or constipation 3) defunctioning stoma, 4) currently active inflammatory bowel disease 5) acute perianal inflammation, 6) a potentially reversible cause of incontinence such as acute diarrhoea 7) untreated full-thickness rectal prolapse.

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)
Sealed opaque envelopes that are numerically listed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated - SAS.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2006
Actual
1/05/2006
Date of last participant enrolment
Anticipated
Actual
31/12/2012
Date of last data collection
Anticipated
Actual
23/01/2013
Sample size
Target
350
Accrual to date
Final
351
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 1065 0
Self funded/Unfunded
Name [1] 1065 0
Country [1] 1065 0
Primary sponsor type
Hospital
Name
Surgical Outcomes Research Centre - based in Royal Prince Alfred Hospital.
Address
Surgical Outcomes Research Centre PO Box M157 Missenden Rd Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 927 0
None
Name [1] 927 0
None
Address [1] 927 0
Country [1] 927 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2367 0
Sydney Local Health Network (RPAH Zone)
Ethics committee address [1] 2367 0
RPAH Medical Centre, 100 Carillon Ave, Newtown, NSW, 2042
Ethics committee country [1] 2367 0
Australia
Date submitted for ethics approval [1] 2367 0
Approval date [1] 2367 0
16/12/2005
Ethics approval number [1] 2367 0
X05-330 and X10-0142
Ethics committee name [2] 2368 0
Sydney Local Health District
Ethics committee address [2] 2368 0
X05-0330 - [email protected] - Research Development Office, Level 8, Building 14, Royal Prince Alfred Hospital, Camperdown, NSW, 2050

X10-0142 - [email protected] - Research Development Office, Level 3, Building 92, Royal Prince Alfred Hospital, Camperdown, NSW, 2050
Ethics committee country [2] 2368 0
Australia
Date submitted for ethics approval [2] 2368 0
Approval date [2] 2368 0
Ethics approval number [2] 2368 0

Summary
Brief summary
Patients with faecal incontinence may be treated by pelvic floor exercises enhanced with real time feedback using trans-rectal ultrasound and mannometry. This clinical trial will compare three different treatment protocols; standard monthly clinic sessions; initial clinic assessment and treatment session followed by monthly telephone follow-up; assessment and single clinic treatment session only.
Trial website
Trial related presentations / publications
C. J. Young, A. Zahid, C. E. Koh, J. M. Young, C. M. Byrne, M. J. Solomon, J. Rex and J. Candido. A randomized controlled trial of four different regimes of biofeedback programme in the treatment of faecal incontinence.Colorectal Disease 2017. doi:10.1111/codi.13932
Public notes

Contacts
Principal investigator
Name 36047 0
Prof Michael Solomon
Address 36047 0
Royal Prince Alfred Hospital, Surgical Outcomes Research Centre (SOuRCe), PO Box M157, Missenden Road, Camperdown NSW 2050
Country 36047 0
Australia
Phone 36047 0
+61295153464
Fax 36047 0
+61295153200
Email 36047 0
[email protected]
Contact person for public queries
Name 9929 0
Professor Michael Solomon
Address 9929 0
Surgical Outcomes Research Centre
PO Box M157
Missenden Rd
Camperdown NSW 2050
Country 9929 0
Australia
Phone 9929 0
+61 2 95157256
Fax 9929 0
+61 2 95191806
Email 9929 0
[email protected]
Contact person for scientific queries
Name 857 0
Prof Michael Solomon
Address 857 0
Royal Prince Alfred Hospital, Surgical Outcomes Research Centre (SOuRCe), PO Box M157, Missenden Road, Camperdown NSW 2050
Country 857 0
Australia
Phone 857 0
+61 2 95157256
Fax 857 0
Email 857 0
[email protected]

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
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYeshttps://doi.org/10.1111/codi.13932 Access to published article (aggregated data). C. ... [More Details]

Documents added automatically
No additional documents have been identified.