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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
4/09/2013
Type of registration
Prospectively registered
Titles & IDs
Public title
Randomized Control Trial of Biofeedback Guided Pelvic Floor Exercises in the
Treatment in Faecal Incontinence
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Scientific title
Randomized Control Trial of Biofeedback Guided Pelvic Floor Exercises in the
Treatment in Faecal Incontinence
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Secondary ID [1]
273328
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nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Faecal incontinence
899
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Condition category
Condition code
Oral and Gastrointestinal
967
967
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0
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Normal oral and gastrointestinal development and function
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
740
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Treatment: Other
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Comparator / control treatment
Standard care - assessment and five sessions of biofeedback training using real time rectal ultrasound and mannometry.
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Control group
Active
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Outcomes
Primary outcome [1]
1285
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Incontinence
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Assessment method [1]
1285
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Timepoint [1]
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5 months after initial visit
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Secondary outcome [1]
2311
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Quality of life
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Assessment method [1]
2311
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Timepoint [1]
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5 months after initial visit
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Eligibility
Key inclusion criteria
1) prior assessment by a doctor, nurse specialist or physiotherapist 2) faecal incontinence.
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Minimum age
Not stated
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Maximum age
Not stated
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes that are numerically listed.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated - SAS.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
1/01/2006
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
350
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
1065
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Self funded/Unfunded
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Name [1]
1065
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Address [1]
1065
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Country [1]
1065
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Primary sponsor type
Hospital
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Name
Surgical Outcomes Research Centre - based in Royal Prince Alfred Hospital.
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Address
Surgical Outcomes Research Centre PO Box M157 Missenden Rd Camperdown NSW 2050
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Country
Australia
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Secondary sponsor category [1]
927
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None
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Name [1]
927
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None
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Address [1]
927
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Country [1]
927
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
2367
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Sydney Local Health Network (RPAH Zone)
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Ethics committee address [1]
2367
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RPAH Medical Centre, 100 Carillon Ave, Newtown, NSW, 2042
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Ethics committee country [1]
2367
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Australia
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Date submitted for ethics approval [1]
2367
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Approval date [1]
2367
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Ethics approval number [1]
2367
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X05-330 and X10-0142
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Ethics committee name [2]
2368
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University of Sydney
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Ethics committee address [2]
2368
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Ethics committee country [2]
2368
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Australia
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Date submitted for ethics approval [2]
2368
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Approval date [2]
2368
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Ethics approval number [2]
2368
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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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
36047
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Address
36047
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Country
36047
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Phone
36047
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Fax
36047
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Email
36047
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Contact person for public queries
Name
9929
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Professor Michael Solomon
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Address
9929
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Surgical Outcomes Research Centre
PO Box M157
Missenden Rd
Camperdown NSW 2050
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Country
9929
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Australia
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Phone
9929
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+61 2 95157256
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Fax
9929
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+61 2 95191806
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Email
9929
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[email protected]
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Contact person for scientific queries
Name
857
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Ms Emily Chew
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Address
857
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Colorectal Reseach Office
Royal Prince Alfred Hospital
Missenden Rd
Camperdown NSW 2050
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Country
857
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Australia
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Phone
857
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+61 2 95157256
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Fax
857
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Email
857
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[email protected]
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No information has been provided regarding IPD availability
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.
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