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Trial registered on ANZCTR


Registration number
ACTRN12606000070538
Ethics application status
Approved
Date submitted
17/02/2006
Date registered
21/02/2006
Date last updated
29/03/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
RCT of supplementary home biofeedback guided exercises in the treatment of faecal incontinence
Scientific title
A randomized study to evaluate the effects of supplementary home biofeedback guided pelvic floor and anal squeeze exercises in the treatment of faecal incontinence to reduce bowel leakage and improve patient quality of life
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Faecal incontinence 1034 0
Condition category
Condition code
Oral and Gastrointestinal 1110 1110 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

2. Home trainer. Assessment and evaluation above. Biofeedback training (2 sessions) using home trainer. Home exercise practice (4 weeks) using home trainer once per day.
Intervention code [1] 906 0
Treatment: Other
Comparator / control treatment
1. Standard care (assessment, 2 sessions of biofeedback training, 4 weeks home practice, final review and evaluation) using clinic mannometric equipment
Control group
Active

Outcomes
Primary outcome [1] 1481 0
Faecal incontinence severity
Timepoint [1] 1481 0
Participants surveyed after consenting to participate prior to treatment in session 1 and after completing therapy 6 weeks/42 days later at the end of session 4.
Secondary outcome [1] 2662 0
Quality of Life
Timepoint [1] 2662 0
Participants surveyed after consenting to participate prior to treatment in session 1 and after completing therapy 6 weeks/42 days later at the end of session 4.

Eligibility
Key inclusion criteria
Faecal incontinence; show some increase in anal sphincter pressure during voluntary squeeze; are able to perceive a distended rectal balloon at a threshold of <150cc; are capable of understanding and of cooperating; and are willing to participate.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children (Under 18); patients with: gastro-intestinal stoma, self reported pregnancy, latex allergy, terminal illness, rectal prolapse, mental illness (by medication type) or serious anal deformity.

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)
Numerically listed, sealed opaque envelope
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/05/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
74
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1215 0
Government body
Name [1] 1215 0
Qld Government Smart State PhD Scholarship
Country [1] 1215 0
Australia
Primary sponsor type
University
Name
James Cook University
Address
James Cook University
Townsville
QLD 4811
Country
Australia
Secondary sponsor category [1] 1073 0
None
Name [1] 1073 0
Nil
Address [1] 1073 0
Country [1] 1073 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 35642 0
Address 35642 0
Country 35642 0
Phone 35642 0
Fax 35642 0
Email 35642 0
Contact person for public queries
Name 10095 0
Professor Yik-Hong Ho
Address 10095 0
School of Medicine
James Cook University
Townsville QLD 4811
Country 10095 0
Australia
Phone 10095 0
+61 7 47961417
Fax 10095 0
+61 7 47961401
Email 10095 0
yikhong.ho@jcu.edu.au
Contact person for scientific queries
Name 1023 0
Lynne Bartlett
Address 1023 0
School of Public Health, Tropical Medicine and Rehabilitation Sciences
James Cook University
Townsville QLD 4811
Country 1023 0
Australia
Phone 1023 0
+61 7 47961721
Fax 1023 0
+61 7 47961767
Email 1023 0
lynne.bartlett@jcu.edu.au

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
SourceTitleYear of PublicationDOI
EmbaseSupplementary home biofeedback improves quality of life in younger patients with fecal incontinence.2015https://dx.doi.org/10.1097/MCG.0000000000000143
N.B. These documents automatically identified may not have been verified by the study sponsor.