Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000258055
Ethics application status
Approved
Date submitted
25/03/2010
Date registered
29/03/2010
Date last updated
11/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Randomised controlled trial (RCT) of biofeedback in patients with faecal incontinence
Scientific title
A randomised clinical study was designed to compare two exercise regimen and determine the effect of an information session on the subjective rating of the symptoms of faecal incontinence and quality of life
Secondary ID [1] 1553 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Faecal incontinence 257038 0
Condition category
Condition code
Oral and Gastrointestinal 257195 257195 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
A regimen of prescribed rapid exercises (up to 40, 1 second squeezes) and sustained (up to 40, 10 second squeeze) per day for 5 weeks (Session 3, Week 3 to Session 5, Week 8). Session 1 included severity, quality of life, and physiological (manometry) assessment, medical/surgical history and review of bowel chart/food diary. Session 2 included re-assessment of severity and quality of life plus relaxation breathing training.
Intervention code [1] 256210 0
Rehabilitation
Comparator / control treatment
Standard exercise regime which used only sustained exercises e.g. (up to 40, 10 second squeeze) per day for 5 weeks (Session 3, Week 3 to Session 5, Week 8)
Session 1 included severity, quality of life, and physiological (manometry) assessment, medical/surgical history and review of bowel chart/food diary. Session 2 included re-assessment of severity and quality of life plus relaxation breathing training.
Control group
Active

Outcomes
Primary outcome [1] 258087 0
Faecal incontinence severity
Timepoint [1] 258087 0
Participants surveyed after consenting to participate in session 1 and after completing therapy 7 weeks/49 days later at the end of session 5.
Secondary outcome [1] 263693 0
Quality of life
Timepoint [1] 263693 0
Participants surveyed after consenting to participate in session 1 and after completing therapy 7 weeks/49 days later at the end of session 5.

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 cooperating; are willing to participate and consent.
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: gastrointestinal stoma, self reported pregnancy, terminal illness, rectal prolapses, mental illness (by medication type)

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
Active, not recruiting
Date of first participant enrolment
Anticipated
19/01/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
72
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2638 0
4810

Funding & Sponsors
Funding source category [1] 256709 0
University
Name [1] 256709 0
James Cook University
Country [1] 256709 0
Australia
Primary sponsor type
University
Name
James Cook University
Address
Angus Smith Drive
Townsville QLD 4811
Country
Australia
Secondary sponsor category [1] 255996 0
None
Name [1] 255996 0
Address [1] 255996 0
Country [1] 255996 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258723 0
Townsville Health Service District Institutional Ethics Committee
Ethics committee address [1] 258723 0
Dr Andrew Johnson
Chairperson
Townsville Health Service District Institutional Ethics Committee
100 Angus Smith Drive
Townsville QLD 4811
Ethics committee country [1] 258723 0
Australia
Date submitted for ethics approval [1] 258723 0
Approval date [1] 258723 0
15/09/2004
Ethics approval number [1] 258723 0
47/04
Ethics committee name [2] 258724 0
ETHICS REVIEW COMMITTEE Human Ethics Sub-Committee
Ethics committee address [2] 258724 0
James Cook University
Angus Smith Drive
Townsville QLD 4811
Ethics committee country [2] 258724 0
Australia
Date submitted for ethics approval [2] 258724 0
Approval date [2] 258724 0
13/11/2004
Ethics approval number [2] 258724 0
H1950

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

Contacts
Principal investigator
Name 30983 0
Address 30983 0
Country 30983 0
Phone 30983 0
Fax 30983 0
Email 30983 0
Contact person for public queries
Name 14230 0
Professor Yik-Hong Ho
Address 14230 0
School of Medicine
James Cook University
Angus Smith Drive
Townsville QLD 4811
Country 14230 0
Australia
Phone 14230 0
+61 7 4796 1417
Fax 14230 0
+61 7 4796 1401
Email 14230 0
yikhong.ho@jcu.edu.au
Contact person for scientific queries
Name 5158 0
Lynne Bartlett
Address 5158 0
School of Public Health, Tropical Medicine and Rehabilitation Sciences
James Cook University
Angus Smith Drive
Townsville QLD 4811
Country 5158 0
Australia
Phone 5158 0
+61 7 4796 1721
Fax 5158 0
+61 7 4796 1767
Email 5158 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
No additional documents have been identified.