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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ANZCTR |
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Last refreshed on:
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13 January 2020 |
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Main ID: |
ACTRN12606000070538 |
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Date of registration:
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21/02/2006 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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RCT of supplementary home biofeedback guided exercises in the treatment of faecal incontinence
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Scientific title:
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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 |
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Date of first enrolment:
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01/05/2006 |
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Target sample size:
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74 |
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Recruitment status: |
Recruiting |
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URL:
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https://anzctr.org.au/ACTRN12606000070538.aspx |
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Study type:
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Interventional |
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Study design:
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Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy;
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Phase:
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Countries of recruitment
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Australia
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Contacts
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Name:
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Lynne Bartlett
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Address:
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School of Public Health, Tropical Medicine and Rehabilitation Sciences
James Cook University
Townsville QLD 4811
Australia |
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Telephone:
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+61 7 47961721 |
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Email:
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lynne.bartlett@jcu.edu.au |
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Affiliation:
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Name:
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Professor Yik-Hong Ho
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Address:
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School of Medicine
James Cook University
Townsville QLD 4811
Australia |
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Telephone:
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+61 7 47961417 |
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Email:
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yikhong.ho@jcu.edu.au |
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Affiliation:
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Key inclusion & exclusion criteria
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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.
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.
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Both males and females
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Health Condition(s) or Problem(s) studied
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Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Faecal incontinence;
Faecal incontinence
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Intervention(s)
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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.
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Primary Outcome(s)
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Faecal incontinence severity[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.]
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Secondary Outcome(s)
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Quality of Life[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.]
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Source(s) of Monetary Support
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Qld Government Smart State PhD Scholarship
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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