Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12605000612617
Ethics application status
Approved
Date submitted
10/08/2005
Date registered
6/10/2005
Date last updated
6/10/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effectiveness of dietry intervention in the management of women with faecal incontinence.
Scientific title
The effectiveness of dietry intervention in the management of women with faecal incontinence.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anal incontinence/ defecation dysfunction 744 0
Condition category
Condition code
Diet and Nutrition 820 820 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cross over dietary intervention study looking at the effect of modified fibre on bowel function over a period of 12 weeks.
Intervention code [1] 165 0
None
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 1052 0
Cleveland Clinic continence scores, with improvement of > 50%
Timepoint [1] 1052 0
Measured at completion of 12 week dietary intervention.
Secondary outcome [1] 1957 0
VAS of patient satisfaction, SF 36, Anorectal Symptom Questionaire, QOL Faecal Incontinence, at completion of 12 week dietary intervention.
Timepoint [1] 1957 0

Eligibility
Key inclusion criteria
Fecal incontinence. Concomitant pelvic floor dysfunction - vaginal prolapse or urinary incontinence may be included.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cultural or religious dietary requirements preclude from participationMedical disorders which require a specific diet eg. Coeliac disease, food allergyPresence of rectovaginal fistula.

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)
Not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated table of random numbers. Blocking used in groups of four.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/10/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 908 0
Hospital
Name [1] 908 0
Royal Womens Hospital Urogynaecology unit
Country [1] 908 0
Australia
Primary sponsor type
Hospital
Name
Royal Womens Hospital Urogynaecology unit
Address
Country
Australia
Secondary sponsor category [1] 767 0
None
Name [1] 767 0
As above
Address [1] 767 0
Country [1] 767 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2195 0
Royal Womens hospital Melbourne
Ethics committee address [1] 2195 0
Ethics committee country [1] 2195 0
Australia
Date submitted for ethics approval [1] 2195 0
Approval date [1] 2195 0
Ethics approval number [1] 2195 0

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

Contacts
Principal investigator
Name 36394 0
Address 36394 0
Country 36394 0
Phone 36394 0
Fax 36394 0
Email 36394 0
Contact person for public queries
Name 9354 0
Dr Marcus Carey
Address 9354 0
Urogynaecology Pelvic Floor Service
Grattan Street
Carlton VIC 3054
Country 9354 0
Australia
Phone 9354 0
+61 3 93442000
Fax 9354 0
Email 9354 0
[email protected]
Contact person for scientific queries
Name 282 0
Kate Sloane
Address 282 0
Urogynaecology Pelvic Floor Service
Grattan Street
Carlton VIC 3054
Country 282 0
Australia
Phone 282 0
+61 3 93442000
Fax 282 0
Email 282 0
[email protected]

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.