Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000651088
Ethics application status
Approved
Date submitted
3/06/2009
Date registered
10/08/2010
Date last updated
10/08/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
PTQ versus Durasphere in the treatment of faecal incontinence – a prospective study comparing two injectable bulking agents
Scientific title
PTQ versus Durasphere in the treatment of faecal incontinence – a prospective study comparing two injectable bulking agents
Secondary ID [1] 252411 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Faecal incontinence 236913 0
Condition category
Condition code
Surgery 237270 237270 0 0
Surgical techniques
Oral and Gastrointestinal 258078 258078 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
Synthetic injectable bulking agent, PTQ (Uroplasty BV, Geleen, The Netherlands), a silicone based implant. A one-off treatment as a day-case under either sedation or general anaesthetic. Agent is injected into the anal sphincter by a surgeon using an 18 gauge or similar. The procedure itself takes approximately 15 minutes.
Intervention code [1] 236702 0
Treatment: Surgery
Comparator / control treatment
Another injectable bulking agent, Durasphere (Carbon Medical Technologies, St. Paul, MN). A pyrolitic carbon. A one-off treatment as a day-case under either sedation or general anaesthetic. Agent is injected into the anal sphincter by a surgeon using an 18 gauge or similar. The procedure itself takes approximately 15 minutes.
Control group
Active

Outcomes
Primary outcome [1] 238083 0
Wexner incontinence score - a functional assessment of incontinence to solid and liquid faeces, and gas.
Timepoint [1] 238083 0
6 weeks post procedure
Primary outcome [2] 258938 0
SF-36 quality of life score - The SF-36 is a multi-purpose, short-form health survey with only 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index.
Timepoint [2] 258938 0
6 weeks post procedure
Secondary outcome [1] 242282 0
Nil
Timepoint [1] 242282 0
Nil

Eligibility
Key inclusion criteria
Patients with faecal incontinence who, after discussion with a specialist, have opted to undergo treament with an injectable bulking agent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Excluding those with external sphincter defects, previous radiotherapy, inflammatory bowel disease, and previous surgery. This method with allow direct comparison of the two agents whilst decreasing confounding factors associated with the different causes of faecal incontinence.

Inability to complete aforementioned questionairres

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)
The patients will be informed of the trial during their visit to the specialist’s rooms. The research assistant will then explain the information sheet and obtain informed consent. The chief investigator will be available to answer further questions. The co-investigators and research assistants will be contacting the participants and will have access to their personal details. Randomisation by selection of sealed envelope from box with equal number of treatment/controls created by admin staff of rooms.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/05/2008
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] 237093 0
Self funded/Unfunded
Name [1] 237093 0
Country [1] 237093 0
Primary sponsor type
Individual
Name
Dr Brian Draganic
Address
John Hunter Hospital
Lookout Rd
New Lambton Heights
NSW 2305
Country
Australia
Secondary sponsor category [1] 4598 0
None
Name [1] 4598 0
Address [1] 4598 0
Country [1] 4598 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239193 0
HUNTER NEW ENGLAND HUMAN RESEARCH ETHICS COMMITTEE
Ethics committee address [1] 239193 0
John Hunter Hospital
Lookout Road
New Lambton
NSW
2305
Ethics committee country [1] 239193 0
Australia
Date submitted for ethics approval [1] 239193 0
Approval date [1] 239193 0
17/04/2008
Ethics approval number [1] 239193 0
08/02/20/3.03

Summary
Brief summary
There are various agents used as injectable bulking agents for the the treatment of faecal incontinence. They are usually injected into the submucosa of the anus or at the site of sphincter defect . The aim of this randomised control trial is to compare the effectiveness of two of those agents, namely PTQ (Uroplasty BV, Geleen, The Netherlands), a silicone based implant, and Durasphere (Carbon Medical Technologies, St. Paul, MN), a pyrolytic carbon. As yet the two treaments have not been directly compared.
The effectiveness of each technique will be assessed with pre- and post-proceedure incontinence scores (Wexner) and quality of life scoring (SF36)
The results of the trial will indicate which of the two agents is more effective in the treatment of faecal incontinence.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29691 0
Address 29691 0
Country 29691 0
Phone 29691 0
Fax 29691 0
Email 29691 0
Contact person for public queries
Name 12938 0
Dr Owen J Morris
Address 12938 0
Dept Surgery
John Hunter Hospital
Lookout Rd
New Lambton
NSW
2305
Country 12938 0
Australia
Phone 12938 0
+61424300491
Fax 12938 0
Email 12938 0
[email protected]
Contact person for scientific queries
Name 3866 0
Dr Owen J Morris
Address 3866 0
Dept Surgery
John Hunter Hospital
Lookout Rd
New Lambton
NSW
2305
Country 3866 0
Australia
Phone 3866 0
+61424300491
Fax 3866 0
Email 3866 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.