|
ISRCTN
|
ISRCTN34920540
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Injectable silicone biomaterial (PTQTM) is more effective than carbon-coated beads (Durasphere®) in treating passive faecal incontinence: a randomised trial
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
N/A
|
|
Study hypothesis
|
To compare safety and efficacy of PTQTM compared with Durasphere® in treating patients with passive faecal incontinence.
|
|
Ethics approval
|
Approved by the Human Resource Ethics Committee of Epworth Hospital
|
|
Study design
|
Randomised controlled trial
|
|
Countries of recruitment
|
Australia
|
|
Disease/condition/study domain
|
Passive faecal incontinence
|
|
Participants - inclusion criteria
|
1. Both males and females, no age limits
2. Faecal seepage or soiling for more than twice a week caused by internal sphincter (IAS) dysfunction
3. Not responding to treatment with dedicated pelvic floor exercises and stool bulking agents
|
|
Participants - exclusion criteria
|
1. Perianal sepsis
2. Anorectal cancer
3. Immunosuppression
4. Rectal prolapse
5. Inflammatory bowel disease
6. Congenital anorectal malformation
7. Neurological disorders such as Parkinson’s disease
8. Multiple sclerosis
9. Spinal-cord injury
10. Stoma in situ
11. Pregnancy
12. External anal sphincter defect of more than 120º of the circumference
13. Bleeding diathesis,
14. Mental or physical disability precluding adherence to study protocol
|
|
Anticipated start date
|
01/08/2005
|
|
Anticipated end date
|
31/10/2006
|
|
Status of trial
|
Completed
|
|
Patient information material
|
|
|
Target number of participants
|
40
|
|
Interventions
|
Injectable bulking agents to augment the bulk of the internal anal sphincter: injectable silicone biomaterial (PTQTM) vs carbon-coated beads (Durasphere®).
|
|
Primary outcome measure(s)
|
Wexner’s continence score, assessed at 2 and 6 weeks, then 6 and 12 months after treatment
|
|
Secondary outcome measure(s)
|
The following were assessed at 2 and 6 weeks, then 6 and 12 months after treatment:
1. Faecal incontinence quality of life (FIQL) scale
2. Short Form 12 (SF-12) health survey questionnaire
3. Adverse events
|
|
Sources of funding
|
Not provided at time of registration
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Dr
Miranda
Chan
|
|
Address
|
Caritas Medical Centre, 111
Wing Hong Street
Shum Shui Po
|
|
City/town
|
Hong Kong
|
|
Zip/Postcode
|
-
|
|
Country
|
Hong Kong
|
|
Tel
|
+852 3408 7785
|
|
Fax
|
+852 2148 4399
|
|
Email
|
mirchan@hotmail.com
|
|
Sponsor
|
Epworth Hospital, University of Melbourne (Australia)
|
|
Address
|
89 Bridge Road
Richmond
|
|
City/town
|
Melbourne
|
|
Zip/Postcode
|
3121
|
|
Country
|
Australia
|
|
Sponsor website:
|
http://www.epworth.org.au
|
|
Date applied
|
22/05/2008
|
|
Last edited
|
10/06/2008
|
|
Date ISRCTN assigned
|
09/06/2008
|
