Contact information
Type
Scientific
Primary contact
Dr Miranda Chan
ORCID ID
Contact details
Caritas Medical Centre
111
Wing Hong Street
Shum Shui Po
Hong Kong
-
Hong Kong
+852 3408 7785
mirchan@hotmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Passive faecal incontinence
Intervention
Injectable bulking agents to augment the bulk of the internal anal sphincter: injectable silicone biomaterial (PTQTM) vs carbon-coated beads (Durasphere®).
Intervention type
Drug
Phase
Not Specified
Drug names
PTQTM, Durasphere®
Primary outcome measures
Wexners continence score, assessed at 2 and 6 weeks, then 6 and 12 months after treatment
Secondary outcome measures
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
Overall trial start date
01/08/2005
Overall trial end date
31/10/2006
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Other
Gender
Both
Target number of participants
40
Participant 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 Parkinsons 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
Recruitment start date
01/08/2005
Recruitment end date
31/10/2006
Locations
Countries of recruitment
Australia
Trial participating centre
Caritas Medical Centre, 111
Hong Kong
-
Hong Kong
Sponsor information
Organisation
Epworth Hospital, University of Melbourne (Australia)
Sponsor details
89 Bridge Road
Richmond
Melbourne
3121
Australia
Sponsor type
University/education
Website
Funders
Funder type
Not defined
Funder name
Not provided at time of registration
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary