Condition category
Signs and Symptoms
Date applied
22/05/2008
Date assigned
09/06/2008
Last edited
10/06/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Wexner’s 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 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

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

http://www.epworth.org.au

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

Publication citations

Additional files

Editorial Notes