Injectable silicone biomaterial (PTQTM) is more effective than carbon-coated beads (Durasphere®) in treating passive faecal incontinence: a randomised trial
| ISRCTN | ISRCTN34920540 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN34920540 |
| Protocol serial number | N/A |
| Sponsor | Epworth Hospital, University of Melbourne (Australia) |
| Funder | Not provided at time of registration |
- Submission date
- 22/05/2008
- Registration date
- 09/06/2008
- Last edited
- 10/06/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Miranda Chan
Scientific
Scientific
Caritas Medical Centre, 111
Wing Hong Street
Shum Shui Po
Hong Kong
-
Hong Kong
| Phone | +852 3408 7785 |
|---|---|
| mirchan@hotmail.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | To compare safety and efficacy of PTQTM compared with Durasphere® in treating patients with passive faecal incontinence. |
| Ethics approval(s) | Approved by the Human Resource Ethics Committee of Epworth Hospital |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | PTQTM, Durasphere® |
| Primary outcome measure(s) |
Wexners continence score, assessed at 2 and 6 weeks, then 6 and 12 months after treatment |
| Key secondary outcome measure(s) |
The following were assessed at 2 and 6 weeks, then 6 and 12 months after treatment: |
| Completion date | 31/10/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | All |
| Target sample size at registration | 40 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/08/2005 |
| Date of final enrolment | 31/10/2006 |
Locations
Countries of recruitment
- Australia
- Hong Kong
Study participating centre
Caritas Medical Centre, 111
Hong Kong
-
Hong Kong
-
Hong Kong
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
