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 |
| Secondary identifying numbers | N/A |
- 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
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | PTQTM, Durasphere® |
| Primary outcome measure | 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 study start date | 01/08/2005 |
| Completion date | 31/10/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | All |
| Target number of participants | 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
Sponsor information
Epworth Hospital, University of Melbourne (Australia)
University/education
University/education
89 Bridge Road
Richmond
Melbourne
3121
Australia
| Website | http://www.epworth.org.au |
|---|---|
"ROR" |
https://ror.org/01ej9dk98 |
Funders
Funder type
Not defined
Not provided at time of registration
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
