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

Caritas Medical Centre, 111
Wing Hong Street
Shum Shui Po
Hong Kong
-
Hong Kong

+852 3408 7785
mirchan@hotmail.com

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesTo 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) studiedPassive faecal incontinence
InterventionInjectable bulking agents to augment the bulk of the internal anal sphincter: injectable silicone biomaterial (PTQTM) vs carbon-coated beads (Durasphere®).
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)PTQTM, Durasphere®
Primary outcome measureWexner’s continence score, assessed at 2 and 6 weeks, then 6 and 12 months after treatment
Secondary outcome measuresThe 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 date01/08/2005
Completion date31/10/2006

Eligibility

Participant type(s)Patient
Age groupOther
SexBoth
Target number of participants40
Key inclusion criteria1. 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 criteria1. 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
Date of first enrolment01/08/2005
Date of final enrolment31/10/2006

Locations

Countries of recruitment

  • Australia
  • Hong Kong

Study participating centre

Caritas Medical Centre, 111
Hong Kong
-
Hong Kong

Sponsor information

Epworth Hospital, University of Melbourne (Australia)
University/education

89 Bridge Road
Richmond
Melbourne
3121
Australia

http://www.epworth.org.au
ROR logo 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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan
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