None listed
Conditions
Brief summary
There are various agents used as injectable bulking agents for the the treatment of faecal incontinence. They are usually injected into the submucosa of the anus or at the site of sphincter defect . The aim of this randomised control trial is to compare the effectiveness of two of those agents, namely PTQ (Uroplasty BV, Geleen, The Netherlands), a silicone based implant, and Durasphere (Carbon Medical Technologies, St. Paul, MN), a pyrolytic carbon. As yet the two treaments have not been directly compared. The effectiveness of each technique will be assessed with pre- and post-proceedure incontinence scores (Wexner) and quality of life scoring (SF36) The results of the trial will indicate which of the two agents is more effective in the treatment of faecal incontinence.
Interventions
Synthetic injectable bulking agent, PTQ (Uroplasty BV, Geleen, The Netherlands), a silicone based implant. A one-off treatment as a day-case under either sedation or general anaesthetic. Agent is injected into the anal sphincter by a surgeon using an 18 gauge or similar. The procedure itself takes approximately 15 minutes.
Sponsors
Dr Brian Draganic
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients with faecal incontinence who, after discussion with a specialist, have opted to undergo treament with an injectable bulking agent.
Exclusion criteria
Excluding those with external sphincter defects, previous radiotherapy, inflammatory bowel disease, and previous surgery. This method with allow direct comparison of the two agents whilst decreasing confounding factors associated with the different causes of faecal incontinence. Inability to complete aforementioned questionairres
Outcome results
None listed