Faecal Incontinence Clinical Trial
Official title:
CONtrol of Faecal Incontinence Using Distal NeuromodulaTion (CONFIDeNT)
Faecal incontinence occurs when a person passes faeces (stools) without the usual control.
It is a distressing condition that is actually very common although under-reported because
of embarrassment. Milder symptoms may be managed by treatments such as dietary change, drugs
and bowel retraining, but many patients still resort to surgery to improve symptoms.
Although several operations exist to treat incontinence e.g. those aiming to repair damaged
anal sphincter muscles, it is now clear that these often have poor results.
Two relatively new treatments called sacral nerve stimulation (SNS) and percutaneous tibial
nerve stimulation (PTNS) involve sending pulses of electricity to the nerves controlling the
bowel and muscles of the anus (anal sphincter).
SNS does this by inserting electrodes in the lower back just above the tailbone and
connecting them to an implanted electrical stimulator which is buried in the buttock and
acts a bit like a heart pacemaker. SNS is a relatively well-established treatment in
specialist centres, which has been used for over 10 years. It has been shown in studies to
be successful for faecal incontinence achieving some improvement in at least three quarters
of patients. In Europe, this procedure is fast becoming first treatment offered when
non-surgical treatments fail. Nevertheless, SNS is not a miracle cure for all, requiring 2
operations, with potential complications and expensive equipment (> £10,000 approx).
PTNS is a newer treatment, which involves electrically stimulating a nerve at the ankle,
using a very small needle, as an outpatient (a bit like acupuncture). This sends signals
back to the spine region to try and improve symptoms of faecal incontinence. Since this is a
newer treatment, fewer studies have been performed to quantify how successful it is, but
early results of PTNS suggest that it may be as good as SNS. If this is true, this is very
important because it is much less invasive and considerably cheaper than SNS (equipment £500
per patient).
This project will for the first time determine how effective PTNS is in the treatment of
patients with faecal incontinence, by comparing it to sham (fake stimulation). This study is
a properly designed clinical trial of 212 patients in at least 14 UK Specialist Centres..
The results of this trial will lead to direct benefits for patients and the NHS.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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