Extrait

Background and study aims 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, 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. In the last 10 years, SNS has been shown 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 two operations, with potential complications and expensive equipment. PTNS is a simpler method in which a nerve is electrically stimulated under the skin by a very small needle at the ankle (a bit like acupuncture). This sends signals back to the spine region to try and achieve the same effect as SNS. 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. The aim of this study is to determine the effectiveness of PTNS in the treatment of patients with faecal incontinence. Who can participate? Patients over the age of 18 who have faecal incontinence symptoms sufficiently severe to receive the treatment being studied. Patients who have suffered anal sphincter injury are also invited to participate as well as patients who have failed appropriate conservative therapies are also allowed to participate. What does the study involve? Participants will be randomly allocated to undergo either treatment with PTNS or have ‘fake’ stimulation (placebo). Treatment will involve attending the hospital or surgery for a 30-minute treatment each week for 12 weeks, as well as an appointment before the treatment commences to discuss the therapy, and an appointment afterwards to evaluate the success of the therapy. What are the possible benefits and risks of participating? This treatment may be successful at treating your incontinence problem. There are no serious side effects to the treatment. Where is the study run from? The study will take place primarily at the Royal London Hospital and 15 other centres in the UK. When is study starting and how long is it expected to run for? The study will commence in October 2011 and will last for 2 years. Each patient will only be involved for 4 months. Who is funding the study? The study is being funded by the National Institute for Health Research, which is a government funding body for the NHS. Who is the main contact? Miss Emma Horrocks (Academic Clinical Fellow) [email protected]

Critère d'inclusion

• Faecal incontinence

Liens

• ictrp
• isrctn