Extrait

Background and study aims Faecal incontinence is the inability to control bowel movement, causing leakage of bowel contents from the back passage. It affects between 1-10% of adults, with 0.5-1% experiencing regular faecal incontinence episodes that affect their quality of life. It is more common in women and with advancing age. This study aims to manage and improve adult faecal incontinence by stimulating the pudendal nerve which controls the anal sphincter (back passage). Who can participate? Patients aged 18 or over who have experienced moderate to severe symptoms of faecal incontinence for more than 6 months and have not responded to conservative treatments What does the study involve? The procedure involves placing an electrode (thin wire) on to the pudendal nerve laparoscopically (keyhole surgery) under general anaesthesia. The wire is then connected to a small temporary battery taped to the lower back of the participant. Regular and gentle electrical pulses are passed along the wire from the battery to stimulate the nerve. During the test period of 2 weeks, the effectiveness of the procedure is measured using a specially designed questionnaire to assess faecal incontinence and quality of life. What are the possible benefits and risks of participating? This procedure aims to improve the symptoms of faecal incontinence and quality of life. It provides an alternative option for those patients who have failed to improve with conservative management and SNS (currently the preferred and approved surgical management of faecal incontinence). General complications include: heart and lung complications, temporary urinary retention (inability to pass urine), and deep vein thrombosis (blood clots). Complications related to the general anaesthetic include: wound infection and haematoma (collection of blood), haemorrhage (bleeding more than anticipated), failure of surgical equipment, and injury to other organs in the pelvis. Device-related complications include: failed implant procedure, wound infection, electrode (lead) dislodgement, lead migration/fragmentation (movement of lead), neurological pains in the legs, perineum and vagina, pain at the battery site due to non-infective cause such as battery rotation, and lack or loss of effectiveness (reduced or lost response after operation). Where is the study run from? St James's University Hospital (UK) When is the study starting and how long is it expected to run for? September 2016 to September 2017 Who is funding the study? Investigator initiated and funded Who is the main contact? Mr Ibrahim Eltilib [email protected]

Critère d'inclusion

• Faecal incontinence

Liens

• ictrp
• isrctn