2 The procedure
2.1.1 Faecal incontinence occurs when a person loses the ability to control their anal sphincter and bowel movements, resulting in leakage of faeces. Causes include neurological disease and perineal injury during vaginal delivery (a relatively common cause in women).
2.1.2 First-line treatment is conservative, with measures such as dietary management or antidiarrhoeal medication. If these are not successful, pelvic floor muscle or anal sphincter training (sometimes including biofeedback therapy) may be used.
2.1.3 If conservative treatments have been unsuccessful, surgical options include sphincter repair, sacral nerve stimulation, stimulated graciloplasty (creation of a new sphincter from other suitable muscles), anorectal or transabdominal implantation of an artificial anal sphincter, or permanent colostomy.
2.2.1 The aim of endoscopic radiofrequency therapy of the anal sphincter for faecal incontinence is to cause a degree of fibrosis, so tightening the ring of muscle that forms the sphincter. It is intended to be less invasive than alternative surgical treatments.
2.2.2 The procedure is usually done with the patient under sedation and local anaesthesia. Under direct visualisation, a specially designed transparent catheter which houses needle electrodes is inserted into the anus. The needle electrodes deliver heat generated by radiofrequency energy to the anal sphincter muscle under temperature feedback control via temperature sensors. Radiofrequency energy is typically applied to each quadrant sequentially, starting at about the level of the dentate line and repeating this at 3 to 5 levels approximately 1 cm apart. Chilled water is used to cool the mucosa.
Sections 2.3 and 2.4 describe efficacy and safety outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the overview, available at www.nice.org.uk/guidance/IP/878/overview
2.3.1 A case series of 50 patients reported improved mean scores in all components of the Fecal Incontinence Quality of Life (FIQL) questionnaire (29 questions on lifestyle, coping, depression, and embarrassment, scored from 1 to 4; higher score indicates better quality of life) from baseline to 6-month follow-up (per protocol analysis: lifestyle, 2.5 to 3.1; coping, 1.9 to 2.4; depression, 2.8 to 3.3; and embarrassment, 1.9 to 2.5; p ≤ 0.0001 for each). A case series of 19 patients reported a significant improvement in mean scores in all components of the FIQL questionnaire from baseline to 5-year follow-up (lifestyle, 2.43 to 3.16, p < 0.00075; coping, 1.73 to 2.6, p < 0.00083; depression, 2.24 to 3.15, p < 0.0002; and embarrassment, 1.56 to 2.51, p < 0.0003).
2.3.2 The case series of 50 patients reported no differences in resting or squeeze pressure, rectal sensation, pudendal nerve motor latency, or sphincter defects on endoanal ultrasound at 6-month follow-up.
2.3.3 The Specialist Advisers listed key efficacy outcomes as improvement in faecal continence and improved quality of life.
2.4.1 The case series of 50 patients reported mucosal ulceration in 2 patients, 2–3 weeks after treatment. In 1 patient this was superficial and settled with local care: continence was improved. In the other patient the ulceration did not involve the underlying muscle but nevertheless caused anal pain: continence was worse at 6-month follow-up.
2.4.2 The case series of 50 patients reported constipation in 2% (1/50) of patients (treatment and outcome not described).
2.4.3 The case series of 50 and 19 patients reported secondary haemorrhage in 2% (1/50) and 32% (6/19) of patients respectively. Both required suture ligation to control the bleeding (not otherwise described).
2.4.4 The case series of 50 patients reported postoperative anal pain in 10% (5/50) of patients.
2.4.5 The case series of 24 patients reported constipation and diarrhoea in 1 patient each. The first patient was treated with laxatives, and the diarrhoea in the second patient resolved spontaneously.
2.4.6 The Specialist Advisers listed anecdotal adverse events to include haemorrhage (acute or secondary) and anal stenosis.