Advice

Summary

Summary

The Secca System is a device that is used to apply radiofrequency energy to the internal anal sphincter muscle in the anal canal (known as Secca Therapy) to treat faecal incontinence. The available evidence, which is of limited quality, quantity and generalisability, shows short‑term improvements in both faecal incontinence and quality of life, with no significant improvements in the relevant patient-reported scores in the medium and long term (1 and 3 years). The single-use Secca handpiece costs £1,495 and the reusable radiofrequency controller costs £25,000 (both excluding VAT).

Product summary and likely place in therapy

  • The Secca System uses thermal energy generated by a radiofrequency (RF) source to treat faecal incontinence in a minimally invasive procedure (known as Secca Therapy).

  • It is intended for use in people with incontinence of solid or liquid stool at least once a week, whose condition has not responded to conservative management options.

  • NICE interventional procedure guidance on endoscopic radiofrequency therapy of the anal sphincter for faecal incontinence recommends that the procedure is only carried out in units specialising in assessing and treating faecal incontinence, as one of a range of treatment options, and that further research is done on the procedure.

Effectiveness and safety

  • Only 1 relevant study, a follow‑up to a study published in 2007, has been published since the development of NICE's interventional procedure guidance on endoscopic radiofrequency therapy of the anal sphincter for faecal incontinence.

  • This study, which included 31 patients, showed that Secca Therapy resulted in significant improvements in the Vaizey faecal incontinence score and the Faecal Incontinence Quality of Life coping subscore at 6 months when compared with baseline. No significant improvements were found 1 year and 3 years after treatment.

Technical and patient factors

  • The Secca System consists of a sterile, single-use handpiece and a reusable RF controller. The handpiece includes 4 expandable needle electrodes, which deliver temperature-controlled thermal energy from a RF source to the internal anal sphincter muscle in the anal canal.

  • Secca Therapy would be done in adults under general anaesthesia as a day case or using local anaesthesia and sedation in an outpatient setting (according to patient and centre preference), by colorectal surgeons trained to use the Secca System.

  • Treatment takes less than 1 hour.

Cost and resource use

  • The Secca System costs £1,495 for the single-use handpiece and £25,000 for the reusable RF generator, excluding VAT.

  • No published evidence on resource consequences was found.