Advice

Technology overview

Technology overview

This briefing describes the regulated use of the technology for the indication specified, in the setting described, and with any other specific equipment referred to. It is the responsibility of healthcare professionals to check the regulatory status of any intended use of the technology in other indications and settings.

About the technology

CE marking

The Secca System, originally developed by Curon Medical in 2002, was acquired by Mederi Therapeutics in 2008. The single-use Secca handpiece and reusable radiofrequency (RF) generator (both class IIb) were first CE marked to Mederi Therapeutics in November 2009. Current certification was issued to Mederi Therapeutics in April 2015 and is valid until November 2019. The Secca System is supplied by CJ Medical in the UK.

Description

The Secca System delivers temperature-controlled thermal energy, generated by an RF source, into the internal anal sphincter muscle from a probe placed in the anal canal (known as Secca Therapy). The manufacturer claims that treatment is non-ablative (that is, it does not remove or destroy tissue).

The Secca System consists of a reusable, pole-mounted 4 channel RF generator and a sterile, single-use RF delivery handpiece. A single-use, gel-type patient return electrode completes the RF circuit. The generator has an integrated irrigation pump to cool the mucosal tissue during therapy and a colour display to guide the user through equipment setup and the treatment procedure. The handpiece consists of a transparent anoscopic probe and 4 expandable needle electrodes, which are spaced 22.5° apart in a line around the barrel of the probe. Electrode tip and surface tissue temperatures are measured by thermocouples in the tip and base of the electrode respectively. Energy delivery is controlled by the operator through a trigger and release button, both located on the handpiece.

The probe is inserted into the anal canal until a marker on the probe is aligned with the anatomical dentate line, which acts as a reference point for starting the therapy. The manufacturer recommends that Secca Therapy is done with the anal canal being divided into 4 sections or quadrants. Five evenly spaced levels are treated within each quadrant, with each treatment level spaced 5 mm apart. When the handpiece trigger is pressed, the needle electrodes expand and push through the anal wall into the internal anal sphincter muscle. Low power (up to 8 watts), temperature controlled (65°C and 85°C) RF energy is delivered for 1 minute at each treatment level. The needle electrodes are then retracted using the needle release button on the handpiece. When all 5 levels have been treated within a quadrant, the handpiece is rotated through 90° and treatment starts in the next quadrant (Efron 2004). The procedure is complete when all 4 quadrants have been treated, resulting in 80 separate treatment sites in total.

Setting and intended use

According to the NICE guidance on endoscopic radiofrequency therapy of the anal sphincter for faecal incontinence, the procedure is usually done in secondary care endoscopy units that specialise in assessing and treating faecal incontinence. The procedure typically takes less than 1 hour to complete and is done under general anaesthesia as a day case or under local anaesthesia and sedation in an outpatient setting (according to patient or centre preference), by colorectal surgeons specifically trained to use the Secca System. People typically return to normal activity within 1 to 3 days. Contraindications to Secca therapy are listed on the company website. Secca therapy is only done as a single procedure and, in UK practice, is not repeated if the initial procedure does not work.

The Secca System is intended as a minimally invasive surgical option for treating faecal incontinence in adults:

  • who have incontinence of solid or liquid stool at least once a week, and

  • whose condition has not responded to conservative options, such as dietary changes, physiotherapy and medication.

Current NHS options

NICE guidance on managing faecal incontinence in adults recommends starting with conservative methods (including dietary changes, addressing bowel habits, and medication), and specialised conservative methods (such as pelvic floor training, bowel retraining, specialist dietary assessment, biofeedback, electrical stimulation and rectal irrigation). If faecal incontinence continues after conservative management, specialist assessments (such as endoanal ultrasound, anorectal physiology studies and proctography) are considered with the aim of treating the condition using minimally invasive or surgical options. Minimally invasive treatments include sacral nerve stimulation and injectable bulking agents. Surgical treatments include anal sphincteroplasty (which repairs or creates a new sphincter from adjacent skeletal muscle), graciloplasty (which creates a new sphincter from gracilis muscle from the thigh), implantation of an artificial anal sphincter or bowel device, or permanent colostomy.

NICE is not aware of any other CE‑marked devices that have a similar function to the Secca System.

Costs and use of the technology

Mederi Therapeutics has provided the following list prices (excluding VAT) for each component of the Secca System:

  • Handpiece: £1,495 (single use, 1 per patient procedure).

  • RF generator: £25,000 (re-usable).

In addition, 1 patient return electrode (costing £4.04) is needed for each procedure. The single-use Secca handpiece has been validated for a 3‑year shelf life. The Secca RF generator, which comes with a 12 month warranty, has an anticipated lifespan of 5 years (or 1,000 uses). Free training on using the Secca System is provided, and includes web-based, hands-on, and supervised training during the first 6 procedures. The manufacturer recommends annual maintenance for the Secca System, which includes safety testing and checking RF output level.

No information on the costs of alternative minimally invasive treatment options (for example, sacral nerve stimulation and injectable bulking agents) was identified in the public domain.

Likely place in therapy

Secca Therapy is a minimally invasive treatment option available for people with incontinence of solid or liquid stool at least once a week, in whom conservative management options have not controlled symptoms.

Specialist commentator comments

One specialist commentator stated that the Secca Therapy procedure is easy to learn and straightforward to use in practice. They also noted that Secca Therapy may prevent the need for more invasive treatments. Two specialist commentators stated that the procedure is better tolerated as a day case procedure under a short general anaesthetic rather than under local anaesthesia with sedation.

One specialist commentator noted that the mechanism of action is uncertain, but it can result in subjective and objective improvements in quality of life for people with faecal incontinence when conservative measures have failed. Another specialist commentator stated that the mechanism of action proven in animal models is a combination of fibrosis and myelofibroblast stimulation to bulk internal sphincter muscle.

One specialist commentator stated that the published evidence on Secca Therapy did not differentiate between the type of faecal incontinence (that is, urge or passive). The specialist commentator noted that sacral nerve stimulation was now considered the standard for persistent urge incontinence after conservative treatment, but it has little efficacy in passive incontinence. Due to the lack of comparative data, the specialist commentator felt there was no evidence to justify Secca Therapy over sacral nerve stimulation. One specialist commentator stated that the reported complications of Secca Therapy are few and not major, and felt a failed Secca Therapy procedure would not preclude other therapies or interventions.

One specialist commentator noted that Secca Therapy is not widely used. However both this commentator and another suggested that the indications for using Secca Therapy could be widened. The first of these specialist commentators suggested it could be used to treat passive incontinence when conservative treatment, such as biofeedback, has failed and anal bulking agents, artificial sphincter insertion, or sphincter repair are being considered. They also suggested that Secca Therapy could be used for urge or mixed incontinence when sacral nerve stimulation is unsuitable or sphincter repair or an artificial sphincter is inappropriate, or after failure of sacral nerve stimulation or sphincter repair. One specialist commentator suggested that Secca Therapy may be more effective in the early treatment of faecal incontinence, rather than in treating end-stage faecal incontinence.

One specialist commentator acted as a specialist adviser to the Interventional Procedures Advisory Committee in the production of NICE's interventional procedure guidance on endoscopic radiofrequency therapy of the anal sphincter for faecal incontinence.

Equality considerations

NICE is committed to promoting equality, eliminating unlawful discrimination and fostering good relations between people with particular protected characteristics and others. In producing guidance and advice, NICE aims to comply fully with all legal obligations to:

  • promote race and disability equality and equality of opportunity between men and women

  • eliminate unlawful discrimination on grounds of race, disability, age, sex, gender reassignment, marriage and civil partnership, pregnancy and maternity (including women post-delivery), sexual orientation, and religion or belief (these are protected characteristics under the Equality Act 2010).

Faecal incontinence is more common in older people and in women (NHS Choices 2016). Age and sex are protected characteristics under the Equality Act 2010.