Faecal incontinence in adults - Emerging treatments

SECCA radiofrequency energy delivery to the anal canal muscle

The SECCA® procedure consists of delivery of temperature-controlled radiofrequency energy to the anal sphincters. This heat causes collagen contraction, healing, and remodelling, leading to shorter and tighter muscle fibres.[87] A multi-centre trial of 50 patients showed the procedure was safe and improved continence at 6 months after treatment.[87][88] This treatment may be a further minimally invasive option in the armamentarium for patients with severe incontinence who have not responded to more conservative treatment options. The 5-year follow-up of 19 patients has demonstrated a >50% sustained improvement in symptoms and quality of life following SECCA® therapy.[89] However, another randomised sham-controlled trial, while showing a statistically significant benefit of radiofrequency over sham, suggested the clinical impact was negligible. Further research into patient-related predictors of success are required before recommending the procedure as an accepted part of the treatment algorithm.[90]

Tibial nerve stimulation

The posterior tibial nerve arises from the sacral plexus. Percutaneous stimulation at the ankle may produce a similar effect to conventional sacral nerve stimulation without the need for an expensive implanted generator. It is also possible to stimulate transcutaneously.[91] Several studies have been performed that suggest significant improvements in some outcome measures.[92][93][94][95] However, one high-quality trial failed to show any improvement in incontinence compared with sham stimulation, and another suggested only a small benefit.[96][97] Subgroups of patients, such as those with an element of obstructed defecation, may benefit more than others.[98] For the moment, tibial nerve stimulation cannot be recommended based on available evidence. The treatment is labour intensive, requiring multiple treatment episodes, and with the potential need for additional top-up therapy. Transcutaneous stimulation is logistically easier with the patient able to apply the pads with minimal instruction and without the need for hospital attendance. However, the results in terms of outcome are also disappointing.[91]

Novel artificial sphincters

Various designs for artificial sphincters have been developed in an attempt to reduce potential complications and increase efficacy. One such device incorporates a row of magnets. The simple design may reduce the incidence of device failure and even infection, although around 20% of patients still undergo device explantation within 1 year of insertion.[99] Further research is awaited, but may be inhibited by current withdrawal of device manufacture for commercial reasons.[100]

Stem cell injections

Autologous myoblast injection of muscle cells placed directly into the external anal sphincter has been investigated. A pilot study of 10 patients showed promising results, and a subsequent phase 2 trial has suggested clinical benefit over placebo in 24 patients at 12 months.[101][102]

Novel anal plugs and vaginal balloons

Anal plugs are poorly tolerated; however, new designs that are better tolerated have been developed and are being tested. The US Food and Drug Administration (FDA) has approved the use of a vaginal balloon that, when inflated, puts pressure on the rectum, thereby reducing incontinent episodes.[103]

Pharmacotherapy

There is limited evidence to suggest that drugs used to enhance sphincter tone such as phenylephrine and sodium valproate may be helpful in patients with incontinence and an intact sphincter complex.[104] Clonidine can reduce rectal sensation and urgency; however, results are inconclusive.[105]