Advice
Evidence review
Evidence review
Clinical and technical evidence
Regulatory bodies
A search of the Medicines and Healthcare Products Regulatory Agency website revealed no manufacturer Field Safety Notices or Medical Device Alerts for the Secca System or Secca Therapy procedure.
A search for 'Secca' on the US Food and Drug Administration (FDA) database: Manufacturer and User Device Facility Experience (MAUDE) identified 2 records (both dated September 2011). Both records were reports of injuries, which included known complications: pain, bleeding, fistula, thermal mucosal injury with infection and necrosis.
Clinical evidence
A systematic literature search identified 10 studies reporting the use of the Secca System. This included 9 prospective single-arm studies and 1 retrospective review of medical records.
A retrospective study (Abbas et al. 2012) was excluded from this briefing because it was of lower quality evidence. Eight of the 9 identified prospective studies have been reviewed before and are summarised in the overview of NICE interventional procedure guidance on endoscopic radiofrequency therapy of the anal sphincter for faecal incontinence. The guidance states that the evidence on endoscopic radiofrequency therapy of the anal sphincter for faecal incontinence raises no major safety concerns. It also states that there is evidence of efficacy in the short term, but in a limited number of patients, and recommends that this procedure should only be used with special arrangements for clinical governance, consent and audit or research. Only 1 study has been published since the guidance (Lam et al. 2014), which included the follow‑up of a cohort included in an earlier published study by Felt-Bersma et al. (2007).
A single-centre study by Felt-Bersma et al. (2007) was carried out in the Netherlands. It included 11 patients and reported outcomes up to 1 year after Secca Therapy. The study showed significant improvement in the Vaizey faecal incontinence score at 3 months after Secca Therapy compared with baseline, lasting 'after 6 and 12 months' (as stated in the paper). This study showed no significant change in physiological measurements at 3 months. One patient (9%) reported moderate discomfort during RF delivery.
The single centre study by Lam et al. (2014), conducted in the same setting, included 31 patients (the original 11 patients reported by Felt-Bersma et al. [2007] and an additional 20 patients) and reported outcomes 3 years after Secca Therapy. This study showed significant improvement in the Vaizey faecal incontinence score at 6 months after Secca Therapy (compared with baseline), with no significant improvement in the score at 1 and 3 years. Significant improvement in the Faecal Incontinence Quality of Life (FIQL) Scale coping subscore was seen at 6 months (compared with baseline) but not in the lifestyle, depression or embarrassment subscores. A stable increase in FIQL was seen at 1 and 3 years after Secca, but this was not deemed to be a statistically significant improvement. The study showed no significant difference in anorectal function between patients with and without a clinical response – defined as patients with a decrease in Vaizey score greater or equal to 20% – at 6 months after Secca Therapy. Reported complications included minor bleeding or haematoma, antibiotic-associated diarrhoea, urinary tract infection, and mucosal discharge. An overview and summary of the results of the Lam et al. (2014) study can be found in table 1 and table 2 of the appendix.
Costs and resource consequences
Secca Therapy would be an additional minimally invasive treatment option in people for whom conservative management options have failed, and would incur NHS costs and resources. The additional costs could be offset if Secca Therapy resulted in a reduction in the number of hospital visits, medications prescribed, or the number of subsequent surgical interventions needed to control faecal incontinence symptoms. No published evidence on resource consequences was found.
Strengths and limitations of the evidence
Only 1 study, including 31 patients, has been published since NICE's interventional procedure guidance on endoscopic radiofrequency therapy of the anal sphincter for faecal incontinence. This was a 3‑year follow‑up of an original study (of 11 patients) which was previously reviewed in the production of the guidance.
The Lam et al. (2014) study reported outcomes at baseline and 6 months, 1 year and 3 years after Secca Therapy. This study reported that the minority of patients noted a clinically significant response and that the response was of a temporary nature. However, this study failed to apply appropriate repeated measures statistics when monitoring changes in the Vaizey faecal incontinence score and the FIQL in the same cohort of patients over time. The authors did state that none of the 31 patients had any additional surgical intervention after Secca Therapy, however they failed to report the use of protective pads and medications before and after Secca Therapy. This study was set in the Netherlands, which may further limit the generalisability of the study findings if Secca Therapy was applied in a UK setting.
There is a lack of comparative data showing the advantages of Secca Therapy over other minimally invasive or surgical treatment options, or when the placebo effect is accounted for. Although multiple published papers (Hull 2007; Felt-Bersma 2014; Parisien and Corman 2005) mention an ongoing randomised sham controlled trial, the authors of this briefing have been unable to identify any published results from comparative studies or any ongoing trials using Secca Therapy.