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Friday 18th January 2013

TPFS Response to National Commissioning Board re Faecal Incontinence & SNS

SSC Consultation Process
NHS Commissioning Board 18/01/13

Response on behalf of The Pelvic Floor Society to the National Commissioning Board in regards to complex interventions for Faecal incontinence and commissioning of SNS services.

1. Complex intervention for FI

National/Local context and evidence base
• Your estimated prevalence of faecal incontinence is way off the mark.

Epidemiological studies suggest a prevalence ranging between 1-10%. This variation is due to a lack of a coherent definition for faecal incontinence, under-reporting by patients and differences in gender, age, health status and place of residence between cross-sectional studies. The actual rate is likely to be 2-3% of the adult population increasing to 5.5% in post-partum females.

(Nelson et al. Gastroenterology 2004; 126:S3-7, Nelson et al. JAMA 1995;274:559-61, Kalantar Med J Aust 2002;176:54-7, Chaliha et al. Obstet Gynecol 1999;94:689-94).

In the elderly, immobile and institutionalized the rate maybe as high as 50%.

• The number of patients referred for behaviour and surgical treatment of faecal incontinence has increased dramatically as patients and GPs alike have become aware of the Rx options available.
• First-line treatment options are optimization of pharmacological and behavioural therapy (biofeedback).
• Rectal irrigation and anal plugs are successful and tolerated in only a small number of patients and in reality are useless.
• Most of these treatments are commenced after referral to a specialist with an interest in faecal incontinence and pelvic floor disorders, and after having excluded prolapse/internal rectal intussusception as a cause.
• Continence clinics can only provide some of these services in the primary care setting.

MDT review
• For patients with 'simple' idiopathic faecal incontinence with no urological/sexual dysfunction where the treatment algorithm is clear, discussion at an MDT is unlikely to offer any additional benefit and only delay therapy. It is also very costly.
• MDTs should be reserved for patients in whom the optimal treatment is unclear e.g., patients with mixed constipation/incontinence, patients with incontinence secondary to recto-anal intussusception / prolapse, patients that have co-existing urological or sexual dysfunctions and that small group with psychosocial issues identified during the initial consultation or during bipfeedback therapy.
• Urogynaecologists have little if anything to offer these groups of patients.
• Radiologists and proctography is mentioned as been essential for the MDT yet you make NO mention of the fact that what we are looking for is internal prolapse, enterocele, sigmoidocele etc which are amenable to surgical Rx i.e., laparoscopic ventral mesh rectopexy, STARR.
• The requirement for every patient to have a physiological assessment and behavioural therapy is time consuming leading to waits approaching 1 year. It is also VERY expensive. It adds nothing to the management of a patient with prolapse.
• All patients with potential psychosocial issues should be discussed within the MDT prior to any surgical intervention.
• Although there is little long term data demonstrating maintained success from biofeedback therapy in the presence of untreated anatomical defects, behavioural therapists should form part of the MDT as they can add valuable information in regards to symptoms, progress with non-operative treatments and psychological conditions.
• Surgery has a major role in patients with faecal incontinence secondary to prolapse (the largest cohort of patients). Ventral mesh rectopexy has been consistently shown to resolve faecal incontinence in approx 90-95% of patients. These results have been maintained for 5years. The results are consistent in all reports. This surgery is very safe in the elderly.
• STARR is also effective in dealing with selected patients with incontinence secondary to internal intussusception but without “middle compartment prolapse”.
• Some patients with post defaecatory soiling benefit from haemorrhoidal Rx eg., THD, PPH.
• These surgical interventions are SIGNIFICANTLY CHEAPER than the pathways suggested in the report

Acceptance and Exclusion Criteria

• The specification criteria state that PTNS and biofeedback should have both been tried prior to referral for surgical treatments for faecal incontinence.
• This is a complete nonsense and contradicts NICE guidelines, which state that PTNS should only be carried out in units specialising in the assessment and treatment of faecal incontinence, as one of the treatment options.
• Biofeedback services are also normally only accessible through a designated pelvic floor service.
• Posterior tibial nerve stimulation (PTNS) is administered mainly at present only in the context of clinical trials. Such a trial examining the hypothesis that it is ONLY WORKING AS A PLACEBO has only just started to recruit!
• NICE guidelines state that the procedure should be used only with special arrangements for clinical governance, consent, audit and research.
• The current evidence for PTNS is confined to small number of un-controlled cohort studies using only small numbers of patients and are of poor quality. Some report on percutaneous stimulation (using needle electrodes) and others report on transcutaneous stimulation (using adhesive electrodes). Two report on the use of PTNS in patients with inflammatory bowel disease and spinal injury. Comparison between studies is difficult to make due to differences in the method used to define and quantify incontinence, disparity in the length of treatment and the stimulation regimes used and variation in the populations studied. Only very short-term results have been reported. The long-term benefits of PTNS are unclear!
• Some studies have claimed that PTNS is a cheaper alternative to SNS however no randomized trial or cost-effectiveness analysis has been performed comparing the two.
• The efficacy of PTNS may not be comparable to SNS.
• PTNS cannot be used to predict whether a patient will respond to SNS. Crude estimation of direct medical costs associated with both procedures in the initial year of treatment is often quoted. This understandably comes out in favour of PTNS due to the high initial cost associated with SNS devices. However, unless clinical effectiveness and a longer treatment time are considered, and non-medical and indirect costs are included in a properly conducted economic analysis, this is purely an assumption that has no scientific or economic basis. A national multi-centre trial is currently being performed that should able to evaluate more robustly the clinical outcomes of PTNS. PTNS may only be working as a placebo
• Until further evidence supporting the use of PTNS exists and the cost-effectiveness evaluated, its current use in the treatment algorithm of faecal incontinence should not be endorsed.
• PTNS should be offered as a specialist service within a designated tertiary referral pelvic floor unit and not at this stage be performed in the context of primary or secondary care.
• PTNS should not be a required pre-requisite for patients to undergo prior to consideration of sacral nerve stimulation or other surgical treatments.
• PTNS is expensive and time consuming

Related services

Why is the secondary care cancer centre responsible for longer-term follow-up?

2. Clinical Commissioning Policy: Sacral nerve stimulation for faecal incontinence in adults.

Patient pathway

• Few GPs have experience in the treatment of faecal incontinence and at present refer patients for exclusion of malignancy as TWW. Few patients are referred direct for assessment and access to non-surgical treatments e.g., behavioural therapy.
• Pelvic floor physiotherapy does not equate to behavioural therapy (+/- biofeedback).
• Behavioural therapy service should be provided only by specialist accredited trained therapists.
• There is NO definition of what constitutes behavioural therapy and biofeedback. It is different in each centre. The Pelvic Floor Society has audited what each centre means by these terms and will produce a consensus statement later in the year,

• The Australian Government HTA review of adverse events reported on the available literature in 2005. This review, and the systematic reviews by Jarrett et al. (2004) and Frazer et al. (2004), included patients that had undergone therapy prior to 2003 when an open technique was employed to implant the the permanent lead. Percutaneous lead insertion only became available in 2003.
• The open technique was associated with higher complication rate, including infection, than that seen in current practice with the percutaneous lead placement.
• Some centres in the early clinical trials did not comply with device manufacturers advice and left a staged percutaneous wire in situ for greater than the recommended maximum three-week period.
• Most large series post-2003 report an infection rate of less than 2%.
• Lead migration/dislocation is often cited as a cause for failure however in most cases is virtually impossible to prove this due to difficulty in replicating true lateral sacral x-rays on separate occasions due to differences in angulation and projection of the x-ray tube. Unless significant lead dislocation had taken place (2.1% in one study of 235 patients (Deng et al. J Urol 2006; 175:2182-5)) then a response to stimulation should still be obtainable by widening the stimulation field or applying monopolar stimulation using the implant as the anode.

Cost effectiveness
• PNE (percutanous nerve evaluation) and insertion of temporary stimulation wire under local anaesthetic lowers direct medical costs.
• Positive outcomes from SNS are dependent on achieving low amplitude sensory or motor response during acute testing (Dudding et al. Colorectal Dis. 2008;10:249-56).
• There are no RCTs that have studied local versus general anaesthetic for SNS.
• Up to 30% of patients are unable to localise the sensory response to stimulation and their outcomes when their SNS has been performed under local anaesthetic may not be as effective as those performed under GA. The opposite can also be seen in the small group of patients where a motor response is not observed. These patients may benefit from a repeat PNE under local anaesthetic.

Direct cost estimated for England

• The suggested follow-up is that of a RCT. In clinical practice the suggested follow- up intensity is only required in a minority.
• The 'new' iCon programmer allows the programming of 4 different settings so that the patient can change the parameters of stimulation at home without the need to re-attend hospital frequently for optimization of treatment. In one study, 25% of patients never required a programme change from their initial settings (Govaert et al. Colorectal Dis. 2011; 13:78-81).
• In current practice, after an initial visit for programming, follow-up can be provided as a patient-led service with access to a specialist nurse who can advise on the phone whether the patient needs to return to the hospital for re-programming or treatment of any adverse effects of stimulation.

In summary, whilst The Pelvic Floor Society welcomes this project we are surprised at the conclusions. We are also surprised that there was no mention of constipation or ODS (obstructed defecation) which often coexists with faecal incontinence. We should be very happy to help develop a more robust report which will have utility in the real world that we work in.

Yours sincerely

Mr AR Dixon
`on behalf of The Pelvic Floor Society