Transanal irrigation systems for neurogenic bowel dysfunction, chronic constipation, and chronic faecal incontinence

Transcription

1 Transanal irrigation systems for neurogenic bowel dysfunction, chronic constipation, and chronic faecal incontinence Lead author: Hayley Johnson Regional Drug & Therapeutics Centre (Newcastle) March

2 Summary Transanal irrigation (TAI, also known as rectal irrigation) refers to the introduction of water (or other solution) into the rectum and left colon, via the anus. Chronic constipation is a common problem, affecting approximately 14% of the global population. Causative factors can be complex and varied. Faecal incontinence affects 3.1 men and 3.6 women per 100, 000 person years. It can be caused by a variety of conditions. It is most commonly a result of chronic faecal loading or impaction. Neurogenic bowel dysfunction occurs due to an interruption in communication between the spinal cord and bowel. Causes can be varied, including spinal cord injury, multiple sclerosis, spina bifida, and Parkinson s Disease. It can result in either chronic constipation, faecal incontinence, or both. NICE states that TAI, as a component of a specialist continence service, could be recommended as an option for people with faecal incontinence unresponsive to initial management. There is a reasonable volume of evidence for TAI in neurogenic bowel dysfunction, though the majority of it is of low quality (e.g. non-randomised studies, no control groups, short follow up, few patients) There is no evidence which directly compares TAI with other bowel management methods

3 Costs vary depending on the type of system used and frequency of use. Costs for one year s treatment vary between and There is little robust evidence to indicate how many patients per year would benefit from TAI, but overall patient numbers are likely to be small.

4 Introduction and background Chronic constipation is a common problem, affecting about 14% of the global population. It can be caused by a wide variety of factors, and is often multifactorial. 1 Diet, immobility, disease, injury, drugs, and psychological/ behavioural factors can all contribute. It may also be idiopathic. 2 It can be associated with a dramatic decrease in quality of life, affecting both physical and mental health. 3 Chronic constipation can lead to impaction of large, dry, hard stools, which weaken the rectum and lead to intestinal stretching. Watery stools from higher up the digestive tract can leak around the impaction, causing leakage and an inability to control bowel movements. This is known as faecal incontinence. 4 It affects 3.1 to 3.6 men and women aged 60 to 89 per 100,000 person. It is an extremely common occurrence in neurological conditions such as spina bifida or Hirschprung s disease. 5 Faecal incontinence can have a large emotional and social impact. Neurogenic bowel dysfunction (NBD) occurs due to an interruption in communication between the spinal cord and bowel. Symptoms, which include chronic constipation and faecal incontinence, are similar regardless of the neurogenic cause. Spina bifida, spinal cord injury, multiple sclerosis, and Parkinson s Disease can all result in NBD. In an ideal world, treatment of chronic constipation involves identifying and eliminating the causes. However, this can be difficult and impractical, particularly where causes are multi-factorial or irreversible. A stepwise treatment approach is usually recommended, beginning with behavioural or lifestyle changes. Pharmacological and minimally invasive management strategies should then be employed. Where these fail, more invasive methods, including surgery, may be considered. 1 Transanal irrigation (TAI, also known as rectal irrigation) is generally considered to be a minimally invasive process. 6 The term describes the introduction of water (or another solution) into the rectum and left colon, via the anus. The fluid stimulates peristalsis, resulting in retained stools and the irrigation fluid being passed out within minutes. TAI is therefore purported to be of value is relief of chronic constipation or faecal incontinence, as well as prevention of faecal impaction through regular use. 7 A variety of TAI systems are available commercially. They are medical devices, and all are CE marked. Some use a manual pump whilst others are electronically controlled. Some have balloon catheters which allow the catheter to be self-retaining and facilitate ease of use. Others use a rectal cone, which needs to be held in place throughout the TAI process. Most products are designed for use over a toilet or commode, but one is specifically designed for bedridden patients. Components and features of the main systems available are summarised in table 1.

5 System Name Manufacturer Components Features Peristeen Coloplast Control unit with manual pump Water bag Rectal catheter Tubing Optional leg straps Qufora IrriSedo Mini Qufora IrriSedo Cone System Qufora IrriSedo Balloon System Qufora IrriSedo Bed System Aquaflush Aquaflush Compact Irypump S MacGregor Healthcare Ltd MacGregor Healthcare Ltd MacGregor Healthcare Ltd MacGregor Healthcare Ltd Aquaflush Medical Ltd Aquaflush Medical Ltd B. Braun Medical Ltd Manual pump Rectal cone Manual pump Water bag Rectal cone Tubing Control unit Manual pump Water bag Rectal catheter Tubing Optional leg straps Manual pump Water bag Rectal catheter Collection bag Tubing Manual pump Water bag Rectal cone Tubing Optional leg straps Manual pump Rectal cone Electronic pump Water tank Rectal cone Catheters are pre-coated with lubricant and are available in different sizes. Balloon catheter Water bag does not require hanging Suitable for small volume irrigations Rectal cone is selflubricating Suitable for one handed operation Water bag requires hanging Rectal cone is hydrophilic and self-lubricating Simple control unit operation Disposable catheters are available in different sizes. Water bag requires hanging Balloon catheter Closed system designed for use in patients unable to leave their bed Water bag requires hanging Catheters are available in different sizes. The water bag features an integral temperature strip Rectal cones have finger holes for easy gripping Water bag requires hanging Suitable for small volume irrigations Rectal cones have finger holes for easy gripping Suitable for one handed operation The electronic pump allows for adjustable flow rate

6 Tubing Optional colostomy accessories Table 1: features and components of TAI systems Reusable rectal cone Water tank does not require hanging Also suitable for colostomy irrigation Battery operated Clinical Evidence There is a reasonable volume of evidence assessing the efficacy of TAI, but the majority of it is of low quality. Robust randomised trials are difficult to design and undertake: given the invasive nature of TAI, adequate blinding is virtually impossible and placebo interventions would be problematic. There may also be ethical concerns, particularly where research is undertaken in children. To date, one randomised controlled trial has been undertaken. The rest of the available evidence consists of case series, outcome studies, or qualitative research. Systematic Reviews/ Meta-analyses The efficacy of TAI in managing faecal incontinence and constipation in adults with central neurological disease was assessed in a Cochrane Review. 8 The review included one small 10 week randomised trial trial (n=87), which had a small risk of bias. Participants used the Peristeen system either daily or every other day in addition to conservative bowel care, or conservative bowel care alone. Statistically significant improvements in constipation scores, NBD scores, and faecal incontinence scores was found in the TAI group versus conservative care. TAI also resulted in a significantly reduced time for bowel care and increased satisfaction. (See table 2). No other relevant studies were found and no trials compared TAI with other interventions. TAI Group Outcome (n) Mean scores (SD) Constipation Score (Cleveland Clinic) Neurogenic bowel dysfunction score Satisfaction with bowel care Conservative group (n) Mean scores Mean difference (SD) (95% CI) (4.4) (3.4) (-4.63, ) (6.8) (6.4) (-5.79, ) (3.5) (2.8) (-2.94, )

7 Faecal incontinence score (St. Marks) Total time for bowel care 42 5 (4.6) (4) (-4.12, ) (25) (59.9) (-49.84, ) (minutes) Table 2. Results from the Christensen randomised controlled trial, as reported in the Cochrane Review Another systematic review by Christensen et al included a total of 27 papers, including the same trial described above. 9 All other 26 studies were uncontrolled, with a high risk of bias. The pooled results included 1901 patients, ranging from 7 months to 90 years old with mainly neurogenic bowel dysfunction or mixed causes. Time of follow up was variable (4 to 30 months)and generally short in all included studies. Overall, successful treatment occurred in 1249 patients, but the details of what constituted success was not clear. The authors claim that the evidence suggests that TAI represents a feasible second line option for NBD treatment in both adults and children. Another review article included only papers with children or adolescents in them. It included many of the same trials as the Christensen review along with some further uncontrolled studies. 10 The authors concluded that TAI may be considered as a first line option for children and adolescents with neurogenic bowel, but that further evidence is required. The results of these reviews are difficult to interpret given the methodological flaws of the included evidence and the declared conflicts of interest in the Christensen review. Uncontrolled studies A variety of additional uncontrolled studies, not included in the above reviews, have been published. They are summarised in table 3.

8 Study name Ng et al, Population (median age, range [years]) Children (7, 3 to 16) Corbett et al, Children (6, 4 to 16) Marte et al, Children (10.5, 4 to 17) Pacilli et al, Children (7, ) Length of follow up (months, unless otherwise stated) 14 (median, range 3-78) 12 (median, range 2-48) N Bowel dysfunction cause Product investigated Results 42 Mixed Peristeen or Qufora 76% of patients remained compliant after one month. 84% of TAI adopters responded well to treatment Rintala score significantly improved with TAI use (6.7 ± 3.5 vs 11.2 ±4.8, p<0.001). Improvements were present in all aspects of scoring. Mean PedsQL scores were significantly improved with TAI (55.6±24.1 vs. 65.5±23.7, p<0.001) 24 Neurogenic Peristeen Median number of soiling incidents per week prior to TAI was 14, vs 1 with use, p< % (median) of bowel movements occurred in the toilet with TAI, compared to 20% prior to use (p<0.0001) Time attending to bowels was 35 minutes per day with TAI and 75 minutes without (p<0.0001) Median QoL score was significantly higher following TAI adoption (51.5 vs 40.5, p<0.0001) Neurogenic Peristeen GI transit time, as measured by the number of radiopaque markers showed a significant reduction following a TAI procedure (30±7.37 to 10.62±6.29, p=0.034) All patients who continued TAI were satisfied after 1.8 years Decrease in number of UTIs after TAI 24 (median, range 8-41) (25 vs 9) 23 Mixed Peristeen 70% of patients were completely clean and 13% reported significant improvement despite occasional soiling. 17% of patients were not satisfied and discontinued use Notes The methods and factors used to decide on device choice were not reported. The Rintala score is specific to faecal incontinence. The mean results described indicate a fair to good improvement in bowel habits. Results are not based on ITT, but instead only those who continued treatment. Retrospective case reviews Significant recall bias may be present Results are not based on ITT, but instead only those who continued treatment. Although significant differences were found for median figures, ranges overlapped for all outcomes. The QoL questionnaire used was specific to faecal incontinence/ constipation (FICQoL ). The clinical significance of the change is unknown. Radiopaque markers were taken on the three days prior to TAI. Abdominal X-rays were performed just prior to, and after a TAI procedure. Transit time results are limited to one TAI procedure. Other methods/ results not adequately reported. Retrospective case reviews Significant recall bias may be present No QoL outcomes Lack of objective rating scales Laxative use prior to TAI was 9%. Use after TAI was not reported.

9 Kim et al, Adults 6 52 Neurogenic Peristeen Compliance rates were 59.6% at 1 month, 48.1% at 3 months, and 34.7% at 6 months. Defecation time was significantly lower after TAI use (p=0.005) QoL score was significantly improved Choi et al, Children (5, ) Loftus et al, Adults (48, ) Preziosi et al, Adults (49, ) 4 (median, range 3 7 months) 53 Neurogenic Peristeen or an irrigation cone, depending on age after 6 months of TAI use (p=0.003) TAI was successful in 81% of the 47 participants who used it (median, range 3 28) 11 Neurogenic Peristeen Mean bowel function score (CCCDD) reduced by 7.55 (39.5%, p<0.001) Mean faecal incontinence score (St Marks ) reduced by 5.36 (41.5%, p<0.001) Mean Neurogenic Bowel Dysfunction score reduced by (42.1%, p<0.005) 6 weeks 30 Neurogenic Peristeen Wexner constipation score significantly improved compared to baseline (12 [ ] vs. 8 [4-12.5], p<0.001). Median change was 0 (-6 to 0) Wexner Incontinence score also appears significantly improved after treatment (12 [ ] vs. 4 [2-8] p<0.001). Median change was -3.5 (- 10 to 0) Table 3: Uncontrolled studies of TAI for bowel dysfunction Significant recall bias may be present Results are not based on ITT, but instead only those who continued treatment. There was a drop off in compliance rates and efficacy over time Results are not based on ITT, but instead only those who continued treatment. Success was defined as faecal continence or pseudo-continence. This study was aimed at evaluating the overall effects of a stepwise bowel management programme, of which TAI was a component. Significant recall bias may be present Results are not based on ITT, but instead only those who continued treatment. No QoL outcomes The clinical significance of changes in scores remains unknown. Although results are significant, the ranges overlap. Minus figures in the Wexner score indicate improvements SF-36 scores are not adequately reported No QoL outcomes The clinical significance of changes in scores remains unknown.

10 Summary of the clinical evidence The bulk of the available evidence consists of uncontrolled case series or retrospective case reviews. There is a large degree of heterogeneity between the studies. Populations, outcomes, follow up lengths, and methods differ widely, precluding any pooling of results. One randomised controlled trial which found statistically significant improvements in constipation, NBD, and faecal incontinence scores constitutes the best available evidence. The majority of available evidence utilises the Peristeen system. One study used either Peristeen or Qufora. No published evidence for either the Irypump S or Aquaflush systems has been identified. There is a lack of published information on use of TAI in adults, or in non-neurogenic chronic constipation or faecal incontinence. Some low quality evidence seems to suggest that patients with non-neurogenic causes may be less compliant.

11 Safety TAI is generally considered a safe procedure, providing users are adequately trained in its use. Discontinuation rates range from around 7% to 35% of patients in uncontrolled studies, but these rates are difficult to interpret. 13,15 The most serious risk is that of bowel perforation, which can be potentially fatal. There are no reliable estimates of incidence at this time, but some evidence seems to suggest an overall risk of 20 perforations per million procedures. The rates may vary depending on the system used, the age and ability of the patient, and the quality of the training provided. A global audit of bowel perforations suggests that incidence with the Peristeen system may be lower than the overall risk, but the reliability of these estimates is unknown. 19 In 2011, the product information for Peristeen was updated to reflect the rare risk of perforation. The MHRA released a Medical Device Alert reminding healthcare professionals to ensure that patients and carers: Have received comprehensive training and are competent in the use of the system before using it unsupervised Are aware of the risk of bowel perforation, how to recognise the symptoms, and action to be taken. 20 Autonomic dysreflexia, characterised by sweating, chills, bradycardia and increases in blood pressure, may be induced by distension of the bowel and bladder in patients with spinal cord injury. Invasive bowel management procedures may also trigger these symptoms. 7 One randomised controlled trial found that TAI with the Peristeen system was associated with less severe autonomic dysreflexia compared to standard digital anorectal stimulation or bladder filling. 21 The differences between groups was small, with unknown clinical significance.

12 Relevant Guidance A European consensus review suggests that TAI should be considered in patients who fail to achieve good bowel care with conservative techniques, regardless of the cause of bowel function. It should only be considered following a thorough baseline assessment. Choice of equipment should be guided by individual patient factors A stepped approach should be used. TAI, which is considered a minimally invasive treatment, should be considered if conservative measures like digital stimulation, suppositories or biofeedback fail and prior to interventions like sacral nerve stimulation, antegrade colonic irrigation, sacral anterior root stimulation, and stoma. 6 Whilst the recommendations in this review seem reasonable, it should be noted that the authors received funding from Coloplast, who manufacture the Peristeen system. TAI is recommended as an option in the NICE clinical guideline for the management of faecal incontinence in adults, where initial management has failed. It is listed as a potential component of a specialist continence service, alongside pelvic floor muscle training, bowel retraining, specialist dietary assessment and management, biofeedback, and electrical stimulation. 22 The Royal College of Surgeons produced a faecal incontinence commissioning guide in Similar to NICE, they list TAI as a component of a nurse or therapist-led specialised bowel management service for level 2 patients. 23 A number of other NHS commissioning groups have issued advice or policy decisions and recommendations regarding TAI. A selection of these are presented in table 4. Group Recommendation Date South East London TAI is not recommended in primary care May 2015 Area Prescribing Committee TAI should be initiated by a specialist after thorough medical history taking TAI may be of benefit in some patients with spinal cord injury, spina bifida, and multiple sclerosis who fail to respond to maximal medical treatment for bowel dysfunction. Thames Valley Priorities Committee Commissioning Policy Statement TAI is considered to have a place in the care pathway for patients with faecal incontinence, supported by NICE and Royal College of Surgeons (RCS) guidelines, yet, as an invasive method of bowel management its place in therapy should be after all other acceptable bowel management strategies have failed. April 2014 Ideally a comprehensive nurse or therapist-led

13 Lancashire Medicines Management Group service should provide a full assessment and access to a range of modalities of treatment, including anal irrigation, tailored to the needs of the individual patient, based on specialised bowel, lifestyle and dietary assessment. TAI may also be recommended by National Spinal Injuries Centre specialists. TAI is not recommended for the treatment of chronic constipation or chronic faecal incontinence. The Peristeen system is recommended in patients with neurogenic bowel dysfunction who have exhausted all other conservative treatment options. (amber level 0 traffic light) Qufora and Aquaflush systems are not recommended (grey traffic light) May 2015 Table 4: A selection of local NHS policies for TAI systems

14 Cost Analysis Costs will be dependent on the system selected and how often they are used. Some products require an initial outlay for a starter pack, whereas the Irypump S is a one off cost thanks it its reusable parts. Additional costs Product Starter Pack cost Maintenance pack cost (30 days, daily use) Aquaflush Aquaflush Compact Aquaflush Quick Irypump S N/A Peristeen (all sizes) Qufora IrriSedo N/A Mini Qufora IrriSedo N/A Bed QuFora IrriSedo Cone QuFora Balloon Table 5: Cost of TAI systems (Drug Tariff, March 2016) Cost for 356 days (daily use, incl. starter pack) Additional costs may be incurred for routine maintenance/ replacement of parts, as well as optional accessories such as additional tubing or leg straps. A supply of wipes and disposal bags should also be dispensed alongside equipment. As well as the directly chargeable equipment costs, patient and carer training will incur an additional cost. Whilst there have been several cost effectiveness analyses presented at conferences, there are no fully published, independent economic assessments of TAI in the medical literature. A reduction in bowel dysfunction symptoms may lead to decreased healthcare costs, but there is currently no reliable evidence of this. There is no robust, published information on how many patients would be eligible for TAI in the region.

15 Points to consider There is currently insufficient evidence to identify groups of patients who are most likely to benefit from TAI. There is a large volume of published evidence for TAI. Generalisation and pooling of results is limited by a lack of shared outcomes and study design. The methodological quality of the evidence is poor on the whole, and bias cannot be ruled out. There is currently only one small randomised controlled trial published, which demonstrates significant reductions in constipation and faecal incontinence scores, though the clinical significance of this remains unknown. Much of the available evidence relates to the Peristeen system. There is little to no evidence for other products. This may reflect the length of time they have been available on the market and/or the manufacturer s size and ability to perform research. There is no evidence directly comparing different TAI systems or other bowel management strategies. A broad array of systems may be required in order to meet the varying needs of individual patients. Choice of system should be guided by individual patient factors. European Consensus guidelines and NICE guideline CG49 suggest that TAI may be an option in patients in whom conservative methods have failed, prior to consideration of more invasive procedures. A number of other commissioning groups have issued recommendations on the use of TAI. These seem to agree that it may be considered as part of a specialised bowel management programme under specialist care only. Author s declaration: The author has no relevant interests to declare.

16 References 1. Henderson R BA. Constipation in Adults Patinet Plus Professional Reference: patient.info; Lacy BE, Levenick JM, Crowell M. Chronic constipation: new diagnostic and treatment approaches. Therap Adv Gastroenterol 2012;5: Sanchez MI, Bercik P. Epidemiology and burden of chronic constipation. Can J Gastroenterol 2011;25 Suppl B:11B-15B. 4. Mayo Clinic Staff. Fecal Incontinence. Patient Care and Health Information; Knott L JC. Faecal Incontinence Patient Plus Professional Reference. Patient. info Emmanuel AV, Krogh K, Bazzocchi G et al. Consensus review of best practice of transanal irrigation in adults. Spinal Cord 2013;51: Coggrave M. Transanal irrigation for bowel management. Nursing Times 2007;103: Coggrave M, Norton C, Cody JD. Management of faecal incontinence and constipation in adults with central neurological diseases. Cochrane Database Syst Rev 2014;1:CD Christensen P, Krogh K. Transanal irrigation for disordered defecation: a systematic review. Scand J Gastroenterol 2010;45: Bray L, Sanders C. An evidence-based review of the use of transanal irrigation in children and young people with neurogenic bowel. Spinal Cord 2013;51: Ng J, Ford K, Dalton S et al. Transanal irrigation for intractable faecal incontinence and constipation: outcomes, quality of life and predicting non-adopters. Pediatr Surg Int 2015;31: Corbett P, Denny A, Dick K et al. Peristeen integrated transanal irrigation system successfully treats faecal incontinence in children. J Pediatr Urol 2014;10: Marte A, Borrelli M. Transanal irrigation and intestinal transit time in children with myelomeningocele. Minerva Pediatr 2013;65: Pacilli M, Pallot D, Andrews A et al. Use of Peristeen(R) transanal colonic irrigation for bowel management in children: a single-center experience. J Pediatr Surg 2014;49:269-72; discussion Kim HR, Lee BS, Lee JE et al. Application of transanal irrigation for patients with spinal cord injury in South Korea: a 6-month follow-up study. Spinal Cord 2013;51: Choi EK, Shin SH, Im YJ et al. The effects of transanal irrigation as a stepwise bowel management program on the quality of life of children with spina bifida and their caregivers. Spinal Cord 2013;51: Loftus C, Wallace E, McCaughey M et al. Transanal irrigation in the management of neurogenic bowel dysfunction. Ir Med J 2012;105: Preziosi G, Gosling J, Raeburn A et al. Transanal irrigation for bowel symptoms in patients with multiple sclerosis. Dis Colon Rectum 2012;55: Christensen P, Krogh K, Perrouin-Verbe B et al. Global audit on bowel perforations related to transanal irrigation. Tech Coloproctol 2016;20: MHRA. Medical Device Alert: Peristeen Anal Irrigation System 2011;MDA/2011/ Faaborg PM, Christensen P, Krassioukov A et al. Autonomic dysreflexia during bowel evacuation procedures and bladder filling in subjects with spinal cord injury. Spinal Cord 2014;52: NICE. Clinical Guideline 49: Faecal incontinence in adults: management Royal College of Surgeons. Commissioning guide: Faecal Incontinence South East London Area Prescribing Committee. Treatment of Chronic Constipation in Adults Thames Valley Priorities Committee. Commissioning Policy Statement TVPC3: Anal Irrigation Systems for the Management of Faecal Incontinence/ Constipation Lancashire Medicines Management Group. New Medicine Assessment: Transanal Irrigation/Rectal Irrigation Systems 2015.