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National Collaborating Centre for Acute Care (UK). Faecal Incontinence: The Management of Faecal Incontinence in Adults. London: National Collaborating Centre for Acute Care (UK); 2007. (NICE Clinical Guidelines, No. 49.)

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Faecal Incontinence: The Management of Faecal Incontinence in Adults.

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3Baseline assessment and initial management of faecal incontinence

Faecal incontinence is a distressing disorder, which may occur at any age; it affects both males and females. There are many causes and it is important to assess patients carefully to determine the optimal management pathway. This guidance has been divided into ‘baseline’ and ‘specialist’ assessment and ‘initial’ and ‘specialised’ management. The aim of this chapter is to provide an initial baseline strategy that will be effective for the many patients in primary and secondary care who might not need to progress onto the specialist assessment and specialised management options.

3.1. Baseline assessment introduction

Once patients have presented with a history of faecal incontinence, the majority never undergo formal functional and structural assessment of anorectal function. Such testing is likely only to be accessible through referral to a specialist. For many patients, a thorough basic assessment will provide enough information for the clinician to recommend an initial management strategy without recourse to more formal testing.

For the purposes of this guideline, we defined baseline assessment to include structured assessment, clinician examination and patient reporting of symptoms.

We undertook literature searches to retrieve RCTs, non-randomised controlled trials, cohort studies and before-after studies which measured the effect of performing an assessment vs not performing an assessment on patient outcomes. As only a small number of studies which met our inclusion criteria were retrieved for this section, we searched for assessment studies with an appropriate ‘gold standard’ to help inform the clinical questions.

3.2. What does a structured assessment add to the assessment of patients with faecal incontinence?

A step-by-step assessment should include a detailed history of the presenting complaint and physical examination. It should focus any further investigations, and therefore has the potential to avoid unnecessary procedures.

3.2.1. Studies considered for this review

A structured assessment was defined as an assessment protocol for patients reporting faecal incontinence which was designed to assess the contributing factors of FI and or plan and manage their care.

3.2.2. Clinical evidence

We did not retrieve any appropriate studies.

3.2.3. Cost-effectiveness evidence

We did not retrieve any appropriate studies.

3.2.4. Conclusions

As no clinical or cost-effective evidence was retrieved for this clinical question the GDG used consensus development methods to propose a recommendation (see section 3.14).

3.3. What does clinician examination add to the assessment of the patient with faecal incontinence?

A physical examination is an important part of the assessment and is key to the management of faecal incontinence. It complements the history given by the patient, assists in excluding organic disease which might be the underlying cause of the symptoms and directs any subsequent investigations according to specific indications.

3.3.1. Studies considered for this review

Clinician examination was considered to cover visual and digital anorectal examination; abdominal and general assessment; neurological examination, clinical assessment and clinician evaluated symptom assessment.

3.3.2. Clinical evidence

We retrieved two diagnostic studies195,392 that reported the diagnostic accuracy of clinical assessment (which usually encompassed history, general examination and anorectal examination) (evidence table 2, appendix D). Keating et al195 (diagnostic study evidence level 2) used a combination of imaging and functional tests (referred to as ‘special investigations’) as a gold standard, while histology was used as the reference standard in Sultan et al392 (diagnostic study evidence level 3).

Keating et al195 report the sensitivity and specificity of clinical assessment for outcomes in patients referred to a specialist centre for assessment of faecal incontinence (N=50). Outcomes measured were structural damage to the sphincter and presence of associated causes of faecal incontinence (for example, rectal prolapse, haemorrhoids/local anal causes and rectocele). The outcomes sensitivities for clinical assessment ranged from 64–100% and the specificities ranged from 94–100% compared to ‘special investigations’. Sultan et al392 reports that both the sensitivity (56%) and specificity (33%) of detection of external sphincter defects by clinical assessment is poor in patients selected for surgical repair (N=12).

Both studies were focused on whether clinical examination could predict structural sphincter integrity. This only has relevance in the specialist setting where surgery is contemplated, which will seldom be the first option for management in the newly presenting patient. Therefore, the significance only becomes relevant at the specialist stage of investigations. The findings reported by Keating et al195 suggest that inspection is as good as imaging at detecting vaginal or rectal prolapse. The results of both studies however should be interpreted with caution. As the study reported by Keating et al195 took place in a specialist referral centre, it is not clear that the results can be replicated in a non-specialist setting. In addition, both studies are small and in the case of Sultan et al392, was undertaken in a highly selected group of patients.

Please note: studies reporting the diagnostic accuracy of digital examination vs manometry are reported in section 5.4.3.

3.3.3. Cost-effectiveness evidence

We did not retrieve any appropriate studies.

3.3.4. Conclusions

In addition to the two studies reported here, studies discussed in section 5.5.3 suggest that a significant proportion of patients who only receive clinical assessment may be inadvertently referred for the wrong surgical treatment. This suggests that in patients with faecal incontinence who are referred to specialist centres, clinical assessment alone cannot be relied upon to inform decisions on surgical options. However, in the initial management phase, clinical assessment is probably sufficient to determine which patients should be fast-tracked for specialist referral and which can proceed with initial management strategies. Recommendations on baseline assessment can be found in section 3.14.

3.4. What does patient-reporting add to the assessment of the patient with faecal incontinence?

A patient-centred approach is desirable, and quantification of the severity of symptoms experienced by patients is also valuable as an outcome measure of treatment. Despite being a subjective measure, the patient’s perception of faecal incontinence is central to the management of this condition, which aims to improve the overall quality of a patient’s life.

3.4.1. Studies considered for this review

We searched for any study related to assessment where patient reported the outcome. Patient reporting was defined as any type of record or score which was completed by the patient (for example, symptom scores, diaries, questionnaires).

3.4.2. Clinical evidence

We did not retrieve any appropriate studies.

3.4.3. Cost-effectiveness evidence

We did not retrieve any appropriate studies.

3.4.4. Conclusions

As no clinical or cost-effective evidence was retrieved for this clinical question the GDG used expert opinion and consensus development methods to propose recommendations for baseline assessment. These can be found in section 3.14.

3.5. Research on patient views of assessment

A systematic review of patients’ views about assessment and conservative management was undertaken. No high-quality studies were retrieved about baseline assessment.

3.6. Initial management: introduction

Initial management will involve attempting to reverse or remedy factors identified as contributing to FI in the baseline assessment. Most are simple, low cost interventions which have a low potential to do harm. This may include addressing the patient’s fluid intake, diet and medication, giving medication and addressing bowel habit and toilet access. Many patients will benefit from a combination of these measures. Products for containment and skin care advice should also be available for initial management purposes.

We undertook literature searches to retrieve RCTs, non-randomised controlled trials, cohort studies and before-after studies which compared the effect of one conservative intervention with a control or another conservative intervention on patient outcomes.

3.7. What is the effectiveness of modifying diet or fluid intake in managing faecal incontinence?

3.7.1. Introduction

Some foods and drinks have components that are likely to alter bowel habit or stool consistency. The aim of dietary and fluid intervention is to promote a regimen that helps maintain an appropriate stool consistency and timing of defaecation. Many patients report clinically that the timing of food intake is important and eating triggers the gastro-colic response and a consequent call to stool. Many alter their diet or restrict intake in an effort to limit FI31.

Some foods (for example, prunes, figs and rhubarb) contain naturally occurring laxative compounds. Artificial sweeteners such as sorbitol and other non-absorbable sugars also have laxative properties. There is a growing interest in the possible value of probiotics (‘good bowel bacteria’) and prebiotics (the foodstuffs that allow these bacteria to multiply in the bowel): these are currently classified as foods (rather than drugs) in the UK.

Many older and/or disabled patients have FI as a result of faecal impaction of hard stool with overflow leakage. Fibre in food or as supplements is often recommended, but must be used with great caution in individuals who have impaction or limited mobility and could, in theory, worsen symptoms.

This section reviews the evidence for any systematic change in content or timing for diet or fluids in managing FI.

3.7.2. Studies considered for this review

We considered RCTs, non-randomised controlled trials, cohort studies and before-after studies. We considered fibre supplements or restriction, probiotics, prebiotics, synbiotics, sorbitol, fructose, modification of eating patterns, any combination of dietary interventions and comparison of the effect of one method of modifying food or fluid intake with another method.

3.7.3. Clinical evidence

One randomised study30 involving 39 adult volunteers with faecal incontinence and loose stool (13 in each of the three arms), evaluated the effects of a fibre supplement containing psyllium (metamucil), gum arabic or a placebo (0.25g of pectin/day) for 31 days (evidence table 3, appendix D, evidence level 1+). The dose reported for psyllium and gum arabic was 25g/day but they also report that the dose was progressively increased over the first 6 days of supplementation to decrease the risk of flatus and worsening faecal incontinence (but the study does not mention what this progressive increase was). The fibre or placebo was mixed in 360 ml of half strength fruit juice and divided into two servings to be ingested at the morning and evening meal. The baseline period was eight days prior to the intervention. The intervention lasted 31 days and follow-up was until the end of the intervention. Three subjects from the psyllium group, two from gum arabic and three from the placebo group took and maintained some type of anti-diarrhoeal medications (atropine chloride, loperamide hydrochloride, bismuth subsalicylate or kaolin pectin) during both periods. The proportion of stools that were incontinent in the groups ingesting fibre supplements during the intervention period was less than half that of the placebo group (psyllium group: 0.17 ± 0.07; gum arabic group: 0.18 ± 0.07; placebo group: 0.50 ± 0.05; p= 0.002). However, this probably overstates the significance since the sample size was too small for the chosen statistical method (ANOVA). Outcomes for stool frequency, weight of stools, fibre fermentation and tolerance and in vitro fibre fermentation did not show significant differences between groups.

One randomised cross-over trial was identified208 (evidence table 3, appendix D, evidence level 1+). This study comprised of 47 adult patients referred to an outpatient service with chronic faecal incontinence. The patients were randomised to loperamide, dietary advice for a low residue diet and placebo supplement or to loperamide, dietary advice for a balanced diet with a fibre supplement. Each intervention was assessed for six weeks and then crossed over to the other intervention. The results of this study 208 found that there was no significant difference between loperamide with a fibre supplement compared with loperamide with a low residue diet and a placebo supplement for faecal incontinence scores.

No appropriate evidence was found comparing different fluid intakes.

3.7.4. Cost-effectiveness evidence

No cost-effectiveness evidence was found.

3.7.5. Conclusions

One small RCT suggests that dietary supplementation with psyllium or gum arabic appeared to decrease the percentage of incontinent stools in people with faecal incontinence related to loose stools. Another larger RCT208 found no difference between patients receiving loperamide with a low residue diet or with a fibre supplement. However, marked variability was found between individual patient results indicating that an individual assessment of fibre content could be beneficial for patients treated with loperamide. The recommendations on diet and fluid intake can be found in section 3.15.2.

3.8. What is the effectiveness of modifying drug administration in managing FI?

3.8.1. Introduction

Anti-diarrhoeal Medication

Patients will typically receive medication to treat faecal incontinence (FI) at one of two extremes of the clinical pathway – either as a first step in primary care or as part of a deliberate plan of management by a specialist. In either context it may represent the sole treatment option, or be an adjuvant part of another therapy. Anti-diarrhoeal medication is suitable for empirical use in primary care and for specialist use. In fact, in the former situation, it could be argued that failure to respond to these medications should be the precursor to specialist referral and functional assessment.

One advantage of the use of loperamide in particular (but also co-phenotrope) is that the drug(s) can be used as both regular treatment, but also on an as-required basis. The drugs are usually used as single agents for routine treatment of faecal incontinence.

Sphincter modifying drugs

A novel development is the use of medication to alter the performance of the anal sphincter mechanism, primarily targeted at raising sphincter pressures. These drugs remain developmental at present and none has reached the general drug tariff.

Drugs to promote bowel emptying

Some patients have faecal incontinence secondary to faecal loading or constipation. Laxatives or rectal evacuants may be used to promote complete rectal emptying.

Side effects of other medications

Many different drugs, usually prescribed for unrelated conditions, have possible side-effects on gut motility or stool consistency. For example, some diabetic oral therapies achieve effect by inducing diarrhoea, which in theory could compromise continence. Iron supplements and non-steroidal anti-inflammatory drugs may cause loose stool in some patients. Many analgesics have constipating side-effects. Changing medications or modifying the regimen may alter episodes of FI in these patients.

Fibre studies

Changes in fibre intake may be achieved by changing diet or use of fibre supplements.

3.8.2. Studies considered for this review

We considered RCTs, non-randomised controlled trials, cohort studies and before-after studies which compared the effectiveness of one drug with placebo, no drugs or another drug.

Two studies30,208 were retrieved reporting the use of fibre at managing FI. These studies are discussed in section 3.7.3.

One study404 was retrieved that used a combination of anti-diarrhoeal medication and laxatives or enemas in a nursing home environment. This study is discussed in section 6.1.3.

3.8.3. Clinical evidence for anti-diarrhoeal/constipating agents

Three randomised crossover studies met our inclusion criteria154,324,393 (evidence table 4, appendix D, evidence level 1+). Read et al investigated the effectiveness of 6 mg of loperamide twice per day in 26 adults with persistent diarrhoea for more than 3 months, who complained of episodes of FI and severe urgency sufficient to limit their life style324. There were a variety of causes of incontinence with irritable bowel syndrome in 11 of the 26 being the most common. This study showed a significant reduction in the episodes of incontinence and urgency during the use of loperamide, but with an increase in the number of adverse events324.

Sun et al investigated the effectiveness of 4 mg of loperamide oxide twice per day in 11 adults with chronic diarrhoea and faecal incontinence393. Any participant with a volume of diarrhoea greater than 500 ml per day was excluded from this study. The cause of FI was irritable bowel syndrome in nine of the participants and as a consequence of surgery in the other two participants. This study used a patient rated visual analogue score for measuring diarrhoea and FI393. There was a significant reduction in the score for diarrhoea and urgency during use of loperamide oxide but no significant difference in the score for FI or abdominal pain.

Hallgren et al154 compared the effectiveness of loperamide hydrochloride with a placebo in a randomised crossover study of 28 participants with FI who had had ileo-anal pouch formation for ulcerative colitis. The covering stoma had been closed between 6 and 72 months previously. Twenty-four of the 30 participants had been using loperamide before entry into the study. The study showed that the use of loperamide several months after ileo-anal pouch formation improved anal resting pressure but not maximal squeeze pressure. The study also showed that the incidence of soiling at night was significantly less in the loperamide group compared to the placebo (p=0.007). There was no significant difference in soiling or leakage during the day.

3.8.4. Cost-effectiveness evidence for anti-diarrhoeal agents

No cost-effectiveness evidence was found.

3.8.5. Conclusions

There is a lack of evidence of good quality data on the effectiveness of anti-diarrhoeal agents on faecal incontinence. Loperamide may help improve a patient’s faecal incontinence but with some minor side effects. Recommendations on initial management can be found in section 3.15.4.

3.8.6. Clinical evidence for drugs enhancing sphincter tone

Three randomised crossover studies were identified (evidence table 4, appendix D, evidence level 1+). The first two studies investigated a 10% gel of phenylephrine. In one study49 the 12 participants had had an ileoanal pouch constructed for ulcerative colitis between 1 and 13 years previously. The episodes of faecal incontinence had been present for a similar amount of time.

In the other study50 the 36 participants had passive FI and a structurally intact sphincter. The episodes of FI had been present for a mean of 5 years. In both studies, patients who were using loperamide before the study were permitted to continue using it during the trial as it had not controlled the episodes of FI. The order of interventions was randomised; they were given one intervention for 4 weeks after which there was a 1 week washout period before the next intervention. There were no side effects from phenylephrine reported for one study49. The other study reported mild dermatitis in three of the 36 participants when receiving the phenylephrine gel and no dermatitis when receiving the placebo50. The difference was not significant and no other side effects were reported. One study50 showed no significant difference between phenylephrine and placebo in the change of incontinence score, percentage improvement in symptom scores or maximum anal resting pressure in patients with ‘idiopathic’ FI. The study49 in patients with FI and an ileoanal pouch showed significantly more participants with a complete cessation of FI when receiving the phenylephrine gel (four compared to none) and more participants perceiving the gel to be better, but the difference was not significant. Incontinence and symptom scores were only reported for the first treatment period because the authors felt the washout period between interventions was not sufficient. The maximum anal resting pressure was significantly higher in the phenylephrine group. This medication is not licensed for FI in the UK.

Kusunoki et al205 conducted a randomised cross over study with a total of 17 adult patients with ulcerative colitis (n=8) or adenomatosis coli (n=9) who had been previously treated with surgical construction of an ileoanal pouch. Patients were randomised to sodium valproate 400 mg four times a day for 7 days or placebo for 7 days. The results of the study (follow up 17 days) showed that more people achieved full continence, less frequent defaecation, and less perianal skin problems with sodium valproate; however the significance was not reported. This medication is not licensed for FI in the UK.

3.8.7. Cost-effectiveness evidence for drugs enhancing sphincter tone

No cost-effectiveness evidence was found.

3.8.8. Conclusions on drugs enhancing sphincter tone

Phenylephrine gel showed no impact on incontinence scores and resting anal pressure in faecally incontinent patients (not related to irritable bowel syndrome) with a structurally intact sphincter. However, the evidence available was only from one study of 36 participants. Phenylephrine gel may relieve incontinence in faecally incontinent patients who had previously had an ileoanal pouch and had tried loperamide without success. Recommendations on modifying drug administration can be found in section 3.15.4.

3.8.9. Clinical evidence for side effects of other drugs

No clinical evidence was retrieved.

3.9. What is the effectiveness of any combination of dietary, fluid or drug administration in managing FI?

3.9.1. Introduction

In clinical practice, dietary, fluid and drug regimens may all be modified at the same time or in combination.

3.9.2. Studies considered for this review

We considered RCTs, non-randomised controlled trials, cohort studies and before-after studies for inclusion which compared one combination of modifying food, liquid and drug administration with a different combination of modifying food, liquid and drug administration or no intervention.

3.9.3. Clinical evidence

No clinical evidence was retrieved.

3.9.4. Cost-effectiveness evidence

We did not retrieve any appropriate studies.

3.9.5. Conclusions

As no clinical or cost-effective evidence was retrieved for this clinical question the GDG used consensus development methods to propose a recommendation (section 3.15).

3.10. What are the most effective products (absorbent products, containment and plugs) to manage faecal incontinence?

3.10.1. Introduction

People experiencing faecal incontinence often need to wear a product (absorbent product or plug) for containment. This may be before consulting a health professional to assess their symptoms. Frequently a product will be worn ‘just in case’ an episode of FI is experienced. Once the problem has been assessed it is likely that management other than products for containment will be initiated. In addition, products will often still be worn to boost self-confidence or when the FI is not amenable to treatment.

Disposable, absorbent products are more suitable and preferable to washable products. Soiling of clothing and loss of solid stool can usually be contained within underwear and pads, but it is difficult to contain profuse diarrhoea or hide unpleasant odours. This should usually be preventable by planning better bowel management programmes.

There are many different treatments for FI but not all patients can be cured and some are left to manage intractable FI. Devices such as anal plugs or faecal collectors have limited use, and are generally only acceptable to certain populations. Although anal plugs are not tolerated by all patients, they may be helpful in preventing FI in selected groups, such as patients with neurological impairment who have less anal sensation. Both the anal plug and faecal collectors may possibly be of help in palliative care; a collector in situations where a patient has acute profuse diarrhoea (for example in intensive care situations).

3.10.2. Studies considered for this review

We considered randomised controlled trials, randomised crossover studies or systematic reviews of randomised controlled trials and/or randomised crossover studies, non-randomised controlled trials, before and after studies and cohort studies which compared: the effectiveness of absorbent products, anal plugs or faecal collector with no intervention; one type of absorbent product with another; or one type of anal plug with another. The review for this clinical question included studies of incontinent patients even if the proportion with faecal incontinence was less than 50% or unknown.

3.10.3. Clinical evidence

Four randomised studies evaluating absorbent products were identified: two investigated doubly incontinent patients174,376, one investigated people with urinary, faecal or double incontinence41 and the last did not specify the type of incontinence158 (evidence table 5, appendix D, evidence level 1+). No studies in just faecally incontinent participants were identified. Two of the studies compared disposable with reusable absorbent products 158,174, one compared diapers with underpads in hospitalised patients41 and one compared absorbent pads with undersheets in bedridden older patients376.

Disposable vs reusable body worn products

One study showed that participants using the disposable products (n=34) had significantly better skin assessment scores and significantly more participants with an improvement in skin condition than those using reusable (n=34) products174. The reusable products were worn during the day but taken off at night. However, the mean number of episodes per day of urinary incontinence (6.7) was higher than the mean number of episodes per day of faecal incontinence (1.2). This could mean that disposable pads have an effect in patients with urinary incontinence but it is difficult to assess whether they have an effect in FI. The other study showed no difference in skin condition158. There was no indication as to the type of incontinence these participants had.

Bodyworn products vs underpads/bedsheets

A single RCT41 of 166 adult incontinent patients at an acute hospital compared five different absorbent products. The randomised comparison was between diapers and underpads. However, there were also cross-over period comparisons within each randomised arm between polymer and non-polymer products. And in one centre cloth underpads were used instead of disposable for the entire study period. Skin integrity scores were reported by assessing five skin areas for redness, integrity and patient symptoms. Points assigned in each in a ranked order where 0 represented no alteration or symptoms. Mean skin integrity scores were significantly different between the five arms for redness (p=0.0001) and integrity (p=0.003), with the polymer diaper having the best outcome. Mean skin integrity scores for patient symptoms were not significantly different between the groups. There was no significant difference in skin integrity scores when comparing diapers with underpads.

Only 29% of the participants were routinely doubly incontinent and it is not clear how many of the new onset patients would have had FI, UI or both. The difference between the episodes of faecal and urinary incontinence was not recorded and no results were provided for the FI sub-group. Therefore it is difficult to draw any conclusions as to the effect of these products on participants with FI.

Absorbent bed pads vs cotton bedsheets

One randomised cross-over study376 compared three interventions: absorbent bed pads, absorbent bed pads impregnated with an antimicrobial agent and heavy cotton bed pads (N=32). Participants using the unimpregnated absorbent bed pads had significantly fewer incidences of wet skin than the group using the bed pads. They also had significantly fewer incidences of dry skin and more incidences of damp skin than the heavy cotton bed pads group; however, this was believed to be as a result of perspiration. These outcomes were heavily influenced by the urinary incontinence.

Anal plugs

One Cochrane review was identified with four studies99 (evidence table 5, appendix D). Two studies315,412 were in children and were therefore out of scope of the guideline. The two other studies included adults. One study looked at both children and adults. Some data was available for adults alone but due to recruitment problems the target of 2:1 randomisation between groups was not achieved, with three times as many adults in the intervention arm. The other had a high dropout rate and incomplete data. Both studies were excluded from our review.

3.10.4. Cost-effectiveness evidence

The approach taken was the same as for the review of clinical evidence – because of the lack of relevant studies; we included studies of incontinent patients even if the proportion with faecal incontinence was less than 50% or unknown. We found three economics studies that evaluated incontinence containment products (evidence table 8, appendix D).

One study172 was based on a matched-pair RCT of 68 elderly care home residents with urinary and/or faecal incontinence comparing disposable with reusable bodyworns. They found the cost of disposables to be lower (product and laundry costs), although not significantly so (£1.90 vs £2.30 per day). There was an improvement in skin quality in the disposable arm compared with deterioration in the reusable arm. This suggests that disposable dominates reusable, although the proportion of patients with FI was not reported.

A second RCT42 of 166 adult incontinent patients at an acute hospital compared five different absorbent products. The randomised comparison was between diapers and underpads. However, there were also cross-over period comparisons within each randomised arm between polymer and non-polymer products; and in one centre, cloth underpads were used instead of disposable for the entire study period. There were not significant differences between the randomized arms. They found polymer underpads dominated nonpolymer underpads; that is, the former had similar skin scores and a lower cost (products, staff time and laundry) (£2.40 vs £3.20 per clean-up episode). Polymer diapers were more effective than nonpolymer diapers but at an increased cost (£3.10 vs £2.80). It is difficult to assess whether the health gain justifies the increased cost since health outcomes were not measured in terms of QALYs, although the cost difference does not seem prohibitive. A limitation of this study is that it does not clearly report the proportion of patients with faecal incontinence.

A Cochrane review37 conducted in the UK developed an economic evaluation from a systematic review of RCTs, which included the two studies just mentioned and four others. They made the general conclusion that disposable products were more effective but more costly than nondisposable products, however, disposable bodyworns had the lowest cost for strategies other than nondisposable underpads. Patients had significantly fewer skin complaints for disposable bodyworns compared to nondisposable bodyworns and had a lower cost. This suggests that disposable bodyworns dominate nondisposable bodyworns, although disposal costs were not measured. There was not enough evidence to compare bodyworns with underpads.

The two RCTs were conducted in a US setting where care pathways and prices are often very different to those in the UK NHS, although the UK Cochrane review reached similar conclusions using UK prices.

3.10.5. Conclusions

No evidence was found to determine whether absorbent products were effective in containing faecal incontinence. Some evidence exists for participants with both faecal and urinary incontinence but the results appear to be biased by the urinary incontinence. No good quality randomised evidence of the effectiveness of anal plugs in adults was found.

Cost-effectiveness: It is difficult to assess whether the health gain from disposable products is high enough to justify the extra cost. One study suggested that disposable bodyworns could be cost-saving compared with nondisposable bodyworns.

Recommendations on products can be found in section 3.15.5.

3.11. What are the most effective skin care products to manage the side effects of faecal incontinence?

3.11.1. Introduction

The majority of people with faecal incontinence (FI) do not experience regular sore skin around the anus. However, certain patients seem to be prone to this, for example those with general frailty, immobility, poor health, continuous passive soiling or profuse diarrhoea. Patients with double incontinence may experience sore skin as urine and faeces can interact, resulting in a moist environment in the anal area. Other contributing factors include skin conditions, diabetes mellitus and patients who have had their colon removed, so that the stool which leaks is ileal contents.

In such circumstances, if no products are used on the patient’s skin there may be redness, soreness and even skin breakdown which can contribute to the development of a pressure sore. Keeping the skin clean and dry is important in maintaining skin integrity. In residential settings, staff adherence to skin care protocols is essential to maintain patients’ skin integrity.

3.11.2. Studies considered for this review

RCTs, non-randomised controlled trials, cohort studies and before-after studies which compared: the effectiveness of skin care products with no intervention or one type of skin care product with another were retrieved for this review. The populations included were adults with faecal incontinence. This included people with double incontinence (that is, with urinary and faecal incontinence).

3.11.3. Clinical evidence

Two RCTs14,76 (evidence level 1+) and one cohort study21 (evidence level 2+) were identified (evidence table 7, appendix D). They were in long term elderly hospital or nursing home patients. A foam cleanser was compared to water in one study where participants (N=93) were predominantly doubly incontinent76. The second study21 was in a UK nursing home setting evaluating 164 incontinent patients (107 with faecal or double incontinence) in a prospective cohort study. The study consisted of a three month pre-intervention period consisting of usual care (soap and water to cleanse and variety of skin protection products) followed by a three month period of a new skin care protocol involving an educational programme for the staff and Cavilon spray cleanser and either Cavilon durable barrier cream or Cavilon barrier film. Two creams (Sudocrem and zinc oxide) were compared in the third study14. Although the type of incontinence was not reported the 67 participants appear to have had some faecal incontinence.

Using a foam cleanser compared to soap and water resulted in significantly more participants retaining healthy skin and significantly fewer participants with a deterioration in skin condition after two weeks of intervention76. The new skin protocol reported in the Bale study 21 significantly reduced incidence of incontinence dermatitis (p=0.021). There were significantly (p=0.042) less Grade 1 pressure ulcers after the new skin care protocol (16 pre-intervention compared to 8 post-intervention). Using Sudocrem resulted in a significant reduction in skin redness after 1 week and 2 weeks of treatment when compared to a zinc oxide cream14.

3.11.4. Cost-effectiveness evidence

The approach taken was the same as for the review of clinical evidence – because of the lack of relevant studies, we included studies of incontinent patients even if the proportion with faecal incontinence was less than 50% or unknown. We found four economics studies that evaluated incontinence skin care products (evidence table 8, appendix D).

A study of 12 elderly care home residents with FI46 found that a no-rinse incontinence cleanser reduced carer time and costs (by £15 per patient per week) compared with soap and water. The study was based on a subgroup of patients from a cohort study, but its design and sample size were not clearly stated. Health outcomes were not reported for the FI subgroup that was the subject of the costing analysis.

The second study418 involved a case series of 19 elderly care home residents with FI. They found that a combined cleanser and barrier cream dominated separate cleanser and barrier cream; the former significantly reduced erythema and pain. Carer time was also reduced and subsequently so were costs by £85 per patient per year. The before and after study design is clearly open to bias and this was compounded by the absence of statistical analysis for carer time or cost.

A third study443 evaluated 271 elderly care home residents with urinary and/or faecal incontinence in four cohorts undergoing different skin care interventions. Cost of product and staff time was substantially lower for a barrier film than for either of two brands of ointment (£1.10–£2.70 vs £6.00–£6.10 per week). There was no significant difference in incontinence dermatitis (3.0%–3.9% vs 2.6%) but the incidence was low and therefore the study was too small to detect a difference. Thrice weekly use of the film was, not surprisingly, less costly than once daily (£1.10 vs £2.70).

All three studies were in a US setting where care pathways and prices are often very different to those in the UK NHS.

A fourth study21 was in a UK care home setting evaluating 164 incontinent patients (107 with faecal or double incontinence) in a cohort study. A skin protocol involving Cavilon spray cleanser and either Cavilon durable barrier cream or Cavilon barrier film was compared with usual practice (soap and water to cleanse and a variety of skin products). The skin protocol significantly reduced incidence of incontinence dermatitis and pressure sores (see clinical evidence review). It also reduced staff time and subsequently overall skin care costs were also significantly reduced (£8.83 vs £3.43 per patient per day, p<0.001). However, given that the control group was so heterogeneous, it is difficult to say whether it was the type of product that was causing the difference or the use of cleanser instead of soap and water.

3.11.5. Conclusions

Foam cleanser was better than soap and water in preventing skin deterioration in doubly incontinent elderly hospital or nursing home residents. Sudocrem improved skin condition over two weeks compared to a zinc oxide cream in incontinent elderly hospital patients. However, the study gave no indication what proportion of the participants had faecal incontinence.

The included cost-effectiveness studies were too small and heterogeneous to reach any reliable conclusions.

Recommendations on skin care can be found in section 3.15.5.

3.12. What is the best practice goal setting (including involving patients) for satisfactory treatment of faecal incontinence?

3.12.1. Introduction

For patients whose symptoms do not improve after a course of treatment, or if patients’ symptoms had reached a plateau of improvement, it can be difficult to decide when and whether to stop treatment or to change to another modality or combination of modalities and whether to refer on or to request further investigations.

3.12.2. Studies considered for this review

Studies considered for this clinical question evaluated the best practice goals for satisfactory treatment of faecal incontinence.

3.12.3. Clinical evidence

We did not retrieve any appropriate studies.

3.12.4. Cost-effectiveness evidence

We did not retrieve any appropriate studies.

3.12.5. Conclusions

As no appropriate evidence was retrieved for this clinical question, the GDG used expert opinion and a consensus development exercise to develop recommendations on initial management (see section 3.15).

3.13. Research on patient views of initial management

A systematic review of patients’ views about initial management was undertaken. One good quality study about management was found310 (evidence table 6, appendix D, evidence level 3).

This Australian study conducted a series of focus groups and interviews with 82 consumers and carers from culturally and linguistically diverse groups from rural/metropolitan/remote areas. All participants raised similar issues about managing FI and in particular, continence products. These issues can be summarised as follows:

  • participants found it difficult to know where to seek information. Sources identified by participants included: continence product packaging, books, magazines, internet, social networks such as social clubs or church groups, health professionals and state-funded subsidy schemes
  • participants highlighted the importance of receiving care from healthcare professionals who are able to respond to patients’ feelings of vulnerability and embarrassment with sensitivity.
  • participants stated they had a lack of faith in health professionals’ knowledge and advice, and ability to empathise with the condition
  • participants stated they had difficulty in identifying products. Often they were unaware that professional assessment and advice for management existed, or they received inconsistent advice. Patients’ choices were limited by cost, availability, quality, comfort and design when choosing products.

Suggestions for improvement included detailed product information, such as reliable estimates of working capacities of continence products, and instructions for use. General information about incontinence in simple language and better marketing and distribution of information sources in general were also identified as a potential improvements.

3.14. Recommendations on baseline assessment

Healthcare professionals should ensure that people who report or are reported to have faecal incontinence are offered:

  • a focused baseline assessment, to identify the contributory factors, before any treatment is considered
  • all appropriate initial management including, where appropriate, condition-specific interventions before any specialised treatment.

Rationale: No specific evidence evaluating the effectiveness of different protocols of assessment and management was retrieved. However, after considering the evidence for the other clinical questions on assessment and management of faecal incontinence, consulting with expert advisors and participating in a consensus development exercise the GDG decided to recommend a step-wise approach to the management of patients with FI. Most people with FI will present in Primary Care, and many problems can be addressed here without immediate onward referral. We do not have specific evidence on cost-effectiveness but logically the employment in the initial stages of simple, safe and relatively cheap interventions in the community will be more cost-effective than more specialised assessment and treatment.

The focused baseline assessment should comprise:

  • relevant medical history (see appendix I)
  • a general examination
  • an anorectal examination (see appendix I)
  • a cognitive assessment, if appropriate.

Rationale: After considering the retrieved evidence in section 3.3.2 and 3.14, consulting with expert advisors and participating in a consensus development exercise, the GDG decided to recommend a focused baseline assessment for all patients reporting faecal incontinence largely based on their expert opinion. The specific components of the baseline assessment listed above and in Appendices I, J, K and L can provide valuable information in formulating not only the causes of faecal incontinence, but also the impact on the patient such as coping strategies and ability to function on a daily basis. The findings from the baseline assessment will also help to plan an appropriate management strategy.

People with the following conditions should have these addressed with condition-specific interventions before healthcare professionals progress to initial management of faecal incontinence:

  • potentially treatable causes of diarrhoea (for example, infective, inflammatory bowel disease and irritable bowel syndrome)
  • warning signs for lower gastrointestinal cancer18
  • rectal prolapse or third-degree haemorrhoids
  • acute anal sphincter injury including obstetric and other trauma
  • acute disc prolapse/cauda equina syndrome.

Rationale: Although no specific evidence was retrieved on evaluating the effectiveness of addressing underlying causes of FI, after considering the evidence for assessment and management of faecal incontinence (discussed chapters 35), consulting with expert advisors and participating in a consensus development exercise, the GDG decided to recommend that patients with the conditions listed above should be offered condition-specific interventions before being offered initial management options to treat faecal incontinence. These conditions will either prevent successful resolution of FI, or warrant further investigation in their own right.

3.15. Recommendations on initial management

Healthcare professionals should discuss with people with faecal incontinence that a combination of initial management interventions is likely to be needed to address faecal incontinence. The specific management intervention(s) offered should be based on the findings from the baseline assessment, tailored to individual circumstances and adjusted to personal response and preference.

Rationale: No specific evidence on combinations of management interventions was retrieved. After considering the evidence for all the clinical questions in section 3.6, consulting with expert advisors and participating in a consensus development exercise the GDG decided that because the symptom of FI often has multiple contributing factors, this will often mean several interventions are appropriate for each patient. The specific combination will depend on the findings of the assessment. It is not appropriate to refer most patients for more specialised assessment until these basic factors have been addressed.

3.15.1. Bowel habit

Healthcare professionals should address the individual’s bowel habit, aiming for ideal stool consistency and satisfactory bowel emptying at a predictable time.

A bowel habit intervention should contain the following elements:

  • encouraging bowel emptying after a meal (to utilise the gastrocolic response)
  • ensuring toilet facilities are private and comfortable and can be used in safety with sufficient time allowed
  • encouraging people to adopt a sitting or squatting position where possible while emptying the bowel
  • teaching people techniques to facilitate bowel evacuation and stressing the importance of avoiding straining

Rationale: No evidence evaluating the effectiveness of interventions to address bowel habit was retrieved. After consulting with expert advisors and participating in a consensus development exercise the GDG decided to recommend the aims and principles of bowel habit interventions. If complete rectal emptying at a predictable time can be achieved many patients will thereby avoid episodes of FI. Evidence on patient views in section 2.3 in chapter 2 was also considered by the GDG who also wanted to draw attention to ensuring that patients are treated with dignity at all times.

3.15.2. Diet and fluid intake

Healthcare professionals should recommend a diet that promotes an ideal stool consistency and predictable bowel emptying. When addressing food and fluid intake healthcare professionals should:

  • take into account existing therapeutic diets
  • ensure that overall nutrient intake is balanced
  • consider a food and fluid diary to help establish a baseline
  • advise patients to modify one food at a time if attempting to identify potentially contributory factors to their symptoms (see appendices K and L)
  • encourage people with hard stools and/or clinical dehydration to aim for at least 1.5 litres’ intake of fluid per day (unless contraindicated). Urinary output should be measured where intake is in doubt
  • consider the opportunity to screen people with faecal incontinence for malnutrition, or risk of malnutrition19.

Rationale: After considering the evidence in section 3.7.3, consulting with expert advisors and participating in a consensus development exercise, the GDG decided to recommend a diet which promotes ideal stool consistency and bowel emptying, as food and fluids may affect faecal consistency and amount the effect of different foods will vary between individuals. These recommendations offer a framework on which to make appropriate adaptations to meet the individual person’s needs. Other than fibre no specific evidence was retrieved defining the components of this diet. However, the GDG wanted to highlight the importance of ensuring that any existing therapeutic diets should be taken into account and that the overall nutrient intake should be balanced when advising patients and or carers. Biochemical deficiency is common in older people particularly those in residential care125. In order that the effects of this diet be optimised, a food and fluid diary should be considered to establish a baseline and patients should be encouraged to modify one food at a time in order to establish contributory factors. Although there was no evidence on the effectiveness of specific amounts of fluid to be consumed for patients with hard stool and or clinical dehydration, the GDG considered that 1.5 litres was an appropriate amount for these patients to aim for. Finally, the GDG wanted to draw specific attention to the risk of malnutrition which may be confounded by some dietary changes.

3.15.3. Toilet access

When problems with toilet access are being addressed in any home or healthcare setting:

  • locations of toilets should be made clear to the individual where appropriate
  • equipment to help people to gain access to a toilet should be provided
  • advice should be given to people with faecal incontinence on easily removable clothing to reduce time needed for access
  • if a person with faecal incontinence is dependent on others for accessing the toilet, help should be readily available
  • if appropriate, the person with faecal incontinence should be referred to the relevant professionals for assessment of their home and/or mobility.

Rationale: No evidence evaluating the effectiveness of interventions to address toilet access was retrieved. After consulting with expert advisors and participating in a consensus development exercise the GDG decided to recommend some simple, good practice points for patients with limited mobility. Difficulty with toilet access can make the difference between urgency and urge FI. People with limited mobility and or disabilities can find it difficult to reach the toilet, transfer, adjust clothing, or sit stably and in comfort for long enough to achieve complete bowel emptying.

3.15.4. Medication

When reviewing medication, healthcare professionals should consider alternatives to drugs that might be contributing to faecal incontinence (see appendix J).

Antidiarrhoeal medication should be offered to people with faecal incontinence associated with loose stools once other causes (such as excessive laxative use, dietary factors and other medication) have been excluded. Antidiarrhoeal medication should be prescribed in accordance with the summary of product characteristics.

The antidiarrhoeal drug of first choice should be loperamide hydrochloride. It can be used long term in doses from 0.5 mg to 16 mg per day as required. For doses under 2 mg, loperamide hydrochloride syrup should be considered. People who are unable to tolerate loperamide hydrochloride should be offered codeine phosphate, or co-phenotrope20.

Loperamide hydrochloride should not be offered to people with:

  • hard or infrequent stools
  • acute diarrhoea without a diagnosed cause
  • an acute flare-up of ulcerative colitis.

When loperamide hydrochloride is used:

  • it should be introduced at a very low dose and the dose should be escalated, as tolerated by the individual until the desired stool consistency has been achieved
  • it should be taken as and when required by the individual
  • the individual should be advised that they can adjust the dose and/or frequency up or down in response to stool consistency and their lifestyle.

Rationale: After considering the evidence retrieved for section 3.8, consulting with expert advisors and participating in a consensus development exercise, the GDG decided to develop recommendations which both consider modifying drugs contributing to faecal incontinence and offering anti-diarrhoeals which are the drugs of first choice in treating faecal incontinence. Once other causes of loose stools have been excluded, anti-diarrhoeals should be offered. We do not have specific evidence on cost-effectiveness of anti-diarrhoeal drugs but the relatively low daily cost of drugs such as loperamide would suggest that for patients that find the drugs effective, they are highly cost-effective. Alternatives are available for people unable to tolerate this drug. The GDG used their expert opinion to recommend several good practice points for the administration of loperamide, relating to contraindications, long term use and modification of dose. While there was no specific evidence on modifying drugs which are contributing to FI, the GDG decided that if possible, alternative medications should be prescribed.

3.15.5. Coping strategies for symptomatic people

During assessment and initial management healthcare professionals should offer people with faecal incontinence advice on coping strategies including:

  • the use of continence products and information about product choice, supply sources and use
  • where to get emotional and psychological support, including counselling or psychological therapy, where appropriate, to foster acceptance and positive attitudes
  • how to talk to friends and family about incontinence and its management
  • strategies such as planning routes for travel to facilitate access to public conveniences, carrying a toilet access card21 or RADAR key22 to allow access to ‘disabled’ toilets in the National Key Scheme.

People with faecal incontinence should be offered:

  • disposable body-worn pads in a choice of styles and designs and disposable bed pads if needed
  • pads in quantities sufficient for the individual’s continence needs. It is inappropriate to limit the number of pads given
  • anal plugs (for people who can tolerate them)
  • skin-care advice that covers both cleansing and barrier products
  • advice on odour control and laundry needs
  • disposable gloves.

The use of reusable absorbent products in the management of faecal incontinence is not generally recommended.

Rationale: After considering the evidence retrieved on patient views in section 2.3 in chapter 2 and 3.10 and 3.13 in this chapter, consulting with expert advisors and participating in a consensus development exercise, the GDG decided to recommend that patients with FI should be offered a number of coping strategies during the baseline assessment and initial management stage of the patient pathway. Uncontrolled FI can be depressing, demoralising and detrimental to social activities. Some interventions may take time to be effective. Sources of information on practical coping are few. Therefore, it is important for healthcare professionals to enable coping while patients undergo initial management. Anecdotal evidence would suggest that access to continence products can allow patients to lead active lives with substantial improvement in quality of life. The supply of such products is therefore likely to be cost-effective. However, if poor-fitting products are provided or products are provided in inadequate numbers, or products have to be regularly laundered then activity and quality of life are likely to be significantly diminished.

3.15.6. Review of treatment

After each intervention healthcare professionals should ask the person whether their faecal incontinence has improved. People continuing to experience symptoms should be:

  • involved in discussions about further treatment options (including effectiveness and adverse effects) or alternative coping strategies
  • asked if they wish to try further treatments.

The options for long-term management should be considered for people who prefer symptomatic management to more invasive measures (see recommendation in section 5.7).

Rationale: Evidence retrieved on patient views in section 2.3 in chapter 2 and 3.10, 3.11 and 3.13 in this chapter was considered by the GDG. After consulting with expert advisors and participating in a consensus development exercise the GDG decided to recommend that the wishes of patients should be checked at each stage of the care pathway. Not all patients want automatically to progress through a hierarchy of assessment and treatment. Some are happy with reassurance that there is no serious pathology underlying symptoms.

Footnotes

18

See the NICE clinical guideline on referral for suspected cancer (www​.nice.org.uk/CG027).

19

See the NICE clinical guideline on nutrition support (www​.nice.org.uk/CG032).

20

Prescribers should check the summary of product characteristics (SPC) for current licensed indications (see http://emc​.medicines.org.uk/). Informed consent is needed when using outside the licensed indications. This should be discussed and documented in the notes.

21

These are available from National Association for Colitis and Crohn’s disease (NACC) (www​.nacc.org.uk), INCONTACT(www​.incontact.org.uk) or the Continence Foundation (www​.continence-foundation.org.uk)

22

These are available from RADAR (www​.radar.org.uk)

Copyright © 2007, National Collaborating Centre for Acute Care.

Apart from any fair dealing for the purposes of research or private study, criticism or review, as permitted under the Copyright, Designs and Patents Act, 1988, no part of this publication may be reproduced, stored or transmitted in any form or by any means, without the prior written permission of the publisher or, in the case of reprographic reproduction, in accordance with the terms of licences issued by the Copyright Licensing Agency in the UK. Enquiries concerning reproduction outside the terms stated here should be sent to the publisher at the UK address printed on this page.

The use of registered names, trademarks, etc. in this publication does not imply, even in the absence of a specific statement, that such names are exempt from the relevant laws and regulations and therefore for general use.

The rights of National Collaborating Centre for Acute Care to be identified as Author of this work have been asserted by them in accordance with the Copyright, Designs and Patents Act, 1988.

Bookshelf ID: NBK50658

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