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4th ICI Lecture Series: Conservative treatment for fecal incontinence (Committee 16)

Presented by Christine Norton, MD, et al., at the Fourth International Consultation on Incontinence (ICI) - July 5 - 8, 2008. Palais des Congres, Paris, France.



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This presentation reflects a work-in-progress, and the science contained herein
will be published in textbook format at a future date.



Committee 16 Conservative and Pharmacological Management of Faecal Incontinence in Adults Christine Norton (UK) William Whitehead (USA) Donna Bliss (USA) Danielle Harari (UK) Julie Lang (Scotland, UK) Topics • Prevention and risk factors • Education and lifestyle interventions • Diet and fluids • Bowel management, retraining and irrigation • Medication • Biofeedback and anal sphincter exercises/PFMT • Electrical stimulation • Faecal incontinence in frail older people • Conclusions and recommendations Definitions • “Anal incontinence (AI) is the involuntary loss of flatus, liquid or solid stool that is a social or hygienic problem”. • “Faecal incontinence (FI) is the involuntary loss of liquid or solid stool that is a social or hygienic problem”. • Epidemiology studies have looked at AI and/or FI • Most intervention studies have FI as outcome measure • Important to specify AI or FI in each context Methods • Specific search for each section (terms in paper) • Priority given to RCT evidence where available • Case series used where it casts light on mechanisms of action or other factors not covered in RCTs • Evidence graded (1-4) and recommendations made (A-D) • Combined algorithm with surgical committee (Madoff) Identifying risk factors: targets for prevention? 1. Patient characteristics –Increasing age –Nursing Home residence –Gender: equivocal • Younger: 6 studies women>men; 8 studies no difference • Older men>women (one study) –Race: no difference except obstetric injuries –Obesity, poor general health and physical limitations, UI & POP, endurance running all associated –Neurological disease or injury (learning disability, dementia, SCI, MS, SB, CVA, head injury, diabetes mellitus) Identifying risk factors: targets for prevention? 2. Gastrointestinal symptoms and disorders –Diarrhoea or loose stools (community & NH) • Drugs (antibiotics, SSRIs, laxatives, digoxin, orlistat), dietary supplements (lactose, fructose, artificial sugars, olestra) foods (prunes, figs) –Urgency (independent of stool consistency) –Constipation (? “overflow”) –Irritable bowel syndrome (IBS) (OR 2-8) –Inflammatory bowel disease (IBD) (diarrhoea + perianal) –Haemorrhoids (before and after surgery) –Congenital anomaly (imperforate anus) Identifying risk factors: targets for prevention? 3. Obstetric factors (disparity population vs. selected clinic studies) –Parity for AI (1st VD, subsequent deliveries: clinic pops) –Sphincter laceration for AI & FI (7 studies ↑ risk, 2 not) –Instrumental delivery (forceps 5 ↑ AI risk, 2 not; vacuum equivocal) –Episiotomy: midline ↑ risk; mediolateral not protective –CS: inconclusive, tending to not protective –Large baby, prolonged 2nd stage: equivocal Identifying risk factors: targets for prevention? 4. Sequelae of surgical procedures –Colectomy & IRA or pouch: diarrhoea + pressures: 18-49% FI –Sphincterotomy: 11% FI in long term –Haemorrhoidectomy: 33% AI –Radical prostatectomy: 9-32% (retropubic vs. perineal) –Pelvic radiotherapy 14-46% (diarrhoea + compliance) Primary prevention of FI: recommendations for practice • Public health measures to prevent diarrhoeal diseases (B/C) • Treat reversible causes of diarrhoea (C) • Obstetric: no convincing evidence of role for preventive CS; avoid midline episiotomy; restrictive episiotomy protocols (A) • Discourage the use of internal anal sphincter myectomy for treatment of anal fissure and haemorrhoids (A) Secondary prevention of FI: recommendations for practice • Active case finding/screening in high risk groups (C) • Proactive bowel management in high risk groups (eg neurological) (C) • Optimise stool consistency in people with loose stools (all ages); hard stools (children and older pops) (B) • Treat obesity? (D) • Consider medication alternatives in patients with FI & medication-induced diarrhoea (C) • Alert patients to risk of FI following colorectal surgery (C) Prevention of FI: recommendations for research • Longitudinal studies to map natural history, especially in women with obstetric risk factors • Prevention studies in childbearing women and other high risk groups • Colorectal surgery and radiotherapy techniques • Bowel management strategies in high risk groups (e.g. neurological) • Understanding mechanisms of FI in men • Frail: community prevention/screening/early treament to prevent NH admission • Measures to prevent/reduce FI in nursing homes (functional FI, staffing etc) Education and lifestyle interventions for FI • Obesity: FI improves after bariatric surgery (Burgio 2007) (Level 3) • Physical exercise: no effect on prevalent or incident FI at 10 years (Osterbye 2004: Level 2) • Smoking: not predictive; no studies (D) • Medication side effects: alternatives if causing diarrhoea (C) • Toilet access for people with disabilities (C) • Education –of patient (Harari 2004; Norton 2003) (B/C) –of carer (Clemesha 2003) (C) • Complementary therapies: no evidence (D) Diet and fluid interventions • Patients manipulate their diet (Bliss 2000/5/6; Chrysos 2001) • No studies found on fluids, probiotics, caffeine, lactose, fructose, alcohol • 2 RCTs on fibre • Bliss 2001: benefit of soluble fibre compared to placebo in FI with loose stools (Level 2) • Lauti 2008: high or low fibre diet + loperamide (stools not all loose): no overall benefit (Level 2) Diet and fluid interventions: clinical recommendations • Addition of soluble fibre for FI + loose stool (B) • Dietary fibre may not be helpful in addition to anti-diarrhoeal medication if stool consistency is normal (B) Diet and fluid interventions: research recommendations • Additional benefit of fibre in combination therapies • Role of fibre and fluid in constipation/impaction related FI • Effect of diet and eating pattern as a management strategy for FI Bowel management and retraining • Constipation a well established risk factor at ends of life span • Unlike bladder, rectum fills episodically • Bowel tends to respond to a habit or pattern • If complete emptying at a predictable time can be achieved, FI may be less likely Bowel management and retraining: the evidence • No studies in adults with learning disabilities • No studies in frail elders or Nursing Homes • No studies in neurological patients • One study in adults (combination intervention: Norton 2003): possibly as effective as biofeedback • One RCT of rectal irrigation in SCI: benefit for FI, constipation, time spent & QoL (Christensen 2006) (2) Bowel management and retraining: recommendations and research • Attempt to establish a bowel routine (C) • Urge resistance training possibly useful for urgency (D: need for research) • No evidence on behaviour modification methods (D: need for research) • Digital stimulation and manual evacuation useful in neurological patients (C) • Rectal irrigation is useful in SCI (B) and has potential in other patients with FI (D) • Recommend research in this area Drug treatment of FI in adults • Targets for medication –Reduce diarrhoea / firm loose stool –Increase anal canal pressure –Prevent or treat constipation Drug treatment of FI in adults the evidence • 6 studies in adults, 3 in children: weak design (small, crossover, case series): loperamide may be useful and superior to diphenoxylate (Palmer 1980: Level 2) • Loperamide effect not enhanced by fibre (Lauti 2008: Level 2) • Conflicting data on phenylephrine gel • Oral laxatives possibly effective in constipation in Nursing Homes Drug treatment of FI in adults: recommendations • Treat FI with diarrhoea with anti-diarrhoeal medication (C): titrate dose to individual response (C) • We are unable to recommend sphincter modifying drugs (D) • Use oral or rectal laxatives/evacuants to treat constipation-associated FI (C): no evidence on most effective agent. Need to confirm impaction is resolved (C) • Need further research on preparations, doses and combination therapies Biofeedback and/or anal sphincter exercises/PFMT • 3 main modalities –EMG, pressure or ultrasound: strength training –Rectal sensation training (increase or decrease) –Coordination training (RAIR: 2 or 3 balloon) –+/- abdominal EMG –Combinations –+/- home equipment –Variety of protocols and exercise regimens Biofeedback and/or anal sphincter exercises/PFMT: the evidence • Cochrane review (Norton 2006): 11 RCTs • 3 additional studies found: 14 RCTs • 3 excluded as abstracts only • 11 studies reviewed (8 last ICI) • 592 patients • Variable quality and size; complex designs; different outcome measures; short follow up; no compliance measures; only one ITT analysis • Many case series: supplemental evidence Biofeedback and/or anal sphincter exercises/PFMT: the evidence • Only one study has found significant differences between groups (Fynes 1999) • Rectal sensation may be important (Miner 1990) • Changes in sphincter strength not necessarily linked to symptoms • Few predictors of outcome (sensation, IBS, age, weight, sphincter disruption?) • PFMT as effective as BFB? (Norton 2003, Solomon 2003); advice alone as effective as PFMT (Norton 2003) • More than 50% of patients in all groups improve Biofeedback and/or anal sphincter exercises/PFMT: recommendations • BFB and PFMT possibly of benefit in addition to well managed conservative care, but unproven • PFMT recommended as an early intervention for FI as part of a conservative management bundle of interventions (low cost and morbidity, weak case series evidence) (C) • Use of BFB considered after other behavioural and medical interventions if inadequate symptom relief obtained (cost & reimbursement issues) (C) Biofeedback and/or anal sphincter exercises/PFMT: research • Standardise protocols and robust patient based outcome measures (cure vs improvement) • Understand physiological effect and relationship to symptom change • Evaluate different elements • Adherence monitoring • Explore UI/FI synergies in studies of PFMT External anal electrical stimulation • 6 RCTs (one last ICI) • Obstetric: between treatments (no control) –Fynes 1999: ES + anal BFB superior to vaginal BFB –Mahony 2004: ES + BFB no difference to BFB –Naimy 2007: ES no difference to BFB • Norton 2005: no difference 1Hz and 35Hz • Healy 2006: no difference home/clinic or BFB • Osterberg 2004: no difference to surgical levatorplasty in FI: QoL better in surgical group • All studies report before-after benefit External anal electrical stimulation: recommendations • Based on currently available evidence it is not possible to recommend electrical stimulation for FI (B) • Need RCTs on all aspects using best evidence on likely optimal parameters • Investigate changes in cortical consciousness • NB implants in surgical committee FI in frail older people • High prevalence (20% community, 50% NH: increases with age; men >women in 80yrs + ; double incontinence high; under-reported) • Multiple risk factors: age, loose stool, impaction, immobility, functional limitations, dementia, neurological disease, other conditions, medications, depression • High social morbidity, reduces QoL • Recommend: active screening; protocols; education of carers (C) FI in frail older people: causes • Healthy ageing has some effect on bowel function –Lower sphincter pressures (IAS & EAS) –Lower rectal compliance –Blunted sensation (anal and rectal) –Motility preserved • Causes of FI: all the same as younger patients + co-morbidities, immobility, dependence, mental agility FI in frail older people: modifiable risk factors • Be alert to red flags for colorectal disease • Polypharmacy + anticholinergics, opiates, iron, calcium channel antagonists, NSAIDs, Parkinson’s disease medication • Impaction • Loose stool (including over use of laxatives) • Diet and fluids (fibre, lactose intolerance, dehydration, caffeine) • Mobility • Anal sphincter weakness? • Depression • Toilet access / carer availability • All grade C recommendations FI in frail older people: treatment • Shamefully few studies, almost no RCTs • None on prevention • Treat impaction with oral or rectal medications (Tobin 1986; Chassagne 2000): ensure compliance and clearance (3) • Optimise use of laxatives (3) • Oral PEG relieves impaction (3) • Treat loose stools (3) • Education helpful after stroke (Harari 2004) (3) • Multi-component interventions likely to be most help (C) • Need for research in all areas (UI study synergies) • Influence of culture and beliefs of carers Active case finding in high risk groups Address reversible risk factor e.g. Medication; toilet access; loose stools Patient and / or carer education Bowel habit and training Manage constipation Diet (e.g. soluble fibre for loose stool) Medication (e.g. loperamide for loose stool) PFMT / anal sphincter exercises Adequate containment (e.g. pads or plugs) and practical management advice (Committee 20) Surgical evaluation or symptom management if adequate relief not obtained from conservative management, depending on symptom severity and patient preference Take out of pathway: Alarm signals: referral for investigation Impaction: treat then evaluate Surgical evaluation needed: e.g. rectal prolapse, recent sphincter injury, fistula Patient presents with FI Basic assessment (e.g. history, examination, medication and diet review) If initial management fails to achieve adequate symptom relief consider: Diagnostic testing; Biofeedback; Irrigation Conservative management of FI in adults: summary • Lack of RCT evidence for most interventions • Many patients improve whatever we do • Difficult to design targeted interventions until pathophysiology better understood: multi-component may be needed • Fertile area for development

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