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Management of faecal incontinence and constipation in adults with central neurological diseases

  1. Maureen Coggrave1,*,
  2. Christine Norton2

Editorial Group: Cochrane Incontinence Group

Published Online: 18 DEC 2013

Assessed as up-to-date: 8 JUN 2012

DOI: 10.1002/14651858.CD002115.pub4


How to Cite

Coggrave M, Norton C. Management of faecal incontinence and constipation in adults with central neurological diseases. Cochrane Database of Systematic Reviews 2013, Issue 12. Art. No.: CD002115. DOI: 10.1002/14651858.CD002115.pub4.

Author Information

  1. 1

    Stoke Mandeville Hospital, The National Spinal Injuries Centre, Aylesbury, Buckinghamshire, UK

  2. 2

    King's College London & Imperial College Healthcare NHS Trust, London, UK

*Maureen Coggrave, The National Spinal Injuries Centre, Stoke Mandeville Hospital, Mandeville Road, Aylesbury, Buckinghamshire, HP21 8AL, UK. Maureen.Coggrave@buckshealthcare.nhs.uk.

Publication History

  1. Publication Status: New search for studies and content updated (no change to conclusions)
  2. Published Online: 18 DEC 2013

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This is not the most recent version of the article. View current version (13 JAN 2014)

 
Characteristics of included studies [ordered by study ID]
Ashraf 1997

MethodsRandomised single-blind trial
Intention-to-treat analysis: no dropouts


ParticipantsSetting and country: Movement Disorders Clinic, USA

Inclusion criteria: 7 Parkinson's disease patients

Exclusion criteria: not mentioned

Age: mean age 66 years, range 54-80

Sex: 3 women, 4 men

Other characteristics: reporting fewer than 3 stools during the final week of a 4-week run-in period. Duration of Parkinson's disease range 4-14 years and mean duration of constipation was 9.4 years


InterventionsPsyllium (5.1 g daily) versus placebo during an 8-week period followed by a 4-week washout period. Four patients received placebo and 3 psyllium


OutcomesStool frequency and symptoms related to bowel function (stool consistency, straining effort, occurrence of anal pain, presence of a sensation of incomplete evacuation). Each symptom was scored on a visual analogue scale that ranged from 1 to 7. Total stool weight during the final week of each phase. Colon transit time and ano-rectal manometry (basal anal sphincter pressure profile, the squeeze response, the recto-anal inhibitory reflex, the threshold for rectal sensation) at entry, at the end of the 4th, 12th and 16th weeks


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskno mention of method

Allocation concealment (selection bias)Unclear riskno mention of method

Blinding (performance bias and detection bias)
All outcomes
Unclear riskno mention of blinding

Incomplete outcome data (attrition bias)
All outcomes
Low riskall 7 completed and reported

Christensen 2006

MethodsRandomised controlled trial

Intention-to-treat analysis: yes


ParticipantsSetting and country: 5 spinal cord injury centres in European countries (Denmark, Italy, UK, Germany, Sweden)

Inclusion criteria: 87 patients with spinal cord injury and neurogenic bowel dysfunction. SCI at any level; at least 3 months after injury and at least one of the following symptoms: 30 minutes + on bowel management; episodes of FI once or more per month; symptoms of autonomic dysreflexia before or during defecation; abdominal discomfort before or during defecation

Exclusion criteria: coexiting major physical problems; using irrigation already; bowel obstruction or inflammatory bowel disease; cerebral palsy or stroke; multiple sclerosis; diabetic polyneuropathy; previous major abdominal or perineal surgery; pregnancy or lactation; spinal shock; mental instability; 5mg+ prednisolone; implant for sacral nerve stimulation

Age: mean 47.5 years (transanal); 50.6 years (conservative)

Sex: female 25; male 62

Other characteristics: details given of ASIA scores and functional level


Interventions10 weeks of transanal irrigation (Peristeen, Coloplast, Denmark) using a specially designed system with a pump and self retaining balloon, used independently after training by a nurse, compared with conservative bowel management (best supportive bowel care using a guideline without using irrigation). Both each day or 2 days


OutcomesPrimary endpoint: Cleveland Clinic constipation score and St Marks faecal incontinence

Secondary outcomes: neurological bowel dysfunction score; modified American Society of Colorectal Surgeons FI score; bowel function; influence on daily activities; general satisfaction; impact on quality of life; urinary tract infection; time for bowel care


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskcomputer generated sequence: block randomisation by centre

Allocation concealment (selection bias)Low risksealed numbered envelopes

Blinding (performance bias and detection bias)
All outcomes
Unclear risknot possible for participants but independent observer "who had not participated in the training" for outcomes

Incomplete outcome data (attrition bias)
All outcomes
Low riskfew missing data; "intention to treat analysis with baseline values carried forward for patients who did not complete"

Coggrave 2010

MethodsRandomised controlled trial

Intention-to-treat analysis: yes


ParticipantsSetting and country: spinal cord injury centre in Stoke Mandeville, UK

Inclusion criteria: 68 traumatic or non-traumatic spinal cord injury. Any ASIA grade, discharged from rehabilitation one year or more

Exclusion criteria: pregnancy, current or past bowel disease or major surgery, stoma

Age: intervention 49.5 years (range 24-73), control 47 years (range 27-62)

Sex: women 23, men 45

Other characteristics: flaccid bowel 9, reflex bowel 59


InterventionsIntervention: stepwise protocol of increasingly invasive evacuation methods (from massage to manual evacuation)

Control: usual care in terms of type, number and order of interventions to achieve evacuation


OutcomesPrimary: duration of bowel care and level of intervention required to complete evacuation

Secondary: time to stool, level of intervention at which evacuation began, frequency of faecal incontinence


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskcomputer generated block randomisation for subjects to each block

Allocation concealment (selection bias)Low risksealed opaque consecutively numbered envelopes, administered by someone not involved in study

Blinding (performance bias and detection bias)
All outcomes
Unclear risknot possible to blind participants or care givers. No mention of outcome assessor blinding

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskintention-to-treat analyses, 10 discontinued: 4 control, 6 intervention

Cornell 1973

MethodsRandomised trial
Intention-to-treat analysis: no.


ParticipantsSetting and country: Comprehensive Rehabilitation Institute, USA

Inclusion criteria: 60 newly admitted SCI inpatients

Exclusion criteria: patients re-admitted or admitted 6 months after the SCI

Age: mean 27.2, range 13 to 58 years

Sex: 8 women, 52 men

Other characteristics: mean duration of SCI 43.9 days


InterventionsPatients randomly assigned to one of 3 bowel programmes:
A) irritant-contact laxative medication, oral and rectal (bisacodyl, Dulcolax), with oral wetting agent (dioctyl)
B) stimulant laxative medication, orally and rectally, with oral wetting agent (dioctyl)
C) mechanical evacuation with tap water (500 ml) instilled into the rectum, and oral wetting agent (dioctyl) and oral bulking agents (psyllium and methylcellulose)

Longitudinal assessment of 6 periods were made: first week of admission, second week, week 3, week 6, week 9 and week of discharge


OutcomesDuration from stimulation until evacuation occurred

Number of unsuccessful attempts at evacuation after stimulation (data from week 9 used)

Number of unstimulated or accidental evacuations (faecal incontinence) (data from week 9 used)

Staining test as oro-anal transit indicator (carmine test)

Global nursing evaluation of the bowel programme rated as "good to fair", "poor" and "questionable"


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear risk"randomly assigned"

Allocation concealment (selection bias)Unclear riskno description

Blinding (performance bias and detection bias)
All outcomes
Unclear risknot mentioned, blinding of intervention not possible

Incomplete outcome data (attrition bias)
All outcomes
High riskparticipants dropped from the study if they "did not have an optimal programme" (A: 7/20, B: 16/20 C: 11/20)

Dahl 2005

MethodsRandomised double-blind crossover study

Intention-to-treat analysis: not mentioned


ParticipantsSetting and country: Canada, setting not specified

Inclusion criteria: 15 wheelchair bound institutionalised adults, multiple sclerosis 7, cerebral palsy 4, spinal cord injury 2, brain injury 2

Exclusion criteria:

Age: under 60 years of age

Sex: not stated

Other characteristics: 10 with dysphagia and 5 without dysphagia


Interventions15g daily inulin-fortified beverage versus standard modified starch-thickened beverages for 3 weeks each


OutcomesChart record of bowel frequency, enema administration, urine samples for calcium, sodium and potassium


NotesNo washout period between crossover


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear risknot mentioned

Allocation concealment (selection bias)Unclear risknot mentioned

Blinding (performance bias and detection bias)
All outcomes
Low riskdouble-blind but no details given

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskblood results on 12/15; other results appear complete

Emly 1998

MethodsRandomised crossover study

Intention-to-treat analysis: no


ParticipantsSetting and country: UK single long stay residential setting and 2 group homes

Inclusion criteria: 32 profoundly disabled institutionalised adults with cerebral palsy or genetic conditions associated with abnormal muscle tone regular use of laxatives or enemas for at least 12 months

Exclusion criteria: none stated

Age: mean 42.25 years (massage); 43.53 years (laxatives)

Sex: 14 men, 18 women

Other characteristics: 71% non-ambulant and totally physically dependent


InterventionsAbdominal massage 5 times a week by physiotherapist or nurse for 20 minutes for 7 weeks versus usual laxative ± enema as a rescue for 7 weeks then crossover. All laxative medication was stopped for both groups for washout period


Outcomes15 days baseline and 10 days after treatment used for assessment. Gastrointestional and segmental transit time; stool frequency; stool size and consistency; need for enemas; assessment of patient well-being


Notes7 day washout period between phases with no laxatives or massage


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear risknot mentioned

Allocation concealment (selection bias)Unclear risknot mentioned

Blinding (performance bias and detection bias)
All outcomes
Low riskradiologists interpreting transit time were blinded

Incomplete outcome data (attrition bias)
All outcomes
Low riskfollow-up for 30/32

Harari 2004

MethodsRandomised trial

Intention-to-treat analysis: yes


ParticipantsSetting and country: 3 stroke rehabilitation units and community in UK

Inclusion criteria: 146 participants, 122 community and 24 stroke rehabilitation inpatients. Had a stroke between 1 month and 4 years previously. Patients screened by questionnaire to identify bowel dysfunction (constipation or faecal incontinence) according to pre-set definitions

Exclusion criteria: people reporting acute diarrhoea or colonic disease other than diverticular disease

Age: intervention 72.2 ± 10.2 years; control 72.9 ± 9.6 years

Sex: 59 women, 87 men

Other characteristics: pre-stroke self reported constipation and faecal incontinence were comparable to similarly aged populations


InterventionsIntervention: one-off assessment by a nurse leading to 1. targeted patient and carer education; 2. provision of a booklet;
3. diagnostic summary and treatment recommendations sent to patient's GP and ward physician if in hospital

Control: routine care


OutcomesPrimary outcome was bowel movements per week. Secondary outcomes were percentage of bowel movements graded as normal by patients and number of episodes of faecal incontinence all measured by postal prospective diary at 1, 3, 6 and 12 months. Other outcomes were bowel related symptoms, stool diary, visual analogue scores for severity rating, quality of life (bowel related and SF-12) and self reported treatment and resource use


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskexternal process using computer generated numbers

Allocation concealment (selection bias)Low riskclosed envelopes

Blinding (performance bias and detection bias)
All outcomes
Unclear risknot mentioned

Incomplete outcome data (attrition bias)
All outcomes
Unclear risk24% dropout at 6 months: 51/73 in usual care and 55/73 in intervention group

House 1997

MethodsRandomised double-blind controlled trial
Intention-to-treat analysis: no, but no dropouts


ParticipantsSetting and country: Physical Medicine and Rehabilitation Center, USA

Inclusion criteria: 15 SCI inpatients; duration of SCI range from 3 months to 45 years. 3 months or longer since SCI, injury above T12, lack of anal sensation, lack of voluntary anal sphincter contraction, stable bowel program, absence of known gastrointestinal disease

Exclusion criteria: not mentioned

Age: age range 26 to 61 years

Sex: not mentioned

Other characteristics: subject history reviewed for consistency in bowel management


InterventionsComparison of two bowel programmes based on the use of different rectal stimulants:

1) hydrogenated vegetable oil-based bisacodyl suppository (HVB)
2) polyethylene glycol-based bisacodyl suppository (PGB)

Randomised sequence for each of the six scheduled bowel care sessions


OutcomesTime to flatus, time to stool flow, defecation duration, total bowel care duration
Duration and frequency of digital stimulation and manual evacuation
Stool amount (0 - none, 1 - minimal, 2 - small, 3 - moderate, 4 - large, 5 - very large)
Number of episodes of faecal incontinence


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskreported as predetermined

Allocation concealment (selection bias)Low riskcentral pharmacy allocated

Blinding (performance bias and detection bias)
All outcomes
Low riskreported as double-blind

Incomplete outcome data (attrition bias)
All outcomes
Low riskall 15 completed

Huang 2002

MethodsRandomised controlled trial

Intention-to-treat analysis: not stated


ParticipantsSetting and country: outpatients and inpatients of a single hospital

Inclusion criteria: 120 stroke patients, 90 patients in treatment group, 30 controls. Patients with a history of stroke evidenced by CT/MRI scan and constipation with bowel opening less frequently than every 72 hours and hard stool causing straining during defecation or difficulty in defecation

Exclusion criteria: not stated

Age: treatment group - average 59 years ± 7 years, control group 60 years ± 9 years

Sex: treatment group - 41 male, 49 female, control group 13 male, 17 female

Other characteristics: other Chinese medicine criteria also applied, other organic causes of constipation excluded


InterventionsA (90): Quiong Runchang oral liquid - a Chinese herbal medicine for intervention group

B (30): Yichi Runchang ointment for controls. Treatment for 2 weeks


OutcomesDefinitions: Cure - normal stool consistency and frequency or a return to pre-morbid level and all symptoms subsided. Good response - significant improvement (near normal) in frequency of defecation and consistency of stool or slightly hard stool and frequency more than once in 72 hours and almost complete subsidence of symptoms of constipation. Partial response - frequency of stool more than or equal to once a day or improvement in consistency of stool and improvement of symptoms of constipation. No response - reaching none of the above


NotesAbstract only


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskrandomised 3:1

Allocation concealment (selection bias)Unclear risknot mentioned

Blinding (performance bias and detection bias)
All outcomes
Unclear risknot mentioned

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskintention-to-treat analysis, dropouts not mentioned

Jeon 2005

MethodsRandomised controlled trial

Intention-to-treat analysis: not stated


ParticipantsSetting and country: one centre, Korea

Inclusion criteria: 31 stroke patients Rome II criteria for constipation. 21 more than one year after stroke

Exclusion criteria:

Age: median 63 years

Sex: 13 men, 18 women

Other characteristics: also used a constipation assessment for participant selection


InterventionsAbdominal meridian massage versus no massage


OutcomesFrequency of defecation, constipation assessment scale


NotesAbstract only


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear risknot mentioned

Allocation concealment (selection bias)Unclear risknot mentioned

Blinding (performance bias and detection bias)
All outcomes
Unclear risknot mentioned

Incomplete outcome data (attrition bias)
All outcomes
Unclear risknot mentioned

Korsten 2004

MethodsRandomised crossover design

Intention-to-treat analysis: data on all 8 participants


ParticipantsSetting and country: USA

Inclusion criteria: 8 spinal cord injured patients, 6 tetraplegic, mean duration of injury 13 years (range 2 -33), fewer than 2 bowel motions per week all with stable bowel regimes

Exclusion criteria:

Age: average 48 ± 14 years

Sex: all men

Other characteristics: none stated


InterventionsAbdominal belt with embedded electrodes applied at level of umbilicus used during bowel care, randomly activated or not activated, during 6 sessions of bowel care over 2 weeks


OutcomesTime to first stool, time for total bowel care


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskno mention

Allocation concealment (selection bias)Unclear riskno mention

Blinding (performance bias and detection bias)
All outcomes
Low riskparticipants were blinded

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskdata on all 8 participants

Korsten 2005

MethodsRandomised crossover blinded study

Intention-to-treat analysis: all subjects completed


ParticipantsSetting and country: Veterans centre USA

Inclusion criteria: 13 spinal cord injury patients, 5 quadriplegics

Exclusion criteria: cardiac or renal disease

Age: mean 46, range 25-69 years

Sex: not mentioned

Other characteristics: mean duration of injury 14 years, range 1-31; bowel care required 1-2 hours at the time of the study


InterventionsIntavenous infusion of neostigmine 2mg versus 2mg neostigmine plus 0.4mg glycopyrrolate versus normal saline


OutcomesAmount of a 200ml barium oatmeal paste evacuated from rectum seen radiographically 30 minutes after infusion (blinded assessor, graded 0-4), blood pressure and pulse rate, total and central airway resistances


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear risknot mentioned

Allocation concealment (selection bias)Unclear risknot mentioned

Blinding (performance bias and detection bias)
All outcomes
Unclear risksubjects blinded as to which infusion receiving

Incomplete outcome data (attrition bias)
All outcomes
Low riskall subjects completed

Krogh 2002

MethodsDouble-blind placebo-controlled, pilot, phase II, dose escalation study

Intention-to-treat analysis: no


ParticipantsSetting and country: two Danish centres.

Inclusion criteria: 23 randomised - 7 received placebo, 8 prucalopride 1 mg and 8 prucalopride 2 mg. SCI, more than 6 months since spinal cord injury; history of constipation subsequent to injury defined as 2 or fewer spontaneous bowel movements per week or needing manual assistance with evacuation in more than 50% of bowel movements per week

Exclusion criteria: cauda equina lesions, drug induced constipation, organic causes of constipation, impaired renal function

Age: 18-60 years

Sex: 5 women, 16 men

Other characteristics: if participants reported constipation pre-spinal cord injury, developed constipation aged >50 years or had macroscopic blood in their faeces underwent colonoscopy


InterventionsStudy consisted of 2 sessions each preceded by a 4 week run-in period when patients' own bowel care recorded. For 1 group this was followed by random allocation to placebo or prucalopride 1 mg for 4 weeks. When safety of this dose established another group was randomised to placebo or prucalopride 2 mg for 4 weeks


OutcomesBowel diary including time of evacuation, use of anal stimulation, stool evacuated or not, stool consistency, use of digital evacuation, time taken for evacuation, presence of faecal impaction. Patient-based outcomes were changes in frequency and consistency of bowel evacuation, abdominal pain and distention, incontinence, laxative use, time to first bowel movement, time taken for defecation. Investigator outcomes were global assessment of treatment efficacy on a 5 point Likert scale and total colonic transit time


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear risknot mentioned

Allocation concealment (selection bias)Unclear risknot mentioned

Blinding (performance bias and detection bias)
All outcomes
Low riskdouble-blind

Incomplete outcome data (attrition bias)
All outcomes
Low risk7/8 completed 2mg intervention, all others completed

McClurg 2011

MethodsRandomised study

Intention-to-treat analysis: no


ParticipantsSetting and country: multicentre, UK

Inclusion criteria: 30 people with confirmed multiple sclerosis, recruited via newsletter, websites, MS groups and day centres, Rome 11 criteria for constipation

Exclusion criteria: history of bowel disease

Age: mean 55 years (SD 13, range 34-83)

Sex: 18 women, 12 men

Other characteristics: EDSS score 2.5-6; 10% could walk unaided, 40% wheelchair bound


InterventionsAbdominal massage daily by participant or carer (with supporting DVD) + lifestyle advice versus lifestyle advice alone. 4 weeks intervention period. Both groups received a weekly visit from a physiotherapist


OutcomesMeasured before intervention and at 4 weeks and 8 weeks after end of intervention

Primary: constipation score

Secondary: Neurogenic Bowel Dysfunction score, MS impact score; Qualiveen questionnaire for bladder function, 7 day bowel diary


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskweb-based system

Allocation concealment (selection bias)Low riskweb-based system

Blinding (performance bias and detection bias)
All outcomes
Low riskresearch assistant analysed data and was blinded

Incomplete outcome data (attrition bias)
All outcomes
Low riskincomplete data on one control patient at 8 weeks

Medaer 1999

MethodsDouble-blind placebo-controlled pilot phase 2 study

Intention-to-treat analysis: no


ParticipantsSetting and country: Belgium, site/s not specified

Inclusion criteria: 11 patients with multiple sclerosis

Exclusion criteria: not mentioned

Age: not mentioned

Sex: not mentioned

Other characteristics: none stated


Interventions4 week run-in. Prucalopride 1 mg for 4 weeks then 2mg for 4 weeks before breakfast, versus placebo


OutcomesStool frequency, number of spontaneous bowel motions per week, median time to first bowel movement after first treatment, unproductive toilet trips, patient evaluation of constipation severity visual analogue score, side effects


NotesAbstract only


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskno mention

Allocation concealment (selection bias)Unclear riskno mention

Blinding (performance bias and detection bias)
All outcomes
Unclear riskstates double-blind but no detail

Incomplete outcome data (attrition bias)
All outcomes
Unclear risknot mentioned

Mun 2011

MethodsRandomised controlled double-blind study

Intention-to-treat analysis: not clear, 6 dropouts


ParticipantsSetting and country: one centre in Korea

Inclusion criteria: 34 bedridden constipated older people following a stroke

Exclusion criteria: none stated

Age: treatment group 67.0 ± 6.0 years, controls 66.7 ± 5.4 years

Sex: male 24, female 10

Other characteristics: none stated


InterventionsOral carbonated water versus oral tap water for two weeks


OutcomesLaxative use, frequency of defecation and constipation symptoms


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear risknot mentioned

Allocation concealment (selection bias)Unclear riskrandom allocation

Blinding (performance bias and detection bias)
All outcomes
Unclear riskdouble-blind

Incomplete outcome data (attrition bias)
All outcomes
Unclear risk6 dropouts

Rosman 2008

MethodsRandomised crossover study

Intention-to-treat analysis: all 7 participants reported


ParticipantsSetting and country: USA, sites not specified

Inclusion criteria: 7 spinal cord injured patients with documented defecation problems; mean duration of injury 15.9 years range 3-27, 4 cervical, 3 thoracic

Exclusion criteria: contraindications to neostigmine

Age: mean age 47 years, range 30-56

Sex: not mentioned

Other characteristics: 5 Afro-American, 2 Hispanic


Interventions2mg neostigmine and 0.4 mg glycopyrrolate intramuscularly for 1 week, 1 week washout, 1 week placebo, in random order plus usual bowel care. Fleet enema administered after 60 minutes if no evacuation


OutcomesTime from injection to completion of bowel care, time to first flatus, time to beginning of bowel movement, time to end of bowel movement, total time for bowel movement including clean up, side effects


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear risknot mentioned

Allocation concealment (selection bias)Low riskorder determined by sealed random assignment

Blinding (performance bias and detection bias)
All outcomes
Unclear risknot mentioned

Incomplete outcome data (attrition bias)
All outcomes
Low riskoutcomes for all 7 participants reported

Venn 1992

MethodsRandomised double-blind controlled trial
Intention-to-treat analysis: no


ParticipantsSetting and country: Hospital Rehabilitation Unit, USA

Inclusion criteria: 58 stroke patients entered the trial. 46 patients were analysed

Exclusion criteria: not mentioned

Age:mean age 72 years, range 36 to 90

Sex: not mentioned

Other characteristics: all participants were actively rehabilitating, were given a diet gradually increasing in fibre and encouraged to maintain a high fluid intake


InterventionsComparison of 4 suppository-based bowel programmes during study period (1 month):

(1) mandatory morning suppository

(2) optional morning suppository

(3) mandatory evening suppository

(4) optional evening suppository


OutcomesNumber of subjects with effective bowel programme defined as a bowel movement within the scheduled time for 5 consecutive days. Efficiency rating determined by the number of days needed to achieve effectiveness. Score starts at 16 and dropped by 1 for each 2 additional days required to establish effectiveness


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear risknot mentioned

Allocation concealment (selection bias)Unclear risknot mentioned

Blinding (performance bias and detection bias)
All outcomes
Unclear risknot mentioned

Incomplete outcome data (attrition bias)
All outcomes
Unclear risk46/58 were analysed: not clear which group

Wang 2008

MethodsRandomised controlled trial

Intention-to-treat analysis: not mentioned


ParticipantsSetting and country: China, site/s not specified

Inclusion criteria: 80 patients with stroke

Exclusion criteria:

Age: not mentioned

Sex: not mentioned

Other characteristics: none stated


InterventionsAbdominal electroacupuncture 30 minutes daily for 2 seven day courses (40 patients) versus 10mg oral cisapride three times a day for two 7 day courses (40 patients)


OutcomesCumulative scores of symptoms, total effective rate (definition unclear)


NotesAbstract only


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskrandom allocation

Allocation concealment (selection bias)Unclear riskmethod not described

Blinding (performance bias and detection bias)
All outcomes
Unclear risknot mentioned

Incomplete outcome data (attrition bias)
All outcomes
Unclear risknot mentioned

Zangaglia 2007

MethodsRandomised placebo-controlled trial

Intention to treat analysis: no


ParticipantsSetting and country: two Italian centres

Inclusion criteria: 57 Parkinson's disease patients, with constipation on Rome ii criteria

Exclusion criteria: pregnant or not using effective contraception, use of drugs affecting gastrointestinal motility, previous gastrointestinal surgery, other causes of constipation

Age: mean age 71 years SD ± 6.5 years

Sex: 34 male, 23 female

Other characteristics: mean disease duration 6.4 years


InterventionsLaxative free baseline followed by 8 weeks isosmotic macrogol electrolyte solution (7.3g in water) versus placebo (flavoured maltodextrine) both dissolved in 250ml water twice daily. Dose could be varied between 1 and 3 sachets daily depending on stool form, patients were asked to keep diet and fluid intake unchanged


OutcomesPredominant symptom, other symptoms, stool frequency (number of evacuations per week), straining (visual analogue scale), stool consistency (4 point scale), use of rectal laxative as a rescue, diary cards, unused sachets of medication


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear risknot mentioned

Allocation concealment (selection bias)Unclear risknot mentioned

Blinding (performance bias and detection bias)
All outcomes
Low riskparticipants were blinded

Incomplete outcome data (attrition bias)
All outcomes
Unclear risk9 out of 29 withdrew from intervention group compared with 5 out of 28 from placebo

 
Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion

Amir 1998Non-randomised trial
Sequential prospective comparison of 4 bowel care regimens (bisacodyl suppository, glycerin suppository, mineral oil enema, docusate sodium mini-enema) in 7 SCI subjects. Docusate mini-enema significantly reduced colonic transit time. Docusate and mineral oil enemas both significantly shortened colonic transit time when compared to bisacodyl or glycerin suppositories. Bowel evacuation time was least for docusate mini-enemas, which also scored best in subjective evaluation scoring for difficulty with evacuation

Badiali 1997Non-randomised trial
Prospective comparison in 10 SCI subjects of a 4 weeks step-by-step protocol based on a high residue diet, a standardised water intake, and on the use of a sequential schedule of evacuating stimuli. When compared to basal period subjects showed a shortened total gastrointestinal transit time and a decreased need for laxatives

Badiali 1991Intervention drug withdrawn from market

Barnes 1985Randomised single blind therapy
Non-specific intervention on bowel function. No proper outcome assessment. Expanded Disability Status Scale (EDSS) is inaccurate, non-quantitative, and does not allow differentiation between bladder and bowel symptoms.
Chronic MS patients assigned to hyperbaric oxygen daily for 20 exposures showed no objective benefit and very little subjective benefit. Improvement was stated as an increase of a point on EDSS for bowel/bladder. This occurred in significantly more patients in the hyperbaric-oxygen group (12 of 51) than in the control group (3 of 47). This benefit was not sustained at 1 year (Barnes 1987)

Binnie 1988Non-randomised trial
Prospective comparison in 10 SCI subjects of cisapride versus baseline

Binnie 1991Non-randomised trial
Prospective comparison of 10 SCI subjects implanted with an electronic Brindley stimulator, 7 non-implanted SCI subjects and 10 healthy volunteers. Implanted subjects had a significant increase in frequency of defecation compared to the non-implanted group. A comparison made before and after implantation would have been much more appropriate. This promising technique has not yet been evaluated in randomised controlled trials (Chia 1996; MacDonagh 1990; Varma 1986)

Bliss 2011Non-neurogenic population

Bond 2005Only 4 out of 27 individuals randomised to the intervention had central neurological conditions and it was not possible to identify their contribution to the data

Carter 1988Stroke patients without identified bowel dysfunction at recruitment and no bowel-specific outcome measure, post hoc analysis

Chapman 1974Non-randomised trial with non-neurological patients

de Both 1992Intervention drug withdrawn from market

Dunn 1994Non-randomised trial
Sequential prospective comparison of a bisacodyl mini-enema (Therevac) with a bisacodyl suppository in 14 SCI inpatients. Ten patients completed the evaluation and experienced a decrease in mean rectal evacuation times with Therevac and a shortening of the time needed for bowel care

Fang 2003Stroke patients without identified bowel dysfunction at baseline and no bowel specific outcome measures

Frisbie 1997Non-randomised trial
Sequential prospective comparison of a polyethylene glycol bisacodyl-based suppository (PGB) with a hydrogenated vegetable oil-based bisacodyl suppository (HVB) in 19 SCI patients. Patients experienced a reduction of time for complete bowel evacuation with PGB versus HVB

Frost 1993Non-randomised trial
Transcutaneous sacral electro-stimulation applied in 7 SCI subjects significantly increased the number of colonic spikes waves. However, no change in the time required to initiate a bowel movement or to complete bowel emptying was noted

Geders 1995Intervention drug withdrawn from the market

Heymen 2005Non-neurogenic population

Kim 1991Continent and incontinent patients not reported separately. No primary bowel outcome measures reported

Latimer 1984Only 2 out of 8 patients with faecal incontinence were neurological (SCI and MS)

Loening-Baucke 1988Efficacy of biofeedback for faecal incontinence in 12 children with myelomeningocele. Three of eight patients in the biofeedback group and three of the four given conventional treatment alone reported greater than or equal to 75% improvement in frequency of soiling 1 year later. Biofeedback did not improve anal squeeze and rectal sensation

Markwell 2006Non-neurogenic population

Marshall 1997Randomised controlled trial in children
Transcutaneous pre-sacral electro-stimulation in 50 children with spina bifida showed a trend in improvement of episodes of spontaneous normal defecation

Munchiando 1993Non-randomised trial
Every-other-day digital stimulation (DS) was compared in 23 cerebrovascular accident patients with daily DS in 25 other patients. More patients performing daily DS established a regular bowel programme than those performing every-other-day DS, although establishing a regular bowel programme took longer in the daily DS group

Petajan 1996Not a specific intervention for bowel function, with no result for bowel function alone (EDSS rates bladder and bowel together)
Randomised trial. No outcome assessment. EDSS is inaccurate and non-quantitative for bowel function.
21 MS patients randomly assigned to a training exercise and compared with 25 control patients non-exercising. Exercise consisted of 15 weeks aerobic fitness training, including maximal aerobic capacity (VO2max) and isometric strength. The training resulted in significantly improved cardiovascular fitness and muscular strength for the exercise group. Exercising subjects experienced significant improvement in physical function as well as in well-being (anger, depression, fatigue). The exercise intervention resulted in significant improvement in EDSS bladder and bowel function

Rajendran 1992Intervention drug withdrawn from the market

Rao 2005Non-neurogenic population

Rao 2010Non-neurogenic population

Stiens 1995Randomised comparison of a hydrogenated vegetable oil-based bisacodyl (HVB) suppository with polyethylene glycol-based bisacodyl suppositories (PGB) in a single SCI subject. The average total bowel care time was significantly shorter with PGB

Stiens 1998Non-randomised trial
Open label crossover controlled trial comparison in 14 SCI inpatients of a hydrogenated vegetable oil-based (HVB) and a polyethylene glycol-based (PGB) bisacodyl suppository. PGB significantly shortened the total bowel care time

Sullivan 2006Intervention drug withdrawn from the market

Tekeoglu 1998Stroke patients without identified bowel problems at baseline and no bowel-specific outcome measures

Van Winckel 2005Children

Weinland 2010Functional bowel disorders not neurogenic

 
Comparison 1. Active treatment versus no treatment or placebo

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Number of bowel motions or successful bowel care routine per week3Mean Difference (IV, Fixed, 95% CI)Totals not selected

    1.1 diet / fibre vs usual care / no treatment
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

    1.2 massage versus usual care / no treatment
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

    1.3 laxative versus placebo
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

 2 Colonic transit time (hours)1Mean Difference (IV, Fixed, 95% CI)Totals not selected

    2.1 diet / fibre vs usual care / no treatment
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

 3 Stool weight (g)1Mean Difference (IV, Fixed, 95% CI)Totals not selected

    3.1 diet / fibre vs usual care / no treatment
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

 4 Numbers NOT responding to treatment1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    4.1 laxative versus placebo
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 5 total bowel care time2Mean Difference (Fixed, 95% CI)Totals not selected

    5.1 neostigmine-glycopyrrolate vs placebo
1Mean Difference (Fixed, 95% CI)0.0 [0.0, 0.0]

    5.2 electrical stimulation vs no electrical stimulation
1Mean Difference (Fixed, 95% CI)0.0 [0.0, 0.0]

 
Comparison 2. One treatment versus another treatment

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Number of bowel motions or successful bowel care routines per week2Mean Difference (IV, Fixed, 95% CI)Totals not selected

    1.1 assessment and education versus usual care
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

    1.2 carbonated water versus tap water
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

 2 Number of people with no evacuation after stimulation (poor response)1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    2.1 irritant-contact laxative versus stimulant laxative
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    2.2 irritant-contact laxative versus tap water enema
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    2.3 stimulant laxative versus tap water enema
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 3 Constipation score (various)3Mean Difference (IV, Fixed, 95% CI)Totals not selected

    3.1 transanal irrigation versus usual bowel programme
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

    3.2 abdominal massage + lifestyle versus lifestyle alone
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

    3.3 carbonated water versus tap water
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

 4 Neurogenic bowel dysfunction score2Mean Difference (IV, Fixed, 95% CI)Totals not selected

    4.1 transanal irrigation versus usual bowel programme
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

    4.2 abdominal massage + lifestyle versus lifestyle alone
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

 5 Satisfaction with bowel care1Mean Difference (IV, Fixed, 95% CI)Totals not selected

    5.1 transanal irrigation versus usual bowel programme
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

 6 Number of people with faecal incontinence1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    6.1 irritant-contact laxative versus stimulant laxative
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    6.2 irritant-contact laxative versus tap water enema
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    6.3 stimulant laxative versus tap water enema
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 7 Faecal incontinence score1Mean Difference (IV, Fixed, 95% CI)Totals not selected

    7.1 transanal irrigation versus usual bowel programme
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

 8 Total time for bowel care1Mean Difference (IV, Fixed, 95% CI)Totals not selected

    8.1 transanal irrigation versus usual bowel programme
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

 9 Number of incontinence episodes between bowel cares, per day or per w1Mean Difference (IV, Fixed, 95% CI)Totals not selected

    9.1 stepwise assessment and education versus usual care
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]