Bowel Irrigation Techniques

Transanal irrigation is a process of facilitating evacuation of stool from the bowel by passing water (or other liquids) in via the anus in a quantity sufficient to reach beyond the rectum into the colon. Pulsed water irrigation uses an electrical pump to deliver intermittent, rapid pulses of warm water into the rectum/colon to break up stool and to stimulate peristalsis (Puet et al. 1997). The enema continence catheter was a specially designed catheter with an inflatable balloon, originally developed by Shandling & Gilmour (1987) for bowel management in individuals with spina bifida. The catheter was inserted into the rectum and the balloon inflated to hold the catheter in place. After the irrigation was administered under gravity, the balloon was deflated, the catheter removed and the bowel contents emptied. In 2006, Christensen et al. assessed the use of the newly developed Peristeen Anal Irrigation system (Coloplast A/S, Kokkedal, Denmark). This system consists of a rectal balloon catheter, a manual pump, and a water container. The catheter is inserted into the rectum and the balloon inflated to hold the catheter in place while tap water is administered using the manual pump (Christensen et al. 2006).

Antegrade irrigation introduces water to the colon (caecum) via a surgically formed non-reflux stoma. Irrigation may be delivered via the stoma using a manual or powered pump, or by gravity.The Malone antegrade continence enema (MACE or ACE) is a continent catheterizable stoma, connecting from the external abominal wall to the caecum, through which a catheter is inserted. An enema can then be given via the catheter

During both transanal and antegrade irrigation a rectal balloon catheter or rectal cone without a balloon is placed into the rectum, and removed once irrigation is completed for controlled voiding of the rectum.

Discussion

Two review papers published in 2010 looked at transanal irrigation in the neurogenic population (Emmanuel 2010) and both the neurogenic and wider population (Christensen & Krogh 2010) respectively.

Both reviews concluded that the use of transanal irrigation resulted in significant improvements in incontinence, constipation, time spent on bowel care, autonomic symptoms around bowel management and quality of life, in comparison to conservative management in individuals with SCI. Irrigation was found to be a safe procedure, as the risk of bowel perforation was approximated as 1/50,000 irrigations. No adverse changes in rectal or colonic function were associated with irrigation use. However, in the long term a significant proportion of users stop using irrigation. The cause of this is not clear but thorough preparation and training for irrigation and continuing support whilst establishing a new regimen are thought to improve compliance.

An international group of specialists from a range of disciplines, experienced in transanal irrigation, have recently published a consensus review (Emmanuel et al. 2013) that provides guidance regarding patient selection, indications and contraindications for transanal irrigation and a step-by-step approach to treatment and follow-up. Absolute contraindications include anal or rectal stenosis, active inflammatory bowel disease, acute diverticulitis, colorectal cancer, ischaemic colitis, rectal surgery within the previous 3 months or endoscopic polylectomy within the previous 4 weeks. Relative contraindications include severe diverticulosis, long term steroid medication, painful anal conditions, planned or current pregnancy, and severe autonomic dysreflexia. Fecal loading/impaction should be treated before irrigation is instigated. No clear patient selection criteria have been identified; any individual whose bowel management is ineffective, lacks contraindications above, and who is suitably motivated may benefit from transanal irrigation. The importance of training the patient and their caregiver, as well as providing follow up support while establishing an individualized program is emphasized.

The evidence for irrigation is mostly in individuals with chronic SCI. There is a need to explore its potential in the subacute rehabilitation phase. Further research is also required to determine the cause of the reduction in use of irrigation over time and how this can be improved, and to develop clear patient selection criteria.

In individuals with SCI for whom transanal irrigation is ineffective or inappropriate, the Malone antegrade continence enema (MACE) can eliminate fecal incontinence (Worsøe et al. 2008; Teichman et al. 2003; Christensen et al. 2000; Teichman et al. 1998), reduce time spent on bowel care (Worsøe et al. 2008; Teichman et al. 2003; Teichman et al. 1998), improve quality of life (Teichman et al. 2003; Christensen et al. 2000), resolve autonomic dysreflexia secondary to the neurogenic bowel (Teichman et al. 1998), and successfully treat constipation (Christensen et al. 2000; Teichman et al. 2003).

Christensen et al. (2000) compared the efficacy of Malone antegrade continence enema with the enema continence catheter and reported successful treatment of fecal incontinence, slow transit or constipation, and obstructed defecation in persons with SCI.

Conclusion

There is level 4 evidence (from one case series: Puet et al. 1997) that supports using pulsed water irrigation (intermittent rapid pulses) to remove stool in individuals with SCI.

There is level 1b evidence (from one RCT: Christensen et al. 2006) that supports the use of transanal irrigation (Peristeen Anal Irrigation system) over conservative bowel treatment (as outlined by the Paralyzed Veterans of America clinical practice guidelines) in individuals with chronic SCI and bowel management problems.

There is level 4 evidence (from one case series, one cross-sectional, and three non-randomized cohort studies: Del Popolo et al. 2008; Christensen et al. 2008; Faaborg et al. 2009; Kim et al. 2013) that supports the use of transanal irrigation to manage neurogenic bowel dysfunction.

There is level 4 evidence (from four retrospective reviews: Teichman et al. 1998; Christensen et al. 2000; Teichman et al. 2003; Worsøe et al. 2008) that the Malone Antegrade Continence Enema successfully treats neurogenic bowel dysfunction.

There is level 4 evidence (from one retrospective review: Christensen et al. 2000) that the enema continence catheter can be used to treat neurogenic bowel dysfunction.

Transanal irrigation can improve all bowel management outcomes in individuals with chronic neurogenic bowel dysfunction following SCI. The Malone Antegrade Continence Enema is a safe and effective treatment for significant GI problems in persons with SCI when conservative and transanal irrigation are unsuccessful or inappropriate. Pulsed water transanal irrigation may help to remove stool in individuals with SCI.

Table 11a. Systematic Review on Irrigation Techniques for Neurogenic Bowel

Authors; Country Date included in the review Total Sample Size Types of Articles Score	Methods Databases Level of Evidence	Conclusions
Christensen & Krogh 2010 Denmark Systematically reviewed articles up until August 2009 N=27 studies (4 studies with SCI patients) Level of evidence: Methodological quality not assessed Type of study: 1 multi-centre, RCT (SCI); all others had no control AMSTAR: 3	Method: Systematic literature search for published reports on transanal irrigation was conducted. Participants of interest were self-administered transanal irrigation, indications, techniques, outcomes, modes of action, complications, quality of life and quality of methods used. Databases: Medline, Embase, CINAHL, Cochrane Library, completed studies from the internet-based trial register (www.clinicaltrials.gov)	17 studies evaluated transanal irrigation in adults; of these, 4 were studies with SCI patients. Treatment was regarded as successful in 53% of all cases; categorized by predominant symptom, success was achieved in constipation (45%), fecal incontinence (47%) and in the mixed symptom group (59%). In a multi-centre RCT with SCI patients, patients treated with transanal irrigation had fewer complaints of constipation, less fecal incontinence, improved symptom-related QoL and reduced time consumption on bowel management than patients using best supportive bowel care without irrigation. Also, symptoms of AD were lower in this study, suggesting transanal irrigation may have a protective effect against AD. A significantly better symptom-related QoLwas found in the irrigation group compared with patients treated with a conservative bowel regime w/o irrigation for the domains ‘coping/behavior’ and ‘embarassment’. A cost-effectiveness analysis with an SCI population indicates that transanal irrigation is cheaper and more effective than conservative bowel management, when taking into account aggregate costs of carer help, treatment of UTIs and associated loss of production productivity.
Emmanuel 2010 UK Systematically reviewed articles (no dates specified) N=23 studies (6 SCI) Level of evidence: Strengths and limitations were assessed for each study Type of study: 1 RCT, the rest were retrospective or observational AMSTAR: 2	Method: Systematic literature search for published reports on TAI in NBD participants. No restrictions on articles by size or design. Databases: Pubmed	In a RCT of TAI with Peristeen compared with conservative bowel management, significant results in favor of TAI were found for all outcome measures (both symptom burden and QoL). At the end of the RCT, 20/45 patients originally randomized to conservative management switched to TAI; at 10-week follow-up, the outcomes of the initial report were confirmed. Another study reported 68% success for fecal incontinence and 63% for constipation with Peristeen and tap water. 2 studies each with follow-up of nearly 10 years have described the successful long-term use of TAI in the SCI population. For patients with traumatic SCI, the success rates were 50% for complete injuries, 58% for high incomplete injuries and 53% for low incomplete injuries. The second long-term follow-up reported success for 62% of patients with SCI.

Authors; Country

Date included in the review

Total Sample Size

Types of Articles

Score

Methods

Databases

Level of Evidence

Conclusions

Christensen & Krogh 2010

Denmark

Systematically reviewed articles up until August 2009

N=27 studies (4 studies with SCI patients)

Level of evidence:

Methodological quality not assessed

Type of study:

1 multi-centre, RCT (SCI);

all others had no control

AMSTAR: 3

Method: Systematic literature search for published reports on transanal irrigation was conducted. Participants of interest were self-administered transanal irrigation, indications, techniques, outcomes, modes of action, complications, quality of life and quality of methods used.

Databases: Medline, Embase, CINAHL, Cochrane Library, completed studies from the internet-based trial register (www.clinicaltrials.gov)

17 studies evaluated transanal irrigation in adults; of these, 4 were studies with SCI patients. Treatment was regarded as successful in 53% of all cases; categorized by predominant symptom, success was achieved in constipation (45%), fecal incontinence (47%) and in the mixed symptom group (59%).
In a multi-centre RCT with SCI patients, patients treated with transanal irrigation had fewer complaints of constipation, less fecal incontinence, improved symptom-related QoL and reduced time consumption on bowel management than patients using best supportive bowel care without irrigation. Also, symptoms of AD were lower in this study, suggesting transanal irrigation may have a protective effect against AD.
A significantly better symptom-related QoLwas found in the irrigation group compared with patients treated with a conservative bowel regime w/o irrigation for the domains ‘coping/behavior’ and ‘embarassment’.
A cost-effectiveness analysis with an SCI population indicates that transanal irrigation is cheaper and more effective than conservative bowel management, when taking into account aggregate costs of carer help, treatment of UTIs and associated loss of production productivity.

Emmanuel 2010

Systematically reviewed articles (no dates specified)

N=23 studies (6 SCI)

Level of evidence:

Strengths and limitations were assessed for each study

Type of study:

1 RCT, the rest were retrospective or observational

AMSTAR: 2

Method: Systematic literature search for published reports on TAI in NBD participants. No restrictions on articles by size or design.

Databases: Pubmed

In a RCT of TAI with Peristeen compared with conservative bowel management, significant results in favor of TAI were found for all outcome measures (both symptom burden and QoL).
At the end of the RCT, 20/45 patients originally randomized to conservative management switched to TAI; at 10-week follow-up, the outcomes of the initial report were confirmed.
Another study reported 68% success for fecal incontinence and 63% for constipation with Peristeen and tap water.
2 studies each with follow-up of nearly 10 years have described the successful long-term use of TAI in the SCI population. For patients with traumatic SCI, the success rates were 50% for complete injuries, 58% for high incomplete injuries and 53% for low incomplete injuries. The second long-term follow-up reported success for 62% of patients with SCI.

Table 11b. Consensus Review on Irrigation Techniques for Neurogenic Bowel

Authors; Country Total Sample Size Types of Articles Score	Methods Databases Level of Evidence	Conclusions
Emmanuel et al. 2013; UK (international panel of experts) N=20 non-pediatric articles	Methods: a consensus group of specialists from a range of nations (Denmark, France, Germany, Italy, the Netherlands, UK) and disciplines (physicians, surgeons, physiology experts, rehab specialists) who have experience in prescribing and monitoring patients using TAI assimilated emerging literature and clinical experience, reaching consensus through a round table discussion process. Databases: PubMed, Athens	Indications for TAI include: patients with NBD, primary or secondary functional bowel disorders. Contraindications for TAI include: stenosis, colorectal cancers, inflammatory bowel diseases, acute diverticulits, ischaemic colitis.2. Optimal patient selection: conservative treatment including biofeedback should be tried without success before TAI is performed. Low rectal volume at urge to defecate and low maximal rectal capacity were significantly associated with a successful outcome of TAI. Clinical examination and preparation: a specialist health-care professional should be consulted before TAI. Bowel diaries and symptom scoring systems should be used. Fecal impaction must be excluded and treated before starting TAI. Patient training: comprehensive training is essential – written info should be available, training a patient until they are comfortable with irrigation is necessary. Patients should be taught to recognise the symptoms of colonic perforation and what actions to take.

Authors; Country

Total Sample Size

Types of Articles

Score

Methods

Databases

Level of Evidence

Conclusions

Emmanuel et al. 2013;

UK (international panel of experts)

N=20 non-pediatric articles

Methods: a consensus group of specialists from a range of nations (Denmark, France, Germany, Italy, the Netherlands, UK) and disciplines (physicians, surgeons, physiology experts, rehab specialists) who have experience in prescribing and monitoring patients using TAI assimilated emerging literature and clinical experience, reaching consensus through a round table discussion process.

Databases: PubMed, Athens

Indications for TAI include: patients with NBD, primary or secondary functional bowel disorders.
Contraindications for TAI include: stenosis, colorectal cancers, inflammatory bowel diseases, acute diverticulits, ischaemic colitis.2. Optimal patient selection: conservative treatment including biofeedback should be tried without success before TAI is performed. Low rectal volume at urge to defecate and low maximal rectal capacity were significantly associated with a successful outcome of TAI.
Clinical examination and preparation: a specialist health-care professional should be consulted before TAI. Bowel diaries and symptom scoring systems should be used. Fecal impaction must be excluded and treated before starting TAI.
Patient training: comprehensive training is essential – written info should be available, training a patient until they are comfortable with irrigation is necessary. Patients should be taught to recognise the symptoms of colonic perforation and what actions to take.

Table 12. Irrigation Techniques for Neurogenic Bowel after Spinal Cord Injury

Author Year; Country Score Research Design Total Sample Size	Methods	Outcome
Christensen et al. 2006; Denmark PEDro = 7 RCT N=87	Population: 1) TAI group: ≥T9: 3 complete, 5 incomplete; T10-L2: 1 complete, 1 incomplete; L3-S1: 1 incomplete); Age: mean 47.5 yrs; 29M 13F. 2) Conservative bowel management (CBM) group: ≥T9: 22 complete,11 incomplete; T10-L2: 1 complete, 3 incomplete; L3-S1, 8 incomplete Age: mean 50.6yrs; 33M 12F Treatment: TAI (Peristeen Anal Irrigation system) or conservative bowel management (Paralyzed Veterans of America clinical practice guidelines) for 10 weeks. Outcome Measures: Cleveland Clinic constipation scoring system (CCCSS), St. Mark’s fecal incontinence grading scale (FIGS), American Society of Colon and Rectal Surgeons fecal incontinence score (symptom-related QOL scale), NBD score.	The TAI group had significantly improved scores over the CBM group for the following scales: CCCSS: TAI=10.3(4.4); CBM=13.2(3.4) FIGS: TAI= 5(4.6); CBM=7.3(4) NBD: TAI=10.4(6.8); CBM=13.3(6.4)2. TAI group scored non-significantly better on 2/4 domains of the symptom-related quality-of-life tool and significantly better on the domains coping/behaviour (TAI=2.8(0.8) vs CBM=2.4(0.7)) and embarrassment (TAI=3.2(0.8) vs CBM=2.8(0.9)). Improvement found in the TAI group as a whole was not confined to the more physically able patients At weeks 7-10 participants had reduced time spent on bowel management each day, and reported being less dependent on help The reported frequency of urinary tract infection during weeks 1-10 was lower in the TAI group (TAI=5.9%, CBM=15.5%).
Effect Sizes: Forest plot of standardized mean differences (SMD ± 95%C.I.) as calculated from pre- and post-intervention data
Kim et al. 2013; Korea Longitudinal N=52	Population: Level of injury: 28 tetraplegics, 24 paraplegics; 41M 11F; Mean (SD) age: 44.5 (11.0) yrs; mean (SD) DOI: 92.9 (118.4) months Treatment: Transanal irrigation (TAI) Outcome Measures: Compliance rate, questionnaire on demographics, bowel care habits, frequency and time needed to defecate, intestinal symptoms, need for assistance during bowel management, participant satisfaction and quality of life, adverse events	Compliance with the use of TAI at 1, 3, and 6 months was 31/52 (59.6%), 25/52 (48.1%) and 18/52 (34.6%). At 6 months, the noncompliant group contained a higher proportion of tetraplegics than paraplegics and a higher need for assistance during bowel management. At 6 months, 6/28 (21.4%) of tetraplegia patients and 12/24 (50%) paraplegic patients were using TAI. In the compliant group, defecation time decreased from baseline to 6 months and quality of life increased from baseline to 6 months.
Smith & Decter 2015 USA Prospective Cohort N=17	Population: N=17 (12M, 5F) Mean (range) age at surgery 33 (6-49) Mean (range) time post SCI at surgery 10 (1-30) years Mean time from surgery to follow-up 56 (4-102) months 10 paraplegia, 7 tetraplegia 9 thoracic, 8 cervical N=5 excluded due to completing pre-operative survey after surgery (N=12 remain for final analysis) Treatment: Anterograde continence enema (ACE) Outcome Measures: Fecal incontinence quality of life (FIQL) instrument	Significant increase in mean (SD) of all categories of FIQL after surgery: Lifestyle: 2.3 (0.9) to 3.7 (0.5) Coping/Behaviour: 2.2 (0.9) to 3.8 (0.3) Depression/self-perception: 2.8 (0.9) to 3.8 (0.4) Embarrassment: 2.2 (1.1) to 3.8 (0.3) Three patients developed stomal stenosis and one developed delayed small-bowel obstruction after surgery
Faaborg et al. 2009; Denmark Post-test N = 211	Population: neurogenic bowel dysfunction 96M 115F; age: median 49yrs, range 7-81 yrs, who were introduced to transanal irrigation between 1994-2007. 74 traumatic SCI participants; 10 high complete, 12 high incomplete, 14 low complete, 38 low incomplete. Treatment: TAI (Enema continence catheter; same as that used in Christensen et al. 2000) Outcome Measures: Rate of success (treatment was considered successful if the patient is currently using TAI, if the patient used TAI until he/she died, or if the patient’s symptoms resolved while using TAI) as evaluated by a questionnaire, as well as the patient’s medical records; incidence of bowel perforation and other side effects	Successful outcomes in 98 (46%) of participants after a mean follow-up of 19 months (range 1-114 months) Dropout rate of 20% in the first 3 months of using TAI Success rate 3 years after introduction of TAI was 35% The male gender, mixed symptoms (patients suffering from both constipation and fecal incontinence), and prolonged colorectal transit times were significantly correlated with successful outcomes Chance One non-lethal bowel perforation occurred in approximately 50,000 irrigations (0.002%), whereas minor side effects were observed in 48%. Other minor side effects (such as abdominal pain, minor rectal bleeding, and general discomfort) were observed in 48% of participants
Worsoe et al. 2008 Denmark Case series N = 80	Population: 64F 16M; Age: mean (range) 51 (17-84) yrs. Main symptom was constipation for 48 participants, fecal incontinence for 20 and a combination of both in 12. Treatment: Antegrade colonic enema (ACE), or ACE combined with colostomy Outcome Measures: A 44-item questionnaire, including whether the patient is still using ACE and if not, why; functional results and side effects of ACE; overall satisfaction with bowel function and quality of life; success of treatment, defined as participants still using ACE or bowel symptoms resolved because of ACE	69 participants were available for follow up, of whom 43 were still using ACE and 8 had their symptoms resolved; ACE success rate was 74% Complications occurred in 30 participants, including wound infection, urinary tract infection, stenosis of the appendicostomy, and problems with catheterization 34 of the 43 patients still using ACE were satisfied or very satisfied with the results; on a 0-100 scale, mean values for subjective bowel function was 12 before and improved to 81 after ACE
Christensen et al. 2008; Europe Pre-post N = 62	Population: 45M 17F; mean (SD) age: 47.5 (15.5) yrs; level of injury: supraconal for 61, conal/cauda equina (S2-S4) for 1. 55/62 completed the studyTreatment: TAI (Peristeen Anal Irrigation) for a 10-week periodOutcome Measures: Cleveland Clinic constipation scoring system (CCCSS), St Mark’s fecal incontinence grading system (FIGS), Neurogenic bowel dysfunction (NBD) score (higher scores = worse outcomes)	Participants’ CCCSS mean scores significantly improved from 13.5 to 10.2. Participants’ FIGS mean scores significantly improved from 8.5 to 4.5. Participants’ NBD mean scores significantly improved from 15.3 to 10.8. Peristeen Anal Irrigation significantly improved constipation, anal continence, and symptom-related quality of life in SCI participants
Del Popolo et al. 2008; Italy Pre-post N = 36	Population: SCI patients with severe NBD and unsatisfactory bowel management; 32/36 completed the study. Cause of SCI: 42.4% trauma, 36.4% spina bifida, 6.1% MS, 3% surgery, 9.1% other, 3% not recorded. 39.4% sensory complete, 42.4% sensory incomplete, 18.2% not specified. Treatment: TAI (Peristeen Anal Irrigation) for three weeks Outcome Measures: Quality of life questionnaire (scale and nominal variables), participants’ opinions on their intestinal functionality, use of pharmaceuticals, dependence on caregivers, incidence of incontinence and constipation, abdominal pain or discomfort	Significant increase in the scores on the quality of life questionnaire, and on intestinal functionality opinion scores. Significant decrease in abdominal pain or discomfort. For the statement regarding abdominal pain or discomfort before or after evacuation, before: 9 answered never, 5 rarely, 6 occasionally, 6 often, 7 always; after: 24 never, 6 rarely, 3 occasionally. Significant decrease in incidence of fecal or gas incontinence. For the statement regarding gas incontinence, Before: 10 answered never, 9 rarely, 8 occasionally, 3 often, 2 always; After: 15 never, 11 rarely, 5 occasionally, 1 often, 1 always. Significant improvement of constipation (63% of participants experiencing constipation reported improvements). For the statement regarding difficult/painful exertion in connection with evacuation, Before: 5 answered never, 5 rarely, 4 occasionally, 10 often, 9 always; After: 21 never, 9 rarely, 3 occasionally, 1 often. 28.6% of participants reduced or eliminated their use of pharmaceuticals
Teichman et al. 2003; USA Retrospective chart review N=6; 3 SCI	Population: (for N=3 SCI) Level of injury: T5 complete, C6 complete, C7 incomplete; all males; Age: mean (range) 36 (29-47) yrs; Treatment: Malone antegrade continence enema (MACE) with mean follow-up 4.5 years Outcome Measures: Bowel incontinence; subjective patient satisfaction (patients were asked: “do you consider the surgical procedure beneficial to you” and “if you could do the ACE procedure again, would you?”)	2/3 participants experienced fecal incontinence prior to the operation. Post-operatively, both these participants became continent All 3 participants were satisfied with their outcomes and rated their quality of life higher after their MACE procedure compared with beforehand. All 3 participants experienced prolonged toileting pre-operatively as a result of bowel status. Post-operatively, the group had a significant reduction in their toileting times (pre-ACE mean (SD) time: 190(45) vs post-ACE: 28(20) min).
Christensen et al. 2000; Denmark Retrospective interviews and case series N=29; 19 SCI	Population: 1) TAI (enema continence catheter): N=21 participants (15/21 were SCI); 10M 11F; Age: mean (range) 39.9 (7-72) yrs; for SCI participants: Level of injury: 3 supraconal (T2 incomplete, T4 complete, T11 complete), 12 incomplete conal or cauda equina injuries; follow-up: mean (range) 16 (1-51) months 2) MACE: 8 patients, (4/8 were SCI); 3M 5F; Age: mean 32.8 years, range 15-66; 2 supraconal SCIs (C5-6 and T2, incomplete); mean follow-up 38 months, range 4-77 Treatment: TAI (enema continence catheter) vs. MACE (out of 8 MACE patients, 3 had tried ECC previously) Outcome Measures: questionnaire on colorectal function, practical procedure, impact on daily living and quality of life, general satisfaction of the patient with the treatment	Overall success with TAI was found in 12/21 patients (57%). In patients with fecal incontinence, TAI was successful in 8/11 (73%), while 4/10 (40%) with constipation were successfully treated. Overall success with the MACE was found in 7/8 (87%) patients. Successful treatment with TAI or the MACE was followed by significant improvement in quality of life
Teichman et al. 1998; USA Retrospective chart review N=7; 4 SCI	Population: (for N=4 SCI participants) Level of injury: 2 C6, 1 C7, 1 T5; all males; Age: mean (range) 32.5 22-47yrs; Mean follow-up: 11 months Treatment: MACE Outcome Measures: Number of fecal incontinence episodes per week, time for evacuation, bowel management episodes attempted	3/4 SCI participants experienced fecal incontinence prior to the operation. All became continent as a result of the operation. Pre-operatively, SCI participants’ toileting times ranged from 1-4 hours as a result of their bowel status. Post-operatively, these participants were able to evacuate within 30 minutes or less. Autonomic dysreflexia secondary to neurogenic bowel was resolved post-operatively.
Puet et al. 1997; USA Case series N=173	Population: 15 complete tetraplegia, 28 incomplete tetraplegia, 35 complete paraplegia, 95 incomplete paraplegia; 31 patients with pulsed irrigation evacuation (PIE). Treatment: Pulsed TAI:. intermittent, rapid pulses of warm water to break up stool impactions and stimulate peristalsis. Outcome Measures: Efficacy of technique (percentage success in removing stool), outpatient use	Successful in removing stool in all but three patients. 11 patients had multiple procedures. 162 procedures were performed on 4 outpatients on a regular basis because they otherwise could not develop an effective bowel routine with the standard digital stimulation, suppositories, or mini enemas.

Author Year; Country

Score

Research Design

Total Sample Size

Methods

Outcome

Christensen et al. 2006;

Denmark

PEDro = 7

RCT

N=87

Population:

1) TAI group: ≥T9: 3 complete, 5 incomplete; T10-L2: 1 complete, 1 incomplete; L3-S1: 1 incomplete); Age: mean 47.5 yrs; 29M 13F.

2) Conservative bowel management (CBM) group: ≥T9: 22 complete,11 incomplete; T10-L2: 1 complete, 3 incomplete; L3-S1, 8 incomplete Age: mean 50.6yrs; 33M 12F

Treatment: TAI (Peristeen Anal Irrigation system) or conservative bowel management (Paralyzed Veterans of America clinical practice guidelines) for 10 weeks.

Outcome Measures: Cleveland Clinic constipation scoring system (CCCSS), St. Mark’s fecal incontinence grading scale (FIGS), American Society of Colon and Rectal Surgeons fecal incontinence score (symptom-related QOL scale), NBD score.

The TAI group had significantly improved scores over the CBM group for the following scales: CCCSS: TAI=10.3(4.4); CBM=13.2(3.4) FIGS: TAI= 5(4.6); CBM=7.3(4) NBD: TAI=10.4(6.8); CBM=13.3(6.4)2. TAI group scored non-significantly better on 2/4 domains of the symptom-related quality-of-life tool and significantly better on the domains coping/behaviour (TAI=2.8(0.8) vs CBM=2.4(0.7)) and embarrassment (TAI=3.2(0.8) vs CBM=2.8(0.9)).
Improvement found in the TAI group as a whole was not confined to the more physically able patients
At weeks 7-10 participants had reduced time spent on bowel management each day, and reported being less dependent on help
The reported frequency of urinary tract infection during weeks 1-10 was lower in the TAI group (TAI=5.9%, CBM=15.5%).

Effect Sizes: Forest plot of standardized mean differences (SMD ± 95%C.I.) as calculated from pre- and post-intervention data

Kim et al. 2013;

Korea

Longitudinal

N=52

Population: Level of injury: 28 tetraplegics, 24 paraplegics; 41M 11F; Mean (SD) age: 44.5 (11.0) yrs; mean (SD) DOI: 92.9 (118.4) months

Treatment: Transanal irrigation (TAI)

Outcome Measures: Compliance rate, questionnaire on demographics, bowel care habits, frequency and time needed to defecate, intestinal symptoms, need for assistance during bowel management, participant satisfaction and quality of life, adverse events

Compliance with the use of TAI at 1, 3, and 6 months was 31/52 (59.6%), 25/52 (48.1%) and 18/52 (34.6%).
At 6 months, the noncompliant group contained a higher proportion of tetraplegics than paraplegics and a higher need for assistance during bowel management. At 6 months, 6/28 (21.4%) of tetraplegia patients and 12/24 (50%) paraplegic patients were using TAI.
In the compliant group, defecation time decreased from baseline to 6 months and quality of life increased from baseline to 6 months.

Smith & Decter 2015

USA

Prospective Cohort

N=17

Population: N=17 (12M, 5F)

Mean (range) age at surgery 33 (6-49)

Mean (range) time post SCI at surgery 10 (1-30) years

Mean time from surgery to follow-up 56 (4-102) months

10 paraplegia, 7 tetraplegia

9 thoracic, 8 cervical

N=5 excluded due to completing pre-operative survey after surgery (N=12 remain for final analysis)

Treatment: Anterograde continence enema (ACE)

Outcome Measures: Fecal incontinence quality of life (FIQL) instrument

Significant increase in mean (SD) of all categories of FIQL after surgery: Lifestyle: 2.3 (0.9) to 3.7 (0.5) Coping/Behaviour: 2.2 (0.9) to 3.8 (0.3) Depression/self-perception: 2.8 (0.9) to 3.8 (0.4) Embarrassment: 2.2 (1.1) to 3.8 (0.3)
Three patients developed stomal stenosis and one developed delayed small-bowel obstruction after surgery

Faaborg et al. 2009;

Denmark

Post-test

N = 211

Population: neurogenic bowel dysfunction 96M 115F; age: median 49yrs, range 7-81 yrs, who were introduced to transanal irrigation between 1994-2007. 74 traumatic SCI participants; 10 high complete, 12 high incomplete, 14 low complete, 38 low incomplete.

Treatment: TAI (Enema continence catheter; same as that used in Christensen et al. 2000)

Outcome Measures: Rate of success (treatment was considered successful if the patient is currently using TAI, if the patient used TAI until he/she died, or if the patient’s symptoms resolved while using TAI) as evaluated by a questionnaire, as well as the patient’s medical records; incidence of bowel perforation and other side effects

Successful outcomes in 98 (46%) of participants after a mean follow-up of 19 months (range 1-114 months)
Dropout rate of 20% in the first 3 months of using TAI
Success rate 3 years after introduction of TAI was 35%
The male gender, mixed symptoms (patients suffering from both constipation and fecal incontinence), and prolonged colorectal transit times were significantly correlated with successful outcomes
Chance One non-lethal bowel perforation occurred in approximately 50,000 irrigations (0.002%), whereas minor side effects were observed in 48%.
Other minor side effects (such as abdominal pain, minor rectal bleeding, and general discomfort) were observed in 48% of participants

Worsoe et al. 2008

Denmark

Case series

N = 80

Population: 64F 16M; Age: mean (range) 51 (17-84) yrs. Main symptom was constipation for 48 participants, fecal incontinence for 20 and a combination of both in 12.

Treatment: Antegrade colonic enema (ACE), or ACE combined with colostomy

Outcome Measures: A 44-item questionnaire, including whether the patient is still using ACE and if not, why; functional results and side effects of ACE; overall satisfaction with bowel function and quality of life; success of treatment, defined as participants still using ACE or bowel symptoms resolved because of ACE

69 participants were available for follow up, of whom 43 were still using ACE and 8 had their symptoms resolved; ACE success rate was 74%
Complications occurred in 30 participants, including wound infection, urinary tract infection, stenosis of the appendicostomy, and problems with catheterization
34 of the 43 patients still using ACE were satisfied or very satisfied with the results; on a 0-100 scale, mean values for subjective bowel function was 12 before and improved to 81 after ACE

Christensen et al. 2008;

Europe

Pre-post

N = 62

Population: 45M 17F; mean (SD) age: 47.5 (15.5) yrs; level of injury: supraconal for 61, conal/cauda equina (S2-S4) for 1.
55/62 completed the studyTreatment: TAI (Peristeen Anal Irrigation) for a 10-week periodOutcome Measures: Cleveland Clinic constipation scoring system (CCCSS), St Mark’s fecal incontinence grading system (FIGS), Neurogenic bowel dysfunction (NBD) score (higher scores = worse outcomes)

Participants’ CCCSS mean scores significantly improved from 13.5 to 10.2.
Participants’ FIGS mean scores significantly improved from 8.5 to 4.5.
Participants’ NBD mean scores significantly improved from 15.3 to 10.8.
Peristeen Anal Irrigation significantly improved constipation, anal continence, and symptom-related quality of life in SCI participants

Del Popolo et al. 2008;

Italy

Pre-post

N = 36

Population: SCI patients with severe NBD and unsatisfactory bowel management; 32/36 completed the study. Cause of SCI: 42.4% trauma, 36.4% spina bifida, 6.1% MS, 3% surgery, 9.1% other, 3% not recorded. 39.4% sensory complete, 42.4% sensory incomplete, 18.2% not specified.

Treatment: TAI (Peristeen Anal Irrigation) for three weeks

Outcome Measures: Quality of life questionnaire (scale and nominal variables), participants’ opinions on their intestinal functionality, use of pharmaceuticals, dependence on caregivers, incidence of incontinence and constipation, abdominal pain or discomfort

Significant increase in the scores on the quality of life questionnaire, and on intestinal functionality opinion scores.
Significant decrease in abdominal pain or discomfort. For the statement regarding abdominal pain or discomfort before or after evacuation, before: 9 answered never, 5 rarely, 6 occasionally, 6 often, 7 always; after: 24 never, 6 rarely, 3 occasionally.
Significant decrease in incidence of fecal or gas incontinence. For the statement regarding gas incontinence, Before: 10 answered never, 9 rarely, 8 occasionally, 3 often, 2 always; After: 15 never, 11 rarely, 5 occasionally, 1 often, 1 always.
Significant improvement of constipation (63% of participants experiencing constipation reported improvements). For the statement regarding difficult/painful exertion in connection with evacuation, Before: 5 answered never, 5 rarely, 4 occasionally, 10 often, 9 always; After: 21 never, 9 rarely, 3 occasionally, 1 often.
28.6% of participants reduced or eliminated their use of pharmaceuticals

Teichman et al. 2003; USA

Retrospective chart review

N=6; 3 SCI

Population: (for N=3 SCI) Level of injury: T5 complete, C6 complete, C7 incomplete; all males; Age: mean (range) 36 (29-47) yrs;

Treatment: Malone antegrade continence enema (MACE) with mean follow-up 4.5 years

Outcome Measures: Bowel incontinence; subjective patient satisfaction (patients were asked: “do you consider the surgical procedure beneficial to you” and “if you could do the ACE procedure again, would you?”)

2/3 participants experienced fecal incontinence prior to the operation. Post-operatively, both these participants became continent
All 3 participants were satisfied with their outcomes and rated their quality of life higher after their MACE procedure compared with beforehand.
All 3 participants experienced prolonged toileting pre-operatively as a result of bowel status. Post-operatively, the group had a significant reduction in their toileting times (pre-ACE mean (SD) time: 190(45) vs post-ACE: 28(20) min).

Christensen et al. 2000;

Denmark

Retrospective interviews and case series

N=29; 19 SCI

Population:

1) TAI (enema continence catheter): N=21 participants (15/21 were SCI); 10M 11F; Age: mean (range) 39.9 (7-72) yrs; for SCI participants: Level of injury: 3 supraconal (T2 incomplete, T4 complete, T11 complete), 12 incomplete conal or cauda equina injuries; follow-up: mean (range) 16 (1-51) months

2) MACE: 8 patients, (4/8 were SCI); 3M 5F; Age: mean 32.8 years, range 15-66; 2 supraconal SCIs (C5-6 and T2, incomplete); mean follow-up 38 months, range 4-77

Treatment: TAI (enema continence catheter) vs. MACE (out of 8 MACE patients, 3 had tried ECC previously)

Outcome Measures: questionnaire on colorectal function, practical procedure, impact on daily living and quality of life, general satisfaction of the patient with the treatment

Overall success with TAI was found in 12/21 patients (57%). In patients with fecal incontinence, TAI was successful in 8/11 (73%), while 4/10 (40%) with constipation were successfully treated.
Overall success with the MACE was found in 7/8 (87%) patients.
Successful treatment with TAI or the MACE was followed by significant improvement in quality of life

Teichman et al. 1998; USA

Retrospective chart review

N=7; 4 SCI

Population: (for N=4 SCI participants) Level of injury: 2 C6, 1 C7, 1 T5; all males; Age: mean (range) 32.5 22-47yrs; Mean follow-up: 11 months

Treatment: MACE

Outcome Measures: Number of fecal incontinence episodes per week, time for evacuation, bowel management episodes attempted

3/4 SCI participants experienced fecal incontinence prior to the operation. All became continent as a result of the operation.
Pre-operatively, SCI participants’ toileting times ranged from 1-4 hours as a result of their bowel status. Post-operatively, these participants were able to evacuate within 30 minutes or less.
Autonomic dysreflexia secondary to neurogenic bowel was resolved post-operatively.

Puet et al. 1997;

USA

Case series

N=173

Population: 15 complete tetraplegia, 28 incomplete tetraplegia, 35 complete paraplegia, 95 incomplete paraplegia; 31 patients with pulsed irrigation evacuation (PIE).

Treatment: Pulsed TAI:. intermittent, rapid pulses of warm water to break up stool impactions and stimulate peristalsis.

Outcome Measures: Efficacy of technique (percentage success in removing stool), outpatient use

Successful in removing stool in all but three patients.
11 patients had multiple procedures.
162 procedures were performed on 4 outpatients on a regular basis because they otherwise could not develop an effective bowel routine with the standard digital stimulation, suppositories, or mini enemas.

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