A Randomized, Controlled Trial of Transanal Irrigation Versus Conservative Bowel Management in Spinal Cord–Injured Patients

GASTROENTEROLOGY 2006;131:738 –747

A Randomized, Controlled Trial of Transanal Irrigation Versus Conservative Bowel Management in Spinal Cord–Injured Patients CLINICAL– ALIMENTARY TRACT

PETER CHRISTENSEN,* GABRIELE BAZZOCCHI,‡ MAUREEN COGGRAVE,§ RAINER ABEL,储 CLAES HULTLING,¶ KLAUS KROGH,# SHWAN MEDIA,** and SØREN LAURBERG* *Surgical Research Unit, Department of Surgery P, and #Department of Hepatology and Gastroenterology, Aarhus University Hospital, Aarhus, Denmark; ‡ Montecatone Rehabilitation Institute, University of Bologna, Bologna, Italy; §National Spinal Injuries Centre, Stoke Mandeville Hospital, Buckinghamshire, England; 储 Orthopädische Universitätsklinik Heidelberg, Heidelberg, Germany; ¶Spinalis, Karolinska Sjukhuset, Stockholm, Sweden; and **Centre for Paraplegia, Viborg Hospital, Viborg, Denmark

Background & Aims: Bowel dysfunction in patients with spinal cord injury often causes constipation, fecal incontinence, or a combination of both with a significant impact on quality of life. Transanal irrigation improves bowel function in selected patients. However, controlled trials of different bowel management regimens are lacking. The aim of the present study was to compare transanal irrigation with conservative bowel management (best supportive bowel care without irrigation). Methods: In a prospective, randomized, controlled, multicenter trial involving 5 specialized European spinal cord injury centers, 87 patients with spinal cord injury with neurogenic bowel dysfunction were randomly assigned to either transanal irrigation (42 patients) or conservative bowel management (45 patients) for a 10-week trial period. Results: Comparing transanal irrigation with conservative bowel management at termination of the study, the mean (SD) scores were as follows: Cleveland Clinic constipation scoring system (range, 0 –30, 30 ⫽ severe symptoms) was 10.3 (4.4) versus 13.2 (3.4) (P ⫽ .0016), St. Mark’s fecal incontinence grading system (range, 0 –24, 24 ⫽ severe symptoms) was 5.0 (4.6) versus 7.3 (4.0) (P ⫽ .015), and the Neurogenic Bowel Dysfunction Score (range, 0 – 47, 47 ⫽ severe symptoms) was 10.4 (6.8) versus 13.3 (6.4) (P ⫽ .048). The modified American Society of Colorectal Surgeon fecal incontinence scores (for each subscale, range is 0 – 4, 4 ⫽ high quality of life) were: lifestyle 3.0 (0.7) versus 2.8 (0.8) (P ⫽ .13), coping/behavior 2.8 (0.8) versus 2.4 (0.7) (P ⫽ .013), depression/ self perception 3.0 (0.8) versus 2.7 (0.8) (P ⫽ .055), and embarrassment 3.2 (0.8) versus 2.8 (0.9) (P ⫽ .024). Conclusions: Compared with conservative bowel management, transanal irrigation improves constipation, fecal incontinence, and symptom-related quality of life.

D

uring the past decade, the magnitude of bowel dysfunction in patients with spinal cord injury has been documented in several studies.1– 6 Spinal cord injury affects colorectal motility,7 transit times,8 –10 and bowel emptying,11,12 often leading to constipation, fecal incontinence, or a combination of both.1–5 Although these symptoms are not life-threatening, they may have a severe impact on quality of life1,2,6 and increase levels of anxiety and depression.2,4 Various bowel management programs have been empirical, and individual solutions have been sought on a trialand-error basis. The Paralyzed Veterans of America organization has proposed clinical practical guidelines regarding bowel management for patients with spinal cord injury,13

including the use of dietary plans, oral laxatives, rectal suppositories, and digital stimulation or digital evacuation. Transanal irrigation has been known since 1500 BC.14 Throughout medical history, transanal irrigation has been performed for various indications, such as cleaning of “toxic substances” from the bowel to prevent “autointoxication,” treatment of ileus, and ritual purification.15 In 1987, transanal irrigation was reinvented with the introduction of the enema continence catheter16 for children with bowel dysfunction due to spina bifida. The more pragmatic aims of this treatment were to prevent fecal incontinence and treat constipation. Since then, several studies have documented the efficacy and safety of the treatment in children.17–21 Transanal irrigation has also been used in selected adults with constipation or fecal incontinence.22–28 In spinal cord– injured patients, treatment with transanal irrigation is often difficult to manage due to immobility or impaired hand function and due to pathologic reflex contractions of the rectum and anal sphincters7,29 when performing transanal irrigation. However, the majority of spinal cord–injured patients in a recent study benefited from the treatment.23 There is limited evidence in the literature supporting any bowel management program in spinal cord injury in favor of another, and well-designed controlled trials are still lacking.30 Therefore, the present study aims to compare transanal irrigation with conservative bowel management, defined as best supportive bowel care without irrigation, in a prospective, randomized, controlled, multicenter study among spinal cord–injured patients with neurogenic bowel dysfunction.

Patients and Methods Patients Between December 2003 and June 2005, 87 patients (Figure 1 and Table 1) with spinal cord injury and neurogenic colorectal dysfunction were randomly assigned to either transanal irrigation or conservative bowel management. Patients were recruited from 5 spinal cord injury centers in 5 European countries (Spinalis, Karolinska Sjukhuset, Stockholm, Sweden; Montecatone Rehabilitation Institute, Bologna, Italy; Orthopädische Universitätsklinik, Heidelberg, Germany; National Spinal Injuries Centre, Stoke Mandeville Hospital, Buckinghamshire, England; and Centre for Para© 2006 by the American Gastroenterological Association (AGA) Institute

0016-5085/06/$32.00 doi:10.1053/j.gastro.2006.06.004

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Figure 1. plegia, Viborg Hospital/Surgical Research Unit, Aarhus University Hospital, Aarhus, Denmark). Each patient was classified according to the international standards for classification of spinal cord injuries based on the spinal segment damaged.31 Patients were then divided into 4 groups according to the effect of the injury on the complex innervations of the colon and rectum32: (1) high supraconal injury (T9 and above), above the level of the sympathetic outflow to the bowel causing loss of supraconal control of sympathetic innervation and loss of supraspinal control of parasympathetic innervation of the left colon and rectum; (2) intermediate supraconal injury (T10 –L2), affecting sympathetic outflow to the bowel and causing loss of supraspinal control of parasympathetic innervation of the left colon and rectum; (3) low supraconal injury (L3–S1), intact sympathetic outflow to the bowel but loss of supraspi-

Trial profile.

nal control of parasympathetic innervation of the left colon and rectum; and (4) conal or cauda equina lesion (S2–S4), causing damage to the sacral defecation center and to the sacral reflex arc, interrupting parasympathetic innervation of the left colon and rectum. Each group was then subdivided into complete or incomplete injuries. Patient baseline demographic data are shown in Table 1. Inclusion criteria were age 18 years or older with a spinal cord injury at any level at least 3 months after injury and at least one of the following symptoms: (1) spending a half hour or more attempting to defecate each day or every second day, (2) episodes of fecal incontinence once or more per month, (3) symptoms reflecting autonomic dysreflexia before or during defecation, and (4) abdominal discomfort before or during defecation. Exclusion criteria were as follows: coexisting major unsolved physical problems due to the injury, performance of

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Table 1. Baseline Demographic Data

CLINICAL– ALIMENTARY TRACT

Age (y), mean (SD) Sex Female Male Etiology Traumatic Vascular Sequelae to operation Tumor Spina bifida Slipped disc Other reason American Spine Injury Association score (complete/incomplete) T9 and above T10–L2 L3–S1 S2 and below Duration of bowel symptoms (mo) Median (range) Mobility Walking Impaired walking Using wheelchair Confined to bed Hand function No restriction Unilateral impaired function Bilateral impaired function No function Predominant symptom Fecal incontinence Constipation Other reason Dependency of help Independent Partly dependent Dependent Colonic transit time (days), mean (SD) Segmental colonic transit time (days), mean (SD) Cecum and ascending colon Transverse colon Descending colon Sigmoid colon and rectum Center United Kingdom Sweden Denmark Germany Italy

Transanal irrigation

Conservative bowel management

47.5 (12.8)

50.6 (14.1)

13 29

12 33

28 1 1 4 2 1 5

28 1 6 2 0 2 5

21/10 3/5 1/1 0/1

22/11 1/3 0/8 0/0

54 (4–780)

60 (3–540)

5 7 29 1

1 4 40 0

33 0 6 3

29 2 13 1

9 32 1

8 34 3

11 7 24 3.8 (1.5)

12 12 21 3.3 (1.5)

1.2 (0.8) 0.5 (0.5) 1.2 (0.9) 0.6 (0.6)

1.0 (0.8) 0.5 (0.5) 0.8 (0.7) 0.6 (0.6)

9 5 5 8 15

11 6 6 8 14

NOTE. Normal values of colonic transit times (days) in healthy controls, mean values (10): colonic transit time, 1.76; cecum and ascending colon, 0.44; transverse colon, 0.1; descending colon, 0.38; sigmoid colon and rectum, 0.34.

transanal irrigation on a regular basis, evidence of bowel obstruction or inflammatory bowel disease, history of cerebral palsy or cerebral apoplexy, multiple sclerosis, diabetic polyneuropathy, previous abdominal or perineal surgery (excluding

minor surgery such as appendectomy or hemorrhoidectomy), pregnancy or lactation, evidence of spinal shock, mental instability, treatment with more than 5 mg/day prednisolone, and implant for sacral nerve stimulation.

Design The study was a prospective, randomized trial and followed the recommendations from the CONSORT statement.33 It was approved by the local research ethics committees. Patients were prospectively screened in both inpatient and outpatient settings. Patients meeting the inclusion criteria were approached and informed both in writing and orally about the trial, after which written consent was obtained. Randomization was then performed from a computer-generated sequence obtained from opening a sealed numbered envelope. Patients were block-randomized across centers to ensure equal representation in the 2 groups at each center. The randomization sequence could not be previewed. Due to the nature of the 2 interventions, any blinding was impossible.

Assessments During the Study The primary end points of the study were scores on the Cleveland Clinic constipation scoring system34 (range, 0 –30, with 30 representing severe symptoms) and St Mark’s fecal incontinence grading system35 (range, 0 –24, with 24 representing severe symptoms). Secondary end points were the neurogenic bowel dysfunction score36 (range, 0 – 47, with 47 representing severe symptoms) (a newly developed and validated symptom score where each symptom of neurogenic bowel dysfunction is weighted concerning its impact on quality of life) and a modification of the American Society of Colon and Rectal Surgeons fecal incontinence score37 (a symptom-related qualityof-life score from which 4 subscales can be extracted: lifestyle [range, 1– 4, with 4 representing high quality of life], coping behavior [range, 1– 4, with 4 representing high quality of life], depression/self-perception [range, 1–5, with 5 representing high quality of life], and embarrassment [range, 1– 4, with 4 representing high quality of life]). The latter score was modified by replacing “symptoms of fecal incontinence” in each question with “symptoms of fecal incontinence or constipation.” The remaining secondary end points were assessed on numeric box scales: bowel function (range, 0 –10, with 10 representing perfect function), influence on daily activities (range, 0 –10, with 10 representing no influence), and general satisfaction (range, 0 –10, with 10 representing perfect satisfaction). At termination, the influence of the current bowel management on quality of life was assessed on a numeric box scale (range, 0 –10, with 0 representing great reduction and 10 representing great improvement). At inclusion, baseline demographic data and baseline values of primary and secondary end points were obtained. Furthermore, total gastrointestinal transit time and segmental colorectal transit times were determined.38 After the 10-week trial period, assessment of primary and secondary end points was repeated. During the trial period, patients were contacted each week by an independent observer who had not participated in the training of the subject. A short structured questionnaire was completed, covering symptoms during or after defecation, time consumption, urinary tract infections, level of dependency, and changes in additional medication with known influence on

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bowel motility. The last 4 weeks of the trial period were defined as steady state and were the period of main interest regarding performance of each intervention. Data collected during all 10 weeks were analyzed when assessing safety and side effects.

Sample Size The power of the study was determined by adding the scores from the Cleveland Clinic constipation scoring system34 and St Mark’s fecal incontinence grading system.35 Comparing means for this combined score at termination with the Student t test, the criterion for significance (␣) was set at .05 (2-tailed), the mean difference was set at 6, the common within-group standard deviation was set at 8.5, and the statistical power was at least 80%. Thereby, the proposed sample size would be 33 for each group. With an estimated withdrawal rate of 20%, a total of 80 patients had to be randomized. The minimum number of subjects to be included at each center was 10. To compensate for asymmetric inclusion rates, other centers were allowed to include more subjects than agreed, thereby increasing the power of the study.

Statistical Analysis For descriptive purposes, data are presented as means with standard deviations for quantitative variables and as absolute and relative frequencies for qualitative variables. Comparison of means at termination was performed with the Student t test. For nonparametric statistics, the Wilcoxon 2-sample test was used when appropriate and the ␹2 test was used for absolute frequencies. All significance tests were 2-sided. Data were analyzed on an intention-to-treat basis.39 Efforts were made to ensure assessments at premature withdrawal from treatment. The potential effect of missing responses was investigated by replacing missing responses at termination with the individual response at baseline. For missing responses in the weekly follow-up, a conservative strategy with last observation carried forward was used. The sponsor monitored data collection and performed data management.

Training of Participating Centers At the Surgical Research Unit of Aarhus University Hospital (Aarhus, Denmark), transanal irrigation has been used since 1994 for treatment of more than 500 selected patients with constipation or fecal incontinence with a heterogeneous pathology. To ensure sufficient knowledge about transanal irrigation at the participating centers, nurses who were selected to conduct the training of patients at each center were trained at an intensive 2-day course at the Surgical Research Unit of Aarhus University Hospital. Afterward, each center treated 5 spinal cord–injured patients with transanal irrigation. These cases were evaluated at a visit to each center by the specialized nurses from the Surgical Research Unit of Aarhus University Hospital before the center was given accreditation to include patients in the study.

Interventions A newly developed integrated system for transanal irrigation, the Peristeen Anal Irrigation system (Coloplast A/S, Kokkedal, Denmark), was used. Peristeen Anal Irrigation is specially designed to ease bowel irrigation in spinal cord– injured patients. It is an integrated system consisting of a coated rectal balloon catheter, a control unit including a man-

Figure 2. Peristeen Anal Irrigation system. (1) Coated rectal catheter with a balloon. (2) Manual pump. (3) Control unit. (4) Water bag. The catheter is inserted into the rectum and the balloon inflated to hold the catheter in the rectum while a tap water enema is administered with the manual pump. Pressure generated in the bag with the manual pump drives the irrigation fluid into the bowel. Subsequently, the balloon is deflated and the catheter is removed, followed by bowel emptying of the enema and other bowel contents.

ual pump, and a water container (Figure 2), thereby making it possible to handle the irrigation procedure without assistance from another person even for immobilized patients and for patients with poor hand function. The catheter was inserted into the rectum and the balloon inflated to hold the catheter in the rectum while a tap water enema was slowly administered with the manual pump. Subsequently, the balloon was deflated and the catheter removed, followed by bowel emptying of the enema and other bowel contents. The volume of water used, the degree of balloon inflation, and the frequency of enema administration were determined during the first weeks of treatment. The usual start volume was 750 mL of tepid tap water administered once a day. When feeling of effective emptying was achieved, the irrigation frequency was reduced to every second day or less. To increase efficacy, the volume could be increased gradually to 1500 mL if necessary. To reduce efficacy or to reduce possible soiling after irrigation, the volume could be reduced gradually to 250 mL. Laxatives or constipating medicine were used if the effect of irrigation was insufficient. Conservative bowel management was defined as best supportive bowel care without using irrigation. The Paralyzed Veterans of America clinical practical guidelines for bowel management13 were recommended. Bowel care was scheduled at least every 2 days, at the same time of the day and after ingestion of food and liquid to develop a habitual, predictable response and to take advantage of the gastrocolic response. Diet, fluids, and regular physical activity were used to modulate stool consistency appropriately. Use of laxatives or constipating medicine was recommended if noninterventional treatment was insufficient. Use of a large-volume phosphate enema and oral polyethylene glycol was restricted as emergency treatment for fecal impaction.

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Table 2. Outcome Measures at Baseline Transanal irrigation

CLINICAL– ALIMENTARY TRACT

Cleveland Clinic constipation scoring system St Mark’s fecal incontinence grading system Neurogenic bowel dysfunction score American Society of Colon and Rectal Surgeons fecal incontinence score Lifestyle Coping/behavior Depression/self-perception Embarrassment Numeric box scale Bowel function Influence on daily activities General satisfaction

Conservative bowel management

n

Mean

SD

n

Mean

SD

38 42 41

13.7 8.8 14.8

4.6 4.4 4.6

41 44 44

12.8 8.4 13.0

3.8 3.9 6.5

42 42 42 42

2.8 2.4 2.7 3.7

0.7 0.7 0.7 0.9

45 45 45 45

2.8 2.4 2.9 3.0

0.8 0.7 0.8 0.9

42 42 42

3.0 3.4 2.4

2.1 2.9 2.2

45 45 45

3.2 4.2 3.1

2.1 2.9 2.3

A specialist nurse conducted training of patients in transanal irrigation or conservative bowel management in the hospital or on an outpatient basis according to the local organization. Patients were encouraged to contact the specialist nurse for advice, especially at the initiation of training. Furthermore, the independent observer performing the weekly interview with the patient was instructed to refer any treatment-related questions to the specialist nurse, who could then refer to the responsible researcher at the local center if necessary.

Results Of the 124 eligible patients, 37 patients could not be included in the study. Therefore, 87 patients were included and randomly assigned to the 2 treatment groups: 45 patients to conservative bowel management and 42 patients to transanal irrigation (Figure 1). At baseline, there was no systematic difference between groups on comparing outcome parameters (Table 2). Of the 45 patients in the conservative bowel management group, 2 patients discontinued before training with the specialist nurse; one of these was lost to follow-up, and the other patient withdrew but completed the termination form. The remaining 43 patients completed the study and filled in termination forms at week 10. Of the 42 patients in the transanal irrigation group, 2 patients discontinued before training with the specialist nurse; one of these patients withdrew due to abdominal distention while taking markers for colonic transit time, and one withdrew informed consent. During training, 3 patients discontinued due to repeated expulsion of the rectal catheters during irrigation. All 3 patients completed the termination form. In study weeks 3 and 4, 5 patients discontinued: one due to lack of compliance, one due to dislike of treatment, one due to bursts of the rectal balloons, one due to insufficient effect, and one due to adverse events. At discontinuation, 4 of these 5 patients completed the termination form. In study weeks 8 –10, a further 2 patients were lost to follow-up. Therefore, assessments at termination can be found in a maximum of 37 in the transanal irrigation group and in a maximum of 44 in the conservative bowel management group (Figure 1). The outcome measures might be listed with a smaller number of patients due to single missing values in the individual score,

making calculation of the individual score impossible (Tables 2– 4). The outcome measures for the 2 groups are compared in Table 3. For all 3 bowel function scoring systems, the severity of symptoms at termination was significantly reduced in the transanal irrigation group. To investigate whether an apparent imbalance of the mobility between the 2 groups (Table 1) affected the outcome measures, the data are reported for mobile and immobile patients separately (Table 4). Performance during the trial period was evaluated each week, but performance in weeks 7–10 was defined as steady state and was therefore the period of main interest (Table 5). At termination, patients were asked for their level of dependency with actual bowel care compared with before the study. In the transanal irrigation group, 15 of 36 patients reported they were less dependent on help and 21 had no change. In the conservative bowel management group, 2 of 44 patients reported they were less dependent on help and 42 had no change (P ⬍ .0001). Performance of transanal irrigation among 37 patients using irrigation in weeks 7–10 is shown in Table 6. Space was left for comments in the questionnaire. Here bursts of the rectal balloon during irrigation were reported by approximately one in every 3 patients. During the trial period, symptoms during or after defecation were recorded in weeks 1–10 (Table 7). Urinary tract infections with prescribed antibiotics were reported during weeks 1–10 in 5.9% of patients in the transanal irrigation group and in 15.5% in the conservative bowel management group (P ⫽ .0052). The use of concomitant medication with known influence on bowel motility was registered at baseline, during the weekly interviews, and at termination. No difference between groups either at baseline or at termination was found. During the trial period, 4 episodes of adverse events were reported in patients randomized to transanal irrigation. One patient reported acute abdominal distention after taking the capsules for determination of colonic transit time before the initial training with the specialist nurse. The patient recovered quickly but decided to discontinue. One patient required hospitalization for treatment of a sacral pressure sore,

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Table 3. Outcome Measures at Termination

Cleveland Clinic constipation scoring system St Mark’s fecal incontinence grading system Neurogenic bowel dysfunction score American Society of Colon and Rectal Surgeons fecal incontinence score Lifestyle Coping/behavior Depression/self-perception Embarrassment Numeric box scale Bowel function Influence on daily activities General satisfaction Improvement in quality of life

N

Mean

SD

N

Mean

SD

P

39 42 41

10.3 5.0 10.4

4.4 4.6 6.8

41 45 45

13.2 7.3 13.3

3.4 4.0 6.4

.0016 .015 .048

42 42 42 42

3.0 2.8 3.0 3.2

0.7 0.8 0.8 0.8

45 45 45 45

2.8 2.4 2.7 2.8

0.8 0.7 0.8 0.9

.13 .013 .055 .024

42 42 42 35

5.2 4.5 5.2 6.3

3.0 3.2 3.5 2.9

45 45 45 44

3.5 4.1 3.6 4.2

2.3 2.8 2.8 2.5

.0048 .48 .023 .00009

NOTE. Intention-to-treat analysis with baseline observations carried forward for patients who did not complete the termination assessment. Numeric box scale for improvement in quality of life only at termination. Student t test for comparison of means.

which predated the study and was not related to bowel management. The same patient experienced repeated expulsion of the catheter during training and therefore discontinued. Severe abdominal pain leading to hospitalization was reported for 2 patients after 3 and 9 weeks of treatment, respectively. No serious conditions were found, and patients improved after disimpaction of constipated stool. One of these patients decided to discontinue.

Discussion Bowel dysfunction exerts a major impact on the life situation of patients with spinal cord injury.1,2,4 The present study is the largest randomized, controlled, multicenter trial addressing bowel management in patients with spinal cord injury. The aim of the study was to compare transanal irrigation with conservative bowel management, defined as best supportive bowel management without using irrigation. Before the study, many of the patients had struggled with bowel dysfunction for years. With their participation in this study, they were offered an opportunity to try transanal irrigation as a novel and attractive solution to managing bowel dysfunction. With a short trial period, this could have

influenced assessment of outcome parameters at termination in favor of transanal irrigation, thereby introducing a possibility of information bias. However, with a trial period of 10 weeks, a realistic short-term assessment of the treatment was possible. For all outcome measures, significant results in favor of transanal irrigation were found. Both the constipation score and the fecal incontinence score were significantly lower in the transanal irrigation group. The neurogenic bowel dysfunction score,36 where each symptom is weighted with respect to its impact on quality of life, was also significantly lower in the transanal irrigation group. Furthermore, the symptom-related quality-of-life tool showed significantly better scores in 2 of 4 subscales and tended to be better in the other 2 subscales. Of the 12 patients from the transanal group who discontinued the study, at least 7 discontinued due to reasons that can be regarded as failure of transanal irrigation. However, assessment at termination was completed in 6 of 7 patients with failure of transanal irrigation. Termination assessment was completed in all but one patient in the conservative bowel management group. Patients who discontinued the study could represent the patients with

Table 4. Influence of Mobility on Outcome Measures at Termination Transanal irrigation

Conservative bowel management

Score

Mobility

n

Mean

SD

n

Mean

SD

P

Cleveland Clinic constipation scoring system

Walking/walking with difficulties Wheelchair/confined to bed

12 27

11.7 9.7

5.1 4.0

5 36

14.2 13.1

1.9 3.5

.30 .0010

St Mark’s fecal incontinence grading system

Walking/walking with difficulties Wheelchair/confined to bed

12 30

8.4 3.6

5.3 3.5

5 40

7.8 7.2

5.4 3.9

.83 .0002

Neurogenic bowel dysfunction score

Walking/walking with difficulties Wheelchair/confined to bed

12 29

10.8 10.3

5.6 7.3

5 40

12.0 13.5

3.9 6.6

.68 .065

NOTE. Corrected values with baseline observations carried forward for patients who did not complete the termination assessment. Student t test for comparison of means.

CLINICAL– ALIMENTARY TRACT

Conservative bowel management

Transanal irrigation

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Table 7. Symptoms During or After Defecation

Table 5. Performance at Weekly Follow-Up

CLINICAL– ALIMENTARY TRACT

Conservative bowel management (n ⫽ 43)

P

47.0 (25.0)

74.4 (59.8)

.040

30.8 (19.4)

49.1 (48.2)

.094

0.3 (0.6)

0.3 (0.7)

.88

0.2 (0.4)

0.2 (0.5)

.83

0.2 (0.5)

0.4 (1.4)

.71

Transanal irrigation (n ⫽ 37) Total time spent on bowel management daily (min) Time spent sitting at the toilet (min) No. of episodes where due to fecal incontinence it was necessary to Change clothes (n ⫽ 39/41) Change bedclothes (n ⫽ 29/42) Take a bath (n ⫽ 29/41)

NOTE. Average in weeks 7–10, means (SD), last-observation-carriedforward, Wilcoxon 2-sample test.

poorest bowel function and the patients experiencing the most problems with treatment. When termination assessment is missing for these patients, the data are unavailable for analyses when following the intention-to-treat principle. Therefore, the missing data at termination were substituted with baseline data from the same patient. The data and the analysis are presented with these corrections. Despite randomization, the mobility status appears to be imbalanced between the 2 groups, with patients in the transanal irrigation group being less immobilized. However, Table 5 shows that wheelchair users and patients confined to bed seem to have the highest benefit of the treatment. Thus, the improvement found in the transanal irrigation group as a whole was not confined to the more physically able patients. Long-term follow-up data are still needed to confirm the results from this study. Variations in the effect of irrigation over time are common, although there is no evidence of tolerance development. It is possible that failures with transanal irrigation in the long term will occur in patients

Transanal irrigation (n ⫽ 37)

Conservative bowel management (n ⫽ 43)

P

63.8 15.7 1.4 7.0 3.0 5.4 10.5 3.0 2.7 5.9

47.9 26.7 9.5 5.8 6.7 5.8 22.3 6.0 8.8 20.2

.052 .15 .41 .60 .088 .21 .017 .28 .16 .062

4.6 17.3

8.1 30.0

.68 .099

No symptoms Abdominal pain (a) Anorectal pain (b) Chills (c) Nausea (d) Dizziness (e) Sweating (f) Pounding headache (g) Facial flushing (h) Pronounced general discomfort (i) Other (j) Symptoms reflecting possible autonomic dysreflexia (at least one of symptoms f–i)

NOTE. Symptoms during or after defecation during the past week were registered at weekly follow-up in weeks 1–10. “Other (j)” reflects rare symptoms not prelisted, such as anal bleeding, goose skin, leg cramps, and tiredness. The table shows the percent of total observations where patients answered “yes” to each symptom. Last observation carried forward. Wilcoxon 2-sample test.

who still experience symptoms of constipation and fecal incontinence despite irrigation treatment. If treatment with transanal irrigation fails, more invasive treatment modalities such as the Malone antegrade continence enema23,40,41 or a colostomy42 often help the patient. The results found in this study support previous findings in long-term studies. Long-term results with transanal irrigation in patients with functional bowel problems of heterogeneous origin have shown that 41%–75% of patients with fecal incontinence and 40%– 65% of patients with constipation benefit from the treatment.23,25,26 Transanal irrigation aims to ensure emptying of the left colon. This prevents fecal leakage between washouts and reestablishes control over time and place of defecation. A regular evacuation of the rectosigmoid furthermore prevents constipation. A recent scintigraphic study demonstrated emptying of the rectosigmoid and the descending colon following irrigation in patients with spinal cord injury and in patients with idiopathic fecal incontinence.24 This indi-

Table 6. Performance in Transanal Irrigation Transanal irrigation Frequency of irrigation Difficulties with insertion of the catheter Expulsion of the catheter Leakage of irrigation fluid beside the catheter Defecation not related to irrigation Needed help with irrigation procedure Volume of tap water (mL), median (range)

Every day 6

Every second day 18

1–3 times per week 13

None 31 27 21

Sometimes 5 6 7

Always 1 3 8

Yes 14 14 700 (200–1500)

No 23 23

NOTE. Average in weeks 7–10, n ⫽ 37, last observation carried forward.

cates that transanal irrigation in spinal cord–injured patients counteracts the usual disordered defecation that arises in response to an altered defecation reflex and disordered colorectal motility.12 In the present study, the inclusion criteria used selected patients experiencing more severe problems with bowel care. However, many spinal cord–injured patients achieve adequate bowel function with laxatives and digital stimulation alone. Further studies are therefore needed to be able to extend the results to the entire spinal cord injury population. The positive effects of transanal irrigation found in the present study also point toward extending the use of transanal irrigation to other selected patients with fecal incontinence or constipation. However, further controlled trials would be required to enable appropriate patient selection. Practical problems with transanal irrigation are to be expected, especially in patients with supraconal spinal cord injury. Studies have shown that these patients experience reduced rectal compliance due to hyperreactivity to distention of the rectum.7,11,43 However, in some cases, patients with supraconal injuries take advantage of this rectal hyperreactivity, because a majority use some kind of rectal stimulus to initiate defecation.1,44 In some patients, rectal hyperreactivity may also increase the effect of irrigation, but in others it may lead to strong contractions of the rectum and subsequently leakage of irrigation fluid or expulsion of the rectal catheter. In a previous study using a rectal balloon catheter (Mallinckrodt, St Louis, MO) in patients with neurogenic colorectal dysfunction, the main reasons for failure of transanal irrigation were expulsion of the rectal catheter and leakage of irrigation fluid beside the catheter.23 Furthermore, 74% of patients reported irrigation-related problems in a study of long-term transanal irrigation using a cone-shaped catheter design for colostomy irrigation (Biotrol Iryflex, B. Braun Medical BV, Oss, The Netherlands) in patients with defecation disturbances of a heterogeneous origin.25 The present study using the Peristeen Anal Irrigation recorded practical problems with irrigation prospectively and showed that difficulties with insertion of the catheter, expulsion of the catheter, leakage of irrigation fluid beside the catheter, or burst of the rectal balloon occurred in approximately one in 3 patients and was the cause of discontinuation in 4 patients. Although not strictly comparable, irrigation-related problems seem to be reduced using Peristeen Anal Irrigation compared with irrigation with the colostomy irrigation tip25 except for the occasional burst of rectal balloons. However, the present study confirms that treatment with transanal irrigation requires a willingness to deal with practical challenges and underlines the need for help and support from dedicated specialized nurses, especially when treatment is initiated. Due to the complex pathophysiology of neurogenic bowel dysfunction and due to the impaired mobility and often diminished hand function, bowel care is a time-consuming procedure in the everyday life of individuals with spinal cord injury, along with many other basic troublesome procedures.1,2 Therefore, any gain in time and any step toward independence improves daily life for these patients. An easyto-handle manual pump and control unit, the coated rectal catheter, and the specially designed water container in the Peristeen Anal Irrigation system are features that make it

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more possible for the spinal cord–injured patient to perform transanal irrigation independent of help. In the study, immobility or impaired hand function was no restriction to transanal irrigation, and in the transanal irrigation group, data from study weeks 7–10 showed significantly reduced time spent on bowel management each day. Furthermore, patients at termination reported being less dependent on help. These issues add to the benefits of transanal irrigation. The present study confirms that mild and transient symptoms during or after defecation are common in spinal cord– injured individuals, and there was a tendency for these to be less frequent in the transanal irrigation group. Theoretically, as for any anal evacuation procedure, there is a risk with transanal irrigation of inducing autonomic dysreflexia in patients with lesions above T9.45 No serious episode of autonomic dysreflexia was reported, and the data even showed that symptoms indicating autonomic dysreflexia (sweating, headache, flushing, or pronounced general discomfort) tended to be less frequent in the transanal irrigation group, most likely because the underlying fecal impaction was treated. This requires further study. Another interesting finding was that the frequency of urinary tract infection was significantly lower in the transanal irrigation group. There is a complex and not yet understood interaction between bladder and bowel dysfunction. An explanation for a possible protective effect of transanal irrigation could be that removal of fecal impaction promotes bladder emptying, thereby protecting against urinary tract infection. However, these findings also require further study. At baseline, there was no difference between groups in the use of per-oral laxatives, rectal suppositories, or constipating medicine. At termination, these proportions were unchanged, indicating that patients using transanal irrigation still have to use adjuvant medication to support bowel function. The conservative bowel management group was defined as “best supportive bowel care without irrigation.” Increasing evidence has been reported regarding the use of per-oral polyethylene glycol in the treatment of chronic constipation.46,47 It is possible that further studies including these modalities can improve noninvasive bowel care without irrigation in spinal cord–injured patients. In conclusion, this large-scale, randomized, controlled trial in spinal cord–injured patients with neurogenic bowel dysfunction shows strong benefits of using transanal irrigation. Compared with conservative bowel management, patients treated with transanal irrigation had fewer complaints of constipation, less fecal incontinence, improved symptomrelated quality of life, and reduced time consumption on bowel management procedures. Transanal irrigation was safe and was associated with only mild and transient side effects. References 1. Krogh K, Nielsen J, Djurhuus JC, Mosdal C, Sabroe S, Laurberg S. Colorectal function in patients with spinal cord lesions. Dis Colon Rectum 1997;40:1233–1239. 2. Glickman S, Kamm MA. Bowel dysfunction in spinal-cord-injury patients. Lancet 1996;347:1651–1653. 3. Harari D, Sarkarati M, Gurwitz JH, McGlinchey-Berroth G, Minaker KL. Constipation-related symptoms and bowel program concerning individuals with spinal cord injury. Spinal Cord 1997;35:394 – 401.

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4. Ng C, Prott G, Rutkowski S, Li Y, Hansen R, Kellow J, Malcolm A. Gastrointestinal symptoms in spinal cord injury: relationships with level of injury and psychologic factors. Dis Colon Rectum 2005;48:1562–1568. 5. Lynch AC, Wong C, Anthony A, Dobbs BR, Frizelle FA. Bowel dysfunction following spinal cord injury: a description of bowel function in a spinal cord-injured population and comparison with age and gender matched controls. Spinal Cord 2000;38:717–723. 6. De Looze D, Van Laere M, De Muynck M, Beke R, Elewaut A. Constipation and other chronic gastrointestinal problems in spinal cord injury patients. Spinal Cord 1998;36:63– 66. 7. Krogh K, Mosdal C, Gregersen H, Laurberg S. Rectal wall properties in patients with acute and chronic spinal cord lesions. Dis Colon Rectum 2002;45:641– 649. 8. Menardo G, Bausano G, Corazziari E, Fazio A, Marangi A, Genta V, Marenco G. Large-bowel transit in paraplegic patients. Dis Colon Rectum 1987;30:924 –928. 9. Nino-Murcia M, Stone JM, Chang PJ, Perkash I. Colonic transit in spinal cord-injured patients. Invest Radiol 1990;25:109 – 112. 10. Krogh K, Mosdal C, Laurberg S. Gastrointestinal and segmental colonic transit times in patients with acute and chronic spinal cord lesions. Spinal Cord 2000;38:615– 621. 11. MacDonagh R, Sun WM, Thomas DG, Smallwood R, Read NW. Anorectal function in patients with complete supraconal spinal cord lesions. Gut 1992;33:1532–1538. 12. Krogh K, Olsen N, Christensen P, Madsen JL, Laurberg S. Colorectal transport during defecation in patients with lesions of the sacral spinal cord. Neurogastroenterol Motil 2003;15: 25–31. 13. Clinical practice guidelines: neurogenic bowel management in adults with spinal cord injury. Spinal Cord Medicine Consortium. J Spinal Cord Med 1998;21:248 –293. 14. The Papyrus Ebers. Copenhagen, Denmark: Levin & Munksgaard, 1937. 15. Székely ED. The Essene Gospel of Peace. British Columbia, Canada: International Biogenic Society, 1937. 16. Shandling B, Gilmour RF. The enema continence catheter in spina bifida: successful bowel management. J Pediatr Surg 1987;22:271–273. 17. Eire PF, Cives RV, Gago MC. Faecal incontinence in children with spina bifida: the best conservative treatment. Spinal Cord 1998; 36:774 –776. 18. Walker J, Webster P. Successful management of faecal incontinence using the enema continence catheter. Z Kinderchir 1989; 44(Suppl 1):44 – 45. 19. Liptak GS, Revell GM. Management of bowel dysfunction in children with spinal cord disease or injury by means of the enema continence catheter. J Pediatr 1992;120:190 –194. 20. Scholler-Gyure M, Nesselaar C, van Wieringen H, van Gool JD. Treatment of defecation disorders by colonic enemas in children with spina bifida. Eur J Pediatr Surg 1996;6(Suppl 1):32–34. 21. Blair GK, Djonlic K, Fraser GC, Arnold WD, Murphy JJ, Irwin B. The bowel management tube: an effective means for controlling fecal incontinence. J Pediatr Surg 1992;27:1269 –1272. 22. Krogh K, Kvitzau B, Jørgensen T, Laurberg S. [Treatment of anal incontinence and constipation with transanal irrigation]. Ugeskr Laeger 1999;161:253–256. 23. Christensen P, Kvitzau B, Krogh K, Buntzen S, Laurberg S. Neurogenic colorectal dysfunction— use of new antegrade and retrograde colonic wash-out methods. Spinal Cord 2000;38:255– 261. 24. Christensen P, Olsen N, Krogh K, Bacher T, Laurberg S. Scintigraphic assessment of retrograde colonic washout in fecal incontinence and constipation. Dis Colon Rectum 2003;46: 68 –76.

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45. McGuire TJ, Kumar VN. Autonomic dysreflexia in the spinal cordinjured. What the physician should know about this medical emergency. Postgrad Med 1986;80:81– 84,89. 46. Attar A, Lemann M, Ferguson A, Halphen M, Boutron MC, Flourie B, Alix E, Salmeron M, Guillemot F, Chaussade S, Menard AM, Moreau J, Naudin G, Barthet M. Comparison of a low dose polyethylene glycol electrolyte solution with lactulose for treatment of chronic constipation. Gut 1999;44:226 –230. 47. Corazziari E, Badiali D, Bazzocchi G, Bassotti G, Roselli P, Mastropaolo G, Luca MG, Galeazzi R, Peruzzi E. Long term efficacy, safety, and tolerability of low daily doses of isosmotic polyethylene

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glycol electrolyte balanced solution (PMF-100) in the treatment of functional chronic constipation. Gut 2000;46:522–526.

Received February 1, 2006. Accepted May 18, 2006. Address requests for reprints to: Peter Christensen, MD, PhD, Surgical Research Unit, Department of Surgery P, Aarhus University Hospital, Tage Hansens Gade 2, DK-8000 Aarhus C, Denmark. e-mail: [email protected]; fax: (45) 89497709. Supported by Coloplast A/S, Continence Care Division, Kokkedal, Denmark.

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