Impact of Transanal Irrigation Device in the Management of Children With Fecal Incontinence and Constipation

Abstract

Objectives: 

Children with fecal incontinence and constipation can be classified into 3 groups: neurogenic bowel dysfunction (NBD) related to spinal cord defects (NBD), refractory constipation (RC), or anorectal malformations (ARMs). The transanal irrigation (TAI) device (Peristeen) was approved in 2012 by the Food and Drug Administration. This system uses a pump rather than gravity to instill water as a colonic irrigant and uses balloon occlusion of the rectum. Our aim was to evaluate the effectiveness of TAI (Peristeen) in children who failed to respond to conservative measures for stool incontinence and constipation.

Methods: 

Retrospective study of 147 patients prescribed TAI between January 2014 and January 2020. Data collected included demographics, prior bowel regimen, symptoms before and after, patient satisfaction scores, and NBD scores.

Results: 

Of the 147 patients initiated, 114 remain active users (13 lost to follow-up and 20 discontinued use). Multiple bowel regimens including laxatives (n = 139), cone enema (n = 40), and cecostomy (n = 7) were tried previously. The majority of our patients (n = 85) have NBD, primarily spina bifida, followed by RC (n = 43), and ARM (n = 19). For all patient groups, there was significant improvement in symptoms of fecal incontinence and constipation (P ≤ 0.001). Abdominal pain was improved in the NBD and RC group, but not significantly in the ARM group.

Conclusions: 

We provide a single-center review of a large pediatric cohort using TAI (Peristeen) for management of fecal incontinence and constipation. Peristeen offered significant improvement in patients with NBD, RC, and ARM.

What Is Known

• Transanal irrigation is a valuable therapeutic alternative in patients with functional or organic bowel dysfunction who have failed standard treatments. This method offers nonsurgical approach in the management of such patients.
• Transanal irrigation is available as a cone-based or catheter-based system and requires a tailored approach.
• Transanal irrigation has been to shown to be effective in the management of fecal incontinence in children with spina bifida, Hirschsprung disease, and defecation disorders due to anorectal malformations.
• Improvement in quality of life scores has been reported in studies evaluating the children treated with Peristeen for defecation disorders due to organic causes.

What Is New

• To our knowledge, our data represent the largest single-centered US-based study reporting treatment effect of catheter-based transanal irrigation in a large pediatric cohort with symptoms of bowel dysfunction in patients with spinal cord defects, refractory constipation, and anorectal malformations.
• Our study highlights patient approach in terms of training protocol, use of catheter, flush volume for irrigation, and bowel protocols.
• Utilizing motility studies to help with patient selection who may benefit from transanal irrigation.
• Earlier initiation of transanal irrigation leads to earlier independence with bowel management, improved satisfaction, and symptom resolution.

Neurogenic bowel dysfunction (NBD) is generally related to spinal cord lesions, mainly represented by open or closed neural tube defects (spina bifida). Spinal cord lesions affect colorectal motility, transit times, and bowel emptying often leading to constipation, fecal incontinence, or a combination of both. These symptoms have a negative impact on social activities and quality of life that worsens with age ^(1–9).

In contrast, patients with anorectal malformations (ARMs) have various degrees of anatomical anorectal deficit but preserved colonic peristalsis. For patients with more severe forms of ARM, a colostomy is often created at birth with the aim of performing a subsequent anorectal reconstruction. Often, they struggle with incontinence and constipation issues. Furthermore, a particular form of NBD may occur in children who have received surgery for Hirschsprung disease ⁽¹⁰⁾ or ARMs ⁽¹¹⁾.

A percentage of children with chronic idiopathic constipation with overflow soiling continue to suffer ^(12,13), and remain refractory to medical treatment ⁽¹⁴⁾. Soh et al ⁽¹⁴⁾ described refractory constipation (RC) as persistent symptoms of constipation following 12 weeks of continuous treatment with pharmacological agents at effective doses.

The quality of life is significantly decreased in each of these groups due to lack of bowel continence and stooling difficulties requiring most children to be diapered despite use of conservative approaches such as diet, exercise, toilet training, laxatives, biofeedback, or cognitive behavior therapy. In addition, some children require invasive surgical approaches such as sacral nerve modulation, bowel resection, ostomy, cecostomy or appendicostomy for antegrade colonic enemas ⁽¹⁾.

Transanal irrigation (TAI) can be traced back to ancient Egyptian papyrus (Eber's Papyri, 1500 BC) as a system for bowel cleansing, attempts to detoxify the bowel and prevent ileus ⁽¹⁵⁾. In 1987, Shandling and Gilmour demonstrated that fecal continence could be achieved by using enema continence catheters in children with spina bifida affected by fecal incontinence ⁽¹⁶⁾. Since then other studies have demonstrated the efficacy and safety of this treatment in children ^(17–21).

TAI with Peristeen for bowel dysfunction has been extended to not only include patients with congenital or acquired spinal cord lesion in adults and children ^{(18,19,22,23)}, but to manage fecal incontinence in patients with chronic constipation, ARM, and Hirschsprung disease ^(2,24). In addition, patient and caregiver satisfaction increase when using TAI in children with fecal incontinence and functional constipation ^(24,25). Together, these studies suggest that pediatric patients other than those with NBD and spina bifida can benefit from TAI.

The objective of our study was to evaluate the effectiveness of TAI catheter-based device (Peristeen) in 3 groups of pediatric patients with bowel dysfunction: NBD, RC, and ARM who are unresponsive to traditional medical management. Data were collected for outcomes on symptoms (stool frequency, incontinence, abdominal pain), NBD scores (for patients with NBD), independence with bowel management, treatment protocol, side effects, and satisfaction with treatment. Improvement in fecal incontinence was defined as having less than 2 stool accidents per month and improvement in constipation was defined as having 3 or more bowel movements per week.

METHODS

Study Population

At the Center for Digestive Health and Nutrition at Arnold Palmer Hospital for Children we retrospectively reviewed the electronic medical charts of 147 patients, aged 2 through 21 years old who were initiated on TAI catheter-based device (Peristeen) for bowel management from January 2014 to January 2020. Patients were stratified into 3 groups: NBD, ARM, and RC.

This study was approved by Institutional Review Board of Arnold Palmer Medical Center.

Measures

The data extracted included demographic information, prior bowel regimen therapies, recorded diagnostic studies, symptoms (i.e., fecal incontinence, constipation, and abdominal pain) age at which independence with bowel management was achieved, bowel protocol used, and NBD scores ⁽²⁶⁾. In addition, patient's and caregivers reported their satisfaction with the use of device (scale of 0–10 with 0 being total dissatisfaction and 10 being perfect satisfaction). Data were collected before device use and at follow-up intervals during clinic appointments which occurred at an average frequency of 4.6 ± 3.2 months.

Transanal Irrigation Catheter-based Device (Peristeen)

The TAI device used in this study was Peristeen. The system consists of a control unit with a pump, a water bag, and a rectal catheter. It is an enclosed catheter system with a precoated catheter and a soft inflatable balloon. The balloon catheter is placed through the anus into the rectum and then gently inflated to create a seal. Irrigation fluid is then passed through the catheter into the rectum, with a resultant retrograde colonic washout. Irrigations are performed with a volume of 10 to 20 mL/kg of water with schedules that are recommended for once daily use but may be adjusted depending on the patient's response. The irrigation goal is to provide the patient with an empty distal colon and rectum until the next washout, thus reducing fecal retention and the risk of fecal incontinence.

An important factor in maintaining compliance with TAI is the first training session which should be structured to promote realistic expectations about treatment efficacy, side effects, and to reduce discontinuation rates ⁽²⁷⁾.

Our Training Protocol

Training begins with review of printed handouts and a product video the parents and patient are required to watch before an in-person teaching session with the device. During the in-person teaching session, they meet with a nurse specialist where equipment assembly is demonstrated. A pediatric gastroenterologist performs a complete physical examination including a rectal examination to gauge anal tone, rectal compliance, and ensure no fecal impaction before training. The catheter size was based on age of the patient. A smaller or larger size catheter was used for a given patient if during training they experienced problem with catheter retention, issues with insertion, or creating a more effective seal during irrigation. Occasionally patients are prescribed laxative regimen before training to facilitate disimpaction based on prior history and examinations. The physician supervises the first TAI which is performed in office with the parent or caregiver to ensure the balloon volume, flush volume, and the technique of catheter insertion is well tolerated by the child. The patient undergoes a supervised irrigation and the caregiver is checked off on ability to show proficiency with the use of the equipment. The duration of the teaching session varies based on patient and family's comfort with the use of the device and outcome of irrigation. On average, sessions last 1 to 2 hours. We believe that having a dedicated team to teach and train the patient and parents who are new to TAI is important because families are often anxious about performing a TAI procedure. Having a training protocol is essential to ensure success, compliance, and confidence with the use of this technique. The nurse specialist remains available via telephone to answer any questions and address any difficulties after the first use.

Neurogenic Bowel Dysfunction Score

The NBD score is a validated standardized symptom-based scoring of bowel function in patients with spinal cord injury or disorders who have NBD ⁽²⁸⁾. This scoring system is intended for use among adult patients and was initially validated in 8 to 88 years old ⁽²⁸⁾. Thereafter, it was validated in the pediatric population ⁽²⁶⁾. These data were collected for our patients with NBD.

Statistical Analysis

Categorical variables are reported as count with percentages (n; %) and continuous variables are expressed as means with standard deviations (mean ± standard deviation). Information on interventions trialed prior Peristeen use and use of device (catheter size, average flush volume, pumps, duration of use, follow-up time [in years], and adverse events) are reported descriptively by group. Patient NBD scores before Peristeen and posttreatment are reported descriptively in the NBD group. To assess symptoms before and after starting Peristeen we used the McNemar test for significant change with a correction for continuity. The correction for continuity is applied to remove error ⁽²⁹⁾. Patient satisfaction scores were reported descriptively for all groups. Changes in sample size are due to missing data and noted when appropriate. SPSS 26.0 was used for statistical calculations; all tests were 2-tailed and statistical significance was set at P < 0.05.

RESULTS

Patients Enrolled

Of the 147 patients that initiated TAI (13 were lost to follow-up and 20 discontinued use). One hundred fourteen are currently using the device and were included in the analysis. The majority of the patients had NBD secondary to spinal cord defects primarily spina bifida (n = 85; 58%), RC (n = 43: 29%), and ARM (n = 19; 13%). Additional information on disease category is described in Table 1.

TABLE 1: Patient characteristics by disease category

Out of the patients who discontinued use 14% (n = 20/147); reasons for discontinuation were personal decision in 45% (n = 8/20), pain with use of the device in 10% (n = 2/20), mechanical problems with catheter in 10% (n = 2/20), surgical intervention in 15% (n = 3), insurance issues in 20% (n = 4/20), and significant improvement no longer requiring the device in 5% (n = 1/20).

Average Age and Duration of Use

The average age at initiation of TAI device was 9 ± 4.6 years old. The median and mean follow-up time is 3 and 4.5 months, respectively. The average duration of usage was 14.4 months. Thirteen percent (n = 19) used the device for >2 years.

Before initiation of Peristeen, multiple bowel regimens had been prescribed, including osmotic and stimulant laxatives 95% (n = 139), cone enema and other enemas 27%; 23% (n = 40; n = 34, respectively), suppositories 25% (n = 36), Botox injection to anal sphincter 10% (n = 15), biofeedback training 17% (n = 25), and cecostomy 5% (n = 7).

Symptoms Before and After Use

There was significant improvement in symptoms of fecal incontinence and constipation in all groups, after starting Peristeen (P ≤ 0.001; Table 2). Abdominal pain was improved in the NBD and RC group (P ≤ 0.001; Table 2), but not significantly in the ARM group (P = 0.219; Table 2). NBD scores decreased with usage showing improvement in bowel function (Fig. 1) in the NBD group ⁽³⁰⁾.

TABLE 2: Symptoms before and after Peristeen initiation

FIGURE 1: Duration of use and NBD scores for spinal cord defect (NBD) group. NBD = neurogenic bowel dysfunction.

Satisfaction Scores

Overall, patient satisfaction (scale 0–10) with the use of Peristeen was 8.75 ± 1.97.

Adverse Events

The most commonly reported adverse events were pain with insertion 2% (n = 3), abdominal cramping with administration of irrigation 2% (n = 3), difficulty with catheter retention 2% (n = 3), and perianal irritation 0.7% (n = 1). One patient in the spinal cord defects group experienced rectal prolapse that was easily reduced with no further occurrence. There were no colonic perforations, fluid and electrolyte abnormalities, or mortalities related to the use of the system.

Bowel Protocol Used

The average flush volume was 15 mL of warm tap water/kg body weight. No additives were used in the irrigation fluid; all of our patients were recommended only warm tap water to perform TAI. Most patients 81% (n = 117) used between 1 and 2 pumps of air to inflate the balloon for catheter retention. Frequency to perform TAI in majority of our patients was once daily, in 4% (n = 6), irrigations were performed every other day.

Surgical Intervention Before or After Using Transanal Irrigation

Of the 7 patients who had cecostomy before Peristeen, all ceased use of their cecostomy and 2 had cecostomy reversal (Table 3). Three patients underwent surgical intervention after initiating Peristeen. One patient lost insurance coverage for the device; another patient did not like using the device. Both elected cecostomy placement. The third patient had a failure of both prior cecostomy and Peristeen and elected for colectomy with diverting ileostomy.

TABLE 3: Demographics of all Peristeen users (past and current) (n = 147)

Motility Studies for Patient Selection

In the NBD group, 23 patients out 85 underwent motility testing. One hundred percent (n = 23/23) showed abnormalities on anorectal manometry testing.

In the RC group, 38 patients out of 43 underwent motility testing. Ninety-seven percent (n = 37/38) patients had abnormalities either on colonic or on anorectal manometry testing.

In the ARM group, 11 patients out of 19 underwent motility testing. One hundred percent (n = 11/11) showed abnormalities on anorectal manometry testing.

Independence With Bowel Management

In the NBD group, 21% (n = 13/63) of patients were fully independent in the use of the system, 28% (n = 18/63) required some assistance, and 51% (n = 32/63) were fully dependent on caregiver assistance. In the RC group, 22% (n = 7/32) of patients were fully independent in the use of the system, 44% (n = 14/32) required some assistance, and 34% (n = 11/32) were fully dependent on a caregiver assistance, and in the ARM group, 27% (n = 3/11) of patients were fully independent in the use of the system, 18% (n = 2/11) required some assistance, and 55% (n = 6/11) were fully dependent on caregiver assistance.

In our study 22% (n = 23/106) achieved full independence with bowel management with an average age of 14 ± 4.6 years old. Some assistance from caregiver was required in 32% (n = 34/106) of the patients, who had an average age of 10.2 ± 4.6 years old. Full assistance was required in 46% (n = 49/106) patients with an average age of 7 ± 4.5 years old.

DISCUSSION

The effective management of children with fecal incontinence, secondary to a variety of congenital and acquired anomalies or to RC, represents a significant challenge to families and caregivers. Incontinence has a significant impact on quality of life, leading to loss of self-esteem, social isolation, and depression ⁽³¹⁾.

Patients with spinal cord lesions, either congenital or acquired have an anatomically intact rectal ampulla, anal canal, and sphincter but experience constipation and incontinence due to compromise to their enteric nervous system, reduced sensation, and limited mobility. In these children, anal squeeze pressure, anorectal sensitivity, and anal resting pressure may also be impaired, whereas rectal compliance may be reduced due to hyperreactivity of the rectum ^(9,32). Anorectal manometry testing is a useful tool to measure anorectal function and anorectal neuropathy in NBD ⁽³³⁾. In our study, motility testing with anorectal and colonic manometry was found to be helpful in patient selection, by identifying abnormal continence mechanisms and colorectal motility in symptomatic children. In these patients, traditional enemas are difficult to administer because they are difficult to retain in patients with NBD, with most of the enema flowing out involuntarily through the weak anus during instillation. Laxatives can cause more incontinence in NBD due to difficulty controlling liquid stools. In these cases, TAI can be useful as it aims to ensure emptying of the left colon, preventing incontinence between the washouts and reestablishes control over time and place of defecation. A regular evacuation of the rectosigmoid furthermore would prevent constipation and fecal incontinence. The exact mechanism behind colonic irrigation is still not well known. The effect of water administration is in part due to a simple mechanical washout effect. It has also been suggested that the administration of water generates colonic mass movements ⁽³⁴⁾.

A systematic review of studies describing the use of different methods of TAI colonic irrigation in children including a total of 672 patients, reported an overall success rate of 88% (81% in children with constipation and 90% in children with incontinence) ⁽³⁵⁾. In those children in whom TAI is not effective in controlling fecal incontinence and constipation, more invasive techniques, such as MACE or sacral nerve stimulation have a place ^(36,37). Alenezi et al ⁽³⁸⁾ prospectively evaluated TAI catheter–based device (Peristeen) in children with neuropathic bladder and bowel dysfunction as an alternative to MACE (Malone antegrade continence enema) and found a success rate of 83.3%. In our study, patients who had treatment failure with cecostomy initiated TAI with good results and discontinued anterograde flushes. Although majority of the patients with RC showed symptom resolution of fecal incontinence and constipation, they failed to demonstrate spontaneous stooling without the use of TAI. In the 1 patient reported with resolution of symptoms, there was demonstration of spontaneous stooling in the absence of using TAI.

There are several articles referring to patient satisfaction ^{(19,20,22,34,39)} and quality of life ^(22,34,39), both of which in the majority of cases are assessed on Likert scales. The studies reported medium to high levels of satisfaction using TAI regimes. Corbett et al ⁽⁸⁾ observed patients using the Peristeen demonstrated improved quality of life scores. Our data also show similar high patient satisfaction scores.

Independence with bowel management using TAI (Peristeen) is defined as self-administering the device. It is an important factor in maintaining bowel continence ⁽³⁴⁾. Other factors that affected independence with use of the system included manual dexterity, level of spinal cord function, body habitus, mobility, and neurodevelopmental status.

The adverse effects of using TAI in our study were similar to others reported in the literature. Potential complications include leakage, catheter expulsion, burst of balloon, or pain on catheter insertion ⁽¹⁾. There is only 1 nonlethal perforation requiring surgery reported in the literature with an estimated risk of perforation 0.0002% per irrigation, in the study for adult patients ⁽⁴⁰⁾. There were no bowel perforations or other lethal complications in our large cohort. In our cohort of patients, we had 3% (n = 4) children report mild abdominal discomfort or pain during TAI use which is similar to that reported by previous studies ^{(19,22,39,41,42)}. The use of TAI is contraindicated in less than 2 years of age in USA, active inflammatory bowel disease, ischemic colitis, anal or colorectal stenosis, or within 3 months of anal or colorectal surgery ⁽¹⁾.

According to recent research, one of the most important factors in maintaining the compliance with TAI is the first training session. This suggests that the initial session should be structured to promote a realistic expectation about treatment efficacy, side effects, and to reduce discontinuation rates ⁽²⁷⁾. In our study, our patients continue to use TAI on average 14.4 months after initiation and we do attribute this to our initial training protocol.

Type of TAI device used may be influenced by availability, reimbursement, and clinical support in different global settings ⁽¹⁾. Our literature search on this topic revealed a majority of the studies were done in European countries, using Peristeen device to provide TAI treatment ⁽¹⁾. There was almost no data from the United States and we suspect this is mainly due to availability of the device that varies regionally, mainly due to reimbursement models, difficulty with insurance coverage for the device. Peristeen has been available in Europe since 2006. It was FDA approved in the USA in 2012. To our knowledge, our study is the largest study in the USA reporting the treatment effect of TAI using Peristeen in a large pediatric cohort with symptoms of refractory bowel dysfunction in patients including NBD, RC, and ARM.

Across our 3 study groups we were able to show statistically significant improvement in symptoms. Our study showed similar results as previous literature on fecal incontinence in children with spina bifida, chronic idiopathic constipation, and ARMs ^(8,34,43).

TAI is a prescribed regime, which should only be considered as a treatment after assessment by a qualified healthcare professional. In recent years, TAI has become a popular option in the management of NBD due to its successful results and acceptable safety profile ⁽¹⁾.

Our study is limited due to the retrospective nature of this study and the inherent bias. The study has limitations including lack of control subjects. We would need more longitudinal data to assess whether RC is amenable to symptom resolution with long-term use of TAI. When studying TAI benefits with NBD and ARM patients, case control studies are needed to compare outcomes using alternative bowel management strategies.

TAI is, however, an increasingly successful treatment in adults and children with bowel dysfunction who do not respond to conservative treatments ^(44–46). It is well tolerated, safe, and effective.