Clinical UM Guideline

Transanal irrigation involves the introduction of water into the rectum using a gravity fed or pump system via a rectal catheter with an integral cone or balloon. Transanal irrigation results in an emptying of the lower bowel (rectum and distal sigmoid colon) and is used to prevent fecal incontinence (FI, uncontrolled bowel movements) or to relieve and prevent constipation. Transanal irrigation may sometimes be included in a bowel management program for patients with neurogenic bowel dysfunction.

Note: Please see the following related documents for additional information:

• CG-REHAB-07 Skilled Nursing and Skilled Rehabilitation Services (Outpatient)
• MED.00141 High-volume Colonic Irrigation
• SURG.00102 Artificial Anal Sphincter for the Treatment of Severe Fecal Incontinence

Note: For a high-level overview of this document, please see "Summary for Members and Families" below.

Medically Necessary:

Transanal irrigation is considered medically necessary when ALL the following criteria (A through D) are met:

1. The individual is at least 2 years of age; and
2. Diagnosed with one or more of the following conditions:
   1. Neurogenic bowel dysfunction; or
   2. Congenital disorder such as Hirschsprung disease or anorectal malformations; or
   3. Fecal incontinence; or
   4. Chronic constipation;
      and
3. Requires bowel management procedures that significantly impact the individual’s quality of life (for example, interferes with ability to fully participate in school or work); and
4. An adequate course of conservative medical management (including any combination of dietary modifications, bowel training, laxatives or constipation medications) has been unsuccessful or is contraindicated.

Not Medically Necessary:

Transanal irrigation is considered not medically necessary when the criteria above are not met.

This document describes clinical studies and expert recommendations, and explains when treatments that use water to help empty the bowels through the rectum (transanal irrigation treatments) are clinically appropriate. The following summary does not replace the medical necessity criteria or other information in this document. The summary may not contain all of the relevant criteria or information. This summary is not medical advice. Please check with your healthcare provider for any advice about your health.

Key Information

Transanal irrigation, or TAI, is a bowel treatment that sends water into the rectum through the anus. It may use a gravity fed or pump system. TAI helps empty the lower bowel. It may help prevent stool accidents or constipation. It may be part of a bowel care plan for people with nerve related bowel problems. People may need training and support to use it safely.

What the Studies Show

Studies suggest TAI may help some people with nerve related bowel problems have fewer stool accidents, less constipation, more independence, and better quality of life. Some studies in children also suggest TAI may help constipation or stool accidents when other treatments have not worked.

Study limits include small groups, short follow up, and different ways of measuring results. Harms can include belly pain, sweating, chills, dizziness, rectal bleeding, discomfort, and pain during use. A rare but serious harm is a tear in the bowel. Better studies are needed to know how well TAI improves health for some groups, such as people without nerve related bowel problems.

When is Transanal Irrigation Clinically Appropriate?

TAI may be appropriate when all of these are present:

• The person is at least 2 years old; and
• The person has nerve related bowel problems, Hirschsprung disease, an anorectal malformation, stool accidents, or long lasting constipation; and
• Bowel care has a major effect on quality of life, such as making it hard to take part in school or work; and
• Other care has not worked or cannot be used, such as diet changes, bowel training, laxatives, or constipation medicines.

When is this Not Clinically Appropriate?

TAI is not clinically appropriate when the criteria above are not met. This is because the document only supports use when age, condition, quality of life impact, and past treatment criteria are met.

(Return to Description)

The following codes for treatments and procedures applicable to this guideline are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services may be Medically Necessary when criteria are met:

Associated Coding

When services may also be Medically Necessary for associated supplies when criteria are met for the device codes listed above:

When services are Not Medically Necessary:
For the procedure codes listed above when criteria are not met.

Summary

Transanal irrigation (TAI) involves the passing of water into the bowel via the anus in a sufficient enough quantity to reach beyond the rectum (Todd, 2024). TAI can be used by individuals with bowel dysfunction to empty the rectum and some of the colon at a time and frequency that is suitable to them, and to avoid constipation and FI. The decision to use TAI does not depend solely on the specific bowel dysfunction but will also be determined by the individual’s degree of mobility, manual dexterity, independence, caregiver availability, home setting and personal preference. Individuals may require time, training, and support to get comfortable with and proficient at using it. Research has demonstrated that in some individuals with spinal cord injury (SCI) with neurogenic bowel dysfunction (NBD), TAI can reduce the severity of chronic constipation, as well as reduce the severity and frequency of FI (Mosiello 2017).

TAI is not considered the first treatment option for individuals with SCI NBD. Alternative treatment options include but are not necessarily limited to medication (oral drugs, suppositories, and enemas), dietary modification, and physiotherapy. Individuals with NBD may also manage their symptoms using biofeedback, bowel washouts and manual evacuation of feces. Some individuals may prefer or require surgical intervention, for example, colostomy, ileostomy, sacral nerve stimulation, an antegrade continence enema or stoma.

The majority of peer-reviewed scientific literature on TAI focuses on individuals with NBD. While some studies are limited by small sample sizes, lack of randomization, and short follow up periods, the overall evidence indicates that TAI may result in a reduction of FI, increased independence, and improved quality of life (QOL) in this population. In addition, TAI provides a non-surgical option in individuals with NBD when other conservative measures have failed. Several professional or medical societies support the use of TAI as a treatment of FI and constipation in individuals with NBD who have not achieved adequate relief through dietary and lifestyle modification, laxatives, enemas, suppositories, or manual evacuation. Evidence of effectiveness in children without NBD (primarily functional constipation) is based on a smaller number of studies as expert opinion and literature reviews.

Discussion

Transanal irrigation (TAI) is a bowel management technique in which water is introduced into the rectum and lower colon through a rectal catheter or cone to facilitate evacuation of stool. TAI is intended to improve bowel emptying and reduce symptoms of constipation, FI, and prolonged bowel management in selected individuals.

Several TAI devices have received 510(k) marketing clearance from the United States Food and Drug Administration (FDA). Available devices include but are not necessarily limited to: Peristeen^® Plus (Coloplast, Minneapolis, MN) TAI system; Navina Smart System and Navina Classic System (Dentsply Sirona, York, PA). According to information on the FDA 510(k) summaries:

The Navina Systems are indicated for use in children (2 - < 12 years old), adolescents (12 - < 18 years old), and transitional adolescents (18 - < 21 years old) patients with neurogenic bowel dysfunction, congenital disorders such as Hirschsprung disease or anorectal malformations, fecal incontinence or chronic constipation where less invasive therapies are not successful, as well as, for adults who suffer from fecal incontinence, chronic constipation, and/or time consuming bowel management. Use for pediatric patients is to be performed under the supervision of a trained healthcare professional or adult caregiver. By instilling water up into the lower part of the colon, the Navina Systems promote evacuation of the contents of the colon and rectum (FDA, 510[k]a).

The Peristeen Anal Irrigation System is intended to instill water into the colon through a rectal catheter - which incorporates an inflatable balloon - inserted into the rectum to promote evacuation of the contents of the lower colon. The Peristeen Anal Irrigation System is indicated for use by children (2 years -< 12 years old), adolescent (12 years - < 18 years old), transitional adolescent (18 - <2 1 years old) and adult patients with neurogenic bowel dysfunction who suffer from fecal incontinence, chronic constipation, and/or time-consuming bowel management procedures (FDA, 510[k]c).

Contraindications for TAI have been suggested (Emmanuel, 2013).

Absolute Contraindications:
Active inflammatory bowel disease; or
Acute diverticulitis; or
Anal stenosis; or
Colorectal cancer; or
Endoscopic polypectomy within the previous 4 weeks; or
Ischemic colitis; or
Rectal stenosis; or
Rectal surgery within the previous 3 months.

Relative Contraindications:
Dense sigmoid disease; or
Diverticular abscess, or
Fecal impactions; or
History of diverticulitis, or
Long-term steroid medication; or
Rectal surgery; or
Severe diverticulosis.

Chronic Constipation and FI

Constipation and FI may be the result of either functional or organic disorders. Functional bowel disorders are diagnosed when symptoms occur without an identifiable structural or neurologic cause, whereas organic bowel disorders result from an underlying anatomic, neurologic, or disease-related condition.

Organic bowel dysfunction is relatively rare and most often caused by a congenital condition that has a neurological or anatomical origin. Individuals with NBD (discussed below) are frequently affected by organic constipation and organic FI related to open or closed spina bifida, anorectal malformations or Hirschsprung disease. In approximately 95% of children, no organic cause is found, and these children are diagnosed with functional constipation (FC). Functional (idiopathic) constipation and functional (idiopathic) FI are diagnosed when an individual is experiencing symptoms of constipation or FI, but no specific cause can be identified. Initial management consists of education, toilet training, and laxative treatment (Baaleman, 2022; Mosiello, 2017).

Juul and colleagues (2017) reported the results of an uncontrolled study that examined the effects of TAI on bowel function and QOL in a group of Danish participants with FI or constipation due to various causes. If the participants did not obtain satisfactory results after conservative bowel management, they were instructed in the use of the TAI procedure and were consecutively recruited for this observational cohort study that lasted from March 2010 to September 2013. Participants completed questionnaires regarding bowel function, QOL, and the TAI procedure at baseline and after 12 months. Of the 507 participants that were introduced to TAI; 83% were women and the median age was 56 (range of 19 to 86) years. At follow-up, 216 (43%) of participants continued to use TAI, while 174 (34%) reported that they had discontinued the treatment for a variety of reasons. Of the 174 participants that discontinued TAI treatment, 86 (49.4%) indicated that they discontinued treatment due to an unsatisfactory outcome. No response was obtained from the remaining 117 (23%) participants. Among participants still using TAI at follow-up, a statistically significant improvement of bowel function scores (St. Marks/Wexner incontinence score, Wexner constipation score and obstructed defecation syndrome score) was demonstrated. The Wexner incontinence score declined from 12.4 at baseline to 10.2 at follow-up (p<0.001); the St. Marks incontinence score declined from 14.9 to 12.7 (p<0.001); the Wexner constipation score declined from 14.3 to 12.4 (p<0.001); and the obstructed defecation syndrome score also decreased, from 15.1 to 11.8 (p<0.001). Additionally, the effect of bowel dysfunction on daily activities and QOL decreased significantly, while the overall satisfaction with bowel function increased significantly (p<0.001 in all 3 measures). The authors concluded that bowel function and QOL improved in the cohort adhering to TAI after 12 months. However, when interpreting the results, one must bear in mind that analysis was only performed for participants who completed the entire study period and more than 1/3 of the participants discontinued TAI treatment within the 1st year. Additionally, QOL and adverse events were not separately evaluated for participants with FI (participants with constipation were also included in analysis). The authors reported no serious adverse events.

Researchers have also investigated the use of TAI in pediatric patients with chronic constipation and FI.

A randomized trial conducted in Denmark found that adding low-volume transanal irrigation (L-TAI) to standard oral laxatives significantly improved outcomes for 50 children suffering from refractory functional constipation and retentive FI (Larsen, 2026). The two-arm randomized controlled trial investigated whether L-TAI is effective as add-on to oral laxative therapy for children with functional constipation and retentive FI. The study enrolled a total of 50 children aged 4-14 suffering from retentive FI refractory to at least 2 months of treatment with stool softening oral laxatives. Participants were included across three pediatric departments in Denmark and randomized into two treatment groups. Participants received the intervention for a span of 6 weeks. The control group remained on oral laxative therapy. The intervention cohort received L-TAI as add-on. The primary objective was to measure how well treatments lowered FI episodes. Secondary goals tracked constipation symptoms, rectal diameter, and overall well-being based on the WHO-5 questionnaire. Participants were grouped by symptom improvement: nonresponders (less than 50% reduction) or responders (partial response = 50%-99% reduction, or full response = 100% reduction). Of the 50 children included in the study, those in the intervention group (median age 7) showed significantly better constipation relief than the control group (median age 6). The intervention group had a 75% response rate with 35% obtaining full relief, while 33% in the control group were responders with 4.8% achieving a full response. Furthermore, at follow-up, only 55% of the intervention group still met Rome-IV constipation criteria, compared to 90.5% of controls. The authors concluded that L-TAI is an effective addition to oral laxatives for managing FI and constipation.

Bolia and colleagues (2024) reported the results of a systematic review and meta-analysis designed to evaluate the effectiveness, safety, and outcomes of TAI in children with functional constipation. A total of 482 articles were included in the systematic search. After the removal of 203 duplicative articles, 279 articles were screened, and 274 articles eliminated. The remaining 5 studies (n=192) included in the final analysis detailed the utility of TAI in functional constipation. Two studies were conducted prospectively, while the remaining were either cross‐sectional surveys or retrospective reviews. These studies included a total of 192 children with a median age ranging from 7 to 12.2 years old. The TAI systems used in these studies included Peristeen, Qufora, Alterna and Navina. The duration of follow‐up ranged from 5.5 months to 3 years. Eleven children (5.7%) did not tolerate TAI and withdrew from treatment soon after initiation. TAI was reported to be successful in 62% of the children with refractory functional constipation. A total of 27 (14%) of participants were successfully weaned off TAI at the last follow‐up. Pain was experienced by 21.7% of children and was the most reported adverse event. The researchers concluded that while TAI is a safe procedure, “there is a need for well-designed prospective trials to evaluate this treatment option in children with refractory functional constipation.” Limitations of this study include but are not limited to the small number of studies included in the analysis and the use of different definitions of treatment success. Additionally, the use of various TAI systems in these studies also makes comparability difficult.

Baaleman and colleagues (2022) conducted a combined retrospective and cross-sectional study investigating the clinical effectiveness and patient experience with the Navina TAI in children with constipation or FI. The researchers retrospectively collected baseline characteristics and data on treatment success at 1- and 6-month follow-up. Successful treatment was defined as defecating at least 3 times per week and having less than 1 episode of FI per week. The researchers cross-sectionally assessed health-related quality of life (HRQoL), treatment adherence, treatment satisfaction (Treatment Satisfaction Questionnaire for Medication [TSQM]), illness perceptions, medication beliefs, and patient empowerment with validated questionnaires. A total of 34 participants were included (median age at start TAI: 11 years old [range, 6-18]), 32 in the retrospective review, and 26 in the cross-sectional survey (median of 3 years after initiation). Most of the participants were diagnosed with functional constipation (n=26; 76%) or a neurogenic bowel disorder (n=6; 18%). Treatment success rates significantly improved at each follow-up compared with baseline (baseline: 4/25 [16%]; At 1-month follow-up: 12/16 [75%], p=0.008; 6-month follow-up: 11/18 [61%], p=0.016; cross-sectional follow-up: 13/26 [50%], p=0.008). HRQoL scores were high (PedsQL median, 73 [interquartile range {IQR}, 54-85]). The Adherence score was low in 36% (defined as Medication Adherence Report Scale [MARS] ≥ 23), whereas TSQM effectiveness scores were high (median, 69 [IQR, 47-86]). Most participants (61%) reported increased independence following the initiation of TAI treatment. Patient empowerment (GYPES) scores were similar to those reported in children with other chronic conditions. The authors concluded that TAI using the Navina system is an effective bowel management system for children with intractable constipation or FI.

Koppen and colleagues (2017) assessed the efficacy of TAI and parental satisfaction in children with intractable functional constipation treated with Peristeen TAI. Researchers surveyed the parents of children (age 0-18 years) treated with Peristeen for functional constipation (based on the Rome III criteria). Questionnaires were mailed to parents. The questionnaire consisted of 25 self-developed, multiple-choice questions regarding the use of Peristeen, current gastrointestinal symptoms, adverse effects of Peristeen, concomitant medication use, and parental satisfaction. A total of 91 families were invited to participate, of which 67 (74%) returned the questionnaire. In total, 84% experienced FI prior to treatment. Of the 49 children who continued to use Peristeen at the time of the survey, FI had resolved completely in 41% of the participants while 12% experienced occasional episodes of FI. The authors concluded that TAI may be an effective treatment for children with functional constipation and renders a high parental satisfaction, but additional prospective studies are necessary to further evaluate this treatment option. The authors noted that the study may have been affected by selection bias because individuals who discontinued Peristeen due to lack of benefit or adverse effects may have been less likely to participate. As a result, the study population may have overrepresented individuals with more favorable experiences and outcomes. The authors also acknowledged that in the present study the participants often used concomitant medication which may have influenced the results.

The American Gastroenterological Association (AGA) and the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition (NASPGHAN) collaborated to develop a clinical care pathway for pediatric primary care providers and pediatric gastroenterologists for the diagnosis and management of functional constipation in children. The group concluded that transanal irrigations for functional constipation offers personal autonomy, provides predictable bowel movements and should be considered as an alternative to surgical options (Rodriguez, 2026).

In a 2017 publication supported by Coloplast (Mosiello, 2017), an international group of pediatric specialists with long-standing experience of bowel management in children stated the following:

Today, transanal irrigation (TAI) is an accepted treatment in children and adults with bowel dysfunction (BD) who do not respond to conservative and medical treatments. TAI use in adults is well-defined in a stepwise pyramid of care, that can be applied when conservative and medical treatment of BD (such as dietary and lifestyle advice, regular use of laxatives, suppositories, enemas, or manual evacuation) have failed (Mosiello, 2017).

Although the group concluded that TAI represents an effective and safe therapeutic approach for treating bowel dysfunction in children, they also acknowledged that its introduction in the pediatric population has been without a standardized approach. Therefore, additional RCTs are needed comparing safety, efficacy, and defining outcome measures including patient and parental satisfaction in individuals with different pathologies. Additionally, the authors recommended development of specific devices for use in the pediatric age group (Mosiello, 2017).

Neurogenic Bowel Dysfunction (NBD)

Neurogenic bowel dysfunction (NBD) is the loss of the ability to control defecation due to injury or deterioration of the nervous system which results in constipation or FI. NBD can be caused by a variety of neurological conditions such as spinal cord injury (SCI), Parkinson disease, multiple sclerosis or other conditions that cause impairment or loss of sphincter control and control of bowel mobility. In children, NBD is most often related to open or closed spina bifida, anorectal malformations or Hirschsprung disease. Bowel dysfunction can also have numerous other causes, such as injury to the bowel or rectum or constipation caused by delayed or slowed transit of stool in the colon (Mosiello, 2017).

Several older studies of TAI, primarily in individuals with spinal cord injury and NBD, reported improvements in constipation, FI, bowel-related quality of life, independence, and time spent on bowel care. A randomized controlled trial demonstrated greater improvement in bowel symptoms, symptom-related quality of life, and bowel management efficiency with TAI compared with conservative bowel management (Christensen, 2006). Other prospective and observational studies reported successful outcomes in approximately 46% to 68% of participants, with some individuals reducing medication use and caregiver dependence (Faaborg, 2009; Del Popolo, 2008). Long-term follow-up suggested that treatment success declined over time, with approximately 35% of participants remaining successful users after 3 years (Faaborg, 2009). In addition, TAI was associated with significant improvements in constipation, FI, and overall NBD symptom scores in individuals with spinal cord injury, although no consistent predictors of treatment success could be identified (Christensen, 2008). Serious adverse events were rare, but minor adverse effects such as abdominal discomfort and rectal bleeding were common. Treatment discontinuation was frequently attributed to inadequate symptom improvement, the time and effort required to perform irrigation, and dissatisfaction with treatment (Faaborg, 2009). Overall, these studies suggest that TAI may improve bowel symptoms and quality of life in some individuals with NBD; however, treatment durability was variable and the available evidence was limited by relatively small study populations and challenges in identifying individuals most likely to benefit (Christensen, 2006; Christensen, 2008; Del Popolo, 2008; Faaborg, 2009).

A 2024 Cochrane review (Todd, 2024) evaluated medical, physical, and surgical interventions for managing FI and constipation in adults with neurological diseases or injury that chronically affect the central nervous system, including multiple sclerosis, spinal cord injury, cerebrovascular disease, Parkinson disease and Alzheimer disease. The review included randomized, quasi-randomized, cross-over, and cluster-randomized trials comparing interventions to placebo, usual care, or no intervention. Evaluated physical therapies included TAI, abdominal massage, standing programs, electrical stimulation, and other interventions. A total of 25 studies with 1598 participants were analyzed. The studies were at high risk of bias due to lack of blinding of personnel and participants. Approximately half of the evaluated studies were also at high risk of selective reporting bias. Outcomes were inconsistently reported across studies, limiting data pooling and comparisons. Although some physical therapies were associated with improvements in constipation symptoms, the certainty of the evidence was low. The reviewers concluded that the evidence base was limited by methodological weaknesses, small study sizes, and heterogeneity, and that there was insufficient evidence to determine the effects of these interventions for specific neurological conditions.

Studies investigating the use of TAI in pediatric patients with NBD have reported success, both in clinical bowel outcomes and in improvement of QoL.

Midrio and colleagues (2015) reported the results of a multi-center study using the Peristeen TAI system in a pediatric group with anorectal malformations and congenital or acquired spinal cord lesions. A total of eight Italian pediatric spina bifida and surgery centers participated in the study. Participants were between the age of 6 to 17 years, weight above 20 kg (40 lbs) and had unsatisfactory bowel management. Individuals with chronic inflammatory bowel disease, mental disability and surgery within the previous 3 months were excluded from the study. The Bristol scale, a questionnaire assessing bowel function and 2 questionnaires on QoL for individuals aged 6 to 11 years (CHQ pf50) and 12 to 17 years (SF36) were administered at the beginning of treatment and after 3 months (T1). A total of 83 participants were enrolled, and 78 completed the study (41 anorectal malformations, 37 spinal cord lesions). At 3 months constipation was reduced in anorectal malformations from 69% to 25.6% and in spinal cord lesions from 92.7% to 41.5%, FI in anorectal malformations from 50% to 18.6%, and in spinal cord lesions from 39% to 9.8%, and flatus incontinence in anorectal malformations from 20.9% to 9.8%, and in spinal cord lesions from 31.7% to 10%. At the beginning of the study the Bristol Stool Scale types were 1 to 2 in 45% of anorectal malformations and 77.5% of the SCL group, whereas at 3 month types 1 to 2 were recorded in only 2.5% of the spinal cord lesions group. QoL improved in both groups. In the younger cohort, a significant improvement in QoL was recorded in participants with anorectal malformations for 8 of 9 variables and in spinal cord lesions participants for 7 of 9 variables. The authors concluded that TAI using the Peristeen system resulted in a significant time reduction in colonic cleansing, increased independence, and improved QoL in children with anorectal malformations and spinal cord lesions.

In 2014, researchers reported the results of a study that explored the use of Peristeen TAI to manage FI due to myelomeningocele, Hirschsprung disease, or anorectal anomalies (Corbett, 2014). This study was a combination of a retrospective chart review and assessment using a validated QoL questionnaire to quantify pre- and post-TAI bowel function and continence. Functional outcomes and QoL scores prior to and during TAI use were compared using the Wilcoxon matched pairs test (p<0.05). A total of 24 children (median age of 6 years) were managed with the Peristeen TAI to treat FI; 3 participants did not tolerate the system. Median QoL scores in 20 of the 21 participants using the PAI demonstrated significant improvement in bowel management and continence; 2 participants discontinued use due to failure to improve; 1 individual underwent the Malone antegrade continence enema (MACE) procedure; and 1 individual returned to oral/rectal medications; 19 of 24 participants (79%) continued using the TAI. The researchers concluded that the TAI is a safe, effective, non-operative alternative to MACE in children with FI, if initial compliance can be achieved.

In another study, Alenzi and colleagues (2014) prospectively evaluated children with neuropathic bladder and bowel dysfunction who needed reconstructive bladder surgery and the MACE procedure. The goal of the trial was to assess the efficacy of TAI (Peristeen) to gain fecal continence in children who need reconstructive bladder surgery and have FI. All participants received TAI at least 3 months prior to surgery to assess their response. Individual bowel function, the frequency of use of the TAI system, satisfaction of patients and their parents, and diaper independence were evaluated pre- and post-reconstructive surgery. A total of 18 participants (11 females, 7 males) were evaluated from April 2006 to 2014. The mean age was 7.6 years (range of 4 to 15). Fifteen individuals (83.3%) demonstrated complete dryness from stools. Of these 15 individuals, 8 (53.3%) were diaper-free while 6 continued wearing diapers due to fear of fecal soiling, and 1 due to urinary incontinence. Individuals continued to use the TAI with the same results after reconstructive bladder surgery. The authors concluded that these initial results suggest that TAI is a successful conservative alternative for the MACE procedure.

Several specialty associations or societies have issued guidance on the use of TAI in individuals with bowel dysfunction and determined it to be an accepted treatment in children and adults with bowel dysfunction, or more specifically, NBD that has not responded to conservative and medical therapies.

The AGA recommends a trial of transanal irrigation as an acceptable option in individuals with neurogenic bowel dysfunction because it “reduces stool burden, improves bowel emptying, and enhances quality of life” (Staller, 2026).

The Consortium of Spinal Cord Medicine (a collaboration of professional and consumer organizations with a common interest in health care for individuals living with SCI), collaborated to develop a clinical practice guideline for the management of NBD in adults following spinal cord injury. Based on evidence from RCTs and meta-analyses, the group recommended that TAI be used in individuals with NBD who have unsatisfactory results with basic bowel management (BBM) (Johns, 2021).

Lower Anterior Resection Syndrome (LARS)

Low anterior resection syndrome (LARS) is a chronic bowel dysfunction that can occur after sphincter-preserving rectal surgery, most commonly for rectal cancer. LARS encompasses a range of symptoms, including FI, urgency, increased stool frequency, clustering of bowel movements, constipation, and a sensation of incomplete evacuation. Symptom severity can vary widely and may substantially impair quality of life, social functioning, and daily activities. The condition is believed to result from multiple factors related to rectal resection, including altered rectal capacity and compliance, changes in anorectal sensation, and disruption of normal bowel and sphincter function (Martellucci, 2025).

Martellucci (2025) reported the results of a multicenter observational study at 13 centers that evaluated the benefits of long-term TAI treatment (up to 24 months) for individuals with LARS. A total of 159 participants were enrolled, although 27 did not complete the training period and were not prescribed TAI. The remaining participants were followed for up to 24 months using validated measures of bowel control satisfaction, quality of life (QoL), LARS severity, and symptom burden. Assessments were administered at baseline and after 1 month, 6 months, 12 months and 24 months. TAI was associated with significantly improved satisfaction and QoL (p<0.001) throughout the assessment periods. At baseline, 84.8% of participants reported major LARS, with this rate decreasing to 16.5% by 24 months. Mean LARS score improved by 19.8 ± 12.3 points from baseline to 24 months, reflecting a sustained and significant long-term improvement (p<0.001). The frequency of symptoms decreased from 4.3 events per participant at baseline to 0.5 at 24 months (p<0.001). The dropout rate was 5 (11.4%) cases at 6 months, 9 (6.8%) by 12 months, and 12 (8.9%) by 24 months. The authors concluded that TAI was associated with sustained improvements in bowel symptoms, satisfaction, and QoL over 24 months. However, interpretation is limited by the observational design, lack of a control group, participant attrition, and reliance on self-reported outcomes.

Meurette and colleagues (2023) conducted a multicenter (7 sites), open-label RCT to evaluate TAI with a cone catheter compared to traditional standard of care (SOC) in participants at least 18 years of age with a low colorectal or coloanal anastomosis who had major LARS (LARS score at least 30) at least 3 months after stoma closure. Thirty-two participants were randomized and 30 completed the 3-month study. Standard care included dietary modification, medications, pelvic floor rehabilitation, and small-volume enemas, while participants assigned to TAI received structured training and performed daily irrigation using a cone catheter device. The primary endpoint was improvement in the LARS score at 3 months. LARS scores improved in both groups but were significantly lower in the TAI group at study completion (21.3 versus 32.2; p=0.008). The TAI group also demonstrated fewer daytime and nighttime toilet visits, less time spent on bowel management, and higher satisfaction scores compared with standard care. A total of 17 adverse events occurred in 14 participants, none of which were severe. Device-related events were limited to abdominal spasms, altered bowel transit during irrigation, anal pain, water leakage, and flow-related issues. All participants assigned to the cone catheter requested to continue treatment after study completion. The authors concluded that TAI using a cone catheter was superior to standard conservative management for improving LARS symptoms over 3 months. However, interpretation is limited by the small sample size, open-label design, short follow-up period, and the potential for spontaneous improvement in LARS symptoms over time. In addition, the study was funded by the device manufacturer, which participated in study design, data collection, and statistical analysis.

Complications and Adverse Events

The most serious complication of TAI is the rare occurrence of bowel perforation. A recent review article by Christensen (2016) estimated the overall risk of perforation to be in the order of 2 per 1 million procedures (all patient groups and ages) but after 8 weeks of long-term use (Christensen, 2016; Mosiello 2017; Ng, 2015). Some of the more commonly reported side effects of TAI include abdominal pain, sweating, chills, dizziness, and a general sense of discomfort (Christensen, 2006; Johns, 2021; NG, 2015).

Autonomic dysreflexia: An unreserved sympathetic nervous system response to a variety of noxious stimuli occurring in individuals with spinal cord injury at or above the thoracic 6 level.

Bowel management: A program for an individual with a bowel disability that is designed to pre-emptively achieve effective bowel evacuation at a specified frequency to manage constipation or FI. Bowel management programs may include a combination of modalities including but not necessarily limited to dietary advice, medication therapy, disposable pads, anal plugs, biofeedback, muscle/bowel training, digital stimulation, and manual evacuation.

Fecal incontinence: The uncontrolled passage of gas or feces.

Functional constipation: A condition in which an individual has hard, infrequent bowel movements that are often difficult or painful to pass. Functional (idiopathic) constipation is not the result of a clearly identifiable anatomic abnormality or disease process.

Functional fecal incontinence: Involuntary passage of stool in the absence of a clearly identifiable structural, neurologic, or metabolic cause.

Low anterior resection syndrome: A group of symptoms including incontinence, urgency, frequency, or the sensation of incomplete emptying that may be experienced by individuals following sphincter-sparing resections of the rectum.

Neurogenic bowel dysfunction (NBD): Impaired gastrointestinal control stemming from central nervous system disorders or nerve injuries. By interrupting the signaling pathway between the brain and the gut, NBD typically manifests as chronic constipation, fecal incontinence, or a combination of both.

Transanal irrigation (TAI): Introduction of water into the rectum and lower colon through a rectal catheter or cone to facilitate bowel emptying.

Peer Reviewed Publications:

1. Alenezi H, Alhazmi H, Trbay M, et al. Peristeen anal irrigation as a substitute for the MACE procedure in children who are in need of reconstructive bladder surgery. Can Urol Assoc J 2014; 8:12-15.
2. Belsey J, Greenfield S, Candy D, Geraint M. Systematic review: impact of constipation on quality of life in adults and children. Aliment Pharmacol Ther. 2010; 31(9):938-949.
3. Bolia R, Goel A, Thapar N. Transanal irrigation in children with functional constipation: a systematic review and meta-analysis. J Pediatr Gastroenterol Nutr. 2024; 78(5):1108-1115.
4. Bray L, Sanders C. An evidence-based review of the use of transanal irrigation in children and young people with neurogenic bowel. Spinal Cord 2013; 51:88-93.
5. Christensen P, Andreasen J, Ehlers L. Cost-effectiveness of transanal irrigation versus conservative bowel management for spinal cord injury patients. Spinal Cord. 2009; 47(2):138-143.
6. Christensen P, Bazzocchi G, Coggrave M, et al. A randomized, controlled trial of transanal irrigation versus conservative bowel management in spinal cord-injured patients. Gastroenterology. 2006;131(3):738-747.
7. Christensen P, Bazzocchi G, Coggrave M, et al. Outcome of transanal irrigation for bowel dysfunction in patients with spinal cord injury. J Spinal Cord Med. 2008; 31(5):560-567.
8. Christensen P, Krogh K, Perrouin-Verbe B, et al. Global audit on bowel perforations related to transanal irrigation. Tech Coloproctol 2016; 20:109-115.
9. Corbett P, Denny A, Dick K, et al. Peristeen integrated transanal irrigation system successfully treats fecal incontinence in children. J Ped Urol 2014; 10:219-22.
10. Del Popolo G, Mosiello G, Pilati C, et al. Treatment of NBD dysfunction using transanal irrigation: a multicenter Italian study. Spinal Cord. 2008; 46(7):517-522.
11. Faaborg PM, Christensen P, Kvitsau B, et al. Long-term outcome and safety of transanal colonic irrigation for neurogenic bowel dysfunction. Spinal Cord 2009; 47: 545-549.
12. Jørgensen CS, Kamperis K, Modin L, et al. Transanal irrigation is effective in functional fecal incontinence. Eur J Pediatr 2017; 176:731-736.
13. Juul T, Christensen P. Prospective evaluation of transanal irrigation for fecal incontinence and constipation. Tech Coloproctol. 2017; 21(5):363-371.
14. Koppen IJN, Kuizenga-Wessel S, Voogt HW, et al. Transanal irrigation in the treatment of children with intractable functional constipation. J Pediatr Gastroenterol Nutr 2017; 64:225-259.
15. Koppen IJ, Vriesman MH, Saps M, et al. Prevalence of functional defecation disorders in children: a systematic review and meta-analysis. J Pediatr 2018; 198:121-130.
16. Lallemant-Dudek P, Cretolle C, Hameury F, et al. Multicentric evaluation of the adherence to Peristeen^® transanal irrigation system in children. Ann Phys Rehabil Med 2020; 63:28-32.
17. Larsen SO, Axelgaard S, Jonsson IM, et al. Efficacy of low volume transanal irrigation in children with retentive fecal incontinence: a randomized controlled trial. J Pediatr Gastroenterol Nutr. 2026; 82(2):425-433.
18. Martellucci J, Falletto E, Ascanelli S, et al. Transanal irrigation in patients affected by low anterior resection syndrome (LARS): long-term results from an Italian national study. Dig Liver Dis. 2025; 57(10):1913-1919.
19. Meurette G, Faucheron JL, Cotte E, et al. Low anterior resection syndrome after rectal resection management: multicentre randomized clinical trial of transanal irrigation with a dedicated device (cone catheter) versus conservative bowel management. Br J Surg. 2023; 110(9):1092-1095.
20. Midrio P, Mosiello G, Ausili C, et al. Peristeen transanal irrigation in pediatric patients with anorectal malformation and spinal cord lesions: a multicentric Italian study. Colorectal Dis 2015; 18:86-93.
21. Ng J, Ford K, Dalton S, et al. Transanal irrigation for intractable faecal incontinence and constipation: outcomes, quality of life and predicting non-adopters. Pediatr Surg Int 2015; 31:729-734.
22. Pacilli M, Pallot D, Andrews A, et al. Use of Peristeen^® transanal colonic irrigation for bowel management in children: A single-center experience. J Pediatr Surg. 2014; 49(2):269-272.
23. Patel S, Hopson P, Bornstein J, et al. Impact of transanal irrigation device in management of children with fecal incontinence and constipation. J Pediatr Gastroenterol Nutr 2020; 71:292-297.
24. Ridolfi TJ, Berger N, Ludwig KA. Low anterior resection syndrome: current management and future directions. Clin Colon Rectal Surg. 2016; 29(3):239-245.
25. Siminas S, Losty PD. Current surgical management of pediatric idiopathic constipation: a systematic review of published studies. Ann Surg 2015; 262:925-933.

Government Agency, Medical Society, and Other Authoritative Publications:

1. American Gastroenterological Association; Bharucha AE, Dorn SD, Lembo A, Pressman A. American Gastroenterological Association medical position statement on constipation. Gastroenterology. 2013; 144(1):211-217.
2. Assmann SL, Keszthelyi D, Kleijnen J, et al. Guideline for the diagnosis and treatment of faecal incontinence-A UEG/ESCP/ESNM/ESPCG collaboration. United European Gastroenterol J. 2022; 10(3):251-286.
3. Emmanuel AV, Krogh K, Bazzocchi G, et al. Consensus review of best practice of transanal irrigation in adults. Spinal Cord 2013; 51:732-738.
4. Johns J, Krogh K, Rodriguez GM, et al. Management of neurogenic bowel dysfunction in adults after spinal cord injury: clinical practice guideline for health care providers. Top Spinal Cord Inj Rehabil. 2021; 27(2):75-151.
5. Mosiello G, Marshall D, Rolle U, et al. Consensus review of best practice of transanal irrigation in children. J Pediatr Gastroenterol Nutr. 2017; 64(3):343-352.
6. Rao SS; American College of Gastroenterology Practice Parameters Committee. Diagnosis and management of fecal incontinence. American College of Gastroenterology Practice Parameters Committee. Am J Gastroenterol. 2004; 99(8):1585-1604.
7. Rodriguez L, Ambartsumyan L, Baumgartner K, et al. American Gastroenterological Association-North American Society for Pediatric Gastroenterology, Hepatology and Nutrition pediatric functional constipation clinical care pathway. Clin Gastroenterol Hepatol. 2026: S1542-3565(26)00159-X.
8. Staller K, Neshatian L, Lembo A, Bharucha AE. AGA clinical practice update on evaluation and management of refractory constipation: expert review. Clin Gastroenterol Hepatol. 2026; 24(2):296-305.
9. Tabbers MM, DiLorenzo C, Berger MY, et al. Evaluation and treatment of functional constipation in infants and children: evidence-based recommendations from ESGHAN and NASPHGAN. J Pediatr Gastroenterol Nutr 2014; 58:258-274.
10. Todd CL, Johnson EE, Stewart F, et al. Conservative, physical and surgical interventions for managing faecal incontinence and constipation in adults with central neurological diseases. Cochrane Database Syst Rev. 2024; 10(10):CD002115.
11. U.S. Food and Drug Administration (FDA):
    • 510(K) Premarket Notification. Navina Classic System, (K170487). 2017. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf17/K170487.pdf. Accessed on August 13, 2026.
    • 510(K) Premarket Notification. Navina Smart System, Navina Classic System (K1990977). 2019. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K190977. Accessed on August 13, 2026.
    • 510(K) Premarket Notification. Peristeen Anal Irrigation System (K083770). 2017.Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf14/K140310.pdf. Accessed on August 13, 2026.

1. National Institute of Diabetes and Digestive and Kidney Diseases. Definition and facts for constipation. Last reviewed: May 2018. Available at: https://www.niddk.nih.gov/health-information/digestive-diseases/constipation/definition-facts#:~:text=About%2016%20out%20of%20100%20adults%20have%20symptoms%20of%20constipation. Accessed on August 13, 2026.

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