Abstract
Objectives
To assess whether low‐volume transanal irrigation (L‐TAI) is effective as add‐on to oral laxative therapy for children with functional constipation and retentive fecal incontinence.
Methods
Two‐arm randomized controlled trial, including children aged 4–14 suffering from retentive fecal incontinence. All included children were refractory to at least 2 months treatment with stool softening oral laxatives. Children were included across three pediatric departments in Denmark and randomized into two treatment groups. Treatment duration was 6 weeks. The control group continued oral laxative therapy. The intervention group received L‐TAI as add‐on. The primary objective was evaluating reduction in fecal incontinence episodes. Secondary objectives included assessment of constipation symptoms, rectal diameter, and well‐being based on the WHO‐5 questionnaire. Participants were classified as nonresponders (0%–49% reduction) or responders (partial response = 50%–99% reduction, or full response = 100% reduction).
Results
Fifty children were included. The respective median ages were 7 (interquartile range [IQR] = 3) in the intervention group and 6 years (IQR = 1) in the control group. In the intervention group, 75% were responders with 35% experiencing full response, while 33% in the control group were responders, with 4.8% experiencing full response (p = 0.007 and p = 0.020 for response and full response respectively). At follow‐up, 55% of the intervention group and 90.5% of the control group still met ROME‐IV criteria for constipation (p = 0.010).
Conclusions
L‐TAI is effective as add‐on to oral laxatives in treating fecal incontinence and constipation. Further studies with longer follow‐up periods are needed to assess long‐term effects.
Clinical Trial identification number: NCT05570318 (https://clinicaltrials.gov/study/NCT05570318).
Keywords: bowel management strategies, functional gastrointestinal disorders, novel therapeutic approach, therapeutic efficacy
What is Known
Functional constipation is common in children and can present with fecal incontinence.
Oral laxative treatment with polyethylene glycols is effective in up to 50%.
What is New
Adding daily low‐volume transanal irrigations to oral laxatives is effective in reducing number of fecal incontinence episodes in children with retentive fecal incontinence, who were refractory to oral stool softening laxative treatment alone.
Low‐volume transanal irrigation as add‐on to oral laxatives also reduces constipation symptoms in children with retentive fecal incontinence.
1. INTRODUCTION
Constipation affects up to 10% of children, 1 with 95% classified as functional constipation (FC) and 5% as organic. 2 , 3 Among children with FC, 75%–90% experience retentive fecal incontinence (RFI). 4
Fecal incontinence (FI) is accidental defecation in children with a developmental age over 4 years. FI occurs weekly in 0.8%–4.1% of school children, 5 with higher prevalence among younger children. 6 FI can be organic or functional, 7 the latter being subdivided into RFI and functional nonretentive FI (FNRFI). 6 RFI accounts for 95% of FI cases. 8
RFI negatively impacts children's quality of life (QoL), affecting social, psychological, and educational aspects. 9 , 10 , 11
Current treatment comprises education, toilet training, and oral laxatives, primarily polyethylene glycols (PEGs). 3 , 12 While up to half respond to PEGs, a significant group remains nonresponders. 11 , 12 , 13 This group is often treated with rectal enemas, which have not proven more effective than laxatives alone. 11
High volume trans anal irrigation (H‐TAI) improves symptoms of constipation and FI in both organic and functional cases 14 , 15 as well as QoL 10 , 16 , 17 , 18 but causes discomfort in half of pediatric patients, 16 , 18 , 19 due to large water volumes and long procedure time. 10
Low volume TAI (L‐TAI) is a less invasive treatment, requiring less time and water, potentially making it more suitable for children.
No randomized clinical trials have investigated L‐TAI in children with FI.
This study hypothesized that L‐TAI, as add‐on to oral laxatives, reduces RFI episodes, improves QoL, and reduces Rome‐IV criteria. The trial aimed to evaluate the efficacy and tolerability of L‐TAI in children with RFI unresponsive to oral laxatives.
2. METHODS
2.1. Ethics statement
The study was approved by the Danish Medical Research Ethics Committees (MREC, ID: 2210826) and registered at clinicaltrials.gov (ID: NCT05570318). To ensure consent, standardized consent forms compiled by MREC were used. As the included children were between 4 and 14, consent was obtained from parent(s) or guardian(s).
2.2. Study design
This multicenter randomized controlled trial investigated the effects of L‐TAI as an add‐on to oral laxatives in children aged 4–14 years with RFI diagnosed per Rome‐IV criteria. 6
Recruitment occurred at three Danish pediatric outpatient clinics (Gødstrup Hospital, Aalborg University Hospital and Aarhus University Hospital) and via official social media platforms of the three hospitals. Recruitment commenced in December 2022 and concluded in June 2024.
Participants had to fulfill at least two Rome‐IV criteria for FC, including one or more episodes of FI per week, persisting for at least 1 month, and be refractory to at least 2 months of treatment with a stool softening oral laxative (PEG, magnesia or lactulose) at maintenance doses (for doses see Table 1). Exclusion criteria were use of any TAI or rectally administered laxative or gastrointestinal surgery within the last 3 months, use of medication known to cause constipation, known Hirschprung's disease, anorectal malformation, intestinal stenosis, or neurogenic or inflammatory bowel disease.
Table 1.
Demographics and baseline characteristics. a
|
Control group n = 25 |
Intervention group n = 25 |
|
|---|---|---|
| Age, median (IQR) | 6 (3) | 7 (1) |
| Sex (male), n (%) | 14 (56) | 18 (75) |
| Duration of PEG treatment before inclusion in months, median (IQR) | 7 (21) | 6 (21) |
| PEG dose before inclusion in g/kg, median (IQR) | 0.6 (0.19) | 0.53 (0.38) |
| PEG dose in g/kg in study period, median (IQR) | 0.65 (0.25) | 0.57 (0.28) |
| Number of FI episodes/week at baseline, median (IQR) | 9.5 (13.5) | 6 (6.5) |
| Rectal diameter in cm at baseline, mean (SD) | 3.34 (0.79) | 3.44 (0.81) |
| WHO‐5 well‐being score at baseline,b mean (SD) | 73.2 (13) | 75.8 (12.5) |
| Daytime urinary incontinence at baseline, n (%) | 15 (60) | 13 (52) |
| Nocturnal enuresis at baseline, n (%) | 10 (40) | 6 (24) |
Abbreviations: IQR, interquartile range; PEG, polyethylene glycol; SD, standard deviation.
Since treatment groups are randomized, no testing has been done to compare the groups. 20
0–100 points.
Eligible patients were randomized into two groups (n = 25 each): one continued oral laxatives, while the other continued oral laxatives and received L‐TAI as add‐on using the Qufora IrriSedo MiniGo®‐system (MiniGo‐system) (Qufora A/S, Lillerød, Denmark). Laxative doses were adjusted in both groups upon inclusion to optimize treatment if needed but remained unchanged thereafter.
The 6‐week trial involved two site visits and one phone call.
2.3. Visit 1—On‐site (Week 0)
At the first visit, parents signed a consent form, and patients were randomized.
Block randomization with permutated blocks of varying size was used. Randomization was carried out in Research Electronic Data Capture (REDCap®) 21 and was stratified by the participating sites.
Participants completed a questionnaire to ensure they fulfilled inclusion criteria. The questionnaire was based on the Rome‐IV criteria and included additional questions, such as number of accidents per week. The families also completed the WHO‐5 well‐being index, 22 and treatment history was obtained. For an example of the questionnaire, see Table S1.
Transverse rectal diameter was assessed via transabdominal ultrasound. The measurement was made with the probe 2 cm above the symphysis pubis angled at 10–15 degrees as described by Klijn et al. 23 The L‐TAI group received instruction in the use of the MiniGo®‐system.
At visit 1, families were introduced to daily diaries to track bowel movements, fecal and urinary incontinence episodes, and treatment compliance. The L‐TAI‐group also answered questions about the usage of the MiniGo®‐system, and whether the child experienced any pain when irrigating on a scale from 1 to 10.
2.4. Visit 2—By phone (Week 3)
Parents were called to assess treatment efficacy, compliance, and adverse effects. Questions focused on reduction in FI episodes and assessment of remaining Rome‐IV criteria.
The L‐TAI group was further evaluated for irrigation outcomes, including effect of irrigation and whether any adverse events had occurred.
2.5. Visit 3—On‐site (Week 6)
Participants completed the same questionnaire as at visit 1, along with the WHO‐5 well‐being index. Diaries were returned, and rectal diameter was reassessed. Nonresponders in the control group were offered 6 weeks of treatment with the MiniGo®‐system.
See Figure 1 for an overview of the visit schedule.
Figure 1.
Flow chart of study participation.
2.6. Irrigation
Irrigations were performed once daily with the Qufora IrriSedo MiniGo® Small system.
According to the manufacturer the MiniGo® water pump contains 180 mL of water, with an estimated 20 mL residual water per use. Families were instructed to use 1 pump full of water to irrigate. If this did not result in defecation, they were instructed to refill and irrigate again. If this was necessary, it was noted in the diary.
2.7. Outcome measures
The primary outcome was reduction in fecal incontinence episodes per week. 0%–49% reduction was considered nonresponse, 50%–99% was considered partial response and 100% reduction was considered full response, in accordance with the ICCS classification. 20
Secondary outcomes included resolution of constipation based on Rome‐IV criteria, 6 change in rectal diameter measured on transabdominal ultrasound, well‐being (WHO‐5), L‐TAI tolerability (1–10 pain rating), and changes in daytime urinary incontinence and nocturnal enuresis.
The WHO‐5 score was calculated by summing the questionnaire items and multiplying the total by four, resulting in a score between 0 and 100 points. 23 A higher result indicated better well‐being.
Outcome measures were assessed via questionnaires at on‐site visits, diaries, and ultrasound examination. No changes were made to trial outcomes after commencement.
2.8. Statistical analysis
A power calculation was performed with a significance level (α) of 0.05 and 80% power, indicating 23 participants per group to detect a significant effect. This was based on a study by Joergensen et al. 14 investigating the effect of H‐TAI in children, since at the commencement of this trial, there were no existing trials investigating L‐TAI in children. Joergensen found full response in 73%. Based on this we assumed effect of L‐TAI in 65%. We assumed a 25% improvement in the control group. To account for potential dropouts, the target recruitment was increased to 25 participants per group.
Baseline characteristics were summarized as counts (%) for categorical variables and mean (standard deviation, SD) for symmetric continuous variables or median (interquartile range, IQR) for asymmetric continuous variables.
The primary outcome was response, meaning a reduction of 50% or more in FI episodes from baseline to follow‐up. Response proportion was compared between groups using a χ 2‐test and the effect quantified by a relative risk.
Secondary outcomes included continuous (rectal diameter, WHO‐5 score), binary (full response, Rome‐IV criteria, and urinary incontinence), and categorical (typical size of accidents) variables. Continuous variables were analyzed by a linear mixed model including group and time and their interaction while constraining baseline means to agree between groups (due to randomization). An unstructured covariance matrix was used along with the Kenward‐Rogers approximation. Model validation was performed by visual inspection of residuals and fitted values. Binary variables were analyzed in the same manner as the primary outcome, defaulting to Fisher's exact test if there were table entries with less than five expected. The categorical variables were analyzed using Fisher's exact test. All analyses of primary and secondary outcomes seek to estimate an intention‐to‐treat effect.
The primary analysis was conducted among complete cases for number of FI episodes. Complete cases were defined as cases with registered number of FI episodes at both baseline and follow‐up. As a sensitivity analysis, a random intercept Poisson regression was fit to the number of accidents at baseline and follow‐up.
Data were stored in RedCAP®. Data management and analyses were performed by the Aarhus University Biostatistics Core (BIAS) using Stata version 18 (StataCorp. 2023. Stata Statistical Software: Release 18. StataCorp LLC).
3. RESULTS
3.1. Recruitment and follow‐up
Children were recruited from December 2022 to June 2024, with follow‐up until August 2024. The trial ended when the last patient completed follow‐up.
3.2. Baseline characteristics
For an overview of all baseline characteristics and demographics, see Table 1. In the control group, 23 used PEG, 1 used magnesia, and 1 used lactulose. In the intervention group, 24 used PEG and 1 used magnesia.
3.3. Drop‐out
Four participants from the control group and five from the intervention group dropped out, resulting in a final sample size of 41.
In the control group, reasons for dropping out included dissatisfaction with being randomized to control treatment (n = 2), worsening of symptoms (n = 1), and faulty initiation of different treatment by the outpatient clinic (n = 1). In the intervention group, reasons for dropping out included discomfort while irrigating (n = 2), anxiety for the irrigating process (n = 1), lack of resources in the family (n = 1), and loss to follow‐up (n = 1).
3.4. Primary outcome
Figure 2 shows the numeric count of children who experienced response and full response, respectively, in the two groups, as well as the relative risk of response and full response, respectively.
Figure 2.
Response versus nonresponse. On the left: numeric count of responders and full responders by randomization group. On the right: Relative risk of response and full response, respectively.
In the intervention group, the response proportion was 75%, compared to 33% in the control group (RR = 2.25 [1.17, 4.33], p = 0.007). Among children randomized to L‐TAI, 35% experienced full response, while this was only true for 4.8% in the control group (RR 7.35 [0.99–54.5], p = 0.020). The sensitivity analysis did not give cause to alter this conclusion: We estimate that the mean number of FI episodes at follow‐up is 72% (59%; 81%) lower in the intervention group compared to the control (p < 0.001).
3.5. Secondary outcomes
3.5.1. Rome‐IV criteria
At baseline, all patients fulfilled two or more criteria and were thus constipated. At follow‐up, this was still true for 90.5% in the control group, and 55% in the intervention group (p = 0.010). We found that children in the intervention group improved specifically on “At least one episode of fecal incontinence per week” (p = 0.037) and “history of retentive posturing or excessive volitional stool retention” (p = 0.024). When it came to the remaining criteria, there was no statistically significant difference in improvement between the two groups.
3.5.2. Transverse rectal diameter
A transverse rectal diameter of 3 cm or more was used as cut‐off for indication of constipation, based on prior studies. 24 There was a significant mean reduction in both groups, but no statistically significant difference in reduction between the groups (see Table 2).
Table 2.
Secondary endpoints.
| Control group N = 21 | Intervention group N = 20 | p values | |
|---|---|---|---|
| N (%) constipated based on ROME IV‐criteria at follow‐upa | 19 (90.5%) | 11 (55%) |
0.010 Relative risk (RR) = 0.61 [0.4, 0.93] |
| Change in rectal diameter (cm), mean difference (95% CI) | −0.46 (−0.74; −0.17) | −0.74 (−1.04; −0.45) |
0.123 Difference of the differences = −0.287 (−0.655; 0.082) |
| Change in WHO‐5 score, mean difference (95% CI) | 1.82 (−4.02; 7.6) | 2.24 (−3.3; 7.8) |
0.912 Difference of the differences = 0.42 (−7.2; 8.02) |
| Fecal matter per accident reduced throughout study period n (%)b | 6 (30%) | 9 (50%) |
0.208 RR = 1.7 (0.74; 3.76) |
Abbreviation: CI, confidence interval.
Fulfills two or more criteria. All patients fulfilled two or more criteria at baseline.
Based on questionnaire; chose between whether accidents typically were “full portions,” “larger lumps,” or “stains.”
3.5.3. Well‐being
At baseline, the mean well‐being score was 73.2 in the control group, and 75.8 in the intervention group. At follow‐up, we found no significant in‐ or decrease in well‐being in either group (Table 2).
3.6. Irrigation
To assess tolerability and usage of the MiniGo®‐system, children randomized to irrigation answered additional questions in the diaries and questionnaires regarding the irrigation process. These analyses were based on responses from 19 participants, as one family failed to complete the diary accurately. The responses revealed that in 17 families, irrigation was consistently carried out by a parent. In three families, the children occasionally performed irrigation independently.
Most families spent less than 5 min irrigating. None spent more than 15 min.
The average volume used to perform irrigation was 160 mL, however, both lower and higher volumes were noted occasionally. The lowest recorded volume was 55 mL, while the highest was 360 mL. Given the average of 160 mL, we conclude that it was generally not necessary to refill the pump multiple times for irrigation to take effect. We found that children rated their level of pain when irrigating higher in the first days of the trial, with a mean score at the beginning of Week 1 being 3.5, falling to 1.5 at the beginning of Week 2, and staying at this level throughout.
To assess compliance, families must note whether irrigation had been performed daily.
On average, families missed 2.3 out of 42 days (6 weeks). The highest number of missed days was eight, and the lowest was zero.
3.7. Adverse effects
No serious adverse effects (SAEs) were reported. Two patients dropped out due to discomfort when irrigating.
4. DISCUSSION
This trial is the first randomized study to demonstrate that L‐TAI is both effective and well tolerated in children with functional FI, refractory to oral laxatives. FI episodes significantly decreased compared to the non‐irrigating group, pain ratings were low, and compliance was high, supporting L‐TAI as a clinically relevant add‐on treatment for RFI.
A recent retrospective study by Hougaard et al. 25 found that 42% of children with RFI or FNRFI achieved full fecal continence after 6 months of L‐TAI treatment. However, variations in laxative use and rectal enemas may have introduced bias. In contrast, our trial ensured all children received L‐TAI as an add‐on to oral laxatives, with no other rectal treatments, allowing for a clearer assessment of L‐TAI's effect. We found that 35% achieved full response within 6 weeks, despite the shorter follow‐up. To date, no other randomized trials have investigated L‐TAI in a pediatric population.
Few studies have evaluated L‐TAI for FI and constipation in adults. 26 , 27 Collins et al. reported symptom improvement in 60% of adults with passive FI or incomplete evacuation using L‐TAI monotherapy. 27 Knowles et al. found that quality of life improved with both H‐TAI and L‐TAI, though more significantly in the H‐TAI group. 26 However, a large proportion of the subjects in the L‐TAI group switched to H‐TAI during the study, limiting applicability. 26
H‐TAI studies in children with FI show mixed effectiveness and tolerability. In a cross sectional survey study, Koppen et al. 16 found that 47% of children using H‐TAI still experienced frequent FI (>1 episode/week) after 11 months of treatment, while a retrospective study by Joergensen et al. 14 reported full symptom resolution in 73% and partial resolution in 17% after 5.5 months. Hougaard 25 found a 42% full response rate after 6 months, raising questions about H‐TAI's long‐term effectiveness compared to L‐TAI. However, Joergensen 14 included only RFI cases, whereas Hougaard included both RFI and FNRFI, which may explain the differences.
Tolerability of L‐TAI in our study was high. Only 8% of participants dropped out due to discomfort, and 4% due to anxiety about irrigation.
Most children rated pain as low, and both parents and children described L‐TAI as tolerable and feasible. Nearly 90% spent less than 10 min irrigating daily, making it easy to integrate into their routine. In contrast, H‐TAI, requires 30–60 min per session, with 66.7% finding H‐TAI bothersome due to the time required. 15 , 16 Baaleman et al. reported that 50% of participants often or occasionally skipped irrigation, though the role of procedure duration remains unclear. 15 Skipping was notably lower in our study.
The major strength of the present study was the randomized controlled design limiting the risk of confounding. We ensured a homogenous study population by only including children with FC and RFI, who had received adequate oral laxative therapy for at least 2 months, ensuring proper evaluation of L‐TAI as an add‐on.
Another strength was the use of daily symptom diaries and two measurements of rectal diameter. FI episodes are easily observable, minimizing recall bias.
Limitations include small sample size (n = 41) which may have limited detection of associations in secondary outcomes. Additionally, reliance on self‐reported diary data resulted in some missing information (12% of participants). No participants had missing data in the baseline and follow‐up questionnaires. Number of FI episodes were reported in the final questionnaire as well as the daily diary, ensuring primary endpoint integrity. Rome‐IV criteria were collected via the final questionnaire, and rectal diameter was assessed during on‐site visits, meaning missing data mainly affected irrigation process variables rather than FI and constipation symptoms. The study was unblinded, which may have influenced recall and reporting.
Baseline variables are independent of randomization, though small samples such as ours may show chance imbalances (e.g., FI episodes: median 9.5 in control group vs. 6 in intervention group). Such imbalances do not bias treatment effect estimates but can increase standard error. In our analyses, continuous outcomes and sensitivity analyses of the primary outcome may be viewed as adjusted for baseline values, as the constrained model improves precision. 28 , 29
A potential limitation is the use of transabdominal ultrasound instead of digital rectal examination to detect fecal impaction. Ultrasound has different sensitivity and specificity for detecting fecal impaction than digital rectal examination, and there is no universally adopted cut‐off point. 30
However, a subset of children is unwilling to undergo rectal examination. To avoid subjecting participants to additional, often uncomfortable procedures, we opted for a noninvasive imaging approach.
To align with our population, we based data interpretation on a study in children aged 4–12 years, which best matches our age range. 24
Some children in the study suffered from daytime urinary incontinence (56%) and/or nocturnal enuresis (32%) besides RFI. Previous studies suggest that treating fecal issues may improve urinary incontinence. 31 Our small sample size and short intervention period limited our ability to detect such effects. Future studies with larger populations with both urinary incontinence and RFI would be valuable.
This study was able to document a significant effect of L‐TAI in 6 weeks. Future trials should consider longer treatment periods to assess the potential for greater efficacy with extended use. As the present study only includes children with RFI, it would be of interest to evaluate the effect of L‐TAI in populations with FNRFI and organic FI.
Another interesting prospect is the possibility to compare L‐TAI and H‐TAI to assess which is more effective and best tolerated in children, especially considering the contrasting findings by Joergensen and Hougaard. 14 , 25
The IrriSedo MiniGo irrigation system is not approved by the FDA, but is approved by the proper authorities in Denmark, where the trial took place.
5. CONCLUSION
In conclusion, this study supports L‐TAI as an effective add‐on to oral laxatives when managing retentive fecal incontinence in children refractory to oral laxative therapy alone, based on effectiveness, tolerability, compliance, and usage.
CONFLICT OF INTEREST STATEMENT
Signe Øbo Larsen has received honoraria from the manufacturer of the irrigation device used in the trial, Qufora A/S (Gydevang 28‐30, 3450 Lillerød, Denmark). Qufora A/S has had no influence on study design, data analysis, or presented results. The remaining authors declare no conflicts of interest.
Supporting information
Supplemental_Table_S1.
ACKNOWLEDGMENTS
Qufora A/S paid for Signe Øbo Larsen's salary during her research year as a medical student. Qufora A/S has had no influence on study design, data analysis, or presented results. No other funding was received for this study.
Larsen SØ, Axelgaard S, Jønsson IM, et al. Efficacy of low volume transanal irrigation in children with retentive fecal incontinence: a randomized controlled trial. J Pediatr Gastroenterol Nutr. 2026;82:425‐433. 10.1002/jpn3.70279
CME module may be found at https://learnonline.naspghan.org/jpgn2
[Correction added on 29 December, 2025 after first online publication. The funder name has been revised.]
REFERENCES
- 1. Koppen IJN, 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.e6. 10.1016/j.jpeds.2018.02.029 [DOI] [PubMed] [Google Scholar]
- 2. Borowitz SM, Cox DJ, Tam A, Ritterband LM, Sutphen JL, Penberthy JK. Precipitants of constipation during early childhood. J Am Board Fam Med. 2003;16:213‐218. 10.3122/jabfm.16.3.213 [DOI] [PubMed] [Google Scholar]
- 3. Tabbers MM, DiLorenzo C, Berger MY, et al. Evaluation and treatment of functional constipation in infants and children: evidence‐based recommendations from ESPGHAN and NASPGHAN. J Pediatr Gastroenterol Nutr. 2014;58:258‐274. 10.1097/MPG.0000000000000266 [DOI] [PubMed] [Google Scholar]
- 4. Tabbers MM, Boluyt N, Berger MY, Benninga MA. Clinical practice: diagnosis and treatment of functional constipation. Eur J Pediatr. 2011;170:955‐963. 10.1007/s00431-011-1515-5 [DOI] [PubMed] [Google Scholar]
- 5. Rajindrajith S, Devanarayana NM, Benninga MA. Review article: faecal incontinence in children: epidemiology, pathophysiology, clinical evaluation and management. Aliment Pharmacol Ther. 2013;37:37‐48. 10.1111/apt.12103 [DOI] [PubMed] [Google Scholar]
- 6. Hyams JS, Di Lorenzo C, Saps M, Shulman RJ, Staiano A, van Tilburg M. Childhood functional gastrointestinal disorders: child/adolescent. Gastroenterology. 2016;150:1456‐1468.e2. 10.1053/j.gastro.2016.02.015 [DOI] [Google Scholar]
- 7. Rajindrajith S, Devanarayana NM, Thapar N, Benninga MA. Functional fecal incontinence in children: epidemiology, pathophysiology, evaluation, and management. J Pediatr Gastroenterol Nutr. 2021;72:794‐801. 10.1097/MPG.0000000000003056 [DOI] [PubMed] [Google Scholar]
- 8. Loening‐Baucke V. Prevalence rates for constipation and faecal and urinary incontinence. Arch Dis Child. 2007;92:486‐489. 10.1136/adc.2006.098335 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 9. Mugie SM, Benninga MA, Di Lorenzo C. Epidemiology of constipation in children and adults: a systematic review. Best Pract Res Clin Gastroenterol. 2011;25:3‐18. 10.1016/j.bpg.2010.12.010 [DOI] [PubMed] [Google Scholar]
- 10. Christensen P, Krogh K. Transanal irrigation for disordered defecation: a systematic review. Scand J Gastroenterol. 2010;45:517‐527. 10.3109/00365520903583855 [DOI] [PubMed] [Google Scholar]
- 11. Bongers MEJ, Van Den Berg MM, Reitsma JB, Voskuijl WP, Benninga MA. A Randomized controlled trial of enemas in combination with oral laxative therapy for children with chronic constipation. Clin Gastroenterol Hepatol. 2009;7:1069‐1074. 10.1016/j.cgh.2009.06.018 [DOI] [PubMed] [Google Scholar]
- 12. Bekkali N‐L‐H, Van Den Berg M‐M, Dijkgraaf MGW, et al. Rectal fecal impaction treatment in childhood constipation: enemas versus high doses oral PEG. Pediatrics. 2009;124:e1108‐e1115. 10.1542/peds.2009-0022 [DOI] [PubMed] [Google Scholar]
- 13. Pijpers M, Bongers M, Benninga M, Berger M. Functional constipation in children: a systematic review on prognosis and predictive factors. J Pediatr Gastroenterol Nutr. 2010;50:256‐268. 10.1097/MPG.0b013e3181afcdc3 [DOI] [PubMed] [Google Scholar]
- 14. Jørgensen CS, Kamperis K, Modin L, Rittig CS, Rittig S. Transanal irrigation is effective in functional fecal incontinence. Eur J Pediatr. 2017;176:731‐736. 10.1007/s00431-017-2902-3 [DOI] [PubMed] [Google Scholar]
- 15. Baaleman DF, Wegh CAM, Hoogveld MTA, Benninga MA, Koppen IJN. Transanal irrigation in children: treatment success, quality of life, adherence, patient experience, and independence. J Pediatr Gastroenterol Nutr. 2022;75:166‐172. 10.1097/MPG.0000000000003515 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 16. Koppen IJN, Kuizenga‐Wessel S, Voogt HW, Voskeuil ME, Benninga MA. Transanal irrigation in the treatment of children with intractable functional constipation. J Pediatr Gastroenterol Nutr. 2017;64:225‐229. 10.1097/MPG.0000000000001236 [DOI] [PubMed] [Google Scholar]
- 17. Nasher O, Hill RE, Peeraully R, Wright A, Singh SJ. Peristeen Ⓒ transanal irrigation system for paediatric faecal incontinence: a single centre experience. Int J Pediatr. 2014;2014:1‐4. 10.1155/2014/954315 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 18. Ng J, Ford K, Dalton S, McDowell S, Charlesworth P, Cleeve S. Transanal irrigation for intractable faecal incontinence and constipation: outcomes, quality of life and predicting non‐adopters. Pediatr Surg Int. 2015;31:729‐734. 10.1007/s00383-015-3735-7 [DOI] [PubMed] [Google Scholar]
- 19. Mosiello G, Marshall D, Rolle U, et al. Consensus review of best practice of transanal irrigation in children. J Pediatr Gastroenterol Nutr. 2017;64:343‐352. 10.1097/MPG.0000000000001483 [DOI] [PubMed] [Google Scholar]
- 20. Austin PF, Bauer SB, Bower W, et al. The standardization of terminology of lower urinary tract function in children and adolescents: update report from the standardization committee of the International Children's Continence Society. Neurourol Urodyn. 2016;35:471‐481. 10.1002/nau.22751 [DOI] [PubMed] [Google Scholar]
- 21. Harris PA, Taylor R, Minor BL, et al. The REDCap consortium: building an international community of software platform partners. J Biomed Inf. 2019;95:103208. 10.1016/j.jbi.2019.103208 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 22. Topp CW, Østergaard SD, Søndergaard S, Bech P. The WHO‐5 well‐being index: a systematic review of the literature. Psychother Psychosom. 2015;84:167‐176. 10.1159/000376585 [DOI] [PubMed] [Google Scholar]
- 23. Klijn AJ, Asselman M, Vijverberg MAW, DIK P, de JONG TPVM. The diameter of the rectum on ultrasonography as a diagnostic tool for constipation in children with dysfunctional voiding. J Urol. 2004;172:1986‐1988. 10.1097/01.ju.0000142686.09532.46 [DOI] [PubMed] [Google Scholar]
- 24. Joensson IM, Siggaard C, Rittig S, Hagstroem S, Djurhuus JC. Transabdominal ultrasound of rectum as a diagnostic tool in childhood constipation. J Urol. 2008;179:1997‐2002. 10.1016/j.juro.2008.01.055 [DOI] [PubMed] [Google Scholar]
- 25. Hougaard NB, Andersen RF, Kamperis K, Jørgensen CS. Low‐volume transanal irrigation (TAI) in the treatment of functional faecal incontinence in children: a cohort study. Int J Colorectal Dis. 2025;40:29. 10.1007/s00384-025-04813-0 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 26. Knowles CH, Booth L, Brown SR, et al. Non‐drug therapies for the management of chronic constipation in adults: the CapaCiTY research programme including three RCTs. Prog Grants Appl Res. 2021;9:1‐134. 10.3310/pgfar09140 [DOI] [PubMed] [Google Scholar]
- 27. Collins B, Norton C. Managing passive incontinence and incomplete evacuation. Br J Nurs. 2013;22(10):575‐579. 10.12968/bjon.2013.22.10.575 [DOI] [PubMed] [Google Scholar]
- 28. Kenward MG, White IR, Carpenter JR. Should baseline be a covariate or dependent variable in analyses of change from baseline in clinical trials? by G. F. Liu, K. Lu, R. Mogg, M. Mallick and D. V. Mehrotra, Statistics in Medicine 2009; 28:2509–2530. Stat Med. 2010;29:1455‐1456. 10.1002/sim.3868 [DOI] [PubMed] [Google Scholar]
- 29. Liu GF, Lu K, Mogg R, Mallick M, Mehrotra DV. Should baseline be a covariate or dependent variable in analyses of change from baseline in clinical trials? Stat Med. 2009;28:2509‐2530. 10.1002/sim.3639 [DOI] [PubMed] [Google Scholar]
- 30. Vos JMBW, Bloem MN, De Geus A, et al. Accuracy of transabdominal ultrasound to diagnose functional constipation and fecal impaction in children: a systematic review and meta‐analysis. Pediatr Radiol. 2024;54:2227‐2242. 10.1007/s00247-024-06083-4 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 31. Borch L, Hagstroem S, Bower WF, Siggaard Rittig C, Rittig S. Bladder and bowel dysfunction and the resolution of urinary incontinence with successful management of bowel symptoms in children. Acta Paediatr (Stockholm). 2013;102(5):e215‐e220. 10.1111/apa.12158 [DOI] [PubMed] [Google Scholar]
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