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Year : 2012  |  Volume : 2  |  Issue : 2  |  Page : 70-73

Bulking agent injection for fecal incontinence in patients with anorectal malformation

Department of Pediatric Surgery, Sick Hospital Children of Bandar Abbas, Hormozgan and Shiraz University of Medical Sciences, Iran

Date of Web Publication3-Apr-2013

Correspondence Address:
Seyed M. V. Hosseini
Department of Pediatric Surgery, Sick Hospital Children of Bandar Abbas
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/2278-9596.110020

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Background: Patients with anorectal malformation (ARM) frequently suffer from fecal incontinence after surgery because they do not have many of the normal mechanisms of continence. The objectibe of this study was to determine the effects of bulking agent for improving the continence in patients with ARM by correcting the high pressure zone during the toilet training process.
Materials and Methods: From December 2008 to June 2011, 16 cases of mid to high ARM that had posterior sagital anorectoplasty were studied prospectively after perianal injection of a bulking agent (Vantris, Promedon/Argentina) into the submucosal layer in high pressure zone of the anal canal about 5 mm from the dentate line, before the start of toilet training. All patients were followed 3 months and 6 months later by manometery, modified defecation pattern scoring and physical examination for complications. They received metronidazole (10 mg/kg/q8h) for 7 days.
Result: Eleven male (68.75) and five female (31.25%) included; age range from 1 year to 2 years (mean 3 ± 1.96); Six patients (37.5%) had high type ARM and the remaining were mid type ARM. Internal sphincter pressure ranged from 19.6 ± 6.7 mmHg before intervention to 27.5 ± 6.5 mmHg, after injection until 28.4 ± 8.3 mmHg 6-months after injection ( P < 0.0001). Defecation pattern score on this study changed from 7.4 ± 1.9 to 6.1 ± 1.4, 6 month after study ( P = 0.002).
Conclusion: The bulking agent injection could be a cornerstone of post-operative management in patients with ARM.

Keywords: Anorectal malformation, bulking agent, incontinence, Vantris

How to cite this article:
Hosseini SM, Zarenezhad M, Sabet B, Maleki M. Bulking agent injection for fecal incontinence in patients with anorectal malformation. Arch Int Surg 2012;2:70-3

How to cite this URL:
Hosseini SM, Zarenezhad M, Sabet B, Maleki M. Bulking agent injection for fecal incontinence in patients with anorectal malformation. Arch Int Surg [serial online] 2012 [cited 2023 Dec 3];2:70-3. Available from:

  Introduction Top

Anorectal malformations (ARM) are one of the most common causes of intestinal obstruction in the newborn. Despite the advances made in its management over the past few decades, affected patients with ARM frequently suffer from many forms of fecal incontinence. Further more they remain a challenge for pediatric surgeons because they do not have adequate high pressure zone mechanism that should be corrected before learning the continence. [1],[2]

Following surgery for ARM, all patients should be put through toilet training, and a fecal continence scoring done, then the patient should receive dietary management, incentives, pharmacological intervention, and enemas (singly or in combination). The combination of hydrocolonic ultrasound, electrical stimulation, and biofeedback exercise of pelvic floor muscles are effective adjunct for treatment in these children. [3],[4],[5],[6],[7]

The fecal continence is a complex physiological function depending on a variety of factor, even in the group who had good sphincters, good sacrum, and a well-located rectum. Many studies report the effect of perianal bulking agent injection for treatment of the symptoms of passive fecal incontinence in adult patients, however, no supposed benefit of the treatment has been mentioned in patients with ARM. [8]

In this study, we demonstrate the effects of bulking agent for improving the continence by correcting the high pressure zone and anal closure in patients with ARM after definitive surgery.

  Materials and Methods Top

From December 2008 to June 2011, 16 cases had mid to high type ARM, 11 males (68.85) and 5 females (31.3%) with age range from 1 year to 2 years (mean 3 ± 1.96). Six patients (37.5%) had high type and all others had mid type ARM [Table 1].
Table 1: Demographic variants, resting pressures, defecation pattern scores in patients with anorectal malformation and bulking agents injection

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All of them underwent anorectoplasty and post-operatively were enrolled in a pilot study for perianal injection of bulking agent to evaluate the changes in internal sphincter pressure and pattern of daily defecation. The procedure was described to parents of the patients and informed written consent was taken from all of them and the Ethical Committee of the University of Medical Sciences approved the study.

The patients underwent anorectal manometry, barium enema, and magnetic resonance imaging of the spine and sphincter complex for defining the anatomy. [6] All patients were followed by manometery, modified defecation pattern scoring and physical examination for shape of anus cosmetically and complications at months 3 and 6 after surgery. All received metronidazole 10 mg/kg of body weight every 8 h for 7 days and had their usual bowel management course.

Manometery was performed by a hand held air inflated manometer that was calibrated and attached to a black nelatone catheter with glove finger [Figure 1]. The internal sphincter pressure was measured by gradually advancing the inflated balloon of manometer from ampulla of rectum through high pressure zone until the highest resting pressure was recorded before and after injection, and 3 months and 6 months later. [9],[10]
Figure 1: Measurement of internal sphincter during injection

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Our modified score of defecation pattern was classified as follows:

Grade 1: No soiling between estimated interval. Grade 2: No fecal accidents between estimated interval. Grade 3: Fecal accidents. Grade 4: Staining not continuous. Grade 5: Staining continuous. Grade 6: All day soiling or accidents. Grade 7: Need for regular enemas. Grade 8: The antegrade colonic enema procedure. Grade 9: No continence with no severe family problem. Grade 10: No continence with severe family problem. Parents checked the diaper of the babies and charting the pattern of defecation. [1],[2],[3],[4]

Vantris (Promedon/Argentina) consists of polyacrylate microsphere and is used for improving the internal sphincter tone, and anal closure. Vantris is considered a device, as it is not a drug and causes no stricture despite being inserted using a needle and syringe [11] [Figure 2]. It is injected into the deep submucosal layer of tissue in the proximal part of the high pressure zone of the anal canal about 5 mm from the dentate line, a visible anatomic landmark in the anal canal.
Figure 2: Submucosal injection of bulking agent vantris in 3,6,9 position

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In this study, 0.5-1 cc of Vantris was injected in each of four quadrants during each treatment session, essentially, adding bulk to the valve that allows for continence and helping anal closure. A second course of injections was applied if continence was not achieved according to score and the needle should be kept in place for 60 s to let Vantris be dried and prevent coming out. [11]

Statistical analysis

Data was analyzed with SPSS version 15 software. Wilcoxon signed ranks test was used for comparing fecal incontinence score. Internal sphincter pressure changes compared with Friedman non-parametric test.

  Results Top

Internal sphincter pressure changes from 19.6 ± 6.7 mmHg before intervention to 27.5 ± 6.5 mmHg 1 month, after injection to 28.4 ± 8.3 mmHg at 6-months after injection showing a significant increase (P < 0.001). Defecation pattern score in this study changes from 7.4 ± 1.9 to 6.1 ± 1.4, 6 months after study (P = 0.002).

The form of anus (closed inverted as good compared to everted open) were good in four patients, However, in five patients anus appearances were bad and in others anus were unchanged cosmetically respectively [Figure 3]. No abscess or other associated complications was encountered during the intervention.
Figure 3: Post vantris injection anal looking

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  Discussion Top

Patients with ARM suffer from post-operative fecal incontinence and other forms of defecation disorders because they have defective external sphincter and absence of internal sphincter. The anal closure and high pressure zone extent are decreased. Post-operative evaluation for fecal incontinence should include accurate identification of the type of ARM and knowledge of the reconstructive procedure. In addition, history, physical examination, and radiological studies are mandatory, with attention to the status of the striated external sphincter musculature and sacrum as our patients underwent above workup before perianal bulking agent injection. [12]

Normally, functioning rectum and anus allow passage of a gas but hold back liquid and solids. Rectal continence is a complex condition controlled by a variety of neurologic pathways and anatomic structures and incontinence occurs whenever the rectal sphincter cannot exert enough force due to ARM or other defect in the complex. The process of learning continence starts near 2 years old and completed up to 8 years therefore, we started injection near 18 months old to give them chance of having internal high pressure zone during the toilet training. [11]

Vantris was approved for the treatment of reflux in infants prone to kidney infections because of an incompetent valve at the ureteral-bladder junction. The Vantris has received approval for the treatment of fecal incontinence in adult patients but has never been used in incontinence of ARM. [11]

In this study, the patients had increase in internal sphincter pressure as compared to pre-injection measurements (P < 0.001). The clinical improvement was seen in patients when comparing their defecation pattern score (P = 0.002) and looking of anus. Anorectal manometry assesses the functional compliance, correlates with score, can predict long-term results, and should be used for decision regarding re-operation. [1]

Many studies have been carried out, however, due to the limited number of identified trials as Maeda, et al.[8] has reported no definitive conclusion can be drawn regarding the effectiveness of perianal injection of bulking agents for fecal incontinence. In Oliveira, et al.[13] study, there was considerable improvement in clinical, high-pressure zone and asymmetry index like our study, but they did not approved significant increase in manometric pressures.

In Graf, et al.[14] series, 71 cases had a 50 or more percent reduction in the number of incontinence episode. They recorded 128 treatment-related adverse events, of which two were serious (1 rectal abscess and 1 prostatic abscess). In our study, no significant complication happened.

  Conclusion Top

Injection of bulking agents can improve the high-pressure zone and asymmetry index of anal canal and is recommended for post-operative management of ARMs.

  Acknowledgment Top

With many thanks to staffs of Pediatric Surgery ward of Bandar Abbas Sick Hospital Children.

  References Top

1.Bhatnagar V. Assessment of postoperative results in anorectal malformations. J Indian Assoc Pediatr Surg 2005;10:80-5.  Back to cited text no. 1
  Medknow Journal  
2.Sowande OA, Adejuyigbe O, Alatise OI, Usang UE. Early results of the posterior sagital anorectoplasty in the treatment of anorectal malformations in Nigerian children. J Indian Assoc Pediatr Surg 2006;11:85-8.  Back to cited text no. 2
  Medknow Journal  
3.Grasshoff-Derr S, Backhaus K, Hubert D, Meyer T. A successful treatment strategy in infants and adolescents with anorectal malformation and incontinence with combined hydrocolonic ultrasound and bowel management. Pediatr Surg Int 2011;27:1099-103.  Back to cited text no. 3
4.Iwai N, Nagashima M, Shimotake T, Iwata G. Biofeedback therapy for fecal incontinence after surgery for anorectal malformations: Preliminary results. J Pediatr Surg 1993;28:863-6.  Back to cited text no. 4
5.Leung MW, Wong BP, Leung AK, Cho JS, Leung ET, Chao NS, et al. Electrical stimulation and biofeedback exercise of pelvic floor muscle for children with faecal incontinence after surgery for anorectal malformation. Pediatr Surg Int 2006;22:975-8.  Back to cited text no. 5
6.Hibi M, Iwai N, Kimura O, Sasaki Y, Tsuda T. Results of biofeedback therapy for fecal incontinence in children with encopresis and following surgery for anorectal malformations. Dis Colon Rectum 2003;46:S54-8.  Back to cited text no. 6
7.Peña A, Guardino K, Tovilla JM, Levitt MA, Rodriguez G, Torres R. Bowel management for fecal incontinence in patients with anorectal malformations. J Pediatr Surg 1998;33:133-7.  Back to cited text no. 7
8.Maeda Y, Laurberg S, Norton C. Perianal injectable bulking agents as treatment for faecal incontinence in adults. Cochrane Database Syst Rev 2010;12:CD007959.  Back to cited text no. 8
9.Rintala RJ, Lindahl HG. Fecal continence in patients having undergone posterior sagittal anorectoplasty procedure for a high anorectal malformation improves at adolescence, as constipation disappears. J Pediatr Surg 2001;36:1218-21.  Back to cited text no. 9
10.Blesa Sierra M, Núñez Núñez R, Blesa Sánchez E, Vargas I, Cabrera García R. Utility of anorectal manometry in the diagnosis and treatment of encopresis. An Pediatr (Barc) 2004;60:310-5.  Back to cited text no. 10
11.Ormaechea M, Paladini M, Pisano R, Scagliotti M, Sambuelli R, Lopez S, et al. Vantris, a biocompatible, synthetic, non-biodegradable, easy-to-inject bulking substance. Evaluation of local tissular reaction, localized migration and long-distance migration. Arch Esp Urol 2008;61:263-8.  Back to cited text no. 11
12.Paidas CN. Fecal incontinence in children with anorectal malformations. Semin Pediatr Surg 1997;6:228-34.  Back to cited text no. 12
13.Oliveira LC, Neves Jorge JM, Yussuf S, Habr-Gama A, Kiss D, Cecconello I. Anal incontinence improvement after silicone injection may be related to restoration of sphincter asymmetry. Surg Innov 2009;16:155-61.  Back to cited text no. 13
14.Graf W, Mellgren A, Matzel KE, Hull T, Johansson C, Bernstein M, et al. Efficacy of dextranomer in stabilised hyaluronic acid for treatment of faecal incontinence: A randomised, sham-controlled trial. Lancet 2011;377:997-1003.  Back to cited text no. 14


  [Figure 1], [Figure 2], [Figure 3]

  [Table 1]

This article has been cited by
1 Injectable bulking treatment of persistent fecal incontinence in adult patients after anorectal malformations
Johan Danielson,Urban Karlbom,Tomas Wester,Wilhelm Graf
Journal of Pediatric Surgery. 2019;
[Pubmed] | [DOI]


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