Role of Interferential Therapy in Children with Fecal Incontinence Postanorectal Malformation Surgeries.

BACKGROUND: Anorectal malformation (ARM) is one of the most common pediatric surgical problems dealt in day-to-day practice. Although the outcome of surgery has improved a great deal over the last three decades fecal incontinence (FI) is still a common long-term morbidity that affects the quality of life of these patients. Bowel wash (BW) program with pelvic floor exercise are standard care of management for these patients. This study was undertaken to assess the role of interferential therapy (IFT) along with BW compared to BW alone in the management of FI.
METHODOLOGY: Twenty-four children more than 2-year-old age previously operated for malformation and having FI with Kelly score <4 were recruited and assigned to one of the two groups. One group was given standard BW regimen and the other BW with IFT for 3 months. Posttherapy Kelly scoring was done, and the results were compared.
RESULTS: IFT with BW provided no added advantage over BW alone for the treatment of FI in patients of ARMs.
CONCLUSION: The time-tested modality of BW is the cornerstone in the management of FI.

RCT Entities:   Population Interventions Outcomes

Introduction

Fecal incontinence (FI) following corrective surgeries of anorectal malformations (ARMs) represents a devastating problem which often prevents the child from becoming socially acceptable, which in turn provokes serious psychological problems. Various treatment strategies have been tried, however, majority of these patients need daily enemas. The basis of any bowel management program is to clean the colon and keep it quiet, thus keeping the patient clean for at least 24 h after the enema.[1] More than 95% of the children who follow this program are artificially clean and dry for the whole day. Nevertheless, a dedicated medical team and proper care by parents are essential. In addition, giving daily self-enemas may not be acceptable to the child, once he grows older. Here, comes the role of alternative therapies such as interferential therapy (IFT). We hypothesize that electro-stimulation therapy could potentially be beneficial in children with FI who have their neorectum placed correctly within the muscle complex, by strengthening their pelvic musculature. To the best of our knowledge, the use of IFT in children with FI has not been evaluated hitherto in India. This study is likely to provide us with an acceptable alternative method of treating FI in operated cases of ARM.

Methodology

All the patients aged more than 2 years who were operated for ARM in the past 10 years were contacted and called for follow-up. Children with true FI were enrolled and those with either of overflow incontinence or incontinence due to hypermotile colon were excluded. Written and informed consent was taken. Those patients who had not completed 6 months after the last surgery and had complex anatomy including pouch colon were also excluded. All patients with FI having Kelly's scores <4 were recruited in the study. Magnetic resonance imaging (MRI) was done to prove that the neorectum was correctly positioned within the pelvic muscle complex if not then those were excluded. A total of 24 patients were recruited and randomized into two groups using randomization computer software. Kelly scoring was done for each group before the start of therapy. IFT was administered through an electrotherapy device (Gymna company, Belgium) [Figure 1].

Figure 1

Interferential therapy machine along with two electrodes which would be placed over the pubic symphysis and sacrum

Group A (bowel wash [BW] + IFT): These patients were administered BW daily with 500 ml−1 liter tap water depending on the clear returns. Pelvic floor exercises (voluntary constriction of anal sphincter as if to prevent soiling) for 10 min thrice daily was taught. IFT (base frequency of 2000 Hz and beat frequency 5–50 Hz) on alternate days (thrice weekly) with two-pole electrode method applied at the pubic symphysis and the sacrum was administered. Amplitude was with respect to beat frequency employed and varied from 12 to 22 mA on the scan mode. Duration of the therapy was for 10 min. Using these parameters, all the motor fibers of the pelvic floor would be recruited.

Group B (BW): Control group, they were administered bowel management in the form of daily enemas and pelvic floor exercises for the same period.

No subject underwent any surgical therapy during the study. Dietary advice along with the needs of drugs whether antimotility/promotility were individualized based on the type of colon. Patients in both groups were evaluated at the end of 3 months, and posttherapy Kelly scoring was done. The outcome score was correlated with the pretherapy Kelly score in both groups. In addition, at the end of the therapy, gross impression was taken in the form of improved, marginal improvement, or no improvement.

An increase in three points after either modality of treatment as improvement and increase in 1–2 points as marginal improvement and no increase as no improvement was employed.

Subjective assessment of improvement was also done mainly on the parent's version of percentage clinical improvement and observing the change in the defecation pattern from that recorded by the same observer at the time entry of the subject in the study.

Statistical analysis

The quantitative variables were expressed as mean ± standard deviation and compared using the Mann–Whitney test between groups and Wilcoxon test within groups. Furthermore, the qualitative variables were expressed as frequencies (percentages) and compared between groups using Chi-square/Fisher's exact test. A P < 0.05 was considered statistically significant. Statistical package for Social Sciences (SPSS) version 15.0 software (Chicago, SPSS Inc.) was used for statistical analysis.

Results

In Group B, one patient was lost to follow-up, thus Group B had 11 patients. Mean age of patients involved in the study in Group A was 6.67 years (range 3.5–9.5 years) and in Group B was 8.23 years (range 3–18 years). In both groups, based on MRI, position of neorectum was within the muscle complex though in most of the cases it was not exactly centrally located. In Group A, six out of twelve patients (50%) and in Group B, two out of eleven patients (18.1%) had associated genitourinary anomalies. In Group A, 2/12 patients (16.6%) and Group B, 3/11 patients (27.2%) had cardiac anomaly. In Group A, 3/12 patients had spinal anomaly (two having hypoplastic sacrum and one with syringomyelia) whereas in Group B, 2/12 patients had spinal anomaly (one with complete and other with partial sacral agenesis). In Group A, the location of rectourinary fistula was rectovesical (1), rectoprostatic (2), and rectobulbar (9). Whereas in Group B, one patient had rectoprostatic and other 10 had rectobulbar fistula.

There was 126% increase in the mean value of Kelly score in Group A, whereas it was 157% in Group B. Thus, in each group, posttherapy Kelly score was both clinically and statistically significant (P < 0.001) [Table 1].

Table 1

Pre- and post-therapy Kelly scoring in both groups

Improvement - Four patients in Group A showed improvement, whereas six patients improved marginally and two patients did not show any improvement after the completion of therapy. In Group B, the patients fared much better as all of them showed some degree of improvement [Table 2].

Table 2

Pre- and post-therapy improvement in both groups

Discussion

Although the outcome of surgery for ARM has improved a great deal over the last three decades, FI is still a common long-term morbidity that affects the quality of life of these patients. BW programs with pelvic floor exercise are standard care of management for these patients. We reviewed literature, but there were no authors who defined the volume and content of an enema based on the characteristics of the patient's colon, which are the most important part and key for success. It is currently possible to have 95% success rate with the administration of individually designed enema to a patient with FI,[23] so that it has become more or less gold standard in the management of FI in patients of ARM. This study was undertaken to assess the role of IFT along with BW compared to BW alone in the management of FI.

There are various scoring system used for the assessment of FI, but none of them has been validated. Kelly score[4] is one of the most popular methods used. We selected Kelly score for assessing the FI both pre- and post-therapy. All the patients in both groups were males, and this can be explained by the fact that most female patients have low ARM and the most common morbidity is constipation rather than FI. Some of these female patients may have overflow incontinence rather than true FI and are best treated when the constipation is managed. We enrolled patients above the age of 2 years, as by this age, child has voluntary control over the bowel movements. The higher mean age in Group B (8.23 vs. 6.67) was due to skewed distributions as four patients were above 10 years.

The idea to incorporate IFT for the management of FI was based on few studies using electrical stimulation therapy for the management of neurogenic bladder. Kajbafzadeh et al. studied the effect of pelvic floor interferential electro-stimulation on urodynamic parameters and incontinence of thirty children and adolescents with myelomeningocele and detrusor overactivity.[5] They found that in the treatment group, 78% of patients gained continence immediately after IFT and 60% had persistent continence for 6 months and even urinary frequency and enuresis improved significantly.

In a study from India, Ratan et al. have described the use of surged faradic stimulation to the pelvic floor muscles as an adjunct to the medical management of children with rectal prolapse.[6] Clark et al. have shown decreased colonic transit time after transcutaneous interferential electrical stimulation in children with slow transit constipation.[7]

Although there is paucity of data regarding the role of IFT in FI. Some studies aimed at strengthening the pelvic floor muscles by electrical stimulation in FI are available.[567] Takahashi et al. used radio-frequency energy delivery to the anal canal for the treatment of FI in adults with positive results.[8] Similarly, sacral nerve stimulation for FI and constipation in adults was studied with mixed result.[9]

In the study group, there was an improvement in Kelly score in both groups posttherapy, which was statistically significant, but none of the two groups were better over each other. There was no improvement in two patients in Group A both these patients might not have been compliant to the BW regimen relying mostly on IFT. This emphasizes that the time-tested modality of BW is the cornerstone in the management of FI.

Although IFT was shown to have beneficial effect in the strengthening of the pelvic floor muscle in neurogenic bladder, our study which intended to use the same principle to the patients with FI did not show any added advantage over the standard BW management program. One important observation made was that in the patient who was enrolled earlier in Group A and showed promising results after therapy deteriorated over time on longer follow-up. These patients assumed that after receiving IFT, there was no need for BW. A randomized, double-blind study done in 144 adults with FI with 3 months of treatment with transcutaneous electrical tibial nerve stimulation showed that it was not significantly better than sham treatment in improving the number of incontinence and urgency episodes.[10]

Although our sample size is small to generalize the results, the role of IFT in the management of patients with FI is not so promising. Furthermore, it adds to the loss of work hours of the parents, loss of school time of the child and increased cost of treatment. There were few limitations of the study as the number of patients included in the study was small. A larger study with more number of patients would have been better to generalize the results. The third group of patients could have been administered IFT alone, however, the Institutional Ethical Committee did not concede to this approach as BWs are considered as gold standard as of date. Moreover, scoring was done as per the parents’ assessment of outcome; objective criteria like electromyography or perineometer were not used to assess the strength of pelvic floor muscles.

Hence, we finally conclude that the time-tested modality of BW is the cornerstone in the management of FI.

Conclusion

Significant improvement in FI in patients of ARM was seen with both the interventions - IFT with BW and with BW alone

IFT, when administered along with BW provides no added advantage over the bowel wash alone for the treatment of FI in patients of ARM

The time tested modality of bowel wash is the cornerstone in the management of FI.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.