Massage With Senna-based Laxatives Versus Senna-based Laxatives in Managing Overflow Retentive Stool Incontinence in Pediatrics
Phase: NA
Conditions: Massage
Sponsor: South Valley University

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Official Title of Study: - 
 
MASSAGE WITH SENNA-BASED LAXATIVES VERSUS 
SENNA-BASED LAXATIVES IN MANAGING OVERFLOW 
RETENTIVE STOOL INCONTINENCE IN PEDIATRICS: A 
Randomized Controlled Trial  
 
 
 
Document Date: - 02/12/2020. 
 
 
 
Human Subjects protection review board approval 
date: - 03/31/2019 
 
 
 
 
 

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MASSAGE WITH SENNA-BASED LAXATIVES VERSUS 
SENNA-BASED LAXATIVES IN MANAGING OVERFLOW 
RETENTIVE STOOL INCONTINENCE IN PEDIATRICS: A 
Randomized Controlled Trial  
 
Nezar Abd Elrouf Abo Halawa 
Assistant Lecturer of pediatric surgery, faculty of medicine, South Valley University, Qena, Egypt 
Nehad Ahmed youness Abo-Zaid. 
Lecture of physical therapy. Department of Physical Therapy for Pediatrics, Faculty of Physical 
Therapy, South Valley University, Qena, Egypt 
Abstract 
Background: Overflow retentive stool incontinence is a common 
disorder affecting children that affect the quality of life in the form of 
shame, humiliation, depression, and decrease reduced self-esteem of 
children. Aim: To compare the effect of massage with senna-based 
laxatives versus senna-based laxatives in managing overflow retentive 
stool incontinence in pediatrics. Methods: Eighty-six children with 
overflow retentive stool incontinence enrolled in this study and were 
assessed for eligibility. Children`s age ranged from four and fourteen. 
They were assigned randomly into two groups. Group (A) received 
abdominal massage with senna-based laxatives and group (B) received 
senna-based laxatives only. The application of massage was applied for 
15 minutes, three times/day for six successive months. Results: Post-
treatment there was a significant improvement in both groups in favor of 
massage group, P< 0.05. Conclusion: Abdominal massage with senna-
based laxatives has a great effect on children with overflow retentive 
stool incontinence than senna-based laxatives only. Keywords:  
Overflow retentive stool incontinence, senna-based laxatives, and 
abdominal massage. 
 
 
 

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Introduction  
Constipation is the most common colonic motility disorder in children affecting 
between 0.7% to 29.6 % of the pediatric population (Rasquin 2006, Mugie 2011) 
and is frequently associated with fecal incontinence secondary to overflow 
(Voskuijl 2004) 
Laxatives are the main line of maintenance therapy of overflow retentive stool 
incontinence (ORSI) with satisfying results (Yik 2012) stimulant laxatives like 
senna based laxatives (SBL) are our standard choice in Egypt due to its availability 
(Bassiuony 2015). 
Massage is the manipulation of muscles and connective tissues (CT) (superficial 
and deeper layers) by using different techniques. It has been practiced in many 
ancient civilizations for thousands of years. (Weerapong 2005) 
Abdominal massage is a noninvasive, effective, and safe form of constipation 
management in the general population. (Lamas et al. 2009, Lamas et al., 2012 
and Turan&Asti 2016) .It provides a low burden of risk, reduces symptoms of 
chronic constipation, improves the quality of life, decreases the use of laxatives 
and increases the frequency and consistency of bowel movements (Smith and 
Moss, 2008; Moss et al., 2007; Richards 1998; Lamas et al., 2010). 
 
Subjects and methods: 
This randomized controlled study was conducted in the out-patient clinic in the 
Faculty of Medicine, South Valley University from March 2016 to March 2019. 
The parents of each child submitted Informed consent. The procedures that 
followed had No: P.T. REC/012/002277 that approved by the Institutional Ethical 
Committee Clearance of the Faculty of Physical Therapy at Cairo University. The 
study had registration number NCT                        registered on Clinicaltrial.gov. 
A total of one hundred and seventy children with overflow retentive stool 
incontinence were evaluated for eligibility. Twenty-seven children did not 
complete the treatment course, fifty-eight child excluded due to unresponsiveness 
or non-compliance to our protocol, and eighty-six child was divided randomly into 
two groups. 

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The children were selected according to these criteria: (i) Children`s aged ranged 
from four to fourteen years, (ii) children were from both sexes, (iii)                     
children had a history of overflow retentive stool incontinence. Other children 
were excluded from our study as they met one of the following criteria:(i) children 
had suspicion of Hirschsprung’s disease, (ii)children had anorectal malformation, 
(iii) children had organic obstruction, (iv)children failed to complete treatment (if 
cramping abdominal pain or vomiting occurred), (v) children required bowel 
surgery. 
Group A: Senna based laxative  
Initial cleanout protocol for dis-impaction of the colon with of the administration 
of one or two enemas per day with 20 ccs/Kg warm tap water with a salt enema 
(0.9 % saline can be made by adding 1.5 teaspoons of salt to 960 ml of water)  
(Levitt  2010)till been clean by radiologically. If initial dis-impaction was failed or 
not tolerated, shift to dis-impaction under general anesthesia. 
Single 10 mg dose senna was given with the start of impaction. After dis-
impaction; senna dose was increased if needed by 10 mg/clinic visit/week till 
achieving no soiling; Documentation of both initial effective starting dose and the 
time slipped till no soiling. Follow-up visits every month unless soiling recurs if 
soiling happens; additional dose (by 10 mg) was done. Treatment was continued 
for 6 months.  
At the end of 6 months, the effective ending dose (maintenance dose) was 
documented. 
Group B: Senna based laxative with massage  
Laxative treatment as group A in addition to massage technique. 
The massage technique was based upon the Tactile Stimulation Method of 
Birkestad that primarily consists of palm-to-skin stroking, gentle pressure and 
static touch (Birkestad 1999). 
The patients lying in a comfortable relaxed supine position and physiotherapist 
performed slow circular clockwise movements on the abdomen, throw tangential 
pushing, with digital pulp, slow and gradual pressure, with fingers inclination 45 

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degrees (Harrington &Haskvitz 2006). The pressure applied to the abdomen on 
each point for 1 min, beginning with the ascending colon, transverse colon, 
descending colon and sigmoid; this sequence was repeated approximately 15 min. 
The therapist teaches the parents this technique and asked them to apply at home 3 
times/day for 15 min.    
Statistical analysis  
The statistical analysis was conducted by using statistical SPSS Package 
program version 25 for Windows (SPSS, Inc., Chicago, IL). Data were normally 
distributed by using the Shapiro-Wilk test (parametric data). Additionally, testing 
for the homogeneity of variance revealed that there was no significant difference 
(P>0.05). Quantitative descriptive statistics included the mean and standard 
deviation for demographic data (age, weight, height, and BMI), constipation 
starting dose, constipation end dose, and time till not soiling variables. Qualitative 
descriptive statistics included number (percentage) for gender, area, breastfeeding, 
previous incomplete therapy for constipation, full urinary continence, fissure, 
psychosocial problems, developmental delay, and history of delayed passage of 
meconium variables. Using paired t-test to compare between rural area and the 
urban area within massage group and without massage group for constipation 
starting dose, constipation end dose, and time till not soiling variables. Using 
independent t-test to compare between massage group and without massage group 
for demographic data (age, weight, height, and BMI), constipation starting dose, 
constipation end dose, and time till not soiling variables. Also, to compare between 
two groups (massage group and without massage group) within the rural area and 
urban area for constipation starting dose, constipation end dose, and time till not 
soiling variables. Chi-square test used to compare between massage group and 
without the massage group for qualitative variables. All statistical analyses were 
significant at the level of probability (P ≤ 0.05).  

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