Biofeedback Vs Electrical Stimulation in Treatment of Fecal Incontinence

Biofeedback Versus Bilateral Transcutaneous Electrical Nerve Stimulation in the Treatment of Functional Non-retentive Fecal Incontinence

Fecal incontinence is one of the most psychological frustrating problems. It occurs in children due to many causes. There is a wide range of non-invasive therapeutic approaches like Kegel exercise, Biofeedback, and posterior tibial nerve stimulation. However, up till now, there are no established guidelines for treatment.

the objective of this study is to evaluate and compare the early effect of Biofeedback therapy versus bilateral transcutaneous posterior tibial nerve stimulation (TPNS) as non-invasive methods in the treatment of functional non-retentive fecal incontinence (FNRFI) in children.

Study Overview

• Status: Completed
• Conditions: Fecal Incontinence; Encopresis; Fecal Soiling
• Intervention / Treatment: Device: Biofeedback; Device: Electrical stimulation; Other: Traditional treatment

Detailed Description

Functional non-retentive fecal incontinence (FNRFI) requires prolonged treatment with a wide range of non-invasive therapeutic approaches like Kegel exercise, Biofeedback, and posterior tibial nerve stimulation (PTNS). However, up till now, there are no established guidelines for treatment.1 The aim of this study is to evaluate and compare the early effect of Biofeedback therapy versus bilateral transcutaneous posterior tibial nerve stimulation (TPTNS) as non-invasive methods in the treatment of (FNRFI) in children.

Methodology: The current prospective randomized controlled study included 93 children with FNRFI who were randomly divided and allocated into three groups. Group A treated by conventional methods through dietetic regulation and Kegal exercises. Group B treated by biofeedback therapy while group C received bilateral (TPTNS). Initial manometric findings including resting pressure, squeeze pressure, 1st sensation, 1st urge, and intense urge were recorded and repeated after 3 and 6 months together with incontinence score recorded in using St' Mark's (Varizey) with the primary endpoint of improvement of the incontinence score more than 50%.

• Study Type: Interventional
• Enrollment (Actual): 93
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Banha
    • Banhā, Banha, Egypt, 13518
      • Banha University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• FecaI incontinence
• Normal defecation frequency,
• Normal bowel habits and
• Normal stool consistency

Exclusion Criteria:

• Children who are not cooperative,
• Children with traumatic sphincter injury,
• Children with fecal impaction,
• Children with spinal diseases causing incontinence,
• Children with anorectal malformation,

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Biofeedback; Biofeedback therapy in addition to the conventional measures done in the control Group. It was performed in the same position used for baseline manometry. The used protocol included strength and sensory training, twice weekly for 3 months. Strength training was performed by a double-lumen rectal PVC balloon clothed catheter (MMS U-72210).	Device: Biofeedback; Biofeedback therapy in addition to the conventional measures done in the control Group. It was performed in the same position used for baseline manometry. The used protocol included strength and sensory training, twice weekly for 3 months. Strength training was performed by a double-lumen rectal PVC balloon clothed catheter (MMS U-72210).
Experimental: Electrical Stimulation; Bilateral (TPTNS); was applied with an electrode above the medial malleolus A second electrode) was applied just below the same malleolus. Electrical stimulation with a low-frequency current (10 Hz), and adjustable intensity. The procedure was done for 20-30 minutes, three times per week for 3 months together with the conventional maneuvers applied in the control group.	Device: Electrical stimulation; A positive auto adhesive electrode was applied above the medial malleolus over the S3 dermatome. A second negative electrode was applied just below the same malleolus. Both electrodes were linked to an electrical stimulation device ( EMS physio Ltd, OX129 F, England) with a low frequency current (10 Hz), and adjustable intensity.; Other Names: Posterior tibial nerve stimulation
Active Comparator: Control group; were managed by conventional methods through Kegal exercises and dietetic regulation where they had received bulky food including vegetables, fruits bran and cereals. Fast foods, spicy drinks and caffeine should be limited in child's diet. Local hygiene and zinc oxide application to the perianal skin were advised to prevent skin excoriation.	Other: Traditional treatment; Conventional treatment through Kegal exercises and dietetic regulation where they had received bulky food including vegetables, fruits bran and cereals. Fast foods, spicy drinks and caffeine should be limited in child's diet. Local hygiene and zinc oxide application to the perianal skin were advised to prevent skin excoriation.; Other Names: Exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incontinence score using St' Mark's (Vaiszey)	Questionnaire ranging from zero (indicating complete continence) to 24 (indicating total incontinence).	3 months after intervention
incontinence score using St' Mark's (Vaiszey)	Questionnaire ranging from zero (indicating complete continence) to 24 (indicating total incontinence).	6 months after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resting pressure (mm hg)	Pressure during relaxation of the anal sphincter	3 months after intervention
Resting pressure (mm hg)	Pressure during relaxation of the anal sphincter	6 months after intervention
Squeeze pressure (mm hg)	Pressure during contraction of the anal sphincter	3 months after intervention
Squeeze pressure (mm hg)	Pressure during contraction of the anal sphincter	6 months after intervention
First sensation (volume of the balloon by cm water)	First sensation of the stool in the rectum	3 months after intervention
First sensation (volume of the balloon by cm water)	First sensation of the stool in the rectum	6 months after intervention
First Urge(volume of the balloon by cm water)	The patient is trying to hold defecation and he can	3 months after intervention
First Urge(volume of the balloon by cm water)	The patient is trying to hold defecation and he can	6 months after intervention
Intense urge (volume of the balloon by cm water)	The Patent can no longer control the defecation	3 months after intervention
Intense urge (volume of the balloon by cm water)	the Patent can no longer control the defecation	6 months after intervention

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Emad M Abdelrhman, PhD, Benha University

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2018
• Primary Completion (Actual): December 27, 2018
• Study Completion (Actual): February 28, 2019

Study Registration Dates

• First Submitted: April 29, 2020
• First Submitted That Met QC Criteria: May 5, 2020
• First Posted (Actual): May 8, 2020

Study Record Updates

• Last Update Posted (Actual): May 8, 2020
• Last Update Submitted That Met QC Criteria: May 5, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Biofeedback; Fecal incontinence; Transcutaneous posterior tibial nerve stimulation; Childern
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Digestive System Diseases; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Elimination Disorders; Fecal Incontinence; Encopresis
• Other Study ID Numbers: Fecal incontinence

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: After Publication, the investigators would like to share the data with authors interested in this topic
• IPD Sharing Time Frame: After Publication
• IPD Sharing Access Criteria: Not available now
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No