Biofeedback Vs Electrical Stimulation in Treatment of Fecal Incontinence

Sponsor

Cairo University (Other)

Overall Status

Completed

CT.gov ID

NCT04380571

Collaborator

(none)

Enrollment

Location

Arms

11.9

Actual Duration (Months)

7.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Fecal Incontinence Encopresis Fecal Soiling	Device: Biofeedback Device: Electrical stimulation Other: Traditional treatment	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

93 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

The current prospective randomized controlled study included 93 children with FNRFI who were randomly divided and allocated into 3 groups. 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.Biofeedback group treated by biofeedback therapy in addition to traditional treatment, while the third group is the electrical stimulation group received bilateral (TPTNS) in addition to the traditional treatment. Initial manometric findings including resting pressure (mm hg), squeeze pressure (mm hg), 1st sensation (cm water), 1st urge (cm water), and intense urge (cm water) were recorded and repeated after 3 and 6 months together with incontinence score recorded in using St' Mark's (Varizey).The current prospective randomized controlled study included 93 children with FNRFI who were randomly divided and allocated into 3 groups. 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.Biofeedback group treated by biofeedback therapy in addition to traditional treatment, while the third group is the electrical stimulation group received bilateral (TPTNS) in addition to the traditional treatment. Initial manometric findings including resting pressure (mm hg), squeeze pressure (mm hg), 1st sensation (cm water), 1st urge (cm water), and intense urge (cm water) were recorded and repeated after 3 and 6 months together with incontinence score recorded in using St' Mark's (Varizey).

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 4, 2018

Actual Primary Completion Date :

Dec 27, 2018

Actual Study Completion Date :

Feb 28, 2019

Arms and Interventions

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

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

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

Outcome Measures

Primary Outcome Measures

Incontinence score using St' Mark's (Vaiszey) [3 months after intervention]
Questionnaire ranging from zero (indicating complete continence) to 24 (indicating total incontinence).
incontinence score using St' Mark's (Vaiszey) [6 months after intervention]
Questionnaire ranging from zero (indicating complete continence) to 24 (indicating total incontinence).

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 15 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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,

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Banha University	Banhā	Banha	Egypt	13518

Sponsors and Collaborators

Cairo University

Investigators

Principal Investigator: Emad M Abdelrhman, PhD, Benha University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Olfat Ibrahim Ali, Assistant professor, Cairo University

ClinicalTrials.gov Identifier:

NCT04380571

Other Study ID Numbers:

Fecal incontinence

First Posted:

May 8, 2020

Last Update Posted:

May 8, 2020

Last Verified:

May 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Olfat Ibrahim Ali, Assistant professor, Cairo University

Fecal incontinence

Biofeedback

Transcutaneous posterior tibial nerve stimulation

Childern

Additional relevant MeSH terms:

Fecal Incontinence

Encopresis

Study Results

No Results Posted as of May 8, 2020