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Biofeedback Vs Electrical Stimulation in Treatment of Fecal Incontinence

Primary Purpose

Fecal Incontinence, Encopresis, Fecal Soiling

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Biofeedback
Electrical stimulation
Traditional treatment
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fecal Incontinence focused on measuring Fecal incontinence, Biofeedback, Transcutaneous posterior tibial nerve stimulation, Childern

Eligibility Criteria

5 Years - 15 Years (Child)All SexesDoes not accept 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,

Sites / Locations

  • Banha University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Biofeedback

Electrical Stimulation

Control group

Arm Description

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).

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.

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.

Outcomes

Primary Outcome Measures

Incontinence score using St' Mark's (Vaiszey)
Questionnaire ranging from zero (indicating complete continence) to 24 (indicating total incontinence).
incontinence score using St' Mark's (Vaiszey)
Questionnaire ranging from zero (indicating complete continence) to 24 (indicating total incontinence).

Secondary Outcome Measures

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

Full Information

First Posted
April 29, 2020
Last Updated
May 5, 2020
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04380571
Brief Title
Biofeedback Vs Electrical Stimulation in Treatment of Fecal Incontinence
Official Title
Biofeedback Versus Bilateral Transcutaneous Electrical Nerve Stimulation in the Treatment of Functional Non-retentive Fecal Incontinence
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
March 4, 2018 (Actual)
Primary Completion Date
December 27, 2018 (Actual)
Study Completion Date
February 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fecal Incontinence, Encopresis, Fecal Soiling
Keywords
Fecal incontinence, Biofeedback, Transcutaneous posterior tibial nerve stimulation, Childern

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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).
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
93 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Biofeedback
Arm Type
Experimental
Arm Description
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).
Arm Title
Electrical Stimulation
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Biofeedback
Intervention Description
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).
Intervention Type
Device
Intervention Name(s)
Electrical stimulation
Other Intervention Name(s)
Posterior tibial nerve stimulation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Traditional treatment
Other Intervention Name(s)
Exercises
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incontinence score using St' Mark's (Vaiszey)
Description
Questionnaire ranging from zero (indicating complete continence) to 24 (indicating total incontinence).
Time Frame
3 months after intervention
Title
incontinence score using St' Mark's (Vaiszey)
Description
Questionnaire ranging from zero (indicating complete continence) to 24 (indicating total incontinence).
Time Frame
6 months after intervention
Secondary Outcome Measure Information:
Title
Resting pressure (mm hg)
Description
Pressure during relaxation of the anal sphincter
Time Frame
3 months after intervention
Title
Resting pressure (mm hg)
Description
Pressure during relaxation of the anal sphincter
Time Frame
6 months after intervention
Title
Squeeze pressure (mm hg)
Description
Pressure during contraction of the anal sphincter
Time Frame
3 months after intervention
Title
Squeeze pressure (mm hg)
Description
Pressure during contraction of the anal sphincter
Time Frame
6 months after intervention
Title
First sensation (volume of the balloon by cm water)
Description
First sensation of the stool in the rectum
Time Frame
3 months after intervention
Title
First sensation (volume of the balloon by cm water)
Description
First sensation of the stool in the rectum
Time Frame
6 months after intervention
Title
First Urge(volume of the balloon by cm water)
Description
The patient is trying to hold defecation and he can
Time Frame
3 months after intervention
Title
First Urge(volume of the balloon by cm water)
Description
The patient is trying to hold defecation and he can
Time Frame
6 months after intervention
Title
Intense urge (volume of the balloon by cm water)
Description
The Patent can no longer control the defecation
Time Frame
3 months after intervention
Title
Intense urge (volume of the balloon by cm water)
Description
the Patent can no longer control the defecation
Time Frame
6 months after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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,
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emad M Abdelrhman, PhD
Organizational Affiliation
Benha University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Banha University
City
Banhā
State/Province
Banha
ZIP/Postal Code
13518
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

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Biofeedback Vs Electrical Stimulation in Treatment of Fecal Incontinence

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