Biofeedback Vs Electrical Stimulation in Treatment of Fecal Incontinence

Fecal Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04380571
• Other study ID #: Fecal incontinence
• Status: Completed
• Phase: N/A
• Start date: March 4, 2018
• Est. completion date: February 28, 2019

Study information

• Verified date: May 2020
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: February 28, 2019
• Est. primary completion date: December 27, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 15 Years

Eligibility

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,

Related Conditions & MeSH terms

• Encopresis
• Fecal Incontinence
• Fecal Soiling

Intervention

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).
• 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:
• 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.

Locations

Country	Name	City	State
Egypt	Banha University	Banha	Banha

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incontinence score using St' Mark's (Vaiszey)	Questionnaire ranging from zero (indicating complete continence) to 24 (indicating total incontinence).	3 months after intervention
Primary	incontinence score using St' Mark's (Vaiszey)	Questionnaire ranging from zero (indicating complete continence) to 24 (indicating total incontinence).	6 months after intervention
Secondary	Resting pressure (mm hg)	Pressure during relaxation of the anal sphincter	3 months after intervention
Secondary	Resting pressure (mm hg)	Pressure during relaxation of the anal sphincter	6 months after intervention
Secondary	Squeeze pressure (mm hg)	Pressure during contraction of the anal sphincter	3 months after intervention
Secondary	Squeeze pressure (mm hg)	Pressure during contraction of the anal sphincter	6 months after intervention
Secondary	First sensation (volume of the balloon by cm water)	First sensation of the stool in the rectum	3 months after intervention
Secondary	First sensation (volume of the balloon by cm water)	First sensation of the stool in the rectum	6 months after intervention
Secondary	First Urge(volume of the balloon by cm water)	The patient is trying to hold defecation and he can	3 months after intervention
Secondary	First Urge(volume of the balloon by cm water)	The patient is trying to hold defecation and he can	6 months after intervention
Secondary	Intense urge (volume of the balloon by cm water)	The Patent can no longer control the defecation	3 months after intervention
Secondary	Intense urge (volume of the balloon by cm water)	the Patent can no longer control the defecation	6 months after intervention