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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04380571
Enrollment
93
Registered
2020-05-08
Start date
2018-03-04
Completion date
2019-02-28
Last updated
2020-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Encopresis, Fecal Incontinence, Fecal Soiling

Keywords

Fecal incontinence, Biofeedback, Transcutaneous posterior tibial nerve stimulation, Childern

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%.

Interventions

DEVICEBiofeedback

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).

DEVICEElectrical 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.

OTHERTraditional 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.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

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).

Eligibility

Sex/Gender
ALL
Age
5 Years to 15 Years
Healthy volunteers
No

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,

Design outcomes

Primary

MeasureTime frameDescription
Incontinence score using St' Mark's (Vaiszey)3 months after interventionQuestionnaire ranging from zero (indicating complete continence) to 24 (indicating total incontinence).
incontinence score using St' Mark's (Vaiszey)6 months after interventionQuestionnaire ranging from zero (indicating complete continence) to 24 (indicating total incontinence).

Secondary

MeasureTime frameDescription
First sensation (volume of the balloon by cm water)3 months after interventionFirst sensation of the stool in the rectum
Resting pressure (mm hg)3 months after interventionPressure during relaxation of the anal sphincter
Intense urge (volume of the balloon by cm water)3 months after interventionThe Patent can no longer control the defecation
First Urge(volume of the balloon by cm water)3 months after interventionThe patient is trying to hold defecation and he can
Squeeze pressure (mm hg)3 months after interventionPressure during contraction of the anal sphincter

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026