Clinical trial NCT04380571: 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
Overall status: COMPLETED
Phase: NA
Conditions: Fecal Incontinence
Encopresis
Fecal Soiling
Keywords: Fecal incontinence
Biofeedback
Transcutaneous posterior tibial nerve stimulation
Childern
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-05-08
Enrollment: 93
Sex: ALL
Minimum age (years): 5
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: TREATMENT

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%.

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,

Primary outcomes:
measure: Incontinence score using St' Mark's (Vaiszey)
timeFrame: 3 months after intervention
measure: incontinence score using St' Mark's (Vaiszey)
timeFrame: 6 months after intervention
Secondary outcomes:
measure: Resting pressure (mm hg)
timeFrame: 3 months after intervention
measure: Resting pressure (mm hg)
timeFrame: 6 months after intervention
measure: Squeeze pressure (mm hg)
timeFrame: 3 months after intervention
measure: Squeeze pressure (mm hg)
timeFrame: 6 months after intervention
measure: First sensation (volume of the balloon by cm water)
timeFrame: 3 months after intervention
measure: First sensation (volume of the balloon by cm water)
timeFrame: 6 months after intervention
measure: First Urge(volume of the balloon by cm water)
timeFrame: 3 months after intervention
measure: First Urge(volume of the balloon by cm water)
timeFrame: 6 months after intervention
measure: Intense urge (volume of the balloon by cm water)
timeFrame: 3 months after intervention
measure: Intense urge (volume of the balloon by cm water)
timeFrame: 6 months after intervention
Other outcomes:
Locations:
city: Banhā
country: Egypt
facility: Banha University
state: Banha
Study officials:
affiliation: Benha University
name: Emad M Abdelrhman, PhD
role: PRINCIPAL_INVESTIGATOR
References: