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Completed

NCT Number: NCT04380571

Biofeedback Vs Electrical Stimulation in Treatment of Fecal Incontinence

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.

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Key information

Conditions

Fecal Incontinence Behavior Behavioral Symptoms Digestive System Diseases Elimination Disorders Encopresis Fecal Soiling Gastrointestinal Diseases Intestinal Diseases Mental Disorders Pathological Conditions, Signs and Symptoms Rectal Diseases Signs and Symptoms Signs and Symptoms, Digestive

Age range

5 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Banha University

Banhā, Banha, 13518, Egypt

About this study

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%.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

biofeedback

Device

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

Device

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

traditional treatment

Other

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

Primary outcomes

  1. Incontinence score using St' Mark's (Vaiszey)

    Time frame: 3 months after intervention

    Questionnaire ranging from zero (indicating complete continence) to 24 (indicating total incontinence).

  2. incontinence score using St' Mark's (Vaiszey)

    Time frame: 6 months after intervention

    Questionnaire ranging from zero (indicating complete continence) to 24 (indicating total incontinence).

Secondary outcomes

  1. Resting pressure (mm hg)

    Time frame: 3 months after intervention

    Pressure during relaxation of the anal sphincter

  2. Resting pressure (mm hg)

    Time frame: 6 months after intervention

    Pressure during relaxation of the anal sphincter

  3. Squeeze pressure (mm hg)

    Time frame: 3 months after intervention

    Pressure during contraction of the anal sphincter

  4. Squeeze pressure (mm hg)

    Time frame: 6 months after intervention

    Pressure during contraction of the anal sphincter

  5. First sensation (volume of the balloon by cm water)

    Time frame: 3 months after intervention

    First sensation of the stool in the rectum

  6. First sensation (volume of the balloon by cm water)

    Time frame: 6 months after intervention

    First sensation of the stool in the rectum

  7. First Urge(volume of the balloon by cm water)

    Time frame: 3 months after intervention

    The patient is trying to hold defecation and he can

  8. First Urge(volume of the balloon by cm water)

    Time frame: 6 months after intervention

    The patient is trying to hold defecation and he can

  9. Intense urge (volume of the balloon by cm water)

    Time frame: 3 months after intervention

    The Patent can no longer control the defecation

  10. Intense urge (volume of the balloon by cm water)

    Time frame: 6 months after intervention

    the Patent can no longer control the defecation

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
May 8, 2020
Registry last updated
May 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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