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Fecal IncontinenceNCT04380571

Biofeedback Vs Electrical Stimulation in Treatment of Fecal Incontinence

A study testing Biofeedback, Electrical stimulation and Traditional treatment in people with Fecal Incontinence and Encopresis, run by Cairo University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 5 to 15 years
Conditions the study is for
Fecal Incontinence, Encopresis, Fecal Soiling
What is being tested?
Biofeedback, Electrical stimulation and Traditional treatment
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
93 participants
Where
1 siteEgypt
Study dates
4 Mar 2018to 28 Feb 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 15 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • FecaI incontinence
  • Normal defecation frequency,
  • Normal bowel habits and
  • Normal stool consistency

Who cannot join

  • Children who are not cooperative,
  • Children with traumatic sphincter injury,
  • Children with fecal impaction,
  • Children with spinal diseases causing incontinence,
  • Children with anorectal malformation,

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Banha University

    Banhā, Banha, 13518

Other trials in Egypt

About this study

Official title: Biofeedback Versus Bilateral Transcutaneous Electrical Nerve Stimulation in the Treatment of Functional Non-retentive 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.

Read the 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%.

Being tested
Biofeedback, Electrical stimulation, Traditional treatment
Keywords
Fecal incontinence, Biofeedback, Transcutaneous posterior tibial nerve stimulation, Childern
Medical subject headings
Fecal Incontinence, Encopresis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BiofeedbackDevice

    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 stimulationDevice

    Also called Posterior tibial nerve 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.

  • Traditional treatmentOther

    Also called Exercises

    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.

Study groups in NCT04380571
Study groupRoleWhat they receive
BiofeedbackExperimentalBiofeedback 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).
Receives: Device: Biofeedback
Electrical StimulationExperimentalBilateral (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.
Receives: Device: Electrical stimulation
Control groupActive comparatorwere 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.
Receives: Other: Traditional treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: 3 months after intervention

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

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

    Measured: 6 months after intervention

Secondary outcomes (10)

  1. Resting pressure (mm hg)

    Pressure during relaxation of the anal sphincter

    Measured: 3 months after intervention

  2. Resting pressure (mm hg)

    Pressure during relaxation of the anal sphincter

    Measured: 6 months after intervention

  3. Squeeze pressure (mm hg)

    Pressure during contraction of the anal sphincter

    Measured: 3 months after intervention

  4. Squeeze pressure (mm hg)

    Pressure during contraction of the anal sphincter

    Measured: 6 months after intervention

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

    First sensation of the stool in the rectum

    Measured: 3 months after intervention

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

    First sensation of the stool in the rectum

    Measured: 6 months after intervention

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

    The patient is trying to hold defecation and he can

    Measured: 3 months after intervention

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

    The patient is trying to hold defecation and he can

    Measured: 6 months after intervention

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

    The Patent can no longer control the defecation

    Measured: 3 months after intervention

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

    the Patent can no longer control the defecation

    Measured: 6 months after intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2020
  2. Study start4 Mar 2018
  3. Primary completion27 Dec 2018
  4. Study completion28 Feb 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
93 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04380571
Sponsor's protocol ID
Fecal incontinence
Status last verified
May 2020
First submitted
29 Apr 2020
Last updated
8 May 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: After Publication, the investigators would like to share the data with authors interested in this topic

Questions about this trial

What is this clinical trial studying?

A study testing Biofeedback, Electrical stimulation and Traditional treatment in people with Fecal Incontinence and Encopresis, run by Cairo University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incontinence score using St' Mark's (Vaiszey) (time frame: 3 months after intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04380571.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2020.

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