Biofeedback Vs Electrical Stimulation in Treatment of Fecal Incontinence

NCT ID: NCT04380571

Last Updated: 2020-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 93 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-04
• Study Completion Date: 2019-02-28

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%.

Conditions

Fecal Incontinence; Encopresis; Fecal Soiling

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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).

Group Type: EXPERIMENTAL

Biofeedback

Intervention Type: 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

Bilateral (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.

Group Type: EXPERIMENTAL

Electrical stimulation

Intervention Type: 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.

Control group

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.

Group Type: ACTIVE_COMPARATOR

Traditional treatment

Intervention Type: 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.

Interventions

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).

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Other Intervention Names

Posterior tibial nerve stimulation; Exercises

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,

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Olfat Ibrahim Ali

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Emad M Abdelrhman, PhD

Role: PRINCIPAL_INVESTIGATOR

Benha University

Locations

Banha University

Banhā, Banha, Egypt

Countries

Egypt

Other Identifiers

Fecal incontinence

Identifier Type: -

Identifier Source: org_study_id