Biofeedback Vs Electrical Stimulation in Treatment of Fecal Incontinence

NCT04380571 | Completed

• 1 other identifier: Fecal incontinence
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

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.

Conditions

Fecal Incontinence; Encopresis; Fecal Soiling

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Incontinence score using St' Mark's (Vaiszey)

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

  3 months after intervention

• incontinence score using St' Mark's (Vaiszey)

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

  6 months after intervention

Secondary Outcomes (10)

• Resting pressure (mm hg)

  3 months after intervention

• Resting pressure (mm hg)

  6 months after intervention

• Squeeze pressure (mm hg)

  3 months after intervention

• Squeeze pressure (mm hg)

  6 months after intervention

• First sensation (volume of the balloon by cm water)

  3 months after intervention

Study Arms (3)

Biofeedback

EXPERIMENTAL

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).

Device: Biofeedback

Electrical Stimulation

EXPERIMENTAL

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.

Device: Electrical stimulation

Control group

ACTIVE COMPARATOR

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.

Other: Traditional treatment

Interventions

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).

Biofeedback

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.

Also known as: Posterior tibial nerve stimulation

Electrical 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.

Also known as: Exercises

Control group

Eligibility Criteria

• Age: 5 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Banha University

Banhā, Banha, 13518, Egypt

Location

MeSH Terms

Conditions

Fecal Incontinence; Encopresis

Interventions

Biofeedback, Psychology; Electric Stimulation; Exercise

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological; Physical Stimulation; Investigative Techniques; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Emad M Abdelrhman, PhD

  Benha University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: 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).

Study Record Dates

• First Submitted: April 29, 2020
• First Posted: May 8, 2020
• Study Start: March 4, 2018
• Primary Completion: December 27, 2018
• Study Completion: February 28, 2019
• Last Updated: May 8, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After Publication
• Access Criteria: Not available now

Locations

EG (1)