Biofeedback Vs Electrical Stimulation in Treatment of Fecal Incontinence
- Conditions
- Fecal IncontinenceEncopresisFecal Soiling
- Interventions
- Device: Electrical stimulationDevice: BiofeedbackOther: Traditional treatment
- Registration Number
- NCT04380571
- Lead Sponsor
- Cairo University
- 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%.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 93
- FecaI incontinence
- Normal defecation frequency,
- Normal bowel habits and
- Normal stool consistency
- Children who are not cooperative,
- Children with traumatic sphincter injury,
- Children with fecal impaction,
- Children with spinal diseases causing incontinence,
- Children with anorectal malformation,
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Electrical Stimulation 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. Biofeedback 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). Control group Traditional treatment 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.
- Primary Outcome Measures
Name Time Method Incontinence score using St' Mark's (Vaiszey) 3 months after intervention Questionnaire ranging from zero (indicating complete continence) to 24 (indicating total incontinence).
incontinence score using St' Mark's (Vaiszey) 6 months after intervention Questionnaire ranging from zero (indicating complete continence) to 24 (indicating total incontinence).
- Secondary Outcome Measures
Name Time Method Resting pressure (mm hg) 6 months after intervention Pressure during relaxation of the anal sphincter
First sensation (volume of the balloon by cm water) 6 months after intervention First sensation of the stool in the rectum
Intense urge (volume of the balloon by cm water) 6 months after intervention the Patent can no longer control the defecation
First Urge(volume of the balloon by cm water) 6 months after intervention The patient is trying to hold defecation and he can
Squeeze pressure (mm hg) 6 months after intervention Pressure during contraction of the anal sphincter
Trial Locations
- Locations (1)
Banha University
🇪🇬Banhā, Banha, Egypt