Effectiveness of Biofeedback Training in Children with Neurogenic Bladder and Bowel Disorder Wıth Spina Bifida

NCT06618378 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-10-01

No results posted yet for this study

Summary

The aim of this study is to examine and compare the bladder and bowel functions, activation of pelvic floor and abdominal muscle groups and quality of life of children diagnosed with spina bifida who did not receive any treatment due to bladder-intestinal dysfunction, received only urotherapy training and received biofeedback training combined with breathing.

The type of study is clinical trial. Question 1: Does biofeedback training combined with breathing have an effect on bladder and bowel functions, activation of pelvic floor and abdominal muscle groups and quality of life in spina bifida patients with neurogenic bladder and bowel disorders? Question 2: Does urotherapy training have an effect on bladder and bowel functions, activation of pelvic floor and abdominal muscle groups and quality of life in spina bifida patients with neurogenic bladder and bowel disorders? Group 1: control group Group 2: urotherapy training group Group 3: Biofeedback exercise training group combined with breathing There will be no extra treatment to group 1. Urotherapy Training: Standard urotherapy is a combined method that includes clinical assessment (recording voiding frequencies, voiding volumes and incontinence episodes in a bladder diary), voiding habit training, behavior modification instructions, lifestyle recommendations regarding fluid intake and supporting children and their parents through the process.

Exercise Training: Urotherapy training will be given at the beginning of the treatment process. Contraction and relaxation will be applied around the external sphincter in combination with diaphragmatic breathing by visual imagery with EMG biofeedback application.

Group 1, group 2 and group 3 will be compared.

Conditions

  • Spina Bifida

Interventions

BEHAVIORAL

Biofeedback exercise combined with breathing exercise

Urotherapy training will be given at the beginning of the treatment process. Contraction and relaxation will be applied around the external sphincter in combination with diaphragmatic breathing by visual imagery with EMG biofeedback application. The second channel EMG will be placed on the transversus abdominus muscle and its activation will be checked. The treatment will be completed with 30-minute sessions twice a week for 12 weeks. Each session will consist of 40 cycles of 10 minutes of diaphragmatic breathing exercise followed by 20 minutes of 10 seconds of contraction followed by 20 seconds of relaxation.

BEHAVIORAL

urotherapy educational group

1. An important part of urotherapy is to provide parents and children with detailed explanations of etiology, prevalence and pathophysiology. This will reassure parents and help them understand the causes of the child's bedwetting accidents and the rationale for treatment. This will increase compliance with treatment. 2. Recommendations are given regarding appropriate fluid intake and regular voiding throughout the day. The child is encouraged to go to the toilet seven times a day and drink seven glasses of water. 3. The correct sitting position for the toilet is explained. If the feet do not touch the floor easily, it is recommended to use a step stool for foot support. Additionally, children are taught to relax their abdomen when peeing. 4. In addition to monitoring and motivation, a bladder diary should be kept to give the child and parents an idea about the progress of treatment, compliance with treatment and continuity.

Sponsors & Collaborators

  • Hasan Kalyoncu University

    lead OTHER

Principal Investigators

  • Fatma Nur Erçetin, MSc · Doctoral thesis

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-21
Primary Completion
2026-07-21
Completion
2026-07-21

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06618378 on ClinicalTrials.gov