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

ConditionSpina Bifida
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-18
SponsorHasan Kalyoncu University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosed with meningomyelocele type spina bifida

Individuals between the ages of 5-18.

Disqualifiers

Presence of lower urinary tract infection

Presence of abdominal surgery in the last 3 months.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Biofeedback exercise combined with breathing exercise

    Behavioral

    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.

  • urotherapy educational group

    Behavioral

    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.

Treatment groups

24 Participants
are divided into 3 treatment groups
Group A: Control GroupNo intervention 0 interventions
Group B: Urotherapy educational groupActive comparator 1 intervention
Group C: Biofeedback exercise group combined with breathing exerciseExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

The effect of biofeedback training combined with breathing on bladder and bowel functions in spina bifida patients with neurogenic bladder and bowel disorders.

The primary outcome measure will be assessed by Voiding Disorders Symptom Score . The lowest score is 34, while the highest score is 170. Scale Evaluation: An increase in the total score obtained from the scale indicates an increase in the quality of life of individuals related to the disease.

Time frame
3 months
2

The effect of biofeedback training combined with breathing on quality of life in spina bifida patients with neurogenic bladder and bowel disorders.

The primary outcome measure will be assessed by The Pediatric Quality of Life Inventory (PedQL). In the inventory prepared according to the five-point Likert system, 0 = Never causes a problem, 1 = Almost never causes a problem, 2 = Sometimes causes a problem, 3 = Often causes a problem and 4 = Always causes a problem. A linear conversion is applied in the calculation of the total score of the scale and it turns into 0-100 points. As the score decreases, the quality of life increases.

Time frame
3 months
3

The effect of biofeedback training combined with breathing on activation of abdominal muscle groups in spina bifida patients with neurogenic bladder and bowel disorders.

The primary outcome measure will be assessed by superficial electromyography (EMG) outcomes. With the EMG device, the maximal, average and minimum contraction stimulation frequencies of the muscles and the maximal voluntary contraction percentage data will be obtained. The measurements will be taken by placing the channel around the transversus abdominus muscle (two fingers above and medial to the anterior superior iliac spine).

Time frame
3 months
4

The effect of biofeedback training combined with breathing on activation of pelvic floor muscle groups in spina bifida patients with neurogenic bladder and bowel disorders.

The primary outcome measure will be assessed by superficial electromyography (EMG) outcomes. With the EMG device, the maximal, average and minimum contraction stimulation frequencies of the muscles and the maximal voluntary contraction percentage data will be obtained. The measurements will be taken by placing the first channel around the external sphincter at 2-7 clock.

Time frame
3 months

Secondary outcomes

1

The effect of urotherapy training on bladder and bowel functions in spina bifida patients with neurogenic bladder and bowel disorders.

The primary outcome measure will be assessed by Voiding Disorders Symptom Score . The lowest score is 34, while the highest score is 170. Scale Evaluation: An increase in the total score obtained from the scale indicates an increase in the quality of life of individuals related to the disease.

Time frame
3 months
2

The effect of urotherapy training on quality of life in spina bifida patients with neurogenic bladder and bowel disorders.

The primary outcome measure will be assessed by The Pediatric Quality of Life Inventory (PedQL). In the inventory prepared according to the five-point Likert system, 0 = Never causes a problem, 1 = Almost never causes a problem, 2 = Sometimes causes a problem, 3 = Often causes a problem and 4 = Always causes a problem. A linear conversion is applied in the calculation of the total score of the scale and it turns into 0-100 points. As the score decreases, the quality of life increases.

Time frame
3 months
3

The effect of urotherapy training combined with breathing on activation of abdominal muscle groups in spina bifida patients with neurogenic bladder and bowel disorders.

The primary outcome measure will be assessed by superficial electromyography (EMG) outcomes. With the EMG device, the maximal, average and minimum contraction stimulation frequencies of the muscles and the maximal voluntary contraction percentage data will be obtained. The measurements will be taken by placing the channel around the transversus abdominus muscle (two fingers above and medial to the anterior superior iliac spine).

Time frame
3 months
4

The effect of urotherapy training on activation of pelvic floor muscle groups in spina bifida patients with neurogenic bladder and bowel disorders.

The primary outcome measure will be assessed by superficial electromyography (EMG) outcomes. With the EMG device, the maximal, average and minimum contraction stimulation frequencies of the muscles and the maximal voluntary contraction percentage data will be obtained. The measurements will be taken by placing the first channel around the external sphincter at 2-7 clock.

Time frame
3 months

Other outcomes

Locations

This trial has no locations.

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