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

NCT06618378 | Not Yet Recruiting

• 1 other identifier: Neurogenic Bladder
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

spina bifida; biofeedback; urotherapy; neurogenicbladder

Outcome Measures

Primary Outcomes (4)

• 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.

  3 months

• 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.

  3 months

• 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).

  3 months

• 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.

  3 months

Secondary Outcomes (4)

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

  3 months

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

  3 months

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

  3 months

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

  3 months

Study Arms (3)

Control Group

NO INTERVENTION

Urotherapy educational group

ACTIVE COMPARATOR

Behavioral: urotherapy educational group

Biofeedback exercise group combined with breathing exercise

EXPERIMENTAL

Behavioral: Biofeedback exercise combined with breathing exercise; Behavioral: urotherapy educational group

Interventions

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.

Biofeedback exercise group combined with breathing exercise

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.

Biofeedback exercise group combined with breathing exercise; Urotherapy educational group

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Diagnosed with meningomyelocele type spina bifida
• Individuals between the ages of 5-18.

You may not qualify if:

• Presence of lower urinary tract infection
• Presence of abdominal surgery in the last 3 months.

Sponsors & Collaborators

• Hasan Kalyoncu University: lead

Related Publications (3)

• Xu L, Fu C, Zhang Q, Xiong F, Peng L, Liang Z, Chen L, He C, Wei Q. Efficacy of biofeedback, repetitive transcranial magnetic stimulation and pelvic floor muscle training for female neurogenic bladder dysfunction after spinal cord injury: a study protocol for a randomised controlled trial. BMJ Open. 2020 Aug 5;10(8):e034582. doi: 10.1136/bmjopen-2019-034582.

  PMID: 32759239 BACKGROUND

• Zivkovic VD, Stankovic I, Dimitrijevic L, Kocic M, Colovic H, Vlajkovic M, Slavkovic A, Lazovic M. Are Interferential Electrical Stimulation and Diaphragmatic Breathing Exercises Beneficial in Children With Bladder and Bowel Dysfunction? Urology. 2017 Apr;102:207-212. doi: 10.1016/j.urology.2016.12.038. Epub 2016 Dec 28.

  PMID: 28040503 BACKGROUND

• Libo LM, Arnold GE, Woodside JR, Borden TA, Hardy TL. EMG biofeedback for functional bladder-sphincter dyssynergia: a case study. Biofeedback Self Regul. 1983 Jun;8(2):243-53. doi: 10.1007/BF00998854.

  PMID: 6357288 BACKGROUND

MeSH Terms

Conditions

Spinal Dysraphism

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Neural Tube Defects; Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Fatma Nur Erçetin, MSc

  Doctoral thesis

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fatma Nur Erçetin, MSc

CONTACT

+905387342516; fnur.sokucu@hku.edu.tr

Serkan Usgu, pHD

CONTACT

+905054828267; serkan.usgu@hku.edu.tr

Study Design

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

Model Details: There will be 3 groups followed at the same time.

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: October 1, 2024
• Study Start: October 21, 2024
• Primary Completion (Estimated): July 21, 2026
• Study Completion (Estimated): July 21, 2026
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share