Study with Electrostimulation on the Skin of the Ankle Region in Children and Adolescents with Bladder Problems due to a Spine Problem

Not Applicable

• Conditions: eurogenic Urinary Bladder; C10.500.680.610

• Registration Number: RBR-8xk82pt
• Lead Sponsor: iversidade Federal de Minas Gerais

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2024-01-05
• Last Update Posted: 23 January 2024
• Study Completion: 2026-12-29

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

A sample will be provided for children and adolescents; aged between four and 18 years; diagnosed with refractory Hyperactive Neurogenic Bladder due to myelomeningocele using anticholinergics and a clean intermittent urinary catheter; patients whose parents or guardians agreed to participate in the study after reading, understanding and signing the Informed Consent Form; participants aged six years or over who decided to participate in the study, after reading, understanding and signing the Informed Consent Form.

Exclusion Criteria

Children and adolescents with neurogenic bladder due to other neurogenic causes such as spinal tumors, cerebral palsy, spinal cord trauma, among others; patients with underlying medical conditions (metabolic diseases, anorectal and urogenital malformations, previous urogenital surgery such as augmentation cystoplasty or vesicostomy); patients using a pacemaker; patients and/or parents or guardians who did not agree to participate in the study and/or did not agree with the Informed Consent Form and/or Informed Assent Form.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
It is expected to reduce urinary incontinence in the intervals between clean intermittent bladder catheterizations and nocturnal urinary loss through the use of diary completion according to the criteria of the International Children's Continence Society.;It is expected that there will be an increase in maximum bladder capacity and bladder compliance, which will be assessed through a urodynamic study.; It is expected to the improvement of intestinal constipation through the use of the Criteria of Rome IV and the Bristol Stool Scale.;It is expected to improve detrusor pressure at maximum cystometric capacity and reduce the lowest detrusor pressure loss by carrying out the urodynamic study.;It is expected that there will be a reduction in discard after emptying by less than 10% of the maximum expected bladder capacity, which will be evaluated through a urodynamic study.

Secondary Outcome Measures

Name	Time	Method
o secondary results are expected.