Neurogenic Urinary Bladder
Conditions
Interventions
This study is a randomized, double-blind, placebo-controlled clinical trial in which these patients will be divided into two groups: an intervention group that will use intermittent bladder catheteriz
the patient should feel a sensory response, that is, up to the maximum level tolerated by the patient (without pain), or a motor response when there is flexion of the ipsilateral hallux or movement of
E02.331.800
Sponsors
UNiversidade Federal de Minas Gerais
UNiversidade Federal de Minas Gerais
Eligibility
Age
4 Years to 18 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| No secondary results are expected. | — |
Countries
Brazil
Contacts
Public ContactFlavia Mrad
UNiversidade Federal de Minas Gerais
Outcome results
None listed