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Clinical Trials/NCT03339609
NCT03339609
Completed
Not Applicable

Micturition Reeductation in Children With Cerebral Palsy: Uroflow/EMG Measurement in Healthy Children

University Hospital, Ghent1 site in 1 country83 target enrollmentSeptember 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lower Urinary Tract Symptoms
Sponsor
University Hospital, Ghent
Enrollment
83
Locations
1
Primary Endpoint
Uroflow curve pattern - Clinical assessment
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

Nowadays there is a growing interest towards non-invasive assessment of urinary dysfunctions in clinical practice. The tendency to use uroflowmetry as a first-line screening tool is based on the inexpensiveness, time efficiency, comfort of the patient, etc. However, it is stated that uroflowmetry as a stand-alone study lacks the potential to make an accurate diagnosis. In regard to this, the International Continence Society indicated that the addition of pelvic floor electromyography might increase the accuracy of this assessment. Despite this recommendation, uroflowmetry in combination with electromyography has not been conducted in a healthy population.

The initial objective of this study was to examine whether adding electromyography to standard uroflowmetry in a healthy paediatric population would change the representation of parameters, especially of voiding patterns. In addition, the influence of several factors on uroflow parameters was analysed to complement current literature.

Registry
clinicaltrials.gov
Start Date
September 2014
End Date
June 2017
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Normal development

Exclusion Criteria

  • (Recurrent) urinary tract infections
  • LUTS which interfered with daily life
  • Fecal incontinence
  • History of genitourinary or renal surgery
  • Medication for incontinence during the last 3 months
  • Pelvic reeducation during the last 6 months
  • Neurologic problems influencing continence

Outcomes

Primary Outcomes

Uroflow curve pattern - Clinical assessment

Time Frame: 2017

Interpretation by pediatric urologist

Uroflow curve pattern - Mathematical assessment

Time Frame: 2017

Interpretation using Flow index methodology

Secondary Outcomes

  • voided volume(2017)
  • Maximal flow(2017)
  • post-void residual urine(2017)
  • voiding time(2017)

Study Sites (1)

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