Can Dynamic Ultrasonography Replace Urodynamics in Follow-up of Patients With Myelomeningocele

Study Overview
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Brief Summary
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Patients with neurogenic bladder need periodic evaluation with urodynamic study, a invasive and uncomfortable procedure. Aim: To evaluate the accuracy of dynamic ultrasonography as a feasible and noninvasive alternative diagnostic method to identify detrusor overactivity in patients with neurogenic bladder

Detailed Description
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The urodynamic study and dynamic ultrasonography were performed concurrently, to identify detrusor overactivity, in patients with myelomeningocele and clinical indication for urodynamics, by investigators without verbal or visual contact. The overactivity was diagnosed through active conformational change of the bladder during filling phase.

Official Title
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Can Dynamic Ultrasonography Replace Urodynamics in the Follow-up of Patients With Myelomeningocele: A Prospective Concurrent Study

Conditions
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Neurogenic Bladder, Myelomeningocele

Intervention / Treatment
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* Diagnostic Test: Dynamic Ultrasonography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All outpatients of the Pediatric Urology Department of the investigator's institution with diagnosis of myelomeningocele and clinical indication for urodynamic study Exclusion Criteria: Previous bladder augmentation surgery Current urinary tract infection Fail to provide consent for participation
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Dynamic ultrasonography was performed in all patients during the urodynamic study.


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Dynamic ultrasonography<br>Dynamic ultrasonography was performed in all patients who underwent urodynamics, simultaneously. | Diagnostic Test: Dynamic Ultrasonography<br>* Dynamic Ultrasonography was performed with patients in supine position, with a suprapubic sagittal position transductor, during filling phase of urodynamics.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the accuracy of dynamic ultrasonography to identify bladder overactivity in neurogenic bladder. | Dynamic Ultrasonography evaluated the dynamic conformational change of the bladder to identify the presence of detrusor overactivity, based on a subjective graduation of contractions, compared to the urodynamic data. | 20 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the accuracy of dynamic ultrasonography to identify maximum cystometric capacity. | The bladder maximum capacity was measured at the end of the filling phase, based on the ellipse formula and compared to the infused volume in urodynamics. | 20 minutes | 
| To assess the ability of dynamic ultrasonography to estimate the pressure of detrusor contractions. | According to the detrusor mobility and bladder deformity, the contractions were graded: 1 - no contractions; 2 - partial contraction of bladder floor; 3 - partial contraction of bladder floor and posterior wall; 4 - generalized contraction with modification of bladder shape from ellipsoid to round. These data were compared to the maximum pressure data recorded in the urodynamic study. | 20 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dynamic Ultrasonography, Spinal Dysraphism