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

Not Applicable

Completed

• Conditions: Neurogenic Bladder; Myelomeningocele
• Interventions: Diagnostic Test: Dynamic Ultrasonography

• Registration Number: NCT03550898
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-06-01
• Primary Completion: 2017-02-01
• Study Completion: 2017-02-01
• Status Verified: 2018-05
• Study First Submitted: 2018-05-28
• Study First Submitted QC: 2018-06-07
• Last Update Submitted: 2018-06-07
• Study First Posted: 2018-06-08
• Last Update Posted: 2018-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dynamic ultrasonography	Dynamic Ultrasonography	Dynamic ultrasonography was performed in all patients who underwent urodynamics, simultaneously.

Primary Outcome Measures

Name	Time	Method
To evaluate the accuracy of dynamic ultrasonography to identify bladder overactivity in neurogenic bladder.	20 minutes	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.

Secondary Outcome Measures

Name	Time	Method
To evaluate the accuracy of dynamic ultrasonography to identify maximum cystometric capacity.	20 minutes	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.
To assess the ability of dynamic ultrasonography to estimate the pressure of detrusor contractions.	20 minutes	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.