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

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

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Key information

Conditions

Neurogenic Bladder Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Meningomyelocele Myelomeningocele Nervous System Diseases Nervous System Malformations Neural Tube Defects Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Dysraphism Urinary Bladder Diseases Urinary Bladder, Neurogenic Urogenital Diseases Urologic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dynamic Ultrasonography

Diagnostic Test

Dynamic Ultrasonography was performed with patients in supine position, with a suprapubic sagittal position transductor, during filling phase of urodynamics.

Primary outcomes

To evaluate the accuracy of dynamic ultrasonography to identify bladder overactivity in neurogenic bladder.

Time frame: 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 outcomes

To evaluate the accuracy of dynamic ultrasonography to identify maximum cystometric capacity.

Time frame: 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.

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hospital de Clinicas de Porto Alegre

Other

Registry information

Official study title

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

Important dates

Study start: 2014
Primary completion: 2017
Study completion: 2017
First posted: Jun 8, 2018
Registry last updated: Jun 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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