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

NCT ID: NCT03550898

Last Updated: 2018-06-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-01

Study Completion Date

2017-02-01

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.

Conditions

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Neurogenic Bladder Myelomeningocele

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Dynamic ultrasonography was performed in all patients during the urodynamic study.
Primary Study Purpose

DIAGNOSTIC

Study Groups

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Dynamic ultrasonography

Dynamic ultrasonography was performed in all patients who underwent urodynamics, simultaneously.

Group Type OTHER

Dynamic Ultrasonography

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Dynamic Ultrasonography

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

Intervention Type DIAGNOSTIC_TEST

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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Brasil S Neto

Role: PRINCIPAL_INVESTIGATOR

Hospital de Clinicas de Porto Alegre

Other Identifiers

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15-0287

Identifier Type: -

Identifier Source: org_study_id

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