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

Sponsor

Hospital de Clinicas de Porto Alegre (Other)

Overall Status

Completed

CT.gov ID

NCT03550898

Collaborator

(none)

Enrollment

Arm

32.1

Actual Duration (Months)

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Neurogenic Bladder Myelomeningocele	Diagnostic Test: Dynamic Ultrasonography	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

81 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

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

Masking Description:

Dynamic ultrasonography was performed during the filling phase of the urodynamic study. The radiologist and the urodynamicist had no verbal or visual contact during the examinations, with use of a siding.

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Jun 1, 2014

Actual Primary Completion Date :

Feb 1, 2017

Actual Study Completion Date :

Feb 1, 2017

Arms and Interventions

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

Arm

Intervention/Treatment

Other: Dynamic ultrasonography

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

Diagnostic Test: Dynamic Ultrasonography

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

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Hospital de Clinicas de Porto Alegre

Investigators

Principal Investigator: Brasil S Neto, Hospital de Clinicas de Porto Alegre

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hospital de Clinicas de Porto Alegre

ClinicalTrials.gov Identifier:

NCT03550898

Other Study ID Numbers:

15-0287

First Posted:

Jun 8, 2018

Last Update Posted:

Jun 8, 2018

Last Verified:

May 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Hospital de Clinicas de Porto Alegre

Dynamic Ultrasonography

Spinal Dysraphism

Additional relevant MeSH terms:

Urinary Bladder, Neurogenic

Meningomyelocele

Spina Bifida Cystica

Study Results

No Results Posted as of Jun 8, 2018