Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03550898
Recruitment Status : Completed
First Posted : June 8, 2018
Last Update Posted : June 8, 2018
Sponsor:
Information provided by (Responsible Party):
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


Condition or disease Intervention/treatment Phase
Neurogenic Bladder Myelomeningocele Diagnostic Test: Dynamic Ultrasonography Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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.
Masking:
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 : June 1, 2014
Actual Primary Completion Date : February 1, 2017
Actual Study Completion Date : February 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03550898


Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
Layout table for investigator information
Principal Investigator: Brasil S Neto Hospital de Clinicas de Porto Alegre
Layout table for additonal information
Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT03550898    
Other Study ID Numbers: 15-0287
First Posted: June 8, 2018    Key Record Dates
Last Update Posted: June 8, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospital de Clinicas de Porto Alegre:
Dynamic Ultrasonography
Spinal Dysraphism
Additional relevant MeSH terms:
Layout table for MeSH terms
Urinary Bladder, Neurogenic
Meningomyelocele
Spina Bifida Cystica
Neurologic Manifestations
Nervous System Diseases
Urinary Bladder Diseases
Urologic Diseases
Neural Tube Defects
Nervous System Malformations
Congenital Abnormalities
Spinal Dysraphism