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
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|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||81 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||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.|
|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|
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.
- 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.
- 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.
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
|Principal Investigator:||Brasil S Neto||Hospital de Clinicas de Porto Alegre|