Can Dynamic Ultrasonography Replace Urodynamics in Follow-up of Patients With Myelomeningocele
Primary Purpose
Neurogenic Bladder, Myelomeningocele
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dynamic Ultrasonography
Sponsored by
About this trial
This is an interventional diagnostic trial for Neurogenic Bladder focused on measuring Dynamic Ultrasonography, Spinal Dysraphism
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Dynamic ultrasonography
Arm Description
Dynamic ultrasonography was performed in all patients who underwent urodynamics, simultaneously.
Outcomes
Primary Outcome Measures
To evaluate the accuracy of dynamic ultrasonography to identify bladder overactivity in neurogenic bladder.
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.
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.
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.
Full Information
NCT ID
NCT03550898
First Posted
May 28, 2018
Last Updated
June 7, 2018
Sponsor
Hospital de Clinicas de Porto Alegre
1. Study Identification
Unique Protocol Identification Number
NCT03550898
Brief Title
Can Dynamic Ultrasonography Replace Urodynamics in Follow-up of Patients With Myelomeningocele
Official Title
Can Dynamic Ultrasonography Replace Urodynamics in the Follow-up of Patients With Myelomeningocele: A Prospective Concurrent Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
June 1, 2014 (Actual)
Primary Completion Date
February 1, 2017 (Actual)
Study Completion Date
February 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurogenic Bladder, Myelomeningocele
Keywords
Dynamic Ultrasonography, Spinal Dysraphism
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Allocation
N/A
Enrollment
81 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dynamic ultrasonography
Arm Type
Other
Arm Description
Dynamic ultrasonography was performed in all patients who underwent urodynamics, simultaneously.
Intervention Type
Diagnostic Test
Intervention Name(s)
Dynamic Ultrasonography
Intervention Description
Dynamic Ultrasonography was performed with patients in supine position, with a suprapubic sagittal position transductor, during filling phase of urodynamics.
Primary Outcome Measure Information:
Title
To evaluate the accuracy of dynamic ultrasonography to identify bladder overactivity in neurogenic bladder.
Description
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.
Time Frame
20 minutes
Secondary Outcome Measure Information:
Title
To evaluate the accuracy of dynamic ultrasonography to identify maximum cystometric capacity.
Description
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.
Time Frame
20 minutes
Title
To assess the ability of dynamic ultrasonography to estimate the pressure of detrusor contractions.
Description
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.
Time Frame
20 minutes
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brasil S Neto
Organizational Affiliation
Hospital de Clinicas de Porto Alegre
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Can Dynamic Ultrasonography Replace Urodynamics in Follow-up of Patients With Myelomeningocele
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