Neurogenic BladderNCT03550898
Can Dynamic Ultrasonography Replace Urodynamics in Follow-up of Patients With Myelomeningocele
A study testing Dynamic Ultrasonography in people with Neurogenic Bladder and Myelomeningocele, run by Hospital de Clinicas de Porto Alegre.
Trial 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 Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Neurogenic Bladder, Myelomeningocele
- What is being tested?
- Dynamic Ultrasonography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2014to 1 Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All outpatients of the Pediatric Urology Department of the investigator's institution with diagnosis of myelomeningocele and clinical indication for urodynamic study
Who cannot join
- Previous bladder augmentation surgery
- Current urinary tract infection
- Fail to provide consent for participation
About this study
Official title: Can Dynamic Ultrasonography Replace Urodynamics in the Follow-up of Patients With Myelomeningocele: A Prospective Concurrent Study
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
Read the 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.
- Conditions
- Neurogenic Bladder, Myelomeningocele
- Being tested
- Dynamic Ultrasonography
- Keywords
- Dynamic Ultrasonography, Spinal Dysraphism
- Medical subject headings
- Urinary Bladder, Neurogenic, Meningomyelocele, Spinal Dysraphism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic UltrasonographyDiagnostic test
Dynamic Ultrasonography was performed with patients in supine position, with a suprapubic sagittal position transductor, during filling phase of urodynamics.
| Study group | Role | What they receive |
|---|---|---|
| Dynamic ultrasonography | Other | Dynamic ultrasonography was performed in all patients who underwent urodynamics, simultaneously. Receives: Diagnostic Test: Dynamic Ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 20 minutes
Secondary outcomes (2)
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.
Measured: 20 minutes
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.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2018
- Study start1 Jun 2014
- Primary completion1 Feb 2017
- Study completion1 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurogenic BladderStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Dynamic ultrasonography was performed in all patients during the urodynamic study.
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brasil S Neto, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03550898
- Sponsor's protocol ID
- 15-0287
- Status last verified
- May 2018
- First submitted
- 28 May 2018
- Last updated
- 8 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Dynamic Ultrasonography Replace Urodynamics in the Follow-up of Patients With Myelomeningocele: A Prospective Concurrent Study
- ClinicalTrials.gov ID
- NCT03550898
- Acronym / sponsor ID
- 15-0287
- Conditions
- Neurogenic Bladder, Myelomeningocele
- Keywords
- Dynamic Ultrasonography, Spinal Dysraphism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 1 Jun 2014 (actual)
- Primary completion
- 1 Feb 2017 (actual)
- Study completion
- 1 Feb 2017 (actual)
- First posted
- 8 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
- Model description
- Dynamic ultrasonography was performed in all patients during the urodynamic study.
| Arm | Type | Receives |
|---|---|---|
| Dynamic ultrasonography | Other | Diagnostic Test: Dynamic UltrasonographyDynamic ultrasonography was performed in all patients who underwent urodynamics, simultaneously. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All outpatients of the Pediatric Urology Department of the investigator's institution with diagnosis of myelomeningocele and clinical indication for urodynamic study
Key exclusion criteria (3 listed)
- Previous bladder augmentation surgery
- Current urinary tract infection
- Fail to provide consent for participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dynamic UltrasonographyDynamic Ultrasonography was performed with patients in supine position, with a suprapubic sagittal position transductor, during filling phase of urodynamics. | Diagnostic test | Dynamic ultrasonography |
Primary outcome
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.
2 secondary outcomes
To evaluate the accuracy of dynamic ultrasonography to identify maximum cystometric capacity.
Time frame: 20 minutes
To assess the ability of dynamic ultrasonography to estimate the pressure of detrusor contractions.
Time frame: 20 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brasil S Neto principal investigator
Hospital de Clinicas de Porto Alegre
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic Ultrasonography in people with Neurogenic Bladder and Myelomeningocele, run by Hospital de Clinicas de Porto Alegre.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the accuracy of dynamic ultrasonography to identify bladder overactivity in neurogenic bladder. (time frame: 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2018.