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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03550898
Enrollment
81
Registered
2018-06-08
Start date
2014-06-01
Completion date
2017-02-01
Last updated
2018-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myelomeningocele, Neurogenic Bladder

Keywords

Dynamic Ultrasonography, Spinal Dysraphism

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.

Interventions

DIAGNOSTIC_TESTDynamic Ultrasonography

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

Sponsors

Hospital de Clinicas de Porto Alegre
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

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.

Intervention model description

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

Eligibility

Sex/Gender
ALL
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

Design outcomes

Primary

MeasureTime frameDescription
To evaluate the accuracy of dynamic ultrasonography to identify bladder overactivity in neurogenic bladder.20 minutesDynamic 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

MeasureTime frameDescription
To evaluate the accuracy of dynamic ultrasonography to identify maximum cystometric capacity.20 minutesThe 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 minutesAccording 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026