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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03550898
Other study ID # 15-0287
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2014
Est. completion date February 1, 2017

Study information

Verified date May 2018
Source Hospital de Clinicas de Porto Alegre
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 81
Est. completion date February 1, 2017
Est. primary completion date February 1, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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

Study Design


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Hospital de Clinicas de Porto Alegre

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 20 minutes
Secondary 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. 20 minutes
Secondary 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. 20 minutes
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