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

Neurogenic Bladder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03550898
• Other study ID #: 15-0287
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Meningomyelocele
• Myelomeningocele
• Neurogenic Bladder
• Urinary Bladder, Neurogenic

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