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

NCT03550898 | Completed

• 1 other identifier: 15-0287
• Study Type: interventional
• Target: 81
• Locations: 0 countries
• Sites: N/A

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

Conditions

Neurogenic Bladder; Myelomeningocele

Keywords

Dynamic Ultrasonography; Spinal Dysraphism

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• To evaluate the accuracy of dynamic ultrasonography to identify maximum cystometric capacity.

  20 minutes

• To assess the ability of dynamic ultrasonography to estimate the pressure of detrusor contractions.

  20 minutes

Study Arms (1)

Dynamic ultrasonography

OTHER

Dynamic ultrasonography was performed in all patients who underwent urodynamics, simultaneously.

Diagnostic Test: Dynamic Ultrasonography

Interventions

Dynamic Ultrasonography DIAGNOSTIC_TEST

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

Dynamic ultrasonography

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All outpatients of the Pediatric Urology Department of the investigator's institution with diagnosis of myelomeningocele and clinical indication for urodynamic study

You may not qualify if:

• Previous bladder augmentation surgery
• Current urinary tract infection
• Fail to provide consent for participation

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

MeSH Terms

Conditions

Urinary Bladder, Neurogenic; Meningomyelocele; Spinal Dysraphism

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neural Tube Defects; Nervous System Malformations; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Brasil S Neto

  Hospital de Clinicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking Details: 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.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: May 28, 2018
• First Posted: June 8, 2018
• Study Start: June 1, 2014
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: June 8, 2018

Record last verified: 2018-05