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

Primary Purpose

Neurogenic Bladder, Myelomeningocele

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dynamic Ultrasonography
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Neurogenic Bladder focused on measuring Dynamic Ultrasonography, Spinal Dysraphism

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Dynamic ultrasonography

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    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.

    Full Information

    First Posted
    May 28, 2018
    Last Updated
    June 7, 2018
    Sponsor
    Hospital de Clinicas de Porto Alegre
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03550898
    Brief Title
    Can Dynamic Ultrasonography Replace Urodynamics in Follow-up of Patients With Myelomeningocele
    Official Title
    Can Dynamic Ultrasonography Replace Urodynamics in the Follow-up of Patients With Myelomeningocele: A Prospective Concurrent Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    June 1, 2014 (Actual)
    Primary Completion Date
    February 1, 2017 (Actual)
    Study Completion Date
    February 1, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Hospital de Clinicas de Porto Alegre

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Neurogenic Bladder, Myelomeningocele
    Keywords
    Dynamic Ultrasonography, Spinal Dysraphism

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Dynamic ultrasonography was performed in all patients during the urodynamic study.
    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.
    Allocation
    N/A
    Enrollment
    81 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Dynamic ultrasonography
    Arm Type
    Other
    Arm Description
    Dynamic ultrasonography was performed in all patients who underwent urodynamics, simultaneously.
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Dynamic Ultrasonography
    Intervention Description
    Dynamic Ultrasonography was performed with patients in supine position, with a suprapubic sagittal position transductor, during filling phase of urodynamics.
    Primary Outcome Measure Information:
    Title
    To evaluate the accuracy of dynamic ultrasonography to identify bladder overactivity in neurogenic bladder.
    Description
    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.
    Time Frame
    20 minutes
    Secondary Outcome Measure Information:
    Title
    To evaluate the accuracy of dynamic ultrasonography to identify maximum cystometric capacity.
    Description
    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.
    Time Frame
    20 minutes
    Title
    To assess the ability of dynamic ultrasonography to estimate the pressure of detrusor contractions.
    Description
    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.
    Time Frame
    20 minutes

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Brasil S Neto
    Organizational Affiliation
    Hospital de Clinicas de Porto Alegre
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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

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