Neurogenic Bladder Clinical Trial
Official title:
Can Dynamic Ultrasonography Replace Urodynamics in the Follow-up of Patients With Myelomeningocele: A Prospective Concurrent Study
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 |
Verified date | May 2018 |
Source | Hospital de Clinicas de Porto Alegre |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Hospital de Clinicas de Porto Alegre |
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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