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NCT02852317 Clinical Trial

Urinary Markers of Detrusor Overactivity in Spina Bifida Patients

Multiple Sclerosis Clinical Trial

— BUHD-SPINA  

Official title:
Urinary Markers of Detrusor Overactivity in Spina Bifida Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02852317
Other study ID # 35RC14_8805
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 16, 2015
Est. completion date July 17, 2017

Study information
Verified date July 2016
Source Rennes University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to assess diagnostic performance of urinary markers of detrusor overactivity (Nerve Growth Factor (NGF), Brain-Derived Neurotrophic Factor (BDNF), adenosine triphosphate (ATP), Prostaglandine E2) in detected high pressure bladder un spina bifida patients.

Recruitment information / eligibility
Status Completed
Enrollment 134
Est. completion date July 17, 2017
Est. primary completion date March 29, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

Study arm:

- Spina bifida patient

- Seen consecutively in outpatient clinics

- Age > 18 years-old

Control arm:

- Patients with multiple sclerosis or spinal cord injury or overactive bladder

- Seen consecutively in urodynamics

- with lower urinary tract symptoms

- Age > 18 years-old

Exclusion Criteria:

- Positive urine culture

- History of urologic neoplasms

- History of interstitial cystitis

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Centre hospitalier universitaire de Rennes Rennes

Sponsors (1)
Lead Sponsor Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Accuracy of urinary markers will be evaluated by area under the curve (AUC) through study completion, an average of 1 year
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