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Urinary Markers of Detrusor Overactivity in Spina Bifida Patients (BUHD-SPINA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02852317
Recruitment Status : Completed
First Posted : August 2, 2016
Last Update Posted : September 11, 2018
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

Brief 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.

Condition or disease
Spina Bifida Multiple Sclerosis Spinal Cord Injury Overactive Bladder

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Study Type : Observational
Actual Enrollment : 134 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Urinary Markers of Detrusor Overactivity in Spina Bifida Patients
Actual Study Start Date : March 16, 2015
Actual Primary Completion Date : March 29, 2017
Actual Study Completion Date : July 17, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Spina Bifida

Group/Cohort
Spina bifida patient
Patients with multiple sclerosis
Patients with spinal cord injury
Patients with overactive bladder



Primary Outcome Measures :
  1. Accuracy of urinary markers will be evaluated by area under the curve (AUC) [ Time Frame: through study completion, an average of 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patient with an urodynamic examination scheduled
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02852317


Locations
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France
Centre hospitalier universitaire de Rennes
Rennes, France, 35000
Sponsors and Collaborators
Rennes University Hospital
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Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT02852317    
Other Study ID Numbers: 35RC14_8805
First Posted: August 2, 2016    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: July 2016
Additional relevant MeSH terms:
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Multiple Sclerosis
Spinal Cord Injuries
Spinal Dysraphism
Urinary Bladder, Overactive
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Spinal Cord Diseases
Central Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Neural Tube Defects
Nervous System Malformations
Congenital Abnormalities