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Completed

NCT Number: NCT02852317

Urinary Markers of Detrusor Overactivity in Spina Bifida Patients

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.

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Key information

Conditions

Spina Bifida Autoimmune Diseases Autoimmune Diseases of the Nervous System Central Nervous System Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Immune System Diseases Lower Urinary Tract Symptoms Male Urogenital Diseases Multiple Sclerosis Nervous System Diseases Nervous System Malformations Neural Tube Defects Overactive Bladder Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Cord Diseases Spinal Cord Injuries Spinal Cord Injury Spinal Dysraphism Trauma, Nervous System Urinary Bladder Diseases Urinary Bladder, Overactive Urogenital Diseases Urologic Diseases Urological Manifestations Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre hospitalier universitaire de Rennes

Rennes, 35000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Accuracy of urinary markers will be evaluated by area under the curve (AUC)

    Time frame: through study completion, an average of 1 year

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Acronym: BUHD-SPINA

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Aug 2, 2016
Registry last updated
Sep 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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