Urinary Markers of Detrusor Overactivity in Spina Bifida Patients

Completed

• Conditions: Spina Bifida; Spinal Cord Injury; Multiple Sclerosis; Overactive Bladder

• Registration Number: NCT02852317
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03-16
• Status Verified: 2016-07
• Study First Submitted: 2016-07-19
• Study First Submitted QC: 2016-08-01
• Study First Posted: 2016-08-02
• Primary Completion: 2017-03-29
• Study Completion: 2017-07-17
• Last Update Submitted: 2018-09-10
• Last Update Posted: 2018-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 134

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Accuracy of urinary markers will be evaluated by area under the curve (AUC)	through study completion, an average of 1 year

Trial Locations

Locations (1)

Centre hospitalier universitaire de Rennes; 🇫🇷 Rennes, France