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

September 10, 2018 updated by: Rennes University Hospital
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

134

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Rennes, France, 35000
        • Centre Hospitalier Universitaire de Rennes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patient with an urodynamic examination scheduled

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rennes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2015

Primary Completion (Actual)

March 29, 2017

Study Completion (Actual)

July 17, 2017

Study Registration Dates

First Submitted

July 19, 2016

First Submitted That Met QC Criteria

August 1, 2016

First Posted (Estimate)

August 2, 2016

Study Record Updates

Last Update Posted (Actual)

September 11, 2018

Last Update Submitted That Met QC Criteria

September 10, 2018

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 35RC14_8805

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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