Urinary Markers of Detrusor Overactivity in Spina Bifida... | NCT02852317

Studies
Urinary Markers of Detrusor Overactivity in Spina Bifida Patients

NCT02852317

Sponsor

Rennes University Hospital

Status

Completed

Last Update Posted

Sep 11, 2018Actual

Enrollment

134Actual

Phase

Not provided

Conditions

Spina Bifida
Multiple Sclerosis
Spinal Cord Injury
Overactive Bladder

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 16, 2015Actual

Primary Completion Date

Mar 29, 2017Actual

Completion Date

Jul 17, 2017Actual

First Submitted Date

Jul 19, 2016

First Submission Date that Met QC Criteria

Aug 1, 2016

First Posted Date

Aug 2, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 10, 2018

Last Update Posted Date

Sep 11, 2018Actual

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

134Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patient with an urodynamic examination scheduled

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre hospitalier universitaire de Rennes		Rennes		35000	France

Condition Browse Module

MeSH Terms

ID	Term
D016135	Spinal Dysraphism
D009103	Multiple Sclerosis
D013119	Spinal Cord Injuries
D053201	Urinary Bladder, Overactive

Ancestor Terms

ID	Term
D009436	Neural Tube Defects
D009421	Nervous System Malformations
D009422	Nervous System Diseases
D000013	Congenital Abnormalities

Browse Leaves

Not provided

Browse Branches

Not provided

Label	Type	Description	Intervention Names
Spina bifida patient
Patients with multiple sclerosis
Patients with spinal cord injury
Patients with overactive bladder