Reflux in Spinal Cord Injury Patients With Neurogenic Low... | NCT01297673

Studies
Reflux in Spinal Cord Injury Patients With Neurogenic Lower Urinary Tract Dysfunction

NCT01297673

Sponsor

Balgrist University Hospital

Status

Completed

Last Update Posted

Dec 16, 2016Estimated

Enrollment

120Actual

Phase

Not provided

Conditions

Vesico-ureteral Reflux
Spinal Cord Injury

Interventions

video-urodynamic examination

Countries

Switzerland

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

Dec 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

Jan 2010

Primary Completion Date

Aug 2010Actual

Completion Date

Aug 2010Actual

First Submitted Date

Feb 16, 2011

First Submission Date that Met QC Criteria

Feb 16, 2011

First Posted Date

Feb 17, 2011Estimated

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

Dec 15, 2016

Last Update Posted Date

Dec 16, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to investigate the incidence of reflux in patients with spinal cord injury in relation to the lesion level, duration of injury and bladder management

Detailed Description

Vesico-ureteral reflux was the main cause for renal failure and reduced life expectancy in patients with neurogenic bladder dysfunction due to spinal cord injury. Neurogenic detrusor overactivity leads to high intravesical pressure and may induce reflux. Decreasing intravesical pressure and increasing bladder capacity is necessary to prevent reflux and secondary renal failure.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

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

120Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Spinal cord injury		Patients with neurogenic lower urinary tract dysfunction due to spinal cord injury with regular urodynamic examination	Procedure: video-urodynamic examination

Interventions

Name	Type	Description	Arm Group Labels	Other Names
video-urodynamic examination	Procedure	Assessment of bladder function during video urodynamic determine of incidence degree and localization of vesico ureteral reflux based on the result of video urodynamics

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence and degree of vesico ureter renal reflux	video urodynamic, ultrasound examination	average: yearly scheduled control

Secondary Outcomes

Measure	Description	Time Frame
pdet (cmH2O)	urodynamic parameter, detrusor pressure	average: yearly scheduled control
Medication	name of drugs and applied dosis

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Spinal cord injury
Neurogenic lower urinary tract dysfunction
Written informed consent

Exclusion Criteria:

Lower urinary tract dysfunction due to other causes than spinal cord injury

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Ages Eligibility: minimum 18 years Genders Eligibility: female and male

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Spinal Cord Injury Center & Research, University of Zürich, Balgrist University Hospital		Zurich	Canton of Zurich	8008	Switzerland

Condition Browse Module

MeSH Terms

ID	Term
D014718	Vesico-Ureteral Reflux
D013119	Spinal Cord Injuries

Ancestor Terms

ID	Term
D001745	Urinary Bladder Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided