Health-related Quality of Life of Patients With Neurogeni... | NCT02179073

Studies
Health-related Quality of Life of Patients With Neurogenic Bladder

NCT02179073

Sponsor

Swiss Paraplegic Research, Nottwil

Status

Completed

Last Update Posted

Nov 18, 2019Actual

Enrollment

87Actual

Phase

Not provided

Conditions

Neurogenic Bladder Dysfunction

Interventions

Not provided

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

Nov 2019

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

Dec 2007

Primary Completion Date

Oct 31, 2019Actual

Completion Date

Nov 14, 2019Actual

First Submitted Date

Jun 26, 2014

First Submission Date that Met QC Criteria

Jun 30, 2014

First Posted Date

Jul 1, 2014Estimated

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

Nov 15, 2019

Last Update Posted Date

Nov 18, 2019Actual

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

Bladder management has a major impact on the quality of life in patients with neurogenic bladder dysfunction. This a prospective investigation of the effects of the method for bladder evacuation on the health-related quality of life in patients with neurogenic bladder dysfunction. The changes in health-related quality of life over time (longitudinal investigation) and the differences between the different methods for bladder evacuation will be investigated. Patients will be given a standardized and validated questionnaire annually for 10 years.

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

87Actual

Label	Type	Description	Intervention Names
neurogenic bladder dysfunction

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
quality of life	Qualiveen questionnaire	up to year 10

Secondary Outcomes

Measure	Description	Time Frame
bladder evacuation method	method for bladder evacuation (i.e. intermittent catheterization, condom urinal, reflex micturition, transurethral catheter, suprapubic catheter, sacral bladder stimulator, neuromodulation)	year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10
urinary tract infections

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Individuals with neurogenic bladder dysfunction

Exclusion Criteria:

Insufficient dexterity to fill in the questionnaire
Insufficient proficiency in the German or French language

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

individuals with neurogenic bladder dysfunction

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Swiss Paraplegic Centre		Nottwil	Canton of Lucerne	6207	Switzerland