Long-term Urodynamics in Individuals With Neurogenic Lowe... | NCT02443870

Studies
Long-term Urodynamics in Individuals With Neurogenic Lower Urinary Tract Dysfunction

NCT02443870

Sponsor

Swiss Paraplegic Research, Nottwil

Status

Completed

Last Update Posted

Sep 28, 2023Actual

Enrollment

250Actual

Phase

Not provided

Conditions

Neurogenic Lower Urinary Tract 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

Sep 2023

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

May 2015Actual

Primary Completion Date

Jul 2023Actual

Completion Date

Sep 2023Actual

First Submitted Date

May 6, 2015

First Submission Date that Met QC Criteria

May 11, 2015

First Posted Date

May 14, 2015Estimated

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 27, 2023

Last Update Posted Date

Sep 28, 2023Actual

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 long-term changes of bladder function in individuals with lower urinary tract dysfunction will be investigated. Patients presenting for regular urodynamic examination of bladder function will be included. Bladder diary details and urodynamic data will be collected in order to investigate bladder function.

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

250Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
maximal detrusor storage pressure		12 month after previous investigation

Secondary Outcomes

Measure	Description	Time Frame
bladder capacity		12 month after previous investigation
bladder compliance	The relationship between a change in bladder volume and the change in detrusor pressure (ΔDV/ΔDP).	12 month after previous investigation

Other Outcomes

Measure	Description	Time Frame
gender		time of injury
age		time of injury
lesion level

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

neurogenic lower urinary tract dysfunction
urodynamic data

Exclusion Criteria:

duration of neurogenic lower urinary tract dysfunction < 10 years
< 5 urodynamic follow-ups

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 lower urinary tract dysfunction

Sampling Method

Non-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	CH-6207	Switzerland