- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02443870
Long-term Urodynamics in Individuals With Neurogenic Lower Urinary Tract Dysfunction
September 27, 2023 updated by: Swiss Paraplegic Centre Nottwil
Retrospective Analysis of Long-term Urodynamics in Individuals With Neurogenic Lower Urinary Tract Dysfunction
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
250
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
-
-
LU
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Nottwil, LU, Switzerland, CH-6207
- Swiss Paraplegic Centre
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-
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
Sampling Method
Non-Probability Sample
Study Population
individuals with neurogenic lower urinary tract dysfunction
Description
Inclusion Criteria:
- neurogenic lower urinary tract dysfunction
- urodynamic data
Exclusion Criteria:
- duration of neurogenic lower urinary tract dysfunction < 10 years
- < 5 urodynamic follow-ups
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
maximal detrusor storage pressure
Time Frame: 12 month after previous investigation
|
12 month after previous investigation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
bladder capacity
Time Frame: 12 month after previous investigation
|
12 month after previous investigation
|
|
bladder compliance
Time Frame: 12 month after previous investigation
|
The relationship between a change in bladder volume and the change in detrusor pressure (ΔDV/ΔDP).
|
12 month after previous investigation
|
maximal detrusor voiding pressure
Time Frame: 12 month after previous investigation
|
12 month after previous investigation
|
|
reflexive bladder volume
Time Frame: 12 month after previous investigation
|
12 month after previous investigation
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
gender
Time Frame: time of injury
|
time of injury
|
age
Time Frame: time of injury
|
time of injury
|
lesion level
Time Frame: time of injury
|
time of injury
|
lesion severity
Time Frame: time of injury
|
time of injury
|
bladder evacuation method
Time Frame: 12 month after previous investigation
|
12 month after previous investigation
|
presence of incontinence
Time Frame: 12 month after previous investigation
|
12 month after previous investigation
|
complications
Time Frame: 12 month after previous investigation
|
12 month after previous investigation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
May 1, 2015
Primary Completion (Actual)
July 1, 2023
Study Completion (Actual)
September 1, 2023
Study Registration Dates
First Submitted
May 6, 2015
First Submitted That Met QC Criteria
May 11, 2015
First Posted (Estimated)
May 14, 2015
Study Record Updates
Last Update Posted (Actual)
September 28, 2023
Last Update Submitted That Met QC Criteria
September 27, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 2013-11
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.
Clinical Trials on Neurogenic Lower Urinary Tract Dysfunction
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Swiss Paraplegic Centre NottwilSuspendedNeurogenic Lower Urinary Tract DysfunctionSwitzerland
-
Samsung Medical CenterCompletedNeurogenic Lower Urinary Tract DysfunctionKorea, Republic of
-
Novartis PharmaceuticalsTerminatedNeurogenic Urinary Bladder | Neurogenic Bladder Disorder | Neurogenic Dysfunction of the Urinary Bladder | Neurogenic Bladder, Uninhibited | Neurogenic Bladder, SpasticNetherlands, Germany, Switzerland
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APOGEPHA Arzneimittel GmbHCompletedUrologic Diseases | Urinary Incontinence | Urinary Bladder, Neurogenic | Neurogenic Urinary Bladder Disorder | Bladder Disorder, Neurogenic | Urinary Bladder Disorder, Neurogenic | Neurogenic Bladder Disorder | Urinary Bladder Neurogenic Dysfunction | Overactive Detrusor FunctionRomania, Austria, Germany
-
Swiss Paraplegic Centre NottwilCompletedSpinal Cord Injury | Neurogenic Detrusor Overactivity | Neurogenic Lower Urinary Tract DysfunctionSwitzerland
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Ulrich MehnertNCCR (National Center of Competence in Resaerch, Switzerland)CompletedHealthy | Neurogenic Bladder Dysfunction Nos | Nonneurogenic Neurogenic Bladder DysfunctionSwitzerland
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University of ZurichTerminatedNeurogenic Bladder DysfunctionSwitzerland
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Swiss Paraplegic Centre NottwilCompletedSpinal Cord Injury | Neurogenic Lower Urinary Tract DysfunctionSwitzerland
-
University of ZurichCompletedLower Urinary Tract DysfunctionSwitzerland
-
University of ZurichCompletedLower Urinary Tract DysfunctionSwitzerland