Neurogenic Lower Urinary Tract DysfunctionNCT02443870
Long-term Urodynamics in Individuals With Neurogenic Lower Urinary Tract Dysfunction
An observational study of Neurogenic Lower Urinary Tract Dysfunction, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurogenic Lower Urinary Tract Dysfunction
- How many people
- 250 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2015to Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: individuals with neurogenic lower urinary tract dysfunction
Who may be able to join
- neurogenic lower urinary tract dysfunction
- urodynamic data
Who cannot join
- duration of neurogenic lower urinary tract dysfunction < 10 years
- < 5 urodynamic follow-ups
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Swiss Paraplegic Centre
Nottwil, Canton of Lucerne, CH-6207
About this study
Official title: 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
maximal detrusor storage pressure
Measured: 12 month after previous investigation
Secondary outcomes (4)
bladder capacity
Measured: 12 month after previous investigation
bladder compliance
The relationship between a change in bladder volume and the change in detrusor pressure (ΔDV/ΔDP).
Measured: 12 month after previous investigation
maximal detrusor voiding pressure
Measured: 12 month after previous investigation
reflexive bladder volume
Measured: 12 month after previous investigation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2015 (estimated)
- Study startMay 2015
- Primary completionJul 2023
- Study completionSep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurogenic Lower Urinary Tract DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Paraplegic Research, Nottwil
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02443870
- Sponsor's protocol ID
- 2013-11
- Status last verified
- Sep 2023
- First submitted
- 6 May 2015
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Analysis of Long-term Urodynamics in Individuals With Neurogenic Lower Urinary Tract Dysfunction
- ClinicalTrials.gov ID
- NCT02443870
- Acronym / sponsor ID
- 2013-11
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Swiss Paraplegic Research, NottwilResearch network
- Study start
- May 2015 (actual)
- Primary completion
- Jul 2023 (actual)
- Study completion
- Sep 2023 (actual)
- First posted
- 14 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- individuals with neurogenic lower urinary tract dysfunction
Key inclusion criteria (2 listed)
- neurogenic lower urinary tract dysfunction
- urodynamic data
Key exclusion criteria (2 listed)
- duration of neurogenic lower urinary tract dysfunction < 10 years
- < 5 urodynamic follow-ups
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
maximal detrusor storage pressure
Time frame: 12 month after previous investigation
4 secondary outcomes
bladder capacity
Time frame: 12 month after previous investigation
bladder compliance
Time frame: 12 month after previous investigation
maximal detrusor voiding pressure
Time frame: 12 month after previous investigation
reflexive bladder volume
Time frame: 12 month after previous investigation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurogenic Lower Urinary Tract Dysfunction, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
maximal detrusor storage pressure (time frame: 12 month after previous investigation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.