Neurogenic Bladder DysfunctionNCT02179073
Health-related Quality of Life of Patients With Neurogenic Bladder
An observational study of Neurogenic Bladder Dysfunction, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurogenic Bladder Dysfunction
- How many people
- 87 participants
- Where
- 1 siteSwitzerland
- Study dates
- Dec 2007to 14 Nov 2019
- 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 bladder dysfunction
Who may be able to join
- Individuals with neurogenic bladder dysfunction
Who cannot join
- Insufficient dexterity to fill in the questionnaire
- Insufficient proficiency in the German or French language
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Swiss Paraplegic Centre
Nottwil, Canton of Lucerne, 6207
About this study
Official title: Effects of Bladder Management on Health-related Quality of Life in Patients With Neurogenic Bladder
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.
- Conditions
- Neurogenic Bladder Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| neurogenic bladder dysfunction | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
quality of life
Qualiveen questionnaire
Measured: up to year 10
Secondary outcomes (3)
bladder evacuation method
method for bladder evacuation (i.e. intermittent catheterization, condom urinal, reflex micturition, transurethral catheter, suprapubic catheter, sacral bladder stimulator, neuromodulation)
Measured: year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10
urinary tract infections
number of annual symptomatic urinary tract infections
Measured: year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10
patient characteristics
gender, age, type of neurogenic bladder dysfunction, duration of neurogenic bladder dysfunction
Measured: time 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2014 (estimated)
- Study startDec 2007
- Primary completion31 Oct 2019
- Study completion14 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurogenic Bladder 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 87 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
- NCT02179073
- Sponsor's protocol ID
- 2007-02
- Status last verified
- Nov 2019
- First submitted
- 26 Jun 2014
- Last updated
- 18 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Bladder Management on Health-related Quality of Life in Patients With Neurogenic Bladder
- ClinicalTrials.gov ID
- NCT02179073
- Acronym / sponsor ID
- 2007-02
- Conditions
- Neurogenic Bladder Dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Swiss Paraplegic Research, NottwilResearch network
- Study start
- Dec 2007
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 14 Nov 2019 (actual)
- First posted
- 1 Jul 2014 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| neurogenic bladder dysfunction | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- individuals with neurogenic bladder dysfunction
Key inclusion criteria (1 listed)
- Individuals with neurogenic bladder dysfunction
Key exclusion criteria (2 listed)
- Insufficient dexterity to fill in the questionnaire
- Insufficient proficiency in the German or French language
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
quality of life
Time frame: up to year 10
Qualiveen questionnaire
3 secondary outcomes
bladder evacuation method
Time frame: year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10
urinary tract infections
Time frame: year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10
patient characteristics
Time frame: time 0
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 18 Nov 2019.
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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 Bladder 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 1 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 18 Nov 2019. 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?
quality of life (time frame: up to year 10). 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 18 Nov 2019.