Spinal Cord InjuriesNCT03898258
Evaluation of the German Short-Form Qualiveen Questionnaire
An observational study of Spinal Cord Injuries, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
Trial summary
Two questionnaires (Qualiveen full version and Qualiveen short-form (SF)), the project information and the consent form will be sent to individuals who are scheduled for an annual control at the urological out-patient clinic of the Swiss Paraplegic Centre and who fulfill the inclusion criteria. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Qualiveen full version and Qualiveen short-form
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- 2 Aug 2019to 31 Dec 2020
- 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 chronic (≥ 12 months) neurogenic lower urinary tract dysfunction due to SCI
Who may be able to join
- chronic (≥ 12 months) neurogenic lower urinary tract dysfunction due to SCI
- age ≥ 18 years
Who cannot join
- no informed consent as documented by signature
- history of concomitant neurological or psychological illness
- history of cognitive impairment
- insufficient German language skills
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Swiss Paraplegic Centre
Nottwil, Canton of Lucerne, 6207
About this study
Two questionnaires (Qualiveen full version and Qualiveen short-form (SF)), the project information and the consent form will be sent to individuals who are scheduled for an annual control at the urological out-patient clinic of the Swiss Paraplegic Centre and who fulfill the inclusion criteria. The patients will be asked to complete the two questionnaires and to bring the completed questionnaires and the signed consent form to the annual control at the Swiss Paraplegic Centre. Participants who have consented and completed the two questionnaires will receive the two questionnaires a second time 14 days later.
The primary objective of this project is to validate the German version of the SF Qualiveen questionnaire. The secondary objective is to evaluate the measurement properties of the German SF Qualiveen questionnaire in comparison with the full version.
- Conditions
- Spinal Cord Injuries
- Being tested
- Qualiveen full version, Qualiveen short-form
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qualiveen full versionOther
Qualiveen full version questionnaire with 40 questions for assessing the quality of life in relation to bladder dysfunction in persons with neurogenic bladder
Qualiveen short-formOther
Qualiveen short-form questionnaire with 8 questions for assessing the quality of life in relation to bladder dysfunction in persons with neurogenic bladder
| Study group | Role | What they receive |
|---|---|---|
| neurogenic bladder | individuals with chronic (≥12 months) neurogenic lower urinary tract dysfunction due to spinal cord injury (SCI) Receives: Other: Qualiveen full version; Other: Qualiveen short-form |
What is being measured
The primary outcome is the main question the study is designed to answer.
total score
Total score of the Qualiveen questionnaire is the arithmetic mean of the four sub-scores. The sub-scores are assessed using a five-point Likert scale (minimum score 0, maximum score 4). The total score indicates how much quality of life is affected by bladder problems. The higher the score the more quality of life is affected.
Measured: baseline
Secondary outcomes (8)
bother with limitations score
Score of the domain bother with limitations of the Qualiveen questionnaire assessed with five-point Likert scale (minimum score 0, maximum score 4).The score indicates how much limitations due to bladder problems bother the affected individual. The higher the score the more the affected individuals are bothered.
Measured: baseline
change in bother with limitations score
Score of the domain bother with limitations of the Qualiveen questionnaire assessed with five-point Likert scale (minimum score 0, maximum score 4).The score indicates how much limitations due to bladder problems bother the affected individual. The higher the score the more the affected individuals are bothered
Measured: baseline; 14 days
frequency of limitations score
Score of the domain frequency of limitations of the Qualiveen questionnaire assessed with five-point Likert scale (minimum score 0, maximum score 4).The score indicates how often affected individuals experience limitations due to bladder problems. The higher the score the more often the affected individuals experience limitations due to bladder problems.
Measured: baseline
change in frequency of limitations score
Score of the domain frequency of limitations of the Qualiveen questionnaire assessed with five-point Likert scale (minimum score 0, maximum score 4).The score indicates how often affected individuals experience limitations due to bladder problems. The higher the score the more often the affected individuals experience limitations due to bladder problems.
Measured: baseline; 14 days
fears score
Score of the domain fears of the Qualiveen questionnaire assessed with five-point Likert scale (minimum score 0, maximum score 4).The score indicates how much fear due to bladder problems the affected individuals experience. The higher the score the more fear the affected individuals experience
Measured: baseline
change in fears score
Score of the domain fears of the Qualiveen questionnaire assessed with five-point Likert scale (minimum score 0, maximum score 4).The score indicates how much fear due to bladder problems the affected individuals experience. The higher the score the more fear the affected individuals experience
Measured: baseline; 14 days
feelings score
Score of the domain feelings of the Qualiveen questionnaire assessed with five-point Likert scale (minimum score 0, maximum score 4).The score indicates how much feelings are affected by bladder problems. The higher the score the more the feelings are affected.
Measured: baseline
change in feelings score
Score of the domain feelings of the Qualiveen questionnaire assessed with five-point Likert scale (minimum score 0, maximum score 4).The score indicates how much feelings are affected by bladder problems. The higher the score the more the feelings are affected.
Measured: baseline; 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2019
- Study start2 Aug 2019
- Primary completion1 Nov 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Paraplegic Research, Nottwil
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Jürgen Pannek, Prof, Principal investigator, Schweizer Paraplegiker-Zentrum Nottwil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03898258
- Sponsor's protocol ID
- 2019-07
- Status last verified
- May 2021
- First submitted
- 29 Mar 2019
- Last updated
- 17 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the German Short-Form Qualiveen Questionnaire
- ClinicalTrials.gov ID
- NCT03898258
- Acronym / sponsor ID
- 2019-07
- Conditions
- Spinal Cord Injuries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Swiss Paraplegic Research, NottwilResearch network
- Study start
- 2 Aug 2019 (actual)
- Primary completion
- 1 Nov 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 1 Apr 2019 (actual)
- 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.
Two questionnaires (Qualiveen full version and Qualiveen short-form (SF)), the project information and the consent form will be sent to individuals who are scheduled for an annual control at the urological out-patient clinic of the Swiss Paraplegic Centre and who fulfill the inclusion criteria. The patients will be asked to complete the two questionnaires and to bring the completed questionnaires and the signed consent form to the annual control at the Swiss Paraplegic Centre. Participants who have consented and completed the two questionnaires will receive the two questionnaires a second time 14 days later.
The primary objective of this project is to validate the German version of the SF Qualiveen questionnaire. The secondary objective is to evaluate the measurement properties of the German SF Qualiveen questionnaire in comparison with the full version.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| neurogenic bladder | – | Other: Qualiveen full version, Other: Qualiveen short-formindividuals with chronic (≥12 months) neurogenic lower urinary tract dysfunction due to spinal cord injury (SCI) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- individuals with chronic (≥ 12 months) neurogenic lower urinary tract dysfunction due to SCI
Key inclusion criteria (2 listed)
- chronic (≥ 12 months) neurogenic lower urinary tract dysfunction due to SCI
- age ≥ 18 years
Key exclusion criteria (4 listed)
- no informed consent as documented by signature
- history of concomitant neurological or psychological illness
- history of cognitive impairment
- insufficient German language skills
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Qualiveen full versionQualiveen full version questionnaire with 40 questions for assessing the quality of life in relation to bladder dysfunction in persons with neurogenic bladder | Other | neurogenic bladder |
| Qualiveen short-formQualiveen short-form questionnaire with 8 questions for assessing the quality of life in relation to bladder dysfunction in persons with neurogenic bladder | Other | neurogenic bladder |
Primary outcome
total score
Time frame: baseline
Total score of the Qualiveen questionnaire is the arithmetic mean of the four sub-scores. The sub-scores are assessed using a five-point Likert scale (minimum score 0, maximum score 4). The total score indicates how much quality of life is affected by bladder problems. The higher the score the more quality of life is affected.
8 secondary outcomes
bother with limitations score
Time frame: baseline
change in bother with limitations score
Time frame: baseline; 14 days
frequency of limitations score
Time frame: baseline
change in frequency of limitations score
Time frame: baseline; 14 days
fears score
Time frame: baseline
change in fears score
Time frame: baseline; 14 days
feelings score
Time frame: baseline
change in feelings score
Time frame: baseline; 14 days
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 17 May 2021.
- Individual participant dataSharing planned: No
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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.
Jürgen Pannek, Prof principal investigator
Schweizer Paraplegiker-Zentrum Nottwil
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 Spinal Cord Injuries, 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 4 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 17 May 2021. 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?
total score (time frame: baseline). 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 17 May 2021.