Spinal Cord InjuriesNCT04185792
Polish Translation and Validation of NBSS, Qualiveen and SF-Qualiveen
An observational study of Spinal Cord Injuries and Multiple Sclerosis, run by Jagiellonian University at 1 site in Poland.
Trial summary
The aim of this study is to translate, culturally adapt, and validate Polish versions of the NBSS, Qualiveen and SF-Qualiveen questionnaires. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries, Multiple Sclerosis
- What is being tested?
- NBSS, Qualiveen and SF-Qualiveen
- How many people
- 200 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2020to 18 Sep 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
- Adult, Older adult
Study population: 200 patients with spinal cord injury and multiple sclerosis
Who may be able to join
- Spinal cord injury patients
- Multiple sclerosis patients
- Age > 18
Who cannot join
- Spinal shock patients
- Urinary tract operation in the last month
- Quality of life changes in the last month
- Urinary tract infections in the last month
- Bladder management changes or drug changes in the last month
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Urology Jagiellonian University
Krakow, Malopolska, 31-531
About this study
Official title: Polish Translation and Validation of the Neurogenic Bladder Symptom Score (NBSS), Qualiveen and Short Form Qualiveen (SF-Qualiveen) Questionnaires
The aim of this study is to translate, culturally adapt, and validate Polish versions of the NBSS, Qualiveen and SF-Qualiveen questionnaires.
Read the detailed description
The aim of this study is to translate, culturally adapt, and validate Polish versions of the NBSS, Qualiveen and SF-Qualiveen questionnaires in patients with spinal cord injury and multiple sclerosis.
- Conditions
- Spinal Cord Injuries, Multiple Sclerosis
- Being tested
- NBSS, Qualiveen and SF-Qualiveen
- Medical subject headings
- Spinal Cord Injuries, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NBSS, Qualiveen and SF-QualiveenDiagnostic test
NBSS, Qualiveen and SF-Qualiveen are self-reported questionnaires.
| Study group | Role | What they receive |
|---|---|---|
| Patients with spinal cord injury | NBSS, Qualiveen and SF-Qualiveen questionnaires will be administered to participants. Receives: Diagnostic Test: NBSS, Qualiveen and SF-Qualiveen | |
| Patients with multiple sclerosis | NBSS, Qualiveen and SF-Qualiveen questionnaires will be administered to participants. Receives: Diagnostic Test: NBSS, Qualiveen and SF-Qualiveen |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICIQ-SF
The ICIQ-SF questionnaire is a brief questionnaire that was devised to assess the burden of urinary incontinence in a patient's life, evaluating its impact on patients' QoL. It is composed by four questions that evaluate frequency, severity, and impact of incontinence on QoL and another section evaluating usual urinary loss situations. The minimum and maximum values range between 0-21 points. Higher the score, the greater the severity of the symptoms.
The ICIQ-SF has been chosen as the validation questionnaire.
Measured: 6 months
Neurogenic Bladder Symptom Score Questionnaire (NBSS)
Neurogenic Bladder Symptom Score Questionnaire is a 24 item self-reported questionnaire (0-74 points). The questionnaire includes 4 subgroups; incontinence (0-29 points), storage\&voiding (0-22 points) and consequences (0-23 points). Higher the score, the greater the severity of the symptoms.
Measured: 6 months
Qualiveen
The Qualiveen is divided in two major sections-Specific Impact of Urinary Problems on Quality of Life (SIUP) and General Quality of Life (GQoL).
The first part, specific for urinary problems, has a total of 30 questions and is divided in four domains: inconvenience, restrictions, fears, and impact on daily life (9, 8, 8, and 5 questions, respectively).
Each answer has five quantified items on a five category ordinal Likert scale with values ranging from 0 (no impact) to 4 (greatest negative impact). The average for each domain is calculated and used to obtain the final SIUP score (average of all domains, range from 0 to 4, 4 being the greatest negative impact).
The second section, GQoL, has nine questions, also with a five-category ordinal Likert scale. It ranges from Very badly to Very well, with values ranging from -2 to +2, respectively.
Final general QoL value is calculated as the average for the nine questions, also ranging from -2 to +2.
Measured: 6 months
Short Form Qualiveen (SF-Qualiveen)
The SF-Qualiveen is a validated short version of the Qualiveen questionnaire and evaluates urinary-specific quality of life. The SF-Qualiveen consists of eight questions and reports on four domains of two questions each: bother with limitations, fears, feelings, and frequency of limitations. Responses are given on a 5-point Likert like scale, where a score of 0 indicates "no impact" and 4 "high impact." The SF-Qualiveen total score is calculated as the mean of the eight responses and the domain scores are calculated as the mean score of the responses per domain.
Measured: 6 months
The King's Health Questionnaire (KHQ)
The King's Health Questionnaire (KHQ) is one of the most widely used for assessing QOL in patients with urinary incontinence (UI).The KHQ consists of two parts and 32 items. The first part (21 items) contains two single-item questions that address General Health Perception and Incontinence Impact and the following seven multi-item domains: Role, Physical, and Social Limitations, Limitations in Personal Relationship, Emotional Problems, Sleep and Energy Disturbances associated with UI, and Severity Measures for UI. The second part has an 11-item Symptom Severity Scale (SSS) that assesses the presence and severity of urinary symptoms. While the entire SSS is scored from 0 (best) to 30 (worst), the minimum possible score is 0 (best health) and the maximum possible score is 100 (worst health) for all other KHQ domains.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2019
- Study start1 Jan 2020
- Primary completion18 Sep 2020
- Study completion18 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Collaborators
- Piotr Chlosta, Full-time Professor, University Hospital, Cracow, Poland
- Responsible party
- Principal investigator, Mikolaj Przydacz, Jagiellonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04185792
- Sponsor's protocol ID
- 1072.6120.222.2019
- Status last verified
- Jul 2022
- First submitted
- 1 Dec 2019
- Last updated
- 6 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Przydacz M, Kornelak P, Golabek T, Dudek P, Chlosta P. Polish versions of the Qualiveen and the SF-Qualiveen: Translation and validation of urinary disorder-specific instruments in patients with multiple sclerosis. Neurourol Urodyn. 2020 Aug;39(6):1764-1770. doi: 10.1002/nau.24419. Epub 2020 Jun 16.
PubMed 32542853
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polish Translation and Validation of the Neurogenic Bladder Symptom Score (NBSS), Qualiveen and Short Form Qualiveen (SF-Qualiveen) Questionnaires
- ClinicalTrials.gov ID
- NCT04185792
- Acronym / sponsor ID
- 1072.6120.222.2019
- Conditions
- Spinal Cord Injuries, Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Collaborators
- Piotr Chlosta, Full-time Professor, University Hospital, Cracow, Poland
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 18 Sep 2020 (actual)
- Study completion
- 18 Sep 2020 (actual)
- First posted
- 4 Dec 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.
The aim of this study is to translate, culturally adapt, and validate Polish versions of the NBSS, Qualiveen and SF-Qualiveen questionnaires.
Detailed description
The aim of this study is to translate, culturally adapt, and validate Polish versions of the NBSS, Qualiveen and SF-Qualiveen questionnaires in patients with spinal cord injury and multiple sclerosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with spinal cord injury | – | Diagnostic Test: NBSS, Qualiveen and SF-QualiveenNBSS, Qualiveen and SF-Qualiveen questionnaires will be administered to participants. |
| Patients with multiple sclerosis | – | Diagnostic Test: NBSS, Qualiveen and SF-QualiveenNBSS, Qualiveen and SF-Qualiveen questionnaires will be administered to participants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 200 patients with spinal cord injury and multiple sclerosis
Key inclusion criteria (3 listed)
- Spinal cord injury patients
- Multiple sclerosis patients
- Age > 18
Key exclusion criteria (5 listed)
- Spinal shock patients
- Urinary tract operation in the last month
- Quality of life changes in the last month
- Urinary tract infections in the last month
- Bladder management changes or drug changes in the last month
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 |
|---|---|---|
| NBSS, Qualiveen and SF-QualiveenNBSS, Qualiveen and SF-Qualiveen are self-reported questionnaires. | Diagnostic test | Patients with multiple sclerosis, Patients with spinal cord injury |
Primary outcome
ICIQ-SF
Time frame: 6 months
The ICIQ-SF questionnaire is a brief questionnaire that was devised to assess the burden of urinary incontinence in a patient's life, evaluating its impact on patients' QoL. It is composed by four questions that evaluate frequency, severity, and impact of incontinence on QoL and another section evaluating usual urinary loss situations. The minimum and maximum values range between 0-21 points. Higher the score, the greater the severity of the symptoms. The ICIQ-SF has been chosen as the validation questionnaire.
Neurogenic Bladder Symptom Score Questionnaire (NBSS)
Time frame: 6 months
Neurogenic Bladder Symptom Score Questionnaire is a 24 item self-reported questionnaire (0-74 points). The questionnaire includes 4 subgroups; incontinence (0-29 points), storage\&voiding (0-22 points) and consequences (0-23 points). Higher the score, the greater the severity of the symptoms.
Qualiveen
Time frame: 6 months
The Qualiveen is divided in two major sections-Specific Impact of Urinary Problems on Quality of Life (SIUP) and General Quality of Life (GQoL). The first part, specific for urinary problems, has a total of 30 questions and is divided in four domains: inconvenience, restrictions, fears, and impact on daily life (9, 8, 8, and 5 questions, respectively). Each answer has five quantified items on a five category ordinal Likert scale with values ranging from 0 (no impact) to 4 (greatest negative impact). The average for each domain is calculated and used to obtain the final SIUP score (average of all domains, range from 0 to 4, 4 being the greatest negative impact). The second section, GQoL, has nine questions, also with a five-category ordinal Likert scale. It ranges from Very badly to Very well, with values ranging from -2 to +2, respectively. Final general QoL value is calculated as the average for the nine questions, also ranging from -2 to +2.
Short Form Qualiveen (SF-Qualiveen)
Time frame: 6 months
The SF-Qualiveen is a validated short version of the Qualiveen questionnaire and evaluates urinary-specific quality of life. The SF-Qualiveen consists of eight questions and reports on four domains of two questions each: bother with limitations, fears, feelings, and frequency of limitations. Responses are given on a 5-point Likert like scale, where a score of 0 indicates "no impact" and 4 "high impact." The SF-Qualiveen total score is calculated as the mean of the eight responses and the domain scores are calculated as the mean score of the responses per domain.
The King's Health Questionnaire (KHQ)
Time frame: 6 months
The King's Health Questionnaire (KHQ) is one of the most widely used for assessing QOL in patients with urinary incontinence (UI).The KHQ consists of two parts and 32 items. The first part (21 items) contains two single-item questions that address General Health Perception and Incontinence Impact and the following seven multi-item domains: Role, Physical, and Social Limitations, Limitations in Personal Relationship, Emotional Problems, Sleep and Energy Disturbances associated with UI, and Severity Measures for UI. The second part has an 11-item Symptom Severity Scale (SSS) that assesses the presence and severity of urinary symptoms. While the entire SSS is scored from 0 (best) to 30 (worst), the minimum possible score is 0 (best health) and the maximum possible score is 100 (worst health) for all other KHQ domains.
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 6 Jul 2022.
- Derived from this study: PubMed 32542853Przydacz M, Kornelak P, Golabek T, Dudek P, Chlosta P. Polish versions of the Qualiveen and the SF-Qualiveen: Translation and validation of urinary disorder-specific instruments in patients with multiple sclerosis. Neurourol Urodyn. 2020 Aug;39(6):1764-1770. doi: 10.1002/nau.24419. Epub 2020 Jun 16.
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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 Spinal Cord Injuries and Multiple Sclerosis, run by Jagiellonian University at 1 site in Poland.
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 3 inclusion and 5 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 6 Jul 2022. 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 Poland. 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?
ICIQ-SF (time frame: 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04185792, which also lists 1 linked publication.
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 6 Jul 2022.