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Evaluation of the German Short-Form Qualiveen Questionnaire

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ClinicalTrials.gov Identifier: NCT03898258
Recruitment Status : Enrolling by invitation
First Posted : April 1, 2019
Last Update Posted : August 6, 2019
Sponsor:
Information provided by (Responsible Party):
Swiss Paraplegic Centre Nottwil

Brief 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. 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.


Condition or disease Intervention/treatment
Spinal Cord Injuries Other: Qualiveen full version Other: Qualiveen short-form

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of the German Short-Form Qualiveen Questionnaire
Actual Study Start Date : August 2, 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
neurogenic bladder
individuals with chronic (≥12 months) neurogenic lower urinary tract dysfunction due to spinal cord injury (SCI)
Other: Qualiveen full version
Qualiveen full version questionnaire with 40 questions for assessing the quality of life in relation to bladder dysfunction in persons with neurogenic bladder

Other: Qualiveen short-form
Qualiveen short-form questionnaire with 8 questions for assessing the quality of life in relation to bladder dysfunction in persons with neurogenic bladder




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. bother with limitations score [ Time Frame: baseline ]
    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.

  2. change in bother with limitations score [ Time Frame: baseline; 14 days ]
    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

  3. frequency of limitations score [ Time Frame: baseline ]
    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.

  4. change in frequency of limitations score [ Time Frame: baseline; 14 days ]
    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.

  5. fears score [ Time Frame: baseline ]
    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

  6. change in fears score [ Time Frame: baseline; 14 days ]
    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

  7. feelings score [ Time Frame: baseline ]
    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.

  8. change in feelings score [ Time Frame: baseline; 14 days ]
    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.


Other Outcome Measures:
  1. age (years) [ Time Frame: baseline ]
  2. gender [ Time Frame: baseline ]
  3. bladder evacuation method [ Time Frame: baseline ]
    type of bladder evacuation method (e.g. intermittent catheterization) as reported by study participant

  4. number of daily bladder evacuations (n/24h) [ Time Frame: baseline ]
    how often does study participant empty bladder during 24h

  5. urinary incontinence [ Time Frame: baseline ]
    presence of urinary incontinence as reported by study participant



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
individuals with chronic (≥ 12 months) neurogenic lower urinary tract dysfunction due to SCI
Criteria

Inclusion Criteria:

  • chronic (≥ 12 months) neurogenic lower urinary tract dysfunction due to SCI
  • age ≥ 18 years

Exclusion Criteria:

  • no informed consent as documented by signature
  • history of concomitant neurological or psychological illness
  • history of cognitive impairment
  • insufficient German language skills

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03898258


Locations
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Switzerland
Swiss Paraplegic Centre
Nottwil, LU, Switzerland, 6207
Sponsors and Collaborators
Swiss Paraplegic Centre Nottwil

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Responsible Party: Swiss Paraplegic Centre Nottwil
ClinicalTrials.gov Identifier: NCT03898258     History of Changes
Other Study ID Numbers: 2019-07
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries