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Completed

NCT Number: NCT03898258

Evaluation of the German Short-Form Qualiveen Questionnaire

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.

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Key information

Conditions

Spinal Cord Injuries Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Swiss Paraplegic Centre

Nottwil, Canton of Lucerne, 6207, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Qualiveen full version

Other

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-form

Other

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

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Swiss Paraplegic Research, Nottwil

Network

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 1, 2019
Registry last updated
May 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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