Evaluation of the German Short-Form Qualiveen Questionnaire

Spinal Cord Injuries Clinical Trial

Official title:

Evaluation of the German Short-Form Qualiveen Questionnaire

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03898258
• Other study ID #: 2019-07
• Status: Completed
• Start date: August 2, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: May 2021
• Source: Swiss Paraplegic Centre Nottwil
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 31, 2020
• Est. primary completion date: November 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries

Intervention

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
• 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

Locations

Country	Name	City	State
Switzerland	Swiss Paraplegic Centre	Nottwil	LU

Sponsors (1)

Lead Sponsor	Collaborator
Swiss Paraplegic Centre Nottwil

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	age (years)		baseline
Other	gender		baseline
Other	bladder evacuation method	type of bladder evacuation method (e.g. intermittent catheterization) as reported by study participant	baseline
Other	number of daily bladder evacuations (n/24h)	how often does study participant empty bladder during 24h	baseline
Other	urinary incontinence	presence of urinary incontinence as reported by study participant	baseline
Primary	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.	baseline
Secondary	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.	baseline
Secondary	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	baseline; 14 days
Secondary	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.	baseline
Secondary	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.	baseline; 14 days
Secondary	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	baseline
Secondary	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	baseline; 14 days
Secondary	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.	baseline
Secondary	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.	baseline; 14 days