Evaluation of the German Short-Form Qualiveen Questionnaire

NCT03898258 | Completed

• 1 other identifier: 2019-07
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• bother with limitations score

  baseline

• change in bother with limitations score

  baseline; 14 days

• frequency of limitations score

  baseline

• change in frequency of limitations score

  baseline; 14 days

• fears score

  baseline

Other Outcomes (5)

• age (years)

  baseline

• gender

  baseline

• bladder evacuation method

  baseline

Study Arms (1)

neurogenic bladder

individuals with chronic (≥12 months) neurogenic lower urinary tract dysfunction due to spinal cord injury (SCI)

Other: Qualiveen full version; Other: Qualiveen short-form

Interventions

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

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

neurogenic bladder

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

individuals with chronic (≥ 12 months) neurogenic lower urinary tract dysfunction due to SCI

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Swiss Paraplegic Research, Nottwil: lead

Study Sites (1)

Swiss Paraplegic Centre

Nottwil, Canton of Lucerne, 6207, Switzerland

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

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

Study Officials

• Jürgen Pannek, Prof

  Schweizer Paraplegiker-Zentrum Nottwil

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2019
• First Posted: April 1, 2019
• Study Start: August 2, 2019
• Primary Completion: November 1, 2020
• Study Completion: December 31, 2020
• Last Updated: May 17, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)