Evaluation of the German Short-Form Qualiveen Questionnaire

NCT ID: NCT03898258

Last Updated: 2021-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-08-02

Study Completion Date

2020-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Spinal Cord Injuries

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

neurogenic bladder

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

Qualiveen full version

Intervention Type 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

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Swiss Paraplegic Research, Nottwil

NETWORK

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jürgen Pannek, Prof

Role: PRINCIPAL_INVESTIGATOR

Schweizer Paraplegiker-Zentrum Nottwil

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Swiss Paraplegic Centre

Nottwil, Canton of Lucerne, Switzerland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Switzerland

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2019-07

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Wheelchair Indoors Curling With SCI patients_RCT
NCT02550834 COMPLETED PHASE1/PHASE2
Living With Spinal Cord Injury.
NCT03709732 COMPLETED