Polish Translation and Validation of NBSS, Qualiveen and SF-Qualiveen

July 4, 2022 updated by: Mikolaj Przydacz, Jagiellonian University

Polish Translation and Validation of the Neurogenic Bladder Symptom Score (NBSS), Qualiveen and Short Form Qualiveen (SF-Qualiveen) Questionnaires

The aim of this study is to translate, culturally adapt, and validate Polish versions of the NBSS, Qualiveen and SF-Qualiveen questionnaires.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim of this study is to translate, culturally adapt, and validate Polish versions of the NBSS, Qualiveen and SF-Qualiveen questionnaires in patients with spinal cord injury and multiple sclerosis.

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Malopolska
      • Kraków, Malopolska, Poland, 31-531
        • Department of Urology Jagiellonian University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

200 patients with spinal cord injury and multiple sclerosis

Description

Inclusion Criteria:

  • Spinal cord injury patients
  • Multiple sclerosis patients
  • Age > 18

Exclusion Criteria:

  • Spinal shock patients
  • Urinary tract operation in the last month
  • Quality of life changes in the last month
  • Urinary tract infections in the last month
  • Bladder management changes or drug changes in the last month

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with spinal cord injury
NBSS, Qualiveen and SF-Qualiveen questionnaires will be administered to participants.
Diagnostic test: NBSS, Qualiveen and SF-Qualiveen
NBSS, Qualiveen and SF-Qualiveen are self-reported questionnaires.
Patients with multiple sclerosis
NBSS, Qualiveen and SF-Qualiveen questionnaires will be administered to participants.
Diagnostic test: NBSS, Qualiveen and SF-Qualiveen
NBSS, Qualiveen and SF-Qualiveen are self-reported questionnaires.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ICIQ-SF
Time Frame: 6 months

The ICIQ-SF questionnaire is a brief questionnaire that was devised to assess the burden of urinary incontinence in a patient's life, evaluating its impact on patients' QoL. It is composed by four questions that evaluate frequency, severity, and impact of incontinence on QoL and another section evaluating usual urinary loss situations. The minimum and maximum values range between 0-21 points. Higher the score, the greater the severity of the symptoms.

The ICIQ-SF has been chosen as the validation questionnaire.
6 months
Neurogenic Bladder Symptom Score Questionnaire (NBSS)
Time Frame: 6 months
Neurogenic Bladder Symptom Score Questionnaire is a 24 item self-reported questionnaire (0-74 points). The questionnaire includes 4 subgroups; incontinence (0-29 points), storage&voiding (0-22 points) and consequences (0-23 points). Higher the score, the greater the severity of the symptoms.
6 months
Qualiveen
Time Frame: 6 months

The Qualiveen is divided in two major sections-Specific Impact of Urinary Problems on Quality of Life (SIUP) and General Quality of Life (GQoL).

The first part, specific for urinary problems, has a total of 30 questions and is divided in four domains: inconvenience, restrictions, fears, and impact on daily life (9, 8, 8, and 5 questions, respectively).

Each answer has five quantified items on a five category ordinal Likert scale with values ranging from 0 (no impact) to 4 (greatest negative impact). The average for each domain is calculated and used to obtain the final SIUP score (average of all domains, range from 0 to 4, 4 being the greatest negative impact).

The second section, GQoL, has nine questions, also with a five-category ordinal Likert scale. It ranges from Very badly to Very well, with values ranging from -2 to +2, respectively.

Final general QoL value is calculated as the average for the nine questions, also ranging from -2 to +2.
6 months
Short Form Qualiveen (SF-Qualiveen)
Time Frame: 6 months
The SF-Qualiveen is a validated short version of the Qualiveen questionnaire and evaluates urinary-specific quality of life. The SF-Qualiveen consists of eight questions and reports on four domains of two questions each: bother with limitations, fears, feelings, and frequency of limitations. Responses are given on a 5-point Likert like scale, where a score of 0 indicates "no impact" and 4 "high impact." The SF-Qualiveen total score is calculated as the mean of the eight responses and the domain scores are calculated as the mean score of the responses per domain.
6 months
The King's Health Questionnaire (KHQ)
Time Frame: 6 months
The King's Health Questionnaire (KHQ) is one of the most widely used for assessing QOL in patients with urinary incontinence (UI).The KHQ consists of two parts and 32 items. The first part (21 items) contains two single-item questions that address General Health Perception and Incontinence Impact and the following seven multi-item domains: Role, Physical, and Social Limitations, Limitations in Personal Relationship, Emotional Problems, Sleep and Energy Disturbances associated with UI, and Severity Measures for UI. The second part has an 11-item Symptom Severity Scale (SSS) that assesses the presence and severity of urinary symptoms. While the entire SSS is scored from 0 (best) to 30 (worst), the minimum possible score is 0 (best health) and the maximum possible score is 100 (worst health) for all other KHQ domains.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jagiellonian University

Collaborators

Piotr Chlosta, Full-time Professor, University Hospital, Cracow, Poland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2020

Primary Completion (ACTUAL)

September 18, 2020

Study Completion (ACTUAL)

September 18, 2020

Study Registration Dates

First Submitted

December 1, 2019

First Submitted That Met QC Criteria

December 3, 2019

First Posted (ACTUAL)

December 4, 2019

Study Record Updates

Last Update Posted (ACTUAL)

July 6, 2022

Last Update Submitted That Met QC Criteria

July 4, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1072.6120.222.2019

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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