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Completed

NCT Number: NCT04185792

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Urology Jagiellonian University

Krakow, Malopolska, 31-531, Poland

About this study

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.

Who can participate

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

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

Treatment and study plan

NBSS, Qualiveen and SF-Qualiveen

Diagnostic Test

NBSS, Qualiveen and SF-Qualiveen are self-reported questionnaires.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Jagiellonian University

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Dec 4, 2019
Registry last updated
Jul 6, 2022

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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