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

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ClinicalTrials.gov Identifier: NCT04185792
Recruitment Status : Recruiting
First Posted : December 4, 2019
Last Update Posted : January 3, 2020
Sponsor:
Collaborator:
Piotr Chlosta, Full-time Professor, University Hospital, Cracow, Poland
Information provided by (Responsible Party):
Mikolaj Przydacz, Jagiellonian University

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

Condition or disease Intervention/treatment
Spinal Cord Injuries Multiple Sclerosis Diagnostic Test: NBSS, Qualiveen and SF-Qualiveen

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.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Polish Translation and Validation of the Neurogenic Bladder Symptom Score (NBSS), Qualiveen and Short Form Qualiveen (SF-Qualiveen) Questionnaires
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : September 18, 2020
Estimated Study Completion Date : September 18, 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
200 patients with spinal cord injury and multiple sclerosis
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04185792


Locations
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Poland
Department of Urology Jagiellonian University Recruiting
Kraków, Malopolska, Poland, 31-531
Contact: Mikolaj Przydacz, MD PhD PGDip    12 424-79-50    mikolaj.przydacz@mail.mcgill.ca   
Sponsors and Collaborators
Jagiellonian University
Piotr Chlosta, Full-time Professor, University Hospital, Cracow, Poland

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Responsible Party: Mikolaj Przydacz, Assistant Professor, Principal Investigator, Jagiellonian University
ClinicalTrials.gov Identifier: NCT04185792    
Other Study ID Numbers: 1072.6120.222.2019
First Posted: December 4, 2019    Key Record Dates
Last Update Posted: January 3, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Spinal Cord Injuries
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Spinal Cord Diseases
Central Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries