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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04185792
• Other study ID #: 1072.6120.222.2019
• Status: Completed
• Start date: January 1, 2020
• Est. completion date: September 18, 2020

Study information

• Verified date: July 2022
• Source: Jagiellonian University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: September 18, 2020
• Est. primary completion date: September 18, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Spinal Cord Injuries

Intervention

Diagnostic Test:
• NBSS, Qualiveen and SF-Qualiveen
NBSS, Qualiveen and SF-Qualiveen are self-reported questionnaires.

Locations

Country	Name	City	State
Poland	Department of Urology Jagiellonian University	Kraków	Malopolska

Sponsors (2)

Lead Sponsor	Collaborator
Jagiellonian University	Piotr Chlosta, Full-time Professor, University Hospital, Cracow, Poland

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ICIQ-SF	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
Primary	Neurogenic Bladder Symptom Score Questionnaire (NBSS)	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
Primary	Qualiveen	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
Primary	Short Form Qualiveen (SF-Qualiveen)	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
Primary	The King's Health Questionnaire (KHQ)	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