Clinical Trials Logo

Clinical Trial Summary

Lower urinary tract symptoms (LUTS) are frequent in worldwide population. In neurogenic condition, LUTS can occur from beginning of neurologic disease (SCI, MS) or during its progression (MS). Neurogenic bladder may be responsible for upper urinary tract complications such as urinary tract infection or renal failure. It can also decrease quality of life and have an important socio-economic impact. For the last few years, patient-reported outcomes (PRO) have been the main way to assess functional urinary symptoms such as urinary incontinence or overactive bladder. Fortunately, Welk and al. developed and validated a new questionnaire in 2013 to allow a multimodal evaluation of LUTS specifically designed for a neurogenic population. The Neurogenic Bladder Symptom Score (NBSS) is composed of 24 items and explores 3 domains (urinary incontinence, bladder storage and voiding, consequences). In addition, NBSS includes two additional questions related to bladder management and quality of life. In 2020, Welk and al. developed a short version of NBSS (NBSS-SF), composed of 10 items exploring the 3 same domains as the NBSS original long version. However, there is no French-validated multi-dimensional questionnaire specifically assessing neurogenic LUTS, the USP questionnaire being a generic tool (Urinary Symptoms Profile (USP)). The objective of our study was to validate the French linguistic version and the cross-cultural adaptation of the NBSS-SF. METHODS: The investigators conducted a prospective monocentric study between June and October 2020 in our neuro-urology clinic. Step 1, translation and back-translation: With the author's agreement, two bilingual translators (fluent in English and native French) created a French version of the NBSS. Both versions were combined and disagreement in wording or item redaction were resolved to maintain a better understanding. Next step was the back-translation with an native English translator. Then, a bilingual expert committee, composed by urologists and neuro-urologists, compared the different versions to create a pre-final version of the questionnaire. Cross-cultural equivalence with analysis of the semantic, idiomatic, conceptual, and empirical equivalence of the source and pre-final versions of the NBSS-Short Form have been validated by the expert committee. Step 2, Pilot study : n = 30 subjects. During this pilot study, acceptability and understanding were evaluated. Participant had to answer with a 3 level Likert scale (A: perfectly; B: good; C: poor) for each item. Comprehension and acceptation were considered as good if they answered A or B. All difficulties and remarks were collected to incorporate these comments in the final version after validation by a panel of experts. Step 3, Validation stud: To perform validation study, the investigators used the same inclusion criteria than Welk and al. and included patients with a neurogenic bladder due to multiple sclerosis (MS), spinal cord injury (SCI) or other neurologic condition such as spina bifida or Parkinson disease. Validation study was performed to determine the psychometric properties of the questionnaire. The investigators calculated the Cronbach's α coefficient, a measure of internal consistency (reliability) ranging from 0-1, with a coefficient greater than 0.7 considered as very good. The NBSS-short form is composed of 2 first items (covering quality of life and bladder management) and 8 items covering 3 subdomains (items 3, 4, 5 for urinary incontinence, items 6, 7, 8 for storage and voiding) and finally 2 items covering the consequences. The investigators calculated a Cronbach's α coefficient for each subscale and a coefficient for the whole questionnaire. For test-retest reliability, the intraclass correlation coefficient (ICC) has been used. An ICC greater than 0.7 is considered as a good test-retest reproducibility. Participants completed the final version of the questionnaire and they had to mail the second questionnaire within 7 to 14 days. As this second questionnaire was completed at home, all participants were called to avoid missing data. Correlations were computed between NBSS-SF scores obtained overall and for each domain on two different occasions, separated by a 7-14-day interval.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04902755
Study type Observational
Source Pierre and Marie Curie University
Contact
Status Completed
Phase
Start date June 1, 2020
Completion date October 30, 2020

See also
  Status Clinical Trial Phase
Recruiting NCT02978638 - Electrical Stimulation for Continence After Spinal Cord Injury N/A
Enrolling by invitation NCT06429631 - The Effect of CIC Education on QOL and Compliance With Mobile Application in Individuals With Spinal Cord Injury. N/A
Completed NCT03573726 - Use of a Diurnal Indwelling Urethral Catheter to Improve Quality of Life N/A
Recruiting NCT06059066 - Optimization of OnabotulinumtoxinA (BTX-A) Injection for the Treatment of Neurogenic Lower Urinary Tract Dysfunction N/A
Completed NCT01429090 - Bioavailability of Vagantin® Coated Tablets Relative to an Oral Methantheline Bromide Solution Phase 1
Recruiting NCT05587101 - Neurogenic Lower Urinary Tract Symptoms in Patients With Multiple Sclerosis
Terminated NCT03843073 - Connected Catheter- Safety and Effectiveness Study N/A
Terminated NCT04059159 - Connected Catheter - Safety and Effectiveness Study N/A
Completed NCT05861024 - Urinary Calculi After Bladder Augmentation in Children
Completed NCT05858840 - Urinary Artificial Sphincter in Children
Completed NCT04074616 - Reducing Anticholinergic Bladder Medication Use in Spinal Cord Injury With Home Neuromodulation N/A
Completed NCT05683938 - GentleCath™ Air Intermittent Catheter Smartwatch Real Life Pilot Study
Completed NCT04543552 - A Comparative Analysis of Portable Bladder Scanner to Determine Age/ Volume Specific Accuracy in 0-6 Years of Children
Active, not recruiting NCT06247033 - Efficacies of Different Managements in Patients With Overactive Bladder With Stroke N/A
Withdrawn NCT01305681 - Bacterial Properties With LoFric® Catheters During Clean Intermittent Catheterization Phase 1/Phase 2
Recruiting NCT04248322 - Qualitative Assessment of the Impact of TTNS on QOL and Participation
Recruiting NCT05301335 - Spinal COrd NeuromodulaTor by SpIneX and ScoNE to Treat NeurogeniC BladdEr - SCONE "CONTINENCE" Clinical Study N/A
Recruiting NCT04924569 - Continence Care Registry
Completed NCT01716624 - Botox Versus Oxybutynin as First Line Treatment for the Poorly Compliant Pediatric Neurogenic Bladder Phase 3
Completed NCT01297647 - Incidence of Urinary Tract Infection After Urodynamic Investigation N/A