Validation of a questionnaire for assessing urinary treatment constraints
Validation of the Short Form of the "Lower Urinary Tract Symptoms Treatment Constraints Assessment" Questionnaire
This study is trying to see if a new questionnaire can help understand how urinary treatments affect the lives of adults with neurological conditions.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 242 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier de Saint-Denis Academic / other |
| Locations | 2 sites (Paris, paris and 1 other locations) |
| Trial ID | NCT06853366 on ClinicalTrials.gov |
What this trial studies
This observational study aims to validate a short form of the 'Lower Urinary Tract Symptoms Treatment Constraints Assessment' questionnaire, which focuses on patient-reported outcomes related to urologic disorders. The study will assess various domains such as patient satisfaction, quality of life, and the constraints or side effects associated with urinary treatments. Adult patients with neurological conditions affecting bladder function will be recruited, and their experiences will be quantified to enhance the understanding of treatment impacts. The study emphasizes the importance of including patient perspectives in evaluating treatment effectiveness.
Who should consider this trial
Good fit: Ideal candidates for this study are adult patients aged 18 and older with neurological conditions affecting bladder function who have been on urinary treatment for more than three months.
Not a fit: Patients who are minors, have stopped urinary treatment, or have significant cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved assessment tools that better capture the patient experience and treatment constraints, ultimately enhancing patient care.
How similar studies have performed: While there are few studies focusing on similar multidimensional questionnaires in neurology, the approach of validating patient-reported outcomes is increasingly recognized, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients (age ≥ 18 years) * Patients with central or peripheral neurological pathology, followed and managed for vesico-sphincter disorders * Patients receiving urinary treatment for more than 3 months * No therapeutic modification between D0 and D14 of the questionnaire * French-speaking patients (able to read, write and understand French) Exclusion Criteria: * Minor patients (age ≤ 17 years) * Patients who have stopped urinary treatment * Patients with major cognitive impairment * Patients who speak little or no French * Patients who refused to participate in research, or who objected to the use of their data for research purposes
Where this trial is running
Paris, paris and 1 other locations
- La pitié salpêtrière — Paris, paris, France (Recruiting)
- Casanova Hospital — Saint-Denis, Seine saint denis, France (Not_yet_recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.