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Validation of the Short Form of the "Lower Urinary Tract Symptoms Treatment Constraints Assessment" Questionnaire

NCT06853366 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 242

Last updated 2025-02-28

No results posted yet for this study

Summary

For many years, the evaluation of treatments has been a central issue in patient care. The various domains assessed have gradually evolved over time, ranging from satisfaction, improvement and quality of life, to the more recent introduction of the Patient Reported Outcome Measure (PROM). These questionnaires or measurement scales (PROMs) focus assessment on the patient and his or her direct experience. Statistical validation of numerous assessment tools has made it possible to quantify objectively many areas of assessment that were initially linked to the patient's feelings, and therefore to their subjectivity. Thus, improvement, quality of life, patient expectations and goal attainment have been the preferred areas for the development of these PROMs.

However, certain areas have been sidelined in the creation of these tools. For example, the constraint of care or the side effects or negative effects of care have not been studied through specific means of evaluation.

In response to this shortcoming, we have developed a questionnaire specifically designed for neuro-urological treatments in a neurological patient population.

The LUTS-TCA (Lower Urinary Tract Symptoms Treatment Constraints Assessment) was developed in French and statistically validated in 2019.

The aim of the study is to create a short form of the LUTS TCA in French, in a population of neurological patients.

This short form, which would be easier to use and interpret, would simplify its use in everyday practice. Indeed, a large majority of neuro-urology patients suffer from neurodegenerative or progressive pathologies, marked by significant and disabling physical and psychological fatigue symptoms. Long-form questionnaires, or the addition of multiple assessment questionnaires during a single visit to the department, make overall assessment more complex.

In addition, this short-form questionnaire is presented in a slightly different form to the long-form version, showing several domains of constraint (physical, social, psychological and care system). This classification should simplify the interpretation and understanding of care constraint, by and for patients.

For the patient, the validation study will take place in 2 phases:

* A first phase at the time of the consultation (Day 0): response to the questionnaires making up the study, i.e. the short form of the LUTS TCA (appendix 2), then the validated form of the LUTS TCA (22 questions) and finally the PGI (two questions).
* A second phase, at a distance from the consultation (Day 14 post-consultation): response to the short form of the LUTS TCA (questionnaire handed out at the consultation, accompanied by a stamped envelope for return).

Conditions

  • Urologic Disorders

Sponsors & Collaborators

  • Centre Hospitalier de Saint-Denis

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-20
Primary Completion
2026-02-20
Completion
2026-12-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06853366 on ClinicalTrials.gov