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

NCT06853366 | Recruiting

• 1 other identifier: 0031_LUTS-TCA
• Study Type: observational
• Target: 242
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (7)

• Demographic data

  Age

  day 1

• Demographic data

  sex

  day 1

• Mecical history

  The medical history of the patient (treatement, diseases, diagnosis...)

  day 1

• Treatment(s)

  Treatment(s) taken by the patient (starting date, dosage, end date (if available)...)

  day 1

• LUTS- TCA Questionnaire (short form)

  This questionnaire only has one question.

  day 1

• LUTS-TCA questionnaire (original)

  The answers provided by this questionnaire (22 items)

  day 1

• PGI questionnaire

  The answers of the PGI questionnaire

  day 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients followed in the urology department of the Casanova and Pitié Salepêtrière Hospital

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier de Saint-Denis: lead

Study Sites (2)

La pitié salpêtrière

Paris, paris, 75013, France

RECRUITING

Casanova Hospital

Saint-Denis, Seine saint denis, 93205, France

NOT YET RECRUITING

MeSH Terms

Conditions

Urologic Diseases

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: February 28, 2025
• Study Start: February 20, 2025
• Primary Completion: February 20, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 28, 2025

Record last verified: 2025-02

Locations

FR (2)