Urologic DisordersFC-LUTS-TCANCT06853366
Validation of the Short Form of the "Lower Urinary Tract Symptoms Treatment Constraints Assessment" Questionnaire
An observational study of Urologic Disorders, run by Centre Hospitalier de Saint-Denis at 2 sites in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urologic Disorders
- How many people
- 242 participants
- Where
- 2 sitesFrance
- Study dates
- 20 Feb 2025to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients followed in the urology department of the Casanova and Pitié Salepêtrière Hospital
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
La pitié salpêtrière
Paris, paris, 75013
Claire HENTZEN, Doctor, +33156017500, claire.hentzen@aphp.fr
- Not yet recruiting
Casanova Hospital
Saint-Denis, Seine saint denis, 93205
Nicolas Turmel, Doctor, +330142356140, nicolas.turmel@ch-stdenis.fr
Nicolas Turmel, Doctor
About this study
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.
Read more
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).
Read the detailed description
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 m ore 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 treatment have been little studied using specific assessment tools.
In the field of neurology or neuro-urology, only a few multidimensional questionnaires take these domains into account. The main one is Qualiveen, which, in addition to quality of life, looks at discomfort, constraint, fear and patient experience. Other questionnaires, less specific in terms of population, enable a multidimensional evaluation of treatments according to 4 domains (efficacy, side effects, ease of use and overall satisfaction) for the Treatment Satisfaction Questionnaire for Medication (TSQM) or 6 domains (side effects, efficacy, practical aspects of drug treatment, effects of drug treatment on daily life, medical follow-up and overall opinion of treatment) for the Treatment Satisfaction with Medicine Questionnaire (SatMed-Q). These 2 multi-dimensional questionnaires do not allow for a targeted assessment of the constraint of care, which represents a much broader domain than the simple side effect or ease of use of a treatment. What's more, a mixed assessment, both positive (improvement, efficacy) and negative (side-effects) on the same questionnaire, may well limit the interpretation of results and patient understanding.
In response to this shortcoming, a specific treatment constraint questionnaire has been developed 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. This 22-item questionnaire provides a general assessment of therapeutic constraint (physical, social, psychological, etc.). The "detailed" study of therapeutic stress is an important part of the overall therapeutic assessment of these neurological patients, as therapeutic management is often multiple and complex in terms of treatments, examinations, follow-up and impact on daily life.
The use of specific, validated tools to take account of care constraints is important, and is just as justified as the assessment of satisfaction or therapeutic improvement.
The "detailed" study of care constraints is an important part of the overall therapeutic assessment of these neurological patients, as therapeutic management is often multiple and complex in terms of treatments, examinations, follow-up and impact on daily life.
The use of specific, validated tools to take account of care constraints is important, and is just as justified as the assessment of satisfaction or therapeutic improvement.
One of the most widely used questionnaires for measuring treatment improvement is the Patient Global Impression of Improvment (PGI-I). The PGI-I takes the form of a single question, with a 7-level Likert scale ranging from +3 (much improved) to -3 (not improved at all). These positive and, above all, negative levels can be confused with the care constraint for the negative part of the response mode. To avoid measuring the same thing twice (negative PGI-I and LUTS TCA), it is vital to be able to measure the 2 parameters independently.
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.
- Conditions
- Urologic Disorders
- Medical subject headings
- Urologic Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographic data
Age
Measured: day 1
Demographic data
sex
Measured: day 1
Mecical history
The medical history of the patient (treatement, diseases, diagnosis...)
Measured: day 1
Treatment(s)
Treatment(s) taken by the patient (starting date, dosage, end date (if available)...)
Measured: day 1
LUTS- TCA Questionnaire (short form)
This questionnaire only has one question.
Measured: day 1
LUTS-TCA questionnaire (original)
The answers provided by this questionnaire (22 items)
Measured: day 1
PGI questionnaire
The answers of the PGI questionnaire
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start20 Feb 2025
- Primary completion20 Feb 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urologic DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 242 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Saint-Denis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06853366
- Sponsor's protocol ID
- 0031_LUTS-TCA
- Acronym
- FC-LUTS-TCA
- Status last verified
- Feb 2025
- First submitted
- 25 Feb 2025
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Short Form of the "Lower Urinary Tract Symptoms Treatment Constraints Assessment" Questionnaire
- ClinicalTrials.gov ID
- NCT06853366
- Acronym / sponsor ID
- FC-LUTS-TCA / 0031_LUTS-TCA
- Conditions
- Urologic Disorders
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 242 participants (estimated)
- Lead sponsor
- Centre Hospitalier de Saint-DenisUniversity, hospital or other
- Study start
- 20 Feb 2025 (actual)
- Primary completion
- 20 Feb 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 28 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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 m ore 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 treatment have been little studied using specific assessment tools.
In the field of neurology or neuro-urology, only a few multidimensional questionnaires take these domains into account. The main one is Qualiveen, which, in addition to quality of life, looks at discomfort, constraint, fear and patient experience. Other questionnaires, less specific in terms of population, enable a multidimensional evaluation of treatments according to 4 domains (efficacy, side effects, ease of use and overall satisfaction) for the Treatment Satisfaction Questionnaire for Medication (TSQM) or 6 domains (side effects, efficacy, practical aspects of drug treatment, effects of drug treatment on daily life, medical follow-up and overall opinion of treatment) for the Treatment Satisfaction with Medicine Questionnaire (SatMed-Q). These 2 multi-dimensional questionnaires do not allow for a targeted assessment of the constraint of care, which represents a much broader domain than the simple side effect or ease of use of a treatment. What's more, a mixed assessment, both positive (improvement, efficacy) and negative (side-effects) on the same questionnaire, may well limit the interpretation of results and patient understanding.
In response to this shortcoming, a specific treatment constraint questionnaire has been developed 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. This 22-item questionnaire provides a general assessment of therapeutic constraint (physical, social, psychological, etc.). The "detailed" study of therapeutic stress is an important part of the overall therapeutic assessment of these neurological patients, as therapeutic management is often multiple and complex in terms of treatments, examinations, follow-up and impact on daily life.
The use of specific, validated tools to take account of care constraints is important, and is just as justified as the assessment of satisfaction or therapeutic improvement.
The "detailed" study of care constraints is an important part of the overall therapeutic assessment of these neurological patients, as therapeutic management is often multiple and complex in terms of treatments, examinations, follow-up and impact on daily life.
The use of specific, validated tools to take account of care constraints is important, and is just as justified as the assessment of satisfaction or therapeutic improvement.
One of the most widely used questionnaires for measuring treatment improvement is the Patient Global Impression of Improvment (PGI-I). The PGI-I takes the form of a single question, with a 7-level Likert scale ranging from +3 (much improved) to -3 (not improved at all). These positive and, above all, negative levels can be confused with the care constraint for the negative part of the response mode. To avoid measuring the same thing twice (negative PGI-I and LUTS TCA), it is vital to be able to measure the 2 parameters independently.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients followed in the urology department of the Casanova and Pitié Salepêtrière Hospital
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Demographic data
Time frame: day 1
Age
Demographic data
Time frame: day 1
sex
Mecical history
Time frame: day 1
The medical history of the patient (treatement, diseases, diagnosis...)
Treatment(s)
Time frame: day 1
Treatment(s) taken by the patient (starting date, dosage, end date (if available)...)
LUTS- TCA Questionnaire (short form)
Time frame: day 1
This questionnaire only has one question.
LUTS-TCA questionnaire (original)
Time frame: day 1
The answers provided by this questionnaire (22 items)
PGI questionnaire
Time frame: day 1
The answers of the PGI questionnaire
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urologic Disorders, run by Centre Hospitalier de Saint-Denis at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demographic data (time frame: day 1). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2025.