Urodynamic ExamCysto-positionNCT05949567
Does Position Influence the Diagnosis of Detrusor Overactivity in a Neurological Population
A study testing urodynamic exam in sitting and lying position in people with Urodynamic Exam and Neurologic Disorder, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
ICS (International Continence Society) recommendations published in 2017 recommend performing urodynamic examinations in the sitting or standing position. These recommendations are based on a review of the literature published in 2008, which has several limitations: heterogeneous populations, old and non-harmonized… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urodynamic Exam, Neurologic Disorder
- What is being tested?
- urodynamic exam in sitting and lying position
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteFrance
- Study dates
- 2 Apr 2024to 2 Apr 2027
- Phase
- Interventional
- 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
Who may be able to join
- Patient with MS or neurologically confirmed Parkinson's disease, with indication for urodynamic assessment - 1st assessment
- Clinical overactive bladder syndrome with USP overactive bladder sub-score > or = 4 - Age ≥18 years
- In men: no prostatic hypertrophy on ultrasonography
- In women: no stress urinary incontinence (SUI); USP SUI subscore ≤ 2
- Affiliated with a social security scheme (excluding AME).
- Free and informed written consent
Who cannot join
- Opposition to the performance of a Urodynamic exam as part of treatment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Physical and Rehabilitation Medicine Pitié Salpêtrière Hospital
Paris, France, 75013
Bertrand M PICHON, MD, 142161047 ext. +33, Bertrand.pichon@aphp.fr
Helene Ms Robert, MD, 142161137 ext. +33, Helene.robert@aphp.fr
About this study
Official title: Does Position Influence the Diagnosis of Detrusor Overactivity in a Neurological Population - a Concordance Study Between Lying and Sitting Position
ICS (International Continence Society) recommendations published in 2017 recommend performing urodynamic examinations in the sitting or standing position. These recommendations are based on a review of the literature published in 2008, which has several limitations: heterogeneous populations, old and non-harmonized techniques, and very few neurological patients. It seems appropriate to focus on neurological patients and to examine the influence of position on the detection of detrusor overactivity in these patients.
The point here is to reexamine the ICS recommendations, which are not designed for neurological patients. Indeed, many patients suffering from Multiple Sclerosis (MS) or Parkinson's disease are unable to sit or stand for the duration of the urodynamic examination. The investigators would like to assess whether exploring sphincter disorders in the supine position is still interpretable.
This would enable us to define ICS good practice recommendations for a neurological population.
Read the detailed description
1st consultation (selection - D-15):
- Targeted questioning of disorders, completion of USP self-questionnaire, and UPDRS or EDSS scales as part of care.
- Verification of ultrasound results (for men).
- Schedule Urodynamic Assessment as part of treatment.
- Verification of eligibility criteria
- Partial information of the patient (or relative/guardian/guardian if applicable) to limit bias, and a period of reflection prior to the urodynamic test to collect consent.
On the day of the Urodynamic Assessment (D0):
- Written, free and informed consent.
- Data collection by a physician trained in the study,
- Randomization of patient to determine starting position (lying or sitting) for urodynamic assessment (via CleanWeb).
- Urodynamic assessment according to ICS recommendations, with constant filling speed over the 2 fillings (50 ml/min), water filling - Laborie machine - T-Doc system in both positions in the order defined by randomization, and printout of curves.
- Entry of socio-demographic data.
- Curves reread by a doctor who had not performed the examination and who did not know the patient or the starting position (single blind).
- Completion of the paper file by the physician reading the curves, with the following data for position 1 and position 2:
- Volume at B1 and B3 (in ml)
- Basal bladder pressure (cm / H2O)
- Occurrence of CNID or mictional reflex arc (diagnosis of detrusor overactivity)
- Volume of leakage or 1st NIDC (Uninhibited Detrusor Contraction) (ml) or
- Bladder pressure at leakage (cm / H2O)
- Maximum bladder pressure (cm / H2O)
- Paper data entry on Excel database by a trained investigator declared on the study
- Conditions
- Urodynamic Exam, Neurologic Disorder
- Being tested
- urodynamic exam in sitting and lying position
- Keywords
- Urodynamic exam, detrusor overactivity, positon
- Medical subject headings
- Nervous System Diseases, Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
urodynamic exam in sitting and lying positionOther
Urodynamic exam with 1st filling in sitting or lying position. Then , during the same procedure, a second filling in the opposite position of the 1st filling (lying or sitting)
| Study group | Role | What they receive |
|---|---|---|
| Lying position first - then sitting position | Experimental | Not described Receives: Other: urodynamic exam in sitting and lying position |
| Sitting position first - then lying position | Experimental | Not described Receives: Other: urodynamic exam in sitting and lying position |
What is being measured
The primary outcome is the main question the study is designed to answer.
concordance diagnosis of detrusor overactivity between lying and sitting position
Measurement concordance of detrusor pressures using the intraclass correlation coefficient statistic
Measured: 24 months
Secondary outcomes (3)
position influence on the overactive detrusor gravity between the 2 positions
Measurement of the concordance of detrusor overactivity diagnostic gravities during urodynamic assessments, between those performed in the supine position and those performed in the seated position. Concordance will be assessed using Cohen's Kappa statistic.
Measured: 24 months
Evaluation of the diagnosis quality of the detrusor overactivity between the 2 position
Measurement of the diagnostic quality of urodynamic testing performed in the supine position in neurological patients to detect detrusor activity, with the seated position being the gold standard: estimation of sensitivity and specificity.
Measured: 24 months
comparison of the distribution of detrusor overactivity diagnoses according to position.
Measurement of the association between position during urodynamic assessment and diagnosis of detrusor overactivity: comparison of the distribution of diagnoses of detrusor overactivity according to position.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study start2 Apr 2024
- Primary completion2 Apr 2027 (estimated)
- Study completion2 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urodynamic ExamStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05949567
- Sponsor's protocol ID
- APHP230769
- Acronym
- Cysto-position
- Status last verified
- Apr 2026
- First submitted
- 10 Jul 2023
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data are available upon reasonable request The procedures carried out with the French data privacy authority (CNIL, National Commission for Computing and Liberties) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Position Influence the Diagnosis of Detrusor Overactivity in a Neurological Population - a Concordance Study Between Lying and Sitting Position
- ClinicalTrials.gov ID
- NCT05949567
- Acronym / sponsor ID
- Cysto-position / APHP230769
- Conditions
- Urodynamic Exam, Neurologic Disorder
- Keywords
- Urodynamic exam, detrusor overactivity, positon
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 2 Apr 2024 (actual)
- Primary completion
- 2 Apr 2027 (estimated)
- Study completion
- 2 Apr 2027 (estimated)
- First posted
- 18 Jul 2023 (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.
ICS (International Continence Society) recommendations published in 2017 recommend performing urodynamic examinations in the sitting or standing position. These recommendations are based on a review of the literature published in 2008, which has several limitations: heterogeneous populations, old and non-harmonized techniques, and very few neurological patients. It seems appropriate to focus on neurological patients and to examine the influence of position on the detection of detrusor overactivity in these patients.
The point here is to reexamine the ICS recommendations, which are not designed for neurological patients. Indeed, many patients suffering from Multiple Sclerosis (MS) or Parkinson's disease are unable to sit or stand for the duration of the urodynamic examination. The investigators would like to assess whether exploring sphincter disorders in the supine position is still interpretable.
This would enable us to define ICS good practice recommendations for a neurological population.
Detailed description
1st consultation (selection - D-15):
- Targeted questioning of disorders, completion of USP self-questionnaire, and UPDRS or EDSS scales as part of care.
- Verification of ultrasound results (for men).
- Schedule Urodynamic Assessment as part of treatment.
- Verification of eligibility criteria
- Partial information of the patient (or relative/guardian/guardian if applicable) to limit bias, and a period of reflection prior to the urodynamic test to collect consent.
On the day of the Urodynamic Assessment (D0):
- Written, free and informed consent.
- Data collection by a physician trained in the study,
- Randomization of patient to determine starting position (lying or sitting) for urodynamic assessment (via CleanWeb).
- Urodynamic assessment according to ICS recommendations, with constant filling speed over the 2 fillings (50 ml/min), water filling - Laborie machine - T-Doc system in both positions in the order defined by randomization, and printout of curves.
- Entry of socio-demographic data.
- Curves reread by a doctor who had not performed the examination and who did not know the patient or the starting position (single blind).
- Completion of the paper file by the physician reading the curves, with the following data for position 1 and position 2:
- Volume at B1 and B3 (in ml)
- Basal bladder pressure (cm / H2O)
- Occurrence of CNID or mictional reflex arc (diagnosis of detrusor overactivity)
- Volume of leakage or 1st NIDC (Uninhibited Detrusor Contraction) (ml) or
- Bladder pressure at leakage (cm / H2O)
- Maximum bladder pressure (cm / H2O)
- Paper data entry on Excel database by a trained investigator declared on the study
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lying position first - then sitting position | Experimental | Other: urodynamic exam in sitting and lying position |
| Sitting position first - then lying position | Experimental | Other: urodynamic exam in sitting and lying position |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient with MS or neurologically confirmed Parkinson's disease, with indication for urodynamic assessment - 1st assessment
- Clinical overactive bladder syndrome with USP overactive bladder sub-score > or = 4 - Age ≥18 years
- In men: no prostatic hypertrophy on ultrasonography
- In women: no stress urinary incontinence (SUI); USP SUI subscore ≤ 2
- Affiliated with a social security scheme (excluding AME).
Key exclusion criteria (1 listed)
- Opposition to the performance of a Urodynamic exam as part of treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| urodynamic exam in sitting and lying positionUrodynamic exam with 1st filling in sitting or lying position. Then , during the same procedure, a second filling in the opposite position of the 1st filling (lying or sitting) | Other | Lying position first - then sitting position, Sitting position first - then lying position |
Primary outcome
concordance diagnosis of detrusor overactivity between lying and sitting position
Time frame: 24 months
Measurement concordance of detrusor pressures using the intraclass correlation coefficient statistic
3 secondary outcomes
position influence on the overactive detrusor gravity between the 2 positions
Time frame: 24 months
Evaluation of the diagnosis quality of the detrusor overactivity between the 2 position
Time frame: 24 months
comparison of the distribution of detrusor overactivity diagnoses according to position.
Time frame: 24 months
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 17 Apr 2026.
- Individual participant dataSharing planned: Yes. Data are available upon reasonable request The procedures carried out with the French data privacy authority (CNIL, National Commission for Computing and Liberties) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
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RecruitingObservational study
e-Sense® Normal Values of Urodynamic Pressures Using e-Sense® Catheters
Lower Urinary Track Symptoms, Urodynamic Exam
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.
Physical and Rehabilitation Medicine Pitié Salpêtrière Hospital
Paris, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing urodynamic exam in sitting and lying position in people with Urodynamic Exam and Neurologic Disorder, run by Assistance Publique - Hôpitaux de Paris at 1 site 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 6 inclusion and 1 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 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
concordance diagnosis of detrusor overactivity between lying and sitting position (time frame: 24 months). 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 17 Apr 2026.