Overactive BladderCUBS-MSNCT05772637
Clinical and Urodynamic Assessment of Bladder Sensation in Multiple Sclerosis
A study testing Repeated cystometries with bladder sensations assessment in people with Overactive Bladder, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The aim of the study is to assess the association between bladder sensations progression during bladder filling and severity of Overactive bladder (OAB) in patients with multiple sclerosis. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Repeated cystometries with bladder sensations assessment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 1 siteFrance
- Study dates
- 14 Feb 2024to 14 Feb 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18
- MS according to the 2017 Mac Donald diagnostic criteria
- Bladder disorders supposedly related to MS
- Indication to perform urodynamics
- No current medication for bladder disorders
- Able to understand and right in French
- Affiliated to the "Securite sociale" or "Couverture Medicale Universelle (CMU)", or equivalent organism.
Who cannot join
- Legal protection
- Pregnancy or breastfeeding mother
- MS relapse during the past month
- Other associated neurological disease
- Genuine stress incontinence related to postpartum
- Treatment with antimuscarinics, alpha blockers, beta3 adrenergic, or tibial nerve stimulation in the past 15 days, or with botulinic toxin injection in the past 6 months
- Previous lower urinary tract surgery
- Inability to use the analogic device due to motor, sensory or ataxic disabilities
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
Hôpital TENON
Paris, Choisir Une Région, 75020
Claire HENTZEN, MD, 0156017500, claire.hentzen@aphp.fr
Claire Hentzen, MD
About this study
The aim of the study is to assess the association between bladder sensations progression during bladder filling and severity of Overactive bladder (OAB) in patients with multiple sclerosis.
Read the detailed description
Lower urinary tract symptoms (LUTS) are frequent in central nervous system disorders especially in patients with multiple sclerosis (PwMS). Prevalence of LUTS is important (32 to 96.8%) and increases with multiple sclerosis (MS) duration and the severity of the neurological deficiencies and disabilities. Overactive bladder (OAB) with urgency, frequency, urgency urinary incontinence, is the most common symptom, reported by 37-99% of the PwMS. Voiding difficulties are less common, from 6 to 49%, and usually appear later with the course of the disease.
Urodynamics is a useful test recommended to understand the mechanism of bladder dysfunction, and look for risk factors of upper tract damage.
Detrusor overactivity is the most reported mechanism of overactive bladder, and describes the occurrence of uninhibited contractions of the detrusor during bladder filling. But abnormal bladder sensations, with increased or decreased sensations, have also been described. The prevalence of these abnormalities is not well described, however, in the absence of detrusor overactivity, abnormal afferent information (i.e., abnormal bladder sensations) is the plausible mechanism involved in urinary disorders.
The assessment of bladder sensations is still a poorly explored field. Bladder diary can be used for the collection of the intensity of need to void with a Likert scale or numerical scale.
During cystometry, it is recommended to collect different bladder sensations: first sensation of filling, first desire to void, strong desire to void, urgent desire to void. However, it has been described that bladder sensations progress in 8 to 9 different levels of intensity in healthy subjects.
The aim of the study is to assess the association between bladder sensations progression during bladder filling and severity of OAB in patients with multiple sclerosis.
- Conditions
- Overactive Bladder
- Being tested
- Repeated cystometries with bladder sensations assessment
- Keywords
- overactive bladder, multiple sclerosis, bladder sensations
- Medical subject headings
- Urinary Bladder, Overactive, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repeated cystometries with bladder sensations assessmentProcedure or surgery
A second cystometry will be performed to assess bladder sensations reliability. A third cystometry with cognitive task (STROOP test) at the same time will be performed to assess the impact of distractive attentional task on bladder sensations
| Study group | Role | What they receive |
|---|---|---|
| MS Patient with Bladder disorders | Experimental | Not described Receives: Procedure: Repeated cystometries with bladder sensations assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
bladder sensation ( area under the sensation-capacity curve (AUC))
The areas under the sensation-capacity curve (AUC) will be calculated for individual participants using the trapezoidal rule for specific capacity ranges.
Measured: Day 1
Secondary outcomes (1)
bladder sensitivity
Bladder sensitivity assessed by the number of steps in the evolution of the need to urinate reported by the patient (number of times the cursor of the analogical scale is moved), during the filling.
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 posted16 Mar 2023
- Study start14 Feb 2024
- Primary completion14 Feb 2027 (estimated)
- Study completion14 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 113 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
- NCT05772637
- Sponsor's protocol ID
- APHP230079
- Acronym
- CUBS-MS
- Status last verified
- Mar 2026
- First submitted
- 22 Feb 2023
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Urodynamic Assessment of Bladder Sensation in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05772637
- Acronym / sponsor ID
- CUBS-MS / APHP230079
- Conditions
- Overactive Bladder
- Keywords
- overactive bladder, multiple sclerosis, bladder sensations
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 113 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 14 Feb 2024 (actual)
- Primary completion
- 14 Feb 2027 (estimated)
- Study completion
- 14 Feb 2027 (estimated)
- First posted
- 16 Mar 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.
The aim of the study is to assess the association between bladder sensations progression during bladder filling and severity of Overactive bladder (OAB) in patients with multiple sclerosis.
Detailed description
Lower urinary tract symptoms (LUTS) are frequent in central nervous system disorders especially in patients with multiple sclerosis (PwMS). Prevalence of LUTS is important (32 to 96.8%) and increases with multiple sclerosis (MS) duration and the severity of the neurological deficiencies and disabilities. Overactive bladder (OAB) with urgency, frequency, urgency urinary incontinence, is the most common symptom, reported by 37-99% of the PwMS. Voiding difficulties are less common, from 6 to 49%, and usually appear later with the course of the disease.
Urodynamics is a useful test recommended to understand the mechanism of bladder dysfunction, and look for risk factors of upper tract damage.
Detrusor overactivity is the most reported mechanism of overactive bladder, and describes the occurrence of uninhibited contractions of the detrusor during bladder filling. But abnormal bladder sensations, with increased or decreased sensations, have also been described. The prevalence of these abnormalities is not well described, however, in the absence of detrusor overactivity, abnormal afferent information (i.e., abnormal bladder sensations) is the plausible mechanism involved in urinary disorders.
The assessment of bladder sensations is still a poorly explored field. Bladder diary can be used for the collection of the intensity of need to void with a Likert scale or numerical scale.
During cystometry, it is recommended to collect different bladder sensations: first sensation of filling, first desire to void, strong desire to void, urgent desire to void. However, it has been described that bladder sensations progress in 8 to 9 different levels of intensity in healthy subjects.
The aim of the study is to assess the association between bladder sensations progression during bladder filling and severity of OAB in patients with multiple sclerosis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MS Patient with Bladder disorders | Experimental | Procedure: Repeated cystometries with bladder sensations assessment |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18
- MS according to the 2017 Mac Donald diagnostic criteria
- Bladder disorders supposedly related to MS
- Indication to perform urodynamics
- No current medication for bladder disorders
Key exclusion criteria (8 listed)
- Legal protection
- Pregnancy or breastfeeding mother
- MS relapse during the past month
- Other associated neurological disease
- Genuine stress incontinence related to postpartum
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 |
|---|---|---|
| Repeated cystometries with bladder sensations assessmentA second cystometry will be performed to assess bladder sensations reliability. A third cystometry with cognitive task (STROOP test) at the same time will be performed to assess the impact of distractive attentional task on bladder sensations | Procedure or surgery | MS Patient with Bladder disorders |
Primary outcome
bladder sensation ( area under the sensation-capacity curve (AUC))
Time frame: Day 1
The areas under the sensation-capacity curve (AUC) will be calculated for individual participants using the trapezoidal rule for specific capacity ranges.
1 secondary outcome
bladder sensitivity
Time frame: Day 1
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 5 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repeated cystometries with bladder sensations assessment in people with Overactive Bladder, 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 7 inclusion and 8 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 5 Mar 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?
Contact Claire Hentzen, MD (0156017500 ext. +33, claire.hentzen@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bladder sensation ( area under the sensation-capacity curve (AUC)) (time frame: Day 1). 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 5 Mar 2026.