How bladder sensations during filling relate to overactive bladder in people with multiple sclerosis
Clinical and Urodynamic Assessment of Bladder Sensation in Multiple Sclerosis
We will test whether changes in bladder sensations during filling are linked to overactive bladder symptoms in adults with multiple sclerosis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 113 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris, Choisir Une Région) |
| Trial ID | NCT05772637 on ClinicalTrials.gov |
What this trial studies
This interventional protocol uses repeated cystometries (urodynamic tests) while recording patients' reported bladder sensations at key filling points, and may include bladder diaries to capture sensation intensity. Participants are adults with multiple sclerosis and bladder symptoms who are not currently taking bladder medications and can undergo urodynamic testing. The goal is to correlate sensation patterns (increased, decreased, or normal) with the severity of overactive bladder symptoms and to distinguish sensation-driven problems from detrusor overactivity. People with recent MS relapse, other neurological disease, pregnancy, recent bladder treatments, or inability to use the sensation-recording device are excluded.
Who should consider this trial
Good fit: Adults (≥18) with MS diagnosed by 2017 McDonald criteria who have bladder symptoms related to MS, are not currently on bladder medications, can read and write French, have required social security coverage, and have an indication for urodynamics are ideal candidates.
Not a fit: Patients with recent MS relapse, other neurological diseases, pregnancy or breastfeeding, recent bladder treatments or surgery, legal protection status, or those unable to use the analog sensation device are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the findings could help clinicians identify when abnormal bladder sensation—not only muscle overactivity—is driving overactive bladder symptoms, allowing more targeted management.
How similar studies have performed: Previous urodynamic work has well described detrusor overactivity, but systematic tracking of bladder sensations during cystometry is relatively novel and not well characterized in MS.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion criteria: * 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
Where this trial is running
Paris, Choisir Une Région
- Hôpital TENON — Paris, Choisir Une Région, France (Recruiting)
Study contacts
- Study coordinator: Claire Hentzen, MD
- Email: claire.hentzen@aphp.fr
- Phone: 0156017500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.