Clinical and Urodynamic Assessment of Bladder Sensation in Multiple Sclerosis (CUBS-MS)

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.

Study Overview

• Status: Recruiting
• Conditions: Overactive Bladder
• Intervention / Treatment: Procedure: Repeated cystometries with bladder sensations assessment

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 Type: Interventional
• Enrollment (Estimated): 113
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Claire Hentzen, MD; Phone Number: +33 0156017500; Email: claire.hentzen@aphp.fr
• Study Contact Backup: Name: Gérard AMARENCO, MD, PhD; Phone Number: +33 0156017500; Email: gerard.amarenco@aphp.fr

Study Locations

• France
  • Choisir Une Région
    • Paris, Choisir Une Région, France, 75020
      • Recruiting
      • Hopital Tenon
      • Contact: Claire HENTZEN, MD; Phone Number: 0156017500; Email: claire.hentzen@aphp.fr
      • Principal Investigator: Claire Hentzen, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MS Patient with Bladder disorders	Procedure: Repeated cystometries with bladder sensations assessment; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 1

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2024
• Primary Completion (Estimated): February 14, 2027
• Study Completion (Estimated): February 14, 2027

Study Registration Dates

• First Submitted: February 22, 2023
• First Submitted That Met QC Criteria: March 6, 2023
• First Posted (Actual): March 16, 2023

Study Record Updates

• Last Update Posted (Actual): March 5, 2026
• Last Update Submitted That Met QC Criteria: March 4, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: overactive bladder; multiple sclerosis; bladder sensations
• Additional Relevant MeSH Terms: Urogenital Diseases; Nervous System Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Autoimmune Diseases; Immune System Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Urinary Bladder Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Multiple Sclerosis; Urinary Bladder, Overactive
• Other Study ID Numbers: APHP230079

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No