search
Back to results

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

Primary Purpose

Overactive Bladder

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Repeated cystometries with bladder sensations assessment
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Overactive Bladder focused on measuring overactive bladder, multiple sclerosis, bladder sensations

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital TENON

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MS Patient with Bladder disorders

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
February 22, 2023
Last Updated
March 6, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
search

1. Study Identification

Unique Protocol Identification Number
NCT05772637
Brief Title
Clinical and Urodynamic Assessment of Bladder Sensation in Multiple Sclerosis
Acronym
CUBS-MS
Official Title
Clinical and Urodynamic Assessment of Bladder Sensation in Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 15, 2023 (Anticipated)
Primary Completion Date
March 15, 2025 (Anticipated)
Study Completion Date
March 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder
Keywords
overactive bladder, multiple sclerosis, bladder sensations

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
113 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MS Patient with Bladder disorders
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Repeated cystometries with bladder sensations assessment
Intervention Description
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
Primary Outcome Measure Information:
Title
bladder sensation ( area under the sensation-capacity curve (AUC))
Description
The areas under the sensation-capacity curve (AUC) will be calculated for individual participants using the trapezoidal rule for specific capacity ranges.
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
bladder sensitivity
Description
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.
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Claire Hentzen, MD
Phone
0156017500
Ext
+33
Email
claire.hentzen@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Gérard AMARENCO, MD, PhD
Phone
0156017500
Ext
+33
Email
gerard.amarenco@aphp.fr
Facility Information:
Facility Name
Hôpital TENON
City
Paris
State/Province
Choisir Une Région
ZIP/Postal Code
75020
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claire HENTZEN, MD
Phone
0156017500
Email
claire.hentzen@aphp.fr
First Name & Middle Initial & Last Name & Degree
Claire Hentzen, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Clinical and Urodynamic Assessment of Bladder Sensation in Multiple Sclerosis

We'll reach out to this number within 24 hrs