Clinical and Urodynamic Assessment of Bladder Sensation in Multiple Sclerosis

Overactive Bladder Clinical Trial

— CUBS-MS  

Official title:

Clinical and Urodynamic Assessment of Bladder Sensation in Multiple Sclerosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05772637
• Other study ID #: APHP230079
• Status: Recruiting
• Phase: N/A
• Start date: February 14, 2024
• Est. completion date: February 14, 2025

Study information

• Verified date: February 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Claire Hentzen, MD
• Phone: 0156017500
• Email: claire.hentzen[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 113
• Est. completion date: February 14, 2025
• Est. primary completion date: February 14, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Overactive Bladder
• Sclerosis
• Urinary Bladder, Overactive

Intervention

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

Locations

Country	Name	City	State
France	Hôpital TENON	Paris	Choisir Une Région

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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