Clinical and Urodynamic Assessment of Bladder Sensation in Multiple Sclerosis

NCT ID: NCT05772637

Last Updated: 2024-02-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 113 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-14
• Study Completion Date: 2025-02-14

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.

Conditions

Overactive Bladder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

MS Patient with Bladder disorders

Group Type: EXPERIMENTAL

Repeated cystometries with bladder sensations assessment

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpital TENON

Paris, Choisir Une Région, France

Site Status: RECRUITING

Countries

France

Central Contacts

Claire Hentzen, MD

Role: CONTACT

claire.hentzen@aphp.fr

0156017500 ext. +33

Gérard AMARENCO, MD, PhD

Role: CONTACT

gerard.amarenco@aphp.fr

0156017500 ext. +33

Facility Contacts

Claire HENTZEN, MD

Role: primary

claire.hentzen@aphp.fr

0156017500

Other Identifiers

APHP230079

Identifier Type: -

Identifier Source: org_study_id