Clinical and Urodynamic Assessment of Bladder Sensation in Multiple Sclerosis

NCT05772637 | Recruiting

• 1 other identifier: APHP230079
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 1

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.

Conditions

Overactive Bladder

Keywords

overactive bladder; multiple sclerosis; bladder sensations

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• bladder sensitivity

  Day 1

Study Arms (1)

MS Patient with Bladder disorders

EXPERIMENTAL

Procedure: Repeated cystometries with bladder sensations assessment

Interventions

Repeated cystometries with bladder sensations assessment 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

MS Patient with Bladder disorders

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital TENON

Paris, Choisir Une Région, 75020, France

RECRUITING

MeSH Terms

Conditions

Urinary Bladder, Overactive; Multiple Sclerosis

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Claire Hentzen, MD

CONTACT

0156017500; claire.hentzen@aphp.fr

Gérard AMARENCO, MD, PhD

CONTACT

0156017500; gerard.amarenco@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2023
• First Posted: March 16, 2023
• Study Start: February 14, 2024
• Primary Completion (Estimated): February 14, 2027
• Study Completion (Estimated): February 14, 2027
• Last Updated: March 5, 2026

Record last verified: 2026-03

Locations

FR (1)