Multiple Sclerosis and Voiding Symptoms: How to Assess?

NCT04928716 | Completed

• 1 other identifier: GRC 01 GREEN
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

In multiple Sclerosis (MS), storage and voiding symptoms are well described. Urodynamic patterns underlying storage symptoms are clearly defined, but the assessment of voiding phase in neurological diseases is a sensitive topic. The international continence society (ICS) recommended performing pressure flow studies to assess voiding phase. Assessments of sphincter relaxation and detrusor contractility during voiding phase are tough aims to achieve. Indeed, there is no consensus for the detrusor contractility assessment on women or on patients with neurogenic bladder. Similarly, assessment of sphincter during bladder filling and during the voiding phase is not included in ICS recommendations. In the end, it is the physicians who conclude from the non-formalized urodynamic data if there is a DSD or detrusor underactivity. In MS patients undergoing urodynamics, studies reported 43% DSD and 12% impaired contractility. These data should be interpreted with caution due to the variability of the assessment methods. This study aims to describe the voiding phase of MS patients with standardized urodynamic evaluation and parameters. This prospective observational study was conducted in a neuro-urology department of a French university hospital. All the MS patients consulting for a first urodynamic evaluation without urinary treatment were included. Standardized urodynamic evaluation included an uroflowmetry, urethral pressure profile, two pressure-flow studies. If no detrusor contractility was observed during the pressure flow studies, cystometries with 100ml/min filling rate and ice water test were performed. Anal sphincter activity was recorded using surface electromyography electrodes. Demographic data (age, sex), disease course of the MS, treatments, Expanded Disability Status Scale, urinary symptoms using the Urinary Symptom Profile and the Neurogenic Bladder Symptom Score were collected. For assessment of detrusor contractility, the following parameters are reported: the bladder voiding efficiency; the projected isovolumetric pressure (PIP) or bladder contractility index (BCI); the Watts factor. For women, the investigators presented 3 more parameters the PIP1; the Valentini-besson-Nelson parameter k and an urodynamic cut-off proposed by Gammie et al. for DUA. Presence of Detrusor-sphincter dyssynergia was reported if there were a detrusor contraction concurrent with an involuntary contraction of the periurethral striated muscle.

Conditions

Multiple Sclerosis; Lower Urinary Tract Symptoms; Voiding Disorders

Keywords

multiple sclerosis; Lower Urinary Tract Symptoms; voiding disorders; neurogenic bladder; urodynamics

Outcome Measures

Primary Outcomes (1)

• Description of the voiding phase

  assessment of the voiding phase in multiple sclerosis patients with description of the existing parameters in urodynamic tests

  1 day

Interventions

voiding phase evaluation OTHER

Assessment of voiding phase in multiple sclerosis patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with multiple sclerosis consulting for a first urodynamic evaluation without urinary treatment were included

You may qualify if:

• Multiple sclerosis (Mc Donalds criterias 2017)
• performing an urodynamic evaluation

You may not qualify if:

• patients with urinary treatment

Sponsors & Collaborators

• Pierre and Marie Curie University: lead

Study Sites (1)

Department of Neuro- Urology, Hôpital Tenon

Paris, 75020, France

Location

MeSH Terms

Conditions

Multiple Sclerosis; Lower Urinary Tract Symptoms; Urinary Bladder, Neurogenic

Condition Hierarchy (Ancestors)

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

Study Officials

• Gérard Amarenco, PHD

  Sorbonne Université, GRC 001, GREEN Groupe de Recherche en Neuro-Urologie, AP-HP, Hôpital Tenon, F-75020, Paris, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor, Head of neurourology department, APHP, Tenon Hospital, Paris, France

Study Record Dates

• First Submitted: June 14, 2021
• First Posted: June 16, 2021
• Study Start: January 1, 2019
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: June 23, 2021

Record last verified: 2021-06

Locations

FR (1)