Multiple Sclerosis and Voiding Symptoms: How to Assess?

NCT04928716 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2021-06-23

No results posted yet for this study

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

Interventions

OTHER

voiding phase evaluation

Assessment of voiding phase in multiple sclerosis patients

Sponsors & Collaborators

  • Pierre and Marie Curie University

    lead OTHER

Principal Investigators

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

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2020-01-01
Completion
2020-01-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04928716 on ClinicalTrials.gov