NCT04928716

Multiple Sclerosis and Voiding Symptoms: How to Assess?

Completed Last updated 23 June 2021

What this trial tests

trial testing voiding phase evaluation in Multiple Sclerosis in 100 participants. Completed in 1 January 2020.

Timeline

1 January 2019

Primary endpoint
1 January 2020

1 January 2020

Quick facts

Lead sponsor	Pierre and Marie Curie University
Status	Completed
Study type	OBSERVATIONAL
Enrollment	100
Start date	1 January 2019
Primary completion	1 January 2020
Estimated completion	1 January 2020
Sites	1 location across France

Drugs / interventions tested

• voiding phase evaluation

Conditions studied

• Multiple Sclerosis — all drugs for Multiple Sclerosis →
• Lower Urinary Tract Symptoms — all drugs for Lower Urinary Tract Symptoms →
• Voiding Disorders — all drugs for Voiding Disorders →

Sponsor

Pierre and Marie Curie University

Who can join

18 and older, any sex, with Multiple Sclerosis or Lower Urinary Tract Symptoms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.