Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04928716 |
Other study ID # |
GRC 01 GREEN |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
January 1, 2019 |
Est. completion date |
January 1, 2020 |
Study information
Verified date |
June 2021 |
Source |
Pierre and Marie Curie University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial 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.
Description:
Lower urinary tract (LUT) dysfunctions are common in multiple sclerosis (MS) with almost all
the patients reporting LUT symptoms at 10 years of duration of MS.LUT dysfunctions affect one
patient out of ten at the time of the first neurological symptoms and negatively impact
patients' quality of life.
In 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 to
perform pressure flow studies to assess voiding phase. In 2018, the ICS defined altered
sphincter function and detrusor function during pressure flow studies in neurogenic LUT
dysfunction. Three types of sphincter dysfunctions are reported: detrusor-sphincter
dyssynergia (DSD) defined as "a detrusor contraction concurrent with an involuntary
contraction of the urethral and/or periurethral striated muscle. Occasionally flow may be
prevented altogether." , non-relaxing urethral sphincter as "a non-relaxing, obstructing
urethral sphincter resulting in reduced urine flow" and delayed relaxation of the urethral
sphincter as "an impaired and hindered relaxation of the sphincter during voiding attempt
resulting in delay of urine flow". Regarding detrusor dysfunction during voiding phase, two
types are reported: Neurogenic detrusor underactivity (DUA) defined as "a contraction of
reduced strength and/or duration, resulting in prolonged bladder emptying and/or a failure to
achieve complete bladder emptying within a normal time span in the setting of a clinically
relevant neurologic disorder", neurogenic acontractile detrusor "is one that cannot be
demonstrated to contract during urodynamic studies in the setting of a clinically relevant
neurologic lesion". In studies in MS patients undergoing urodynamic testing, this
classification was not used. First because these definitions are recent, secondly because
assessing 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 in order to identify contractility of the detrusor. Anal sphincter activity was
recorded during the urodynamic testing using surface electromyography electrodes. Urodynamic
evaluation was realized in accordance with ICS recommendation.
Demographic data (age, sex), disease course of the MS, treatments, Expanded Disability Status
Scale (EDSS), urinary symptoms using the Urinary Symptom Profile (USP) and the Neurogenic
Bladder Symptom Score (NBSS) were collected.
Detrusor contractility assessment.
For assessment of detrusor contractility on patients with neurological disease, the following
parameters are reported: (i) the bladder voiding efficiency (BVE) defined as a percentage
(BVE= (voided volume/total bladder capacity) x 100) ; (ii) the projected isovolumetric
pressure (PIP) or bladder contractility index (BCI) given by the formula BCI=PdetQmax + 5Qmax
with a strong contractility if BCI >150, normal contractility if BCI of 100-150 and weak
contractility if BCI <100 ; (iii) the Watts factor (WF) = [(Pdet + a)(vdet + b) - ab]/2π
where Pdet is the detrusor pressure, vdet is the velocity of detrusor contraction, and a (25
cmH2O) and b (0.6 cm/s) are back-calculated muscle constants representing the heat of
shortening and the rate of energy liberation, respectively.
For women, the investigators presented 3 more parameters (i) the PIP1= PdetQmax + Qmax ; (ii)
the Valentini-besson-Nelson (VBN) parameter k (simulating detrusor force) and (iii) an
urodynamic cut-off proposed by Gammie et al. for DUA with PdetQmax <20; Qmax <15, and BVE
<90%.
The conclusions of the detrusor contractility assessment were reported. This conclusion was
made with a double reading of the urodynamic curves: the first assessment was made by the
physician who initially received the patient; a second reading of the pressure-flow studies
was made in blind by CC.
Bladder outlet obstruction was assessed with the Bladder Obstruction outlet index (BOOI).
Presence of Detrusor-sphincter dyssynergia was reported if there were a detrusor contraction
concurrent with an involuntary contraction of the periurethral striated muscle.