Lower Urinary Tract Symptoms Clinical Trial
Official title:
Filling and Emptying Cystometries: a Feasibility and Validation Study in Order to Simplify the Manometric Follow-up of Overactive Detrusor in Neurological Patients Under Anticholinergic or Botulinum Toxin Injections.
This study evaluate the feasibility and the accuracy of an emptying cystometry in order to simplify the manometric follow-up of overactive detrusor in neurological patients under anticholinergic or botulinum toxin injections.
Bladder pressure assessment is necessary for the diagnosis, the prognostic assessment and the
management of neurogenic bladder. High bladder pressures increase the rate of urological
complications and mortality in patients with neurogenic bladder. Thus many treatments are
proposed in order to improve bladder compliance and reduce uninhibited detrusor contractions
(anticholinergic drugs, botulinum toxin injections, cystoplasty, sacral neuromodulation,
beta-3-agonist, posterior tibial nerve stimulation).
Clinical data, symptoms scales, quality of life questionnaires, renal ultrasound, biological
tests of renal function and urodynamic studies are used to control the treatment efficacy of
neurogenic lower urinary tract dysfunction. Filling cystometry is the usual way to record
bladder pressure. Urodynamic techniques using external pressure transducers (microtip,
air-filled or fluid-perfused catheters) connected to the patient with fluid-filled lines are
recommended. This multichannel cystometry is performed in a specialized department with the
inconvenience of delays for appointments and cost of the urodynamic assessment. Moreover,
only some parameters are important and are taken in account in the follow-up of these
neurogenic bladders: bladder capacity, bladder compliance and maximum detrusor pressure at
the end of the filling phase. All these parameters can be recorded with a self-assessment of
bladder pressure at home with a very simple device made of 1) a self-intermittent catheter;
2) a three way stopcock; 3) a simple graduated tube. This device has in fact been used in the
past to realize cystometries, in particular in the elderly subject. A such device should
provide a monitoring in changes in bladder pressure in order to initiate adjustments in
treatment sooner than would be achieved when patients are evaluated periodically but less
frequently in the neurourology department. The early detection of high bladder pressures may
avoid bladder deformation, reflux and upper tract deterioration. Moreover, the home control
of appropriate bladder pressure may improve the patients' quality of live by reducing the
constraint linked to the time-consuming specialized follow-up.
In this study, the investigators will test a reverse single channel cystometry performed just
after a classical filling cystometry during the usual emptying by means of a device allowing
serial bladder pressure measurements during the bladder emptying. In case of such a
feasibility and a good precision of the reverse cystometry, the manometric follow-up of
overactive detrusor in neurological patients under anticholinergic or botulinum toxin
injections could be simplified.
The aim of this study is to assess the feasibility and the accuracy of sequential
measurements of bladder pressure during the bladder emptying and to compare the evolution of
bladder pressures during the emptying phase with the bladder pressures recorded during the
filling phase.
Patients over 18 years old, consulting for lower urinary tract symptoms and performing an
urodynamic examination with a cystometry in a tertiary center are included.
History, treatment and urodynamics data are recorded. Conventional supine multichannel
cystometry with isotonic saline infused at 50ml/min (filling cystometry), conform to the
International Continence Society (ICS) recommendations will be performed. At the end of the
standard cystometry when the maximum cystometric capacity will be reached, if no micturition
was obtained, urodynamic catheter was withdrawn and a CH12 urinary catheter will be
introduced in the bladder according to the usual department procedure (usually, this catheter
allows to empty the bladder). This catheter will be connected to a three-way stopcock. The
second way of the stopcock will permit the emptying into a measuring container, graduated
each 50ml. The third way of the stopcock will be connected via a tube extension to a rigid
vertical 70cm tube (central venous pressure set) graduated each centimeter. The zero pressure
of the vertical tube will be set at the upper edge of the symphysis pubis. For measuring the
bladder pressure at the maximum cystometric capacity, the valve will be open between the
bladder and the graduated tube, manometric data will be derived by observing the rise of the
column of fluid in the centimeter scale tube. This procedure will be repeated every 50ml
until bladder full emptying.
The investigators will compared each bladder pressure measures every 50ml during the
"backwards cystometry" with each bladder pressure measured every 50ml from the maximum
capacity during the filling cystometry.
Primary outcome is the agreement between the two cystometries evaluated using a kappa
coefficient.
Secondary outcome is the correlation between the pressures during the two cystometries.
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