To study in a small group of male volunteers the feasibility of estimating urinary flow velocity and turbulence caused by obstruction using rf ultrasound. Subsequently, to compare in a group of patients eligible for TURP according to clinical…
ID
Source
Brief title
Condition
- Bladder and bladder neck disorders (excl calculi)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The raw ultrasound data will be processed using Matlab procedures developed in
an earlier study resulting in decorrelation curves.
Secondary outcome
In healthy volunteers from free flow-rate measurement:
Maximum urinary flow-rate and voided volume are quantitative parameters that
will be derived using earlier developed Matlab procedures in the flowmeter
setup. They will be used to verify/support the stratification of patients
according to the degree of obstruction.
In patients from free flow-rate measurement:
Maximum urinary flow-rate and voided volume are quantitative parameters that
are automatically calculated by Audact software used in the clinical urodynamic
setups. The parameters are stored in Ms-Access databases in Erasmus MC servers.
They will be to verify/support the stratification of patients according to the
degree of obstruction.
In patients from invasive pressure flow study:
Detrusor pressure at maximum flow-rate
Maximum flow-rate
Urethral resistance parameters
URA (Urethral Resistance Factor)
BOOI (Bladder Outlet Obstruction Index)
Slope of lowest part of PURR (Passive Urethral Resistance Relation)
Bladder contractility parameters
Wmax (maximum bladder contractility)
BCI (Bladder Contractility Index)
These parameters will be used to relate the (de)correlation of the ultrasound
images to the degree of obstruction and/or bladder contractility of the
patients.
Background summary
From a clinical point of view, a simple and non-invasive measurement device
that objectively grades and localizes urethral obstruction in one voiding would
be a major breakthrough. Such a device would significantly lower the threshold
for urodynamic testing in the increasing aging male patient population.
Study objective
To study in a small group of male volunteers the feasibility of estimating
urinary flow velocity and turbulence caused by obstruction using rf ultrasound.
Subsequently, to compare in a group of patients eligible for TURP according to
clinical criteria an invasive routinely clinically derived measure of bladder
outlet obstruction (BOOI, URA, slope of PURR) with criteria derived from the
noninvasive rf ultrasound analysis. Finally to compare the results calculated
from raw ultrasound data between the healthy volunteers and the obstructed
patients.
Study design
This is a prospective, observational, exploratorive, pilot study.
Study burden and risks
There are no benefits and risks expected. The burden is minimal and consists of
one or two non-invasive urodynamic measurements during one visit to Erasmus MC
for the patient group. The healthy male volunteers group will exist of students
and staff members of Erasmus MC. They will be asked to void a maximal number of
10 times, which means they have to come by maximal 10 times. Visits for this
population will be planned on days on which the volunteers will already be
present at Erasmus MC, so they don*t have tpo come to Erasmus MC especially for
a study visit. Also both groups will be asked to fill out a questionnaire
regarding lower urinary tract symptoms (the IPSS questionnaire) once. In case
of incidental medical findings, the participant will be advised to visit a
physician.
Wytemaweg 80
Rotterdam 3015 CN
NL
Wytemaweg 80
Rotterdam 3015 CN
NL
Listed location countries
Age
Inclusion criteria
1) Male 18 years or older
2) Healthy volunteers: student or staff member at Erasmus MC
3) Patients: eligible for TURP based on clinical criteria who will be urodynamically investigated at Erasmus MC
4) Mentally and physically able to visit the Erasmus MC
5) Signed informed consent
Exclusion criteria
1) Unable to urinate in a standing position
2) Previous lower urinary tract surgery
3) Congenital disease of the lower urinary tract
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL47107.078.13 |