The study is devided in two distinct groups a male and female group: The male group consist of patients with lower urinary tract symptoms (LUTS). The female group consist of patients with the overactive bladder syndrome OAB.The primary objective of…
ID
Source
Brief title
Condition
- Bladder and bladder neck disorders (excl calculi)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary Objectives
· To characterise non-micturition activity during normal bladder filling
· To determine the nature of any change in this activity associated with OAB
· To relate this activity to bladder volume and sensation.
· To demonstrate the micromotions
· To study the link between OAB and micromotions in relation to bladder neck
obstruction
Secondary outcome
Secondary objectives
· To identify possible mechanisms underlying OAB
· To gain ideas for a better treatment for OAB
· To explore the possibility that therapeutically important drugs for OAB exert
their action via inhibition of non-
micturition activity
Background summary
The sensation of the need for urination (urge) is a complex and only partially
understood mechanism. It is our hypothesis that this mechanism is disrupted in
patients suffering fro overactive bladder syndrome.
The Overactive Bladder syndrome (OAB) has been defined as a spectrum of
symptoms in which incontinence may or may not overlap with urgency, frequency
and nocturia. This syndrome is estimated to affect approximately 17% of the
adult population in Europe and the United States. The symptoms of overactive
bladder have many potential causes and contributing factors. One of these
factors is an outlet obstruction of the bladder due to benign prostatic
hyperplasia (BPH). Nowadays antimuscarinic drugs are used for treatment of the
overactive bladder. Antimuscarinic agents have been proven to work slightly to
moderately better than placebo*s and are associated with side effects such as a
dry mouth, blurred vision and constipation.
Many patients with lower urinary tract symptoms (LUTS) develop OAB. In this
group of patients with LUTS and OAB, there is not always a clear obstruction
found. So, at least in some patients, with LUTS, there must be another reason
for OAB than obstruction.
The autonomous bladder activity has been introduced by, among others the
Maastricht Urology research group. In animal models, the bladder is shown to
have rhythmic low amplitude contractions (micro motions). It is hypothesised
that this activity has a sensory function in the micturation regulation system
which is mainly located in the bladder wall. These so called micromotions have
never been demonstrated in the human bladder. The sensing function of the
bladder and the micturation reflex remain mainly unclear. We hypothesise that
there is a disregulation of the autonomous bladder activity (micro motions) in
patients with OAB.
We want to explore and study the relationship between OAB, obstruction and the
micro motions in order to gain a better understanding of the bladder
(patho)physiology. reason for This on its turn, can help us in the quest for
better treatment strategies for patients suffering from OAB.
Study objective
The study is devided in two distinct groups a male and female group:
The male group consist of patients with lower urinary tract symptoms (LUTS).
The female group consist of patients with the overactive bladder syndrome OAB.
The primary objective of this pilot experiment is to describe via an
observational study the relation between non-micturation bladder activity and
sensation during the filling phase of the bladders in women. We want to explore
if there is a relation between non-micturation bladder activity and the
sensation of urgency during the filling phase.
Furthermore in men, we want to study the relationship between non-micturation
bladder activity and the amount of obstruction.
We would also like to visualize the micro motions of the bladder in both men
and women during filling phase and study the influence of (visual and
cognitive) stimuli on bladder activity.
We want to explore if there is a relation between non-micturation bladder
activity and the sensation of urgency during the filling phase in male patients
with Lower urinary tract symptoms. In order to gain a better understanding in
bladder (patho)physiology.
Study design
A pilot observational study to describe the non-micturation bladder activity
and sensation measurement during filling phase.
Study burden and risks
There is no burden on patient taking part in this study other than the extra
time spent in the hospital which will be between 30 to 60 minutes.
There are no riscs in taking part in this study.
Postbus 5800
6202 AZ Maastricht
NL
Postbus 5800
6202 AZ Maastricht
NL
Listed location countries
Age
Inclusion criteria
Female patients who will undergo ambulatory urodynamics to investigate their symptoms of urge and frequency (>8 micturitions per day)
Male and female patients with LUTS who will undergo a classic stationairy urodynamic measurement to investigate their symptoms of urge and frequency.
Exclusion criteria
None
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 | NL22285.068.08 |