The primary objective of this experiment is to describe via an observational study the relation between conditions of sitting/standing up versus laying down in terms of bladder sensation in both volunteers and patients with OAB. We also want to…
ID
Source
Brief title
Condition
- Genitourinary tract disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
· To study the effect of position on bladder sensation in volunteers and
patients with overactive bladder syndrome
· To study the effect of position on voided volumes in volunteers and patients
with overactive bladder syndrome
· To study the relationship between bladder sensation and the voided volumes in
both volunteers and patients.
Secondary outcome
Secondary objectives
· To characterise self consciousness in patients with OAB
· To characterise the difference between volunteers and patients with OAB in
regards to self consciousness and bladder perceptions
· To characterise the difference between men and women in regards to self
consciousness and bladder perceptions.
· To determine the relationship between self-consciousness and bladder
perceptions in patients with OAB
· To determine the relationship between the functional bladder capacity and OAB
symptoms in relation to patient perception
· To relate voided volumes to patient perception.
· To study the link between OAB symptoms and patient bother from OAB to self
consciousness and bladder perception
· To study the relationship between the functional and maximal bladder capacity
in relation to OAB symptoms and bother in OAB patients.
Background summary
We would like to study the regulation mechanism of the bladder. This is in the
light of finding new treatment strategies for OAB. Patients suffering from OAB
have symptoms of urgency and/or frequency.
according to recent studies the prevalnce of OAB is about 17 % of the
population opver 40 years , in the western world
We would like to study the relationship between position and bladder sensation
in both OAB patients and healthy volunteers.
Study objective
The primary objective of this experiment is to describe via an observational
study the relation between conditions of sitting/standing up versus laying down
in terms of bladder sensation in both volunteers and patients with OAB.
We also want to explore if there is a relation between bladder volume and the
sensation of urgency.
Furthermore we would like to study the level of self-consciousness and bladder
filling correlated to voided volumes and the perception of the sensation during
the filling phase of the bladders in these patients
We want to explore if there is a relation between the postural position, the
bladder filling, the volume voided, the trait and state level of patient
self-consciousness and the sensation of urgency during the filling phase in
these patients with OAB.
Study design
Group 1. OAB Patients:
Patients will be recruited from our patient pool of the urology department.
That means known or new patients from our out patient clinic in Maastricht
diagnosed with OAB. Patients will be asked to go to a toilet and empty their
bladder on inclusion at the outpatient clinic. The residual volume in the
bladder will be assessed. All patients with a post voidal residu of more than
100 cc will be excluded from the study. Since this will influence the urge
sensations and therefore the study outcome.
All patients using anticholinergic medication will be asked to stop taking
their anticholinergic for at least 10 days prior to the study date to eliminate
the effect of anticholinergics on urge sensations.
The inclusion criteria for patients is > 8 micturitions per day, and a minimum
of one episode of urgency per day).There will be no catheter insertion or any
medication used. After receiving detailed information about the study and
receiving informed consent, patients will be asked to come to our outpatient
clinic (urology function room) after drinking 1 litre of water (SPA blauw) at
home prior to arrival. At arrival patients will be asked to fill in a self
consciousness questionnaire which will take about 5 minutes. Then they will be
asked to drink another 0.5 litre of water and drink additional 250 ml of water
every 15 minutes in our clinic for one hour. We will wait for them to void when
they can in a special toilet that can measure the amount of urine flowing in
it.
.
From that urine, a sedimentation test will be done in order to assess if there
is any ongoing urinary infection, which can influence our study data. After
voiding the patients residual urine volume will be assessed, non-invasively by
an ultra sound scan 3D echo. Every 10 minutes participants are asked to change
posture (lying down or standing up). Just before and just after this posture
change they grade their bladder sensation at that time point. For that purpose
we will use a special visual analogue scale (VAS) on which the patient can
point out his feeling in a scale running from no sensation at all to very
strong voiding sensation. Furthermore they will be asked to complete a
seven-item VAS-scale that measure different aspects of level of state
self-consciousness. Patients will be asked to keep their urine as long as
possible and only void at a strongest urge sensation they can withstand.
. When they can*t hold the urine any longer, they will void in the toilet and
their voided volume will be measured. And again an ultrasound bladder scan will
be conducted to assess the residual volume post micturition. This whole session
will take between 60 to 120 minutes depending on the patients functional
bladder capacity and the time that he can hold up his urine.
The study procedure will be performed two times on two different days within a
time period of 10 days.
Group 2. volunteers without OAB symptoms.
Volunteers will be recruited by means of a newspaper add or a poster. After
receiving detailed information about the study and receiving informed consent,
these volunteers will be asked to come to our outpatient clinic (urology
function room). Subsequently they will be subjected to the exact same protocol
as Group 1.
Study burden and risks
There are no direct riscs in taking part of this study. stopping
anticholinergic medicatioon might re introduce the patients voidning complaints
but these complaints will dissappear after restarting the medication. Drinkng
large amounts of water might be dangerous to patients with congestive
heartfailure, therefore these patients are excluded from this study.
Postbus 5800
6202 AZ Maastricht
Nederland
Postbus 5800
6202 AZ Maastricht
Nederland
Listed location countries
Age
Inclusion criteria
Patient arm: patients older than 18 years with OAB diagnosed by their urologist using the criteria of more than 8 micturitions on three consecutive days of these three days they keep a micturation diary with a VAS score for urge sensation. Patients should have at least one episode of urge: sudden compelling desire to void which can not be postponed.
Volunteers arm: volunteers older than 18 years are considered eligible if they have no urologic history or urinary complaints.
Exclusion criteria
Patient arm: congestive heart disease or history of heart failure; patients on anticholinergic medication that are not willing to stop this medication; presence of post void residual urine > 100cc determined by ultrasound; presence of urinary tract infection, determined by urine sticks. Patients with urinary tract infection will be treated by antibiotics. After resolution of the infection, the patient can re-enter the study if the urine is sterile at that moment.
Volunteer arm: urinary complaints or urologic history; congestive heart disease or history of hear failure; presence of postvoid residual urine > 100cc determined by ultrasound; presence of urinary tract infection, determined by urine sticks. Volunteers that present with urinary tract infection will be definitively excluded from participation.
Design
Recruitment
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
Register | ID |
---|---|
CCMO | NL25982.068.08 |
Other | volgt |