1) Is the difference in diuresis between patients and volunteers caused by a dept in water household in patients and if so can we increase the diuresis in patients by correcting this?2) Can we influence the pattern of bladder sensations by…
ID
Source
Brief title
Condition
- Bladder and bladder neck disorders (excl calculi)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Increase diuresis rates within patients suffering from OABsc by advising them
to drink more during daytime.
Evaluate whether this higher diuresis induces a changed velocity of
intensification of bladder sensations (as a result: change the curve drawn
while following a physiological bladder filling following a water load
protocol) in patients.
Secondary outcome
Treat symptoms of patients suffering OABsc by means of altering (increasing)
their diuresis velocity.
Background summary
The average natural forced diuresis for patients (mean 6.90, SD 2.8 ml/min) is
significantly lower than the diuresis for volunteers (mean 12.1, SD 3.4 ml/min)
(p<0.001).This could mean that patients had a deficit in water household,
probably because their drinking behaviour was different from the healthy
volunteers. We know people with OABsc drink less than healthy volunteers
because drinking has been associated by the patients with need to go to the
toilet.
However we hypothesize that patients could get a development of bladder
sensations more similar to healthy volunteers when their diuresis velocity
increases. The clinical relevance of this hypothesis can be that we can help
patients with OABsc to make their urgency and intensity of sensations develop
different (e.g. more equal to healthy volunteers) and maybe get rid of a
component of their symptoms. This hypothesis will be the tested in our future
study.
Study objective
1) Is the difference in diuresis between patients and volunteers caused by a
dept in water household in patients and if so can we increase the diuresis in
patients by correcting this?
2) Can we influence the pattern of bladder sensations by increasing the
diuresis in patients with OABsc?
Study design
We have to gain information about the baseline of sensation-development during
bladder filling for al the patients when diuresis is assumed to be *not
optimal*; this means a suspected diuresis rate lower than the diuresis in
healthy people. Afterwards we have to conduct information about the development
of the bladder sensations when diuresis rate has increased and approaches
diuresis rate of healthy volunteers. This will be done by organising 2
(group)sessions for all patients: session 1: normal intake; session 2: higher
intake. The principal investigator will be present during the sessions.
Before every session each subject will be asked to drink 1000 ml of water in
the hour before the session begins to establish a normal but elevated diuresis.
On arrival at the session the subject will be asked to void and continue
drinking a further 1000 ml through out the session (200 ml per 10 minutes).
This water load will facilitate urine production and bladder filling reaching a
capacity over approximately 1-2 hr period (numbers based on our preliminary
work).
During the normal intake session (about 1 hour) the patients are asked to
record their sensation and grade it every 10 minutes (see appendix1). Moreover
they are asked to fill in this sensation on an empty curve (appendix2) which we
developed during the focus-group study and with which we objectivised the
different shapes of curves between patients and healthy subjects. For each
subject the bladder capacity at maximum sensation will be determined by
measuring the urine volume voided at the end of the session. Afterwards we can
calculate the diuresis velocity during this first session.
Study burden and risks
No risks.
Patients may benefit because we hypothesise that their symptoms may alter en
decrease after drinking more and getting rid of their deficit in
waterhousehold.
P. Debyelaan 25
6229 HX Maastricht
Nederland
P. Debyelaan 25
6229 HX Maastricht
Nederland
Listed location countries
Age
Inclusion criteria
Patients with OAB diagnosed by their urologist using the criteria of more than 8 micturitions on three consecutive days. While investigation starts they will not use any anticholinergic or other therapy. Patients on anticholinergic therapy will be asked to stop this therapy for at least 10 days before they enter the first session. Well versed in Dutch.
Exclusion criteria
Congestive heart disease or history of heart failure
Presence of urinary tract infection. These patients will be treated by antibiotics.
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 | NL36836.068.11 |