MAIN: To study the influence of increasing diuresis rate on sensation development in patients with OAB complaints. SECONDARY:To study changes in sensory complaints induced by increasing diuresis rate in patients with OAB complaints. If the…
Source
Brief title
Condition
- Bladder and bladder neck disorders (excl calculi)
Synonym
Research involving
Sponsors and support
Intervention
No registrations found.
Outcome measures
Primary outcome
The difference in diuresis between session 1 and 2. The (difference in) voided
volumes during the different sessions and the (difference in) duration time of
the different sessions.
Secondary outcome
Relieve of urgency and frequency symptoms of OAB patients (difference in
introspection curve0 by a non-invasive advice to increase diuresis rate.
Information to validate non-invasive therapy to decrease symptoms of OAB
patients
Background summary
Overactive bladder (OAB) is a functional urologic disease which causes
significant health complaints and also social and economic problems for both
individual patients as public health systems and the patient-population in
general. The main complaints OAB patients suffer from are urgency (with or
without incontinence), frequency and nocturia.
During former focus-group investigations we focussed on how healthy controls
and OAB patients describe their bladder sensations. We also investigated
whether there was a difference in developing these bladder sensations between
controls and patients.
The main information we got from these sessions are a comparable use of
terminology between patients and controls. However there was a difference in
how sensations of bladder filling developed between healthy controls and
patients. We objectivised these sensation developments and bladder feelings by
using an urgency scale, a VAS scale, micturition diaries and an introspection
curve conducted during a focus-group session with an antegrade waterload
protocol to physiologically increase diuresis.
We noticed a significant difference in introspection curve between patients and
healthy controls (even after controlling for a difference in diuresis). But we
also found a significant difference in diuresis between control and patients
and this was a significant independent variable. It is known from previous
literature and research that OAB patients drink less fluid than normal controls
because they assume that this will help them to go to the toilet less
frequently. But during the focus group sessions we found that this difference
in water household may influence the development of their bladder sensations in
a more abnormal way and this had not been reported before.
In summary we have found a difference in introspection curve between patients
and controls but we can not tell whether a lower diuresis in patients has also
a significant influence on this introspection curve and so also on the
development of bladder sensation.
Study objective
MAIN:
To study the influence of increasing diuresis rate on sensation development in
patients with OAB complaints.
SECONDARY:
To study changes in sensory complaints induced by increasing diuresis rate in
patients with OAB complaints. If the hypothesis that reduced diuresis rate may
aggravate disturbed sensation development, proves to be true, increasing
diuresis rate may be the first non-invasive and very inexpensive step in the
treatment of OAB patients.
Study design
Quantitative explorative study.
All patients have to follow a session with an antegrade waterload protocol
before altering diuresis and after increasing diuresis. These sessions will be
under supervision of the principal investigator following the same waterload
protocol as used in the focus-group sessions (MEC 09-4-045.8) performed before.
The diuresis of the patients will be changed by advising them to drink at least
1,5 L of extra fluid (of which at least 1,0L has to be water be water) for 3
consecutive days between the 2 sessions.
A day before each session patients need to fill out a micturition diary for 1
day and collect 24hour urine and take the diary and urine to the hospital. (for
appendix see protocol)
We will ask half of the patients/subject (13/13) to do the lower intake session
before the higher intake session. And we will ask half of the patients/subject
(12/12) to do the higher intake session before the low intake session.
Study burden and risks
There is no direct benefit for the patients involved in this study. They will
improve the medical and scientific knowledge about overactive bladder and its
causes and risk factors.
While participating in this study they have to adapt to a different amount of
fluid intake for 3 days. This means they have to change their
drinking-behaviour for 3 days. The amount of 1.5 liter extra is the amount that
is used in current clinical practice to increase diuresis in patients with
recurrent urinary tract infections. From this clinical experience, it is clear
that there are no risks associated. The increased diuresis may transiently
increase voiding frequency. This will be clearly discussed upfront with the
participants.
Patients on anticholinergic medication have to stop their medication for 10
days to eliminate drug bias. This is without risk, as this in clinical practice
these drugs are also temporarily stopped before functional tests (urodynamics)
are performed. Again this may transiently increase voiding frequency, which
will be clearly discussed upfront with the participants.
P. Debyelaan 25
6229 HX Maastricht
NL
P. Debyelaan 25
6229 HX Maastricht
NL
Listed location countries
Age
Inclusion criteria
Patients with OAB (over 18 years) 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.;Healthy subjects:
• Men and women
• Under 65 years of age)
• Over 18 years of age
• Well versed in Dutch
Exclusion criteria
Older dan 65 years
Congestive heart disease or history of heart failure
Presence of urinary tract infection. These patients will be treated by antibiotics.
History or (current) neurologic disease (not including good regulated diabetes)
Stress urinary incontinence
Postmicturition residual volume of > 75 cc
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 | NL37511.068.11 |