The main objective is to evaluate the average time span within which *time of onset* and *time of offset* occurs in patients with overactive bladder syndrome or non-obstructive urinary retention who respond to SNM.
ID
Source
Brief title
Condition
- Bladder and bladder neck disorders (excl calculi)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The transition point between no effect and time of onset is determined by
assessing when symptoms are reduced by 50% compared to baseline. Vice versa for
time of offset. Time of on set and offset will be assessed in days (24 hours).
Secondary outcome
Not applicable.
Background summary
Sacral neuromodulation is a minimally invasive secondary treatment for
overactive bladder syndrome (OAB) or for non-obstructive urinary retention
(NOR), when refractory to conservative treatment. Success rates range from 70
to 80%, and good long-term results are reported.
The working mechanism of SNM is not completely understood, and the only
prognostic factor for good response to this treatment is a successful test
stimulation period. There is no consensus on the duration of this test
stimulation period.
The experience in our clinic during test stimulation period is that for
responders it takes up to one week to achieve maximal effect, after the system
is turned *on*. On the other hand we notice that after turning the
neuromodulation system *off*, it will take a few hours for symptoms to return
to the baseline situation. The fact is: no information concerning the so called
*time of onset* and *time of offset* (or popular called: wash-in / wash-out) of
sacral neuromodulation is available in current literature.
Study objective
The main objective is to evaluate the average time span within which *time of
onset* and *time of offset* occurs in patients with overactive bladder syndrome
or non-obstructive urinary retention who respond to SNM.
Study design
The study is designed as a prospective patient series.
Intervention
After inclusion and informed consent, patients will fill out a baseline voiding
diary throughout seven days. The 28 day test stimulation period starts on the
day of the first tined lead procedure. On day 14 the stimulation is turned
*off*, on day 22 the stimulation is turned *on* again. During the study period
patients should fill out an elaborate voiding dairy for in total 28
(non-consecutive) days.
Study burden and risks
Patients will have to fill out micturition lists for a longer time period than
during regular sacral neuromodulation treatment. Within the test stimulation
period the included patients have to turn the stimulation *off** during 7 days,
whereas in regular patients stimulation is *on* during the full 28 days of the
test period. The voiding dairies should be filled out during four time periods,
within a time span of six months. There are no additional risks, that we know
of, associated with participation.
P. Debyelaan 25
Maastricht 6229 HX
NL
P. Debyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all
of the following criteria: Patients should have been diagnosed with overactive
bladder syndrome or non-obstructive urinary retention and should be put on the
waiting list for scheduling treatment with sacral neuromodulation.
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
a) patients receiving neurological or psychiatric medication without being
diagnosed with a neurological or psychiatric disease;
b) patients who have been treated by means of bladder wall botuline toxine
injections in the past twelve months;
c) patients with evident subsequent complains of bladder pain syndrome or other
pelvic pain.
Design
Recruitment
Medical products/devices used
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 | NL44879.068.13 |