The aim is to elongate the service life of the implantable neurostimulator while achieving a minimal improvement of 50% of the symptoms of OAB.
ID
Source
Brief title
Condition
- Bladder and bladder neck disorders (excl calculi)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint will be incontinence episodes per day compared to
baseline.
Secondary outcome
- Urinary frequency per 24 hours
- Number of pads used
- Average volume per voiding
This will be derived from the voiding diaries. The change from baseline to
intermittent stimulation will be determined. The difference between
intermittent and continuous stimulation will also be determined, for
incontinence episodes per day as well.
Standard scores derived from the questionnaires (IIQ-7, UDI-6, PFDI-20, PFIQ-7,
PISQ, EuroQOL-5, FICI, FIQL):
- Change from baseline to intermittent stimulation.
- Difference between intermittent and continuous stimulation.
Background summary
Neuromodulation has been proven to be a successful treatment for OAB. One of
the main forms of neuromodulation is sacral neuromodulation (SNM). The reason
why this method is used to a limited degree include the total costs and its
invasiveness. Other forms of neuromodulation use intermittent stimulation with
a proven reduction of symptoms of OAB. Several studies have shown the
effectiveness of SNM using continuous stimulation. However, there has been no
report of intermittent stimulation using SNM. Given the results of these
alternative forms of neuromodulation it appears this intermittent stimulation
must have a similar effect for SNM. This will improve the accessibility of SNM
in two areas; significant cost saving and a reduction in invasiveness because
of a reduction in the total amount of battery changes that patients need to
undergo.
Study objective
The aim is to elongate the service life of the implantable neurostimulator
while achieving a minimal improvement of 50% of the symptoms of OAB.
Study design
A prospective cohort study in a singel-center setting.
Intervention
In all patients the implantable neurostimulator will be automatically turnes
off for 18 hours a day.
Study burden and risks
OAB symptoms may increase during the wash out period and the intermittent
stimulation period. During the study patients will not be exposed to risks
other than known for the standard use of the implantable neurostimulator. Four
hospital visits are required for participating patients. Study visits will be
combined with regular outpatient visits if possible.
Wytemaweg 80
Rotterdam 3015 CN
NL
Wytemaweg 80
Rotterdam 3015 CN
NL
Listed location countries
Age
Inclusion criteria
- written informed consent
- sufficient knowledge of the Dutch language to understand the informed consent form and to complete the questionnaires
- female at least 18 years of age
- subjective successful treatment for at least 6 months through sacral neuromodulation using InterStim for OAB
- at least three months of anticholinergic treatment without result or had to stop anticholinergic treatment because of adverse side effects before implantation of the neuromodulator
- currently not using anticholinergic or other medical treatment for idiopathic OAB
- last intravesical Botox treatment at least 12 months ago
Exclusion criteria
- neuropathic bladder
- symptomatic urinary tract infection
- indwelling catheter or clean intermittent catheterization
- implantable neurostimulator of which the estimated service life of the battery is less than 1 year at the moment of inclusion in the study
- radiation therapy of the pelvis
- (previous) bladder cancer
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 | NL45630.078.13 |