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Intermitterende sacrale neuromodulatie bij idiopathische overactieve blaas.


- candidate number19410
- NTR NumberNTR4773
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR8-sep-2014
- Secondary IDsMEC-2013-351 NL45630.078.13
- Public TitleIntermitterende sacrale neuromodulatie bij idiopathische overactieve blaas.
- Scientific TitleIntermittent sacral neuromodulation for treatment of idiopathic overactive bladder in women.
- ACRONYMIntermittent sacral neuromodulation
- hypothesisTo elongate the service life of the implantable neurostimulator while achieving a minimal improvement of 50% of the symptoms of overactive bladder compared to baseline.
- Healt Condition(s) or Problem(s) studiedOveractive bladder
- Inclusion criteriaPatients who:
have given written informed consent
have sufficient knowledge of the Dutch language to understand the informed consent form and to complete the questionnaires
are female and are at least 18 years of age
have had subjective successful treatment for at least 6 months through sacral neuromodulation using InterStim for OAB
have had at least three months of anticholinergic treatment without result or who had to stop anticholinergic treatment because of adverse side effects before implantation of the neuromodulator
currently do not use anticholinergic or other medical treatment for idiopathic OAB
have had their last intravesical Botox treatment at least 12 months ago
- Exclusion criteriaPatients who:
have a neuropathic bladder
have a symptomatic urinary tract infection
have an indwelling catheter or who apply clean intermittent catheterization
have an implantable neurostimulator of which the estimated service life of the battery is less than 1 year at the moment of inclusion in the study
have had radiation therapy of the pelvis
have had bladder cancer
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-jun-2014
- planned closingdate1-jun-2015
- Target number of participants16
- InterventionsIn all patients the implantable neurostimulator will be automatically turned off for 18 hours a day.
- Primary outcomeIncontinence episodes per day compared to baseline, derived from voiding diaries.
- Secondary outcomeDerived from voiding diaries
- Urinary frequency per 24 hours
- Number of pads used
- Average volume per voiding.
Change from baseline to intermittent stimulation
Difference between intermittent and continuous stimulation.

Standard scores from 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.
- TimepointsWeeks 1,2,3,4,5,8,12,16.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs L.A. Hoen, 't
- CONTACT for SCIENTIFIC QUERIESDrs L.A. Hoen, 't
- Sponsor/Initiator Erasmus Medical Center, Department of Urology
- Funding
(Source(s) of Monetary or Material Support)
Stichting Theia, Noordwijk, SUWO Stichting Urologisch Wetenschappelijk Onderzoek
- Publications
- Brief summaryOveractive bladder (OAB) is a condition that is difficult to treat. Due to the increasing age in the population, it is also a condition that increases in incidence and prevalence in coming years. 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.
Patients will have to visit the hospital four times. This will be combined with a regular outpatient appointment if possible. An increase in symptoms of overactive bladder may occur during the study period. The service life of the battery of the neurostimulator may be elongated which will result in a reduction of the total amount of battery substitutions for this group of patients, given that intermittent neurostimulation has a minimal improvement of 50% of the symptoms of OAB compared to baseline.
- Main changes (audit trail)
- RECORD8-sep-2014 - 27-sep-2014


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