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Onderzoek naar de optimale duur van de testperiode van behandeling met sacrale neuromodulatie.


- candidate number15686
- NTR NumberNTR4259
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR12-nov-2013
- Secondary IDsABR Nummer 44879 Dossiernummer NL44879.068.13
- Public TitleOnderzoek naar de optimale duur van de testperiode van behandeling met sacrale neuromodulatie.
- Scientific TitleTime of onset and time of offset of sacral neuromodulation effect
- ACRONYM“Wash in – wash out”
- hypothesisThe 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 at least a few hours for symptoms to return to the baseline situation.
- Healt Condition(s) or Problem(s) studiedOveractive bladder, Non obstructive urinary retention,
- Inclusion criteriaIn 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 criteriaA 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.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeintervention
- planned startdate 1-dec-2013
- planned closingdate31-dec-2014
- Target number of participants40
- InterventionsAfter 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 diary for in total 28 (non-consecutive) days.
- Primary outcomeThe transition point between no effect and time of onset is determined by assessing when certain complaints parameters are reduced by 50% compared to baseline per 24 hours. Vice versa (50% increase) for offset of effect. Onset and offset of effect will be assessed in days.
- Secondary outcomeNot applicable.
- TimepointsDuring the course of 5 to 6 months there are four measuring moments.
- Trial web siteNot applicable.
- statusplanned
- CONTACT FOR PUBLIC QUERIESdrs. J. Drossaerts
- CONTACT for SCIENTIFIC QUERIESdrs. J. Drossaerts
- Sponsor/Initiator Maastricht University Medical Center (MUMC+)
- Funding
(Source(s) of Monetary or Material Support)
Stichting wamU (wetenschappelijke activiteiten maastrichtse urologie)
- PublicationsN/A
- Brief summarySacral 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. 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.
- Main changes (audit trail)
- RECORD12-nov-2013 - 2-dec-2013


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