overactive bladder urinary incontinence
Conditions
Interventions
In all patients the implantable neurostimulator will be automatically turnes
off for 18 hours a day.
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint will be incontinence episodes per day compared to baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| - 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. | — |
Countries
Netherlands
Outcome results
None listed