Overactive bladder, sacral neuromodulation
Conditions
Interventions
In all patients the implantable neurostimulator will be automatically turned off for 18 hours a day.
Sponsors
Erasmus Medical Center Rotterdam, Department Urology.
Eligibility
Inclusion criteria
Inclusion criteria: Patients 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 criteria
Exclusion criteria: Patients 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
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Derived 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. | — |
Primary
| Measure | Time frame |
|---|---|
| Incontinence episodes per day compared to baseline, derived from voiding diaries. | — |
Contacts
Public ContactL.A. Hoen, 't
Outcome results
None listed