No registrations found.
ID
Source
Brief title
Health condition
Overactive bladder, sacral neuromodulation
Sponsors and support
SUWO
Intervention
Outcome measures
Primary outcome
Incontinence episodes per day compared to baseline, derived from voiding diaries.
Secondary outcome
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.
Background summary
Overactive 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.
Study objective
To elongate the service life of the implantable neurostimulator while achieving a minimal improvement of 50% of the symptoms of overactive bladder compared to baseline.
Study design
Weeks 1,2,3,4,5,8,12,16.
Intervention
In all patients the implantable neurostimulator will be automatically turned off for 18 hours a day.
L.A. Hoen, 't
Dept. Urology, room Na-17
Erasmus MC
Wytemaweg 80
Rotterdam 3015 CN
The Netherlands
010 - 703 65 59
l.thoen@erasmusmc.nl
L.A. Hoen, 't
Dept. Urology, room Na-17
Erasmus MC
Wytemaweg 80
Rotterdam 3015 CN
The Netherlands
010 - 703 65 59
l.thoen@erasmusmc.nl
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
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
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 |
|---|---|
| NTR-new | NL4622 |
| NTR-old | NTR4773 |
| Other | NL45630.078.13 : MEC-2013-351 |