Intermittent sacral neuromodulation for treatment of idiopathic overactive bladder in wome

Completed

Conditions: overactive bladder
urinary incontinence
10004994

Registration Number: NL-OMON40167

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 16

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

- 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint will be incontinence episodes per day compared to<br /><br>baseline.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Urinary frequency per 24 hours<br /><br>- Number of pads used<br /><br>- Average volume per voiding<br /><br>This will be derived from the voiding diaries. The change from baseline to<br /><br>intermittent stimulation will be determined. The difference between<br /><br>intermittent and continuous stimulation will also be determined, for<br /><br>incontinence episodes per day as well.<br /><br><br /><br>Standard scores derived from the questionnaires (IIQ-7, UDI-6, PFDI-20, PFIQ-7,<br /><br>PISQ, EuroQOL-5, FICI, FIQL):<br /><br>- Change from baseline to intermittent stimulation.<br /><br>- Difference between intermittent and continuous stimulation.</p><br>