Integrale Overactieve Blaas Clinical Trial in de klinische praktijk III.

Conditions: overactive bladderclinical practiceclinical trialintegratedoveractieve blaasklinische praktijkklinische studieintegraal

Lead Sponsor: Maastricht University Medical Center + , P.O.Box 5800, 6202 az, Maastricht, the Netherlands,

Recruitment & Eligibility

Inclusion Criteria

1. Written informed consent has been obtained;

2. Written documentation has been obtained in accordance with local privacy requirements, where applicable;

Exclusion Criteria

OAB patients not eligible for SNS and botulinum toxin type A:

1. Residual urine after micturition > 100 cc determined using sonography or catheterisation;

Primary Outcome Measures

Name	Time	Method
1. The proportion of patients who have a treatment response of improvement of at least 2 categories on the PPBC (Coyne 2006). As stated before, the power calculation to define the sample size for this study is based on the PPBC;<br /><br>2. The mean change from baseline to endpoint in Incontinence Episodes Frequency (IEF) as recorded in the 3 day micturition chart (frequency volume chart).<br /><br>Related to primary objective 2:<br /><br>Safety measures:<br /><br>1. Adverse events;<br /><br>2. Serious medical events.<br><br /><br /><br>To evaluate the safety of the procedure through prospective observation of serious adverse events<br>and serious adverse device effects.<br><br /><br /><br>Endpoint: The analysis of the incidence of serious adverse device effects through the course of the<br>study. Safety data (vital signs, occurrence and duration of adverse events (AEs), and drop-out/discontinuation during study due to AEs). Measurement of post void residual (PVR) urine volume.

Secondary Outcome Measures

Name	Time	Method
1. Intensity of urgency scale ( Patient Perception of Intensity of Urgency Sensation (PPIUS)) (Cartwright 2010);<br /><br>2. Mean absolute change in number of voids/24 hrs (3-days micturition diary);<br /><br>3. Volume involuntary loss of urine (from 3-days micturition diary);<br /><br>4. Urinary Incontinence-Specific Quality-of-Life Instrument Dutch (I-QOL) Total score change from baseline, subscale change from baseline;<br /><br>5. PRAFAB (Impact and severity of urinary incontinence) Total score change from baseline;<br /><br>6. Patient's satisfaction;<br /><br>7. Percentage patients with a positive response on Behandeling Baat Schaal . (score is 1 or 2, i.e., fors verbeterdor verbeterd.