NL-OMON56105
Not yet recruiting
Not Applicable
The influence of sacral neuromodulation on brain areas involved in the sensation of bladder filling in patients with Overactive Bladder (OAB) using fMRI - fMRI study of the influence of sacral neuromodulation on brain activity
Medisch Universitair Ziekenhuis Maastricht0 sites95 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Medisch Universitair Ziekenhuis Maastricht
- Enrollment
- 95
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •In order to be eligible to participate in this study, a subject must meet all
- •of the following criteria:
- •1\. Female subjects above 18 years of age.
- •2\. Has provided written informed consent prior to any study related procedures.
- •3\. Indication for treatment with sacral neuromodulation (for patient group)
- •4\. History of signs and symptoms of OAB including urinary frequency, urgency or
- •urge incontinence for greater than or equal to 3 months. (for patient group)
- •5\. The subjects must have (for patient group):
- •a. At least 1 episode of urgency with or without incontinence in the last 3\-day
- •micturition diary.
Exclusion Criteria
- •1\. Stress urinary incontinence more profound than urge urinary incontinence,
- •urethral sphincter incompetence and neurogenic detrusor overactivity.
- •2\. Current urinary tract infection (confirmed by positive urine analysis).
- •3\. Bladder outlet obstruction (not including detrusor\-overactivity), for
- •example bladder/vesico\-uterine prolapse (\> grade II) or chronic obstruction.
- •4\. History of urinary tract surgery less than or equal to 6 months prior to
- •5\. Intermittent catheterization or permanent catheter.
- •6\. History of pelvic area radiotherapy treatment.
- •7\. Has a history of treatment of OAB with botulinum toxin within less than 12
- •months prior to screening.
Outcomes
Primary Outcomes
Not specified
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