The influence of sacral neuromodulation on brain areas involved in the sensation of bladder filling in patients with Overactive Bladder (OAB) using fMRI

Conditions: Overactive Bladder Syndrome (OAB) / Overactive Bladder
10046590

Registration Number: NL-OMON56105

Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 95

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.
b. Frequency of micturition greater than or equal to 8 per 24 hours period
during the 3-day micturition diary period
6. At the screening visit, when patient is on medicinal treatment for OAB they
should be willing to undergo a washout period for 3 weeks. (for patient group)

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
screening.
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.
8. Patients with any metal implants in the body (except dental implants) that
would prevent the patients to undergo fMRI scan, excluding MRI safe nerve
stimulators.

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>We measure BOLD signal intensity changes in a priori supraspinal regions of<br /><br>interest (ROI), for example, periaqueductal grey, pons, insula, anterior<br /><br>cingulate cortex, thalamus, hypothalamus, supplementary motor area and<br /><br>prefrontal cortex, during fMRI in relation to the specific conditions, that is,<br /><br>low versus full bladder volume. The subjects register their bladder sensation<br /><br>during the fMRI scan. This is performed during tthree visits, once at baseline,<br /><br>once during testing phase of sacral neuromodulation (short-term) and once 3<br /><br>months after implantation of a sacral neurostimulator (long-term). This will<br /><br>hopefully provide us with a better understanding of the working mechanism of<br /><br>sacral neuromodulation, which could lead to better assessment of patients that<br /><br>might be eligible for treatment with sacral neuromodulation.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- The fMRI is made at two timepoints during the treatment: 2-5 days after<br /><br>implanting the neurostimulator, and 3 months later, comparing the difference<br /><br>between short-term and long-term activation patterns of the brain during sacral<br /><br>neuromodulation, and comparing results with healthy participants without OAB.<br /><br>- A comparison will be made between responders and non-responders, looking at<br /><br>possible structural differences in brain activation during the pre-implantation<br /><br>phase, and comparing results with healthy participants without OAB. This could<br /><br>contribute to the assessment of patients that have an indication for treatment<br /><br>with sacral neuromodulation.<br /><br>- The extent of bladder filling and bladder sensations will be compared before<br /><br>and after implantation of the neurostimulator, correlating it to changes in<br /><br>brain activation, and comparing results with healthy participants without OAB.</p><br>