Overactive Bladder Syndrome (OAB) / Overactive Bladder
Conditions
Interventions
Patients in the group OAB with SNM will receive treatment for OAB with sacral neuromodulation as part of their regular care. Patients in the group OAB without SNM and healthy volunteers will not recei
Sponsors
Maastricht Universitair Medisch Centrum +
Eligibility
Age
18 Years to 99 Years
Inclusion 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 with SNM) 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 groups with and without SNM) 5. The subjects must have (for patient groups with and without SNM): 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 groups with and without SNM)
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| We measure BOLD signal intensity changes in a priori supraspinal regions of interest (ROI), for example, periaqueductal grey, pons, insula, anterior cingulate cortex, thalamus, hypothalamus, supplementary motor area and prefrontal cortex, during fMRI in relation to the specific conditions, that is, low versus full bladder volume. The subjects register their bladder sensation during the fMRI scan. This is performed during tthree visits, once at baseline, once during testing phase of sacral neuromodulation (short-term) and once 3 months after implantation of a sacral neurostimulator (long-term). This will hopefully provide us with a better understanding of the working mechanism of sacral neuromodulation, which could lead to better assessment of patients that might be eligible for treatment with sacral neuromodulation. | — |
Secondary
| Measure | Time frame |
|---|---|
| - The fMRI is made at two timepoints during the treatment: 2-5 days after implanting the neurostimulator, and 3 months later, comparing the difference between short-term and long-term activation patterns of the brain during sacral neuromodulation, and comparing results with healthy participants without OAB. - A comparison will be made between responders and non-responders, looking at possible structural differences in brain activation during the pre-implantation phase, and comparing results with healthy participants without OAB. This could contribute to the assessment of patients that have an indication for treatment with sacral neuromodulation. - The extent of bladder filling and bladder sensations will be compared before and after implantation of the neurostimulator, correlating it to changes in brain activation, and comparing results with healthy participants without OAB. | — |
Countries
Netherlands
Contacts
Public ContactM.M. Rijk
Universiteit Maastricht
Outcome results
None listed