Supraspinal Control of Lower Urinary Tract Function in Healthy Control
The Bladder and the Brain - Investigation of the Supraspinal Neural Control of Lower Urinary Tract Function in Healthy Subjects and Patients With Neurogenic and Non-neurogenic Bladder Dysfunction Using Advanced Neuroimaging Techniques
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- fMRI
- bladder filling
- bladder cooling
- additional post-treatment fMRI scan
What it measured
Main measures
Bold signal
baseline and 4 weeks
Thinking and memoryNerve conduction testsBladder, bowel and sexual functionStructural and functional connectivity
baseline and after potential OAB treatment
Thinking and memoryNerve conduction testsBladder, bowel and sexual function
Other measures (1)
Side effects
3 years
Bladder, bowel and sexual functionPainSafety
Who could take part
MS (type not specified) · 18 to 55
Show the full criteria
Inclusion criteria
Healthy controls * Right handed * MR suitability * Written informed consent * unimpaired LUT function MS patients with OAB * Right handed * MR suitability * Written informed consent * diagnosis of MS according to the McDonald criteria * Expanded Disability Status Scale (EDSS) ≤ 6 * OAB symptoms since > 6 months * ≥ 3 episodes of urinary urgency * frequency > 8/24h * with or without detrusor overactivity MS patients without OAB * Right handed * MR suitability * Written informed consent * diagnosis of MS according to the McDonald criteria * Expanded Disability Status Scale (EDSS) ≤ 6 Patients with NNOAB * Right handed * MR suitability * Written informed consent * idiopathic OAB symptoms since > 6 months * ≥ 3 episodes of urinary urgency * frequency > 8/24h * refractory to antimuscarinic treatment for ≥ 1 month * indication for intradetrusor injections of Botulinumtoxin Type A * willingness and ability to perform self-catheterization SCI patients with neurogenic detrusor overactivity * Right handed * MR suitability * Written informed consent * neurogenic detrusor overactivity due to SCI * indication for intradetrusor injections of botulinum toxin type A
Exclusion criteria
Healthy controls * impaired LUT function * pregnancy or breast feeding * no informed consent * any craniocerebral injury or surgery * any permanent ferromagnetic implant * any previous surgery of the LUT or genitalia * any anatomical anomaly of the LUT or genitalia * any LUT malignancy * postvoid residual urine volume (PVR) > 150ml * current urinary tract infection * any LUT symptoms * ≥ 3 episodes of urinary urgency * frequency > 8/24h MS patients with OAB * pregnancy or breast feeding * any permanent ferromagnetic implant * any neurological or psychological disease despite MS * any craniocerebral injury or surgery * any previous surgery of the LUT or genitalia * any anatomical anomaly or malignancy of the LUT or genitalia * any metabolic disease * PVR > 150ml * any concomitant treatment for the LUT (e.g. neuromodulation) * Stress urinary incontinence * any condition other than MS that might explain OAB symptoms * current urinary tract infection * indwelling catheters or the necessity to perform self-catheterization MS patients without OAB * pregnancy or breast feeding * any permanent ferromagnetic implant * any neurological or psychological disease despite MS * any craniocerebral injury or surgery * any previous surgery of the LUT or genitalia * any anatomical anomaly or malignancy of the LUT or genitalia * any metabolic disease * PVR > 150ml * any concomitant treatment for the LUT (e.g. neuromodulation) * Stress urinary incontinence * any LUT symptoms * ≥ 3 episodes of urinary urgency * frequency > 8/24h * indwelling catheters or the necessity to perform self-catheterization * detrusor overactivity * current urinary tract infection Patients with NNOAB * pregnancy or planned within next 8 months, breast feeding * any permanent ferromagnetic implant * any neurological, psychological, metabolic or cardiovascular disease * any craniocerebral injury or surgery * any previous surgery of the LUT or genitalia within the last year or that is related to the OAB symptoms * any anatomical anomaly or malignancy of the LUT or genitalia * PVR > 150ml * Stress urinary incontinence * indwelling catheters or the necessity to perform self-catheterization * any concomitant treatment for the LUT (e.g. neuromodulation) * current urinary tract infection SCI patients with neurogenic detrusor overactivity * pregnancy or breast feeding * any permanent ferromagnetic implant * any neurological or psychological disease despite SCI * any craniocerebral injury or surgery * any previous surgery of LUT of genitalia * any anatomical anomaly or malignancy of the LUT or genitalia * any metabolic disease * any concomitant treatment for the LUT (e.g. neuromodulation) * current urinary tract infection
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The purpose of this study is to provide profound insight into the supraspinal neuronal mechanisms and networks responsible for lower urinary tract (LUT) control and to verify, amend or adjust neuronal circuitry models established from findings in healthy subjects in the context of neurogenic and non-neurogenic LUT dysfunction.
Papers
Results
Protocol for a prospective magnetic resonance imaging study on supraspinal lower urinary tract control in healthy subjects and spinal cord injury patients undergoing intradetrusor onabotulinumtoxinA injections for treating neurogenic detrusor overactivity.BMC Urol · 2014
Results
Walter M, Michels L, Kollias S, van Kerrebroeck PE, Kessler TM, Mehnert U. Protocol for a prospective neuroimaging study investigating the supraspinal control of lower urinary tract function in healthy controls and patients with non-neurogenic lower urinary tract symptoms. BMJ Open. 2014 May 21;4(5):e004357. doi: 10.1136/bmjopen-2013-004357.Results
Leitner L, Walter M, Jarrahi B, Wanek J, Diefenbacher J, Michels L, Liechti MD, Kollias SS, Kessler TM, Mehnert U. A novel infusion-drainage device to assess lower urinary tract function in neuro-imaging. BJU Int. 2017 Feb;119(2):305-316. doi: 10.1111/bju.13655. Epub 2016 Oct 20.Results
Walter M, Leitner L, Michels L, Liechti MD, Freund P, Kessler TM, Kollias S, Mehnert U. Reliability of supraspinal correlates to lower urinary tract stimulation in healthy participants - A fMRI study. Neuroimage. 2019 May 1;191:481-492. doi: 10.1016/j.neuroimage.2019.02.031. Epub 2019 Feb 15.
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History
Started
Dec 2011
Main results due
Jul 2015
Finished
Dec 2018