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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 4
- 主要终点
- Bold signal
研究概览
简要总结
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.
详细描述
The subject recruitment will be performed within the Neuro-Urology outpatient clinic at the Balgrist University Hospital and in collaboration with the Departments of Neurology, Urology and Gynecology at the University Hospital Zürich.
The following subject groups will be recruited: 1) healthy controls (n=22), Non-neurogenic overactive bladder (NNOAB) patients (n=20), multiple sclerosis (MS) patients with OAB (n=15), MS patients without OAB (n=15), spinal cord injury (SCI) patients with neurogenic detrusor overactivity (n=24).
After inclusion, all subjects and patients will undergo one to two functional magnetic resonance imaging (fMRI) sessions. NNOAB patients might undergo an additional fMRI session after receiving overactive bladder (OAB) treatment (such as antimuscarinics, intradetrusor injections of botulinum toxin type A). Spinal cord injury (SCI) patients with neurogenic detrusor overactivity will undergo an additional fMRI session 5-7 weeks after intradetrusor injections of botulinum toxin type A.
High-resolution anatomical images and functional blood-oxygen-level-dependent (BOLD)-signal sensitive images will be acquired. In addition to the fMRI, diffusion tensor imaging (DTI) sequences will be recorded after the anatomical scans to provide information about the structural supraspinal connectivity.
Study endpoints are changes of the BOLD signal in regard to location and intensity, structural and functional connectivity (FC) between previously described supraspinal centers involved in LUT control, and statistical differences of changes in BOLD signals, structural and functional connectivity between patients and healthy controls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
- 另有 17 项未显示
研究组 & 干预措施
Healthy controls
Procedure: 1-2 fMRI measurements within 4 weeks from first exam. Measurements include repetitive retrograde bladder filling via transurethral catheter at different bladder volumes and temperatures (e.g. bladder cooling, body warm or room temperature)of the filling liquid.
干预措施: fMRI (Other)
NNOAB
Procedure: 1-2 measurements within 4 weeks from first exam. Measurements include repetitive bladder filling via transurethral catheter at different bladder volumes and temperatures of the filling liquid plus additional post-treatment fMRI scan 5 to 7 weeks after OAB treatment (such as antimuscarinics, intradetrusor injections of botulinum toxin type A)
干预措施: fMRI (Other)
Healthy controls
Procedure: 1-2 fMRI measurements within 4 weeks from first exam. Measurements include repetitive retrograde bladder filling via transurethral catheter at different bladder volumes and temperatures (e.g. bladder cooling, body warm or room temperature)of the filling liquid.
干预措施: bladder filling (Other)
Healthy controls
Procedure: 1-2 fMRI measurements within 4 weeks from first exam. Measurements include repetitive retrograde bladder filling via transurethral catheter at different bladder volumes and temperatures (e.g. bladder cooling, body warm or room temperature)of the filling liquid.
干预措施: bladder cooling (Other)
MS with OAB
Procedure: 1-2 fMRI measurements within 4 weeks from first exam. Measurements include repetitive retrograde bladder filling via transurethral catheter at different bladder volumes and temperatures of the filling liquid.
干预措施: fMRI (Other)
MS with OAB
Procedure: 1-2 fMRI measurements within 4 weeks from first exam. Measurements include repetitive retrograde bladder filling via transurethral catheter at different bladder volumes and temperatures of the filling liquid.
干预措施: bladder filling (Other)
MS with OAB
Procedure: 1-2 fMRI measurements within 4 weeks from first exam. Measurements include repetitive retrograde bladder filling via transurethral catheter at different bladder volumes and temperatures of the filling liquid.
干预措施: bladder cooling (Other)
MS without OAB
Procedure: 1-2 measurements within 4 weeks from first exam. Measurements include repetitive bladder filling via transurethral catheter at different bladder volumes and temperatures of the filling liquid.
干预措施: fMRI (Other)
MS without OAB
Procedure: 1-2 measurements within 4 weeks from first exam. Measurements include repetitive bladder filling via transurethral catheter at different bladder volumes and temperatures of the filling liquid.
干预措施: bladder filling (Other)
MS without OAB
Procedure: 1-2 measurements within 4 weeks from first exam. Measurements include repetitive bladder filling via transurethral catheter at different bladder volumes and temperatures of the filling liquid.
干预措施: bladder cooling (Other)
NNOAB
Procedure: 1-2 measurements within 4 weeks from first exam. Measurements include repetitive bladder filling via transurethral catheter at different bladder volumes and temperatures of the filling liquid plus additional post-treatment fMRI scan 5 to 7 weeks after OAB treatment (such as antimuscarinics, intradetrusor injections of botulinum toxin type A)
干预措施: bladder filling (Other)
NNOAB
Procedure: 1-2 measurements within 4 weeks from first exam. Measurements include repetitive bladder filling via transurethral catheter at different bladder volumes and temperatures of the filling liquid plus additional post-treatment fMRI scan 5 to 7 weeks after OAB treatment (such as antimuscarinics, intradetrusor injections of botulinum toxin type A)
干预措施: bladder cooling (Other)
NNOAB
Procedure: 1-2 measurements within 4 weeks from first exam. Measurements include repetitive bladder filling via transurethral catheter at different bladder volumes and temperatures of the filling liquid plus additional post-treatment fMRI scan 5 to 7 weeks after OAB treatment (such as antimuscarinics, intradetrusor injections of botulinum toxin type A)
干预措施: additional post-treatment fMRI scan (Other)
SCI with neurogenic detrusor overactivity
Procedure: 1-2 measurements within 4 weeks from first exam. Measurements include repetitive bladder filling via transurethral catheter at different bladder volumes and temperatures of the filling liquid plus 1 additional post-treatment fMRI scan 5 to 7 weeks after intradetrusor injections of botulinum toxin type A
干预措施: fMRI (Other)
SCI with neurogenic detrusor overactivity
Procedure: 1-2 measurements within 4 weeks from first exam. Measurements include repetitive bladder filling via transurethral catheter at different bladder volumes and temperatures of the filling liquid plus 1 additional post-treatment fMRI scan 5 to 7 weeks after intradetrusor injections of botulinum toxin type A
干预措施: bladder filling (Other)
SCI with neurogenic detrusor overactivity
Procedure: 1-2 measurements within 4 weeks from first exam. Measurements include repetitive bladder filling via transurethral catheter at different bladder volumes and temperatures of the filling liquid plus 1 additional post-treatment fMRI scan 5 to 7 weeks after intradetrusor injections of botulinum toxin type A
干预措施: bladder cooling (Other)
SCI with neurogenic detrusor overactivity
Procedure: 1-2 measurements within 4 weeks from first exam. Measurements include repetitive bladder filling via transurethral catheter at different bladder volumes and temperatures of the filling liquid plus 1 additional post-treatment fMRI scan 5 to 7 weeks after intradetrusor injections of botulinum toxin type A
干预措施: additional post-treatment fMRI scan (Other)
结局指标
主要结局
Bold signal
时间窗: baseline and 4 weeks
During fMRI measurements the changes of BOLD signal intensity in respect to certain supraspinal areas (e.g. pons, insula, anterior cingulate cortex, thalamus, supplementary motor area, prefrontal cortex) will be evaluated. Variables are age, bladder volume, urgency and attention.
Structural and functional connectivity
时间窗: baseline and after potential OAB treatment
Acquired data from the above mentioned measurements will be used to analyze structural and functional connectivity between supraspinal areas involved in the LUT control, especially between prefrontal, thalamus, insula, and anterior cingulate cortex. Variables are age, bladder volume, urgency and attention. Correlations of neuronal activity from the fMRI-data will be estimated using SPM8, brain connectivity tool box.
次要结局
- Side effects(3 years)