NCT03256656撤回不适用
The Effect of Lower Urinary Tract Electrical Stimulation on Renal Urine Production (diuresis) - a Monocentric Basic Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in urine output (ml/s)
研究概览
简要总结
In previous studies, in which the perception threshold and / or sensory evoked potentials at different points of the lower urinary tract were examined and measured by means of electrical stimulation, a clear increase in the volume of the bladder and thus the urine excretion under the stimulation could be observed. This observation is now to be investigated more closely in a separate study, in order to strengthen the observation with further measured data and to find possible physiological connections. A detectable influence of electrical stimulation in the lower urinary tract on renal urine production would have a significant relevance both therapeutically and for the neurophysiological understanding of interactions between the lower and upper urinary tracts.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers:
- •Written informed consent
- •Good mental and physical health
- •Age >18 years
- •Patients with SCI:
- •Written informed consent
- •Good mental condition
- •Age >18 years
- •Complete spinal cord injury (AIS A)
排除标准
- •Healthy volunteers:
- •Any neurological or urological pathology
- •Pregnancy or breast feeding
- •Urinary tract infection (UTI), frequent UTIs
- •Hematuria
- •Any previous pelvic or spine surgery
- •Any craniocerebral surgery
- •Any anatomical anomaly of the LUT or genitalia
- •Any metabolic disease
- •Any renal disease
- •Any urinary tract malignancy
- •Bladder capacity <150mL or strong desire to void (SDV) already at 60mL
- •Patients with SCI:
- •Any urinary tract malignancy
- •Any anatomical anomaly of the LUT or genitalia
- •Pregnancy or breast feeding
- •Urinary tract infection (UTI), frequent UTIs
- •Hematuria
- •Any metabolic disease
- •Any renal disease
结局指标
主要结局
Change in urine output (ml/s)
时间窗: 10 minutes
次要结局
- Number of used pads per 24 hours(Once at screening visit)
- Pain level score (0 none - 10 worst possible)(Once at screening visit)
- Urine leakage (none-heavy)(Once at screening visit)
- Wetness of pads (dry-soaked)(Once at screening visit)
- Swiss German Overactive Bladder (OAB) questionnaire(Once at screening visit)
- Systolic and diastolic blood pressure(Immediately before, during and immediately after the intervention)
- Sympathetic skin response(Immediately before, during and immediately after the intervention)
- Renal restistance index(Immediately before, during and immediately after the intervention)
- International Consultation on Incontinence Questionnaire-Female Lower Urinary Tract Symptoms (ICIQ-FLUTS)(Once at screening visit)
- International Prostate Symptom Score (IPSS)(Once at screening visit)
- MoCA test(Once at screening visit)
- Safety outcomes: Incidence of side effects as well as number and intensity/severity (mild/moderate/severe) of adverse events (AE) and serious adverse events (SAE) (Follow-up)(Through study completion until two weeks after last measurement)
- Number of voids per 24 hours(Once at screening visit)
- Level of urgency (0 none - 4 severe with incontinence)(Once at screening visit)
- Heart rate(Immediately before, during and immediately after the intervention)
- International Consultation on Incontinence Questionnaire-Male Lower Urinary Tract Symptoms (ICIQ-MLUTS)(Once at screening visit)
- Female Sexual Functioning Index (FSFI) questionnaire(Once at screening visit)
- Hospital Anxiety and Depression Scale (HADS) questionnaire(Once at screening visit)
- Mean oral fluid intake in mL(Once at screening visit)
- Number of intermittent catheterizations per 24h(Once at screening visit)
- International Index of Erectile Function (IIEF) questionnaire(Once at screening visit)
- Mean voided volume in mL(Once at screening visit)
- Mean catheterized post void residual volume in mL(Once at screening visit)
- Number of leakages per 24 hours(Once at screening visit)
- Qualiveen questionnaire(Once at screening visit)
- Lower Urinary Tract Symptoms Quality of Life (LUTS-qol) questionnaire(Once at screening visit)
- Number of daytime voids(Once at screening visit)
- Number of nighttime voids(Once at screening visit)
- Number of daytime, intermittent catheterizations per 24h(Once at screening visit)
- Number of nighttime, intermittent catheterizations per 24h(Once at screening visit)
研究者
研究点 (1)
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