The Effect of Lower Urinary Tract Electrical Stimulation on Renal Urine Production (Diuresis)

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of Lower Urinary Tract Electrical Stimulation on Renal Urine Production (Diuresis) - A Monocentric Basic Study

Conditions
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Diuresis Under Eletrical Stimulation

Intervention / Treatment
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* Other: electrical stimulation (non painful) of the lower urinary tract to determine the current perception threshold and record sensory evoked potentials


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy subjects<br> | Other: electrical stimulation (non painful) of the lower urinary tract to determine the current perception threshold and record sensory evoked potentials<br> <br> |
| Active Comparator: Patients with SCI<br> | Other: electrical stimulation (non painful) of the lower urinary tract to determine the current perception threshold and record sensory evoked potentials<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in urine output (ml/s) |  | 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic and diastolic blood pressure | Blood pressure is measured using Finometer® device (Finapres Medical Systems, the Netherlands). Unit: mmHg. | Immediately before, during and immediately after the intervention | 
| Heart rate | Finometer® device (Finapres Medical Systems, the Netherlands). Unit: beats per minute. | Immediately before, during and immediately after the intervention | 
| Sympathetic skin response | The sympathetic skin response is measured using Finometer® device (Finapres Medical Systems, the Netherlands). Unit: mVs. | Immediately before, during and immediately after the intervention | 
| Renal restistance index | The resistive index (RI) is measured using Doppler ultrasound | Immediately before, during and immediately after the intervention | 
| International Consultation on Incontinence Questionnaire-Female Lower Urinary Tract Symptoms (ICIQ-FLUTS) | The ICIQ-FLUTS (International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms Module) questionnaire assesses female lower urinary tract symptoms and impact on quality of life. It consists of 12 items covering 3 domains, namely filling symptoms, voiding symptoms and incontinence symptoms. The filling symptoms subscale is the sum of is the sum of item 2 to 5, the voiding symptom subscale is the sum of item 6 to 8 and the incontinence symptoms subscale is the sum of item 9 to 13. The lowest possible score is 0 for all subscales, while the highest possible score is 16 for the filling symptoms subscale, 12 for the voiding symptoms subscale and 20 for the incontinence symptoms subscale. The higher the score, the more symptomatic. | Once at screening visit | 
| International Consultation on Incontinence Questionnaire-Male Lower Urinary Tract Symptoms (ICIQ-MLUTS) | The ICIQ-MLUTS (International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms Module) questionnaire assesses male lower urinary tract symptoms and impact on quality of life. It consists of 13 items covering 2 domains, namely voiding symptoms and incontinence symptoms. The voiding symptoms subscale is the sum of item 2 to 6, while the incontinence symptoms subscale is the sum of item 7-12. The lowest possible score is 0 for both subscales, while the highest possible score is 20 for voiding symptoms subscale and 24 for incontinence symptoms subscale. The higher the score, the more symptomatic | Once at screening visit | 
| International Prostate Symptom Score (IPSS) | The IPSS (International Prostate Symptom Questionnaire) score is based on questions concerning urinary symptoms and quality of life (QoL). It consists of 8 items covering 7 urinary symptoms related dimensions (subscales) and 1 additional item assessing quality of life. Each item is rated on a 6-point scale (0=not at all; 5=almost always). The lowest possible score in the total IPSS score is 0 (asymptomatic); the highest possible score is 35 (symptomatic). The QoL index is rated on a 7-point scale, with 0 indicating delighted and 6 terrible. | Once at screening visit | 
| International Index of Erectile Function (IIEF) questionnaire | The IIEF (International Index of Erectile Function) is based on questions concerning erectile dysfunction. It consists of 15 items covering 5 domains, namely erectile functioning, orgasmic functioning, sexual desire, and intercourse satisfaction along with a fifth component which encompasses the concept of overall sexual satisfaction. While items 1-10 are rated on a 6-point Likert-type scale from 0 to 5, items 11-15 are rated on a 5-point Likert-type scale from 1 to 5. Higher scores are reflecting less dysfunction. Domain scores are computed by summing the sores for individual items in each domain. | Once at screening visit | 
| Female Sexual Functioning Index (FSFI) questionnaire | The FSFI (Female Sexual Function Index) is based on questions concerning female sexual functions. It consists of 19 items covering 6 domains, namely sexual desire, arousal (both subjective and physiologic), lubrication, orgasm, satisfaction, and pain. The lowest possible score in the total FSFI is 2 (asymptomatic); the highest possible score is 36 (symptomatic). | Once at screening visit | 
| Qualiveen questionnaire | Qualiveen-30 assesses the Specific Impact of Urinary Problems (SIUP) on Quality of Life. It consists of 30 items covering 4 domains, namely inconvenience (9 questions), restrictions (8 questions), fears (8 questions), and impact on daily life (5 questions). Each item is rated on a 5-point ordinal scale (0=asymptomatic; 4=symptomatic). The index of the SIUP on Quality of Life is the mean of the four individual scores. The lowest possible overall score in the Qualiveen-30 is 0 (Urinary problems have no specific impact on QoL); the highest possible score is 30 (Urinary problems have a huge specific impact on QoL). | Once at screening visit | 
| Lower Urinary Tract Symptoms Quality of Life (LUTS-qol) questionnaire | The LUTS-qol (International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life Module) questionnaire assesses the impact of lower urinary tract symptoms on quality of life. It consists of 20 items. The lowest possible score is 19, while the highest possible score is 76. Greater values are indicating increasing impact on quality of life. | Once at screening visit | 
| Swiss German Overactive Bladder (OAB) questionnaire | The Swiss German OAB (Swiss German Overactive Bladder) questionnaire assesses to what extent certain bladder symptoms complicated life. It consists of 19 items covering 2 domains, namely symptom bother and health-related quality of life. Each item is rated on an ordinal scale (1-6). The symptom bother score is the sum of item 1 to 6, while the health-related quality of life score is the sum of 13 items. For both domains, the lowest possible score is 0 (no problem), while the highest possible score is 36 for the symptom bother score and 78 for the health-related quality of life score. | Once at screening visit | 
| Hospital Anxiety and Depression Scale (HADS) questionnaire | The HADS assesses anxiety and depression. It consists of 14 items covering 2 domains, namely anxiety (7 items) and depression (7 items). Each item is rated on an ordinal scale (0-3). An index is separately calculated for the anxiety and depression items. The lowest possible score for anxiety and depression is 0, the highest possible score is 21. A score <8 is considered as normal. | Once at screening visit | 
| MoCA test | The MoCA (Montreal Cognitive Assessment) is a screening assessment for detecting cognitive impairment. The lowest possible score is 0, the highest possible score is 31. A score >26 is considered as normal. | 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) | Assessed by a 3-day bladder diary | Through study completion until two weeks after last measurement | 
| Mean oral fluid intake in mL | Assessed by a 3-day bladder diary | Once at screening visit | 
| Number of voids per 24 hours | Assessed by a 3-day bladder diary | Once at screening visit | 
| Number of daytime voids | Assessed by a 3-day bladder diary | Once at screening visit | 
| Number of nighttime voids | Assessed by a 3-day bladder diary | Once at screening visit | 
| Number of intermittent catheterizations per 24h | Assessed by a 3-day bladder diary | Once at screening visit | 
| Number of daytime, intermittent catheterizations per 24h | Assessed by a 3-day bladder diary | Once at screening visit | 
| Number of nighttime, intermittent catheterizations per 24h | Assessed by a 3-day bladder diary | Once at screening visit | 
| Mean voided volume in mL | Assessed by a 3-day bladder diary | Once at screening visit | 
| Mean catheterized post void residual volume in mL | Assessed by a 3-day bladder diary | Once at screening visit | 
| Pain level score (0 none - 10 worst possible) | Assessed by a 3-day bladder diary | Once at screening visit | 
| Level of urgency (0 none - 4 severe with incontinence) | Assessed by a 3-day bladder diary | Once at screening visit | 
| Number of leakages per 24 hours | Assessed by a 3-day bladder diary | Once at screening visit | 
| Urine leakage (none-heavy) | Assessed by a 3-day bladder diary | Once at screening visit | 
| Number of used pads per 24 hours | Assessed by a 3-day bladder diary | Once at screening visit | 
| Wetness of pads (dry-soaked) | Assessed by a 3-day bladder diary | Once at screening visit |