Clinical trial NCT03256656: The Effect of Lower Urinary Tract Electrical Stimulation on Renal Urine Production (diuresis)
Official title: The Effect of Lower Urinary Tract Electrical Stimulation on Renal Urine Production (diuresis) - a Monocentric Basic Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Diuresis Under Eletrical Stimulation
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2017-08-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in urine output (ml/s)
timeFrame: 10 minutes
Secondary outcomes:
measure: Systolic and diastolic blood pressure
timeFrame: Immediately before, during and immediately after the intervention
measure: Heart rate
timeFrame: Immediately before, during and immediately after the intervention
measure: Sympathetic skin response
timeFrame: Immediately before, during and immediately after the intervention
measure: Renal restistance index
timeFrame: Immediately before, during and immediately after the intervention
measure: International Consultation on Incontinence Questionnaire-Female Lower Urinary Tract Symptoms (ICIQ-FLUTS)
timeFrame: Once at screening visit
measure: International Consultation on Incontinence Questionnaire-Male Lower Urinary Tract Symptoms (ICIQ-MLUTS)
timeFrame: Once at screening visit
measure: International Prostate Symptom Score (IPSS)
timeFrame: Once at screening visit
measure: International Index of Erectile Function (IIEF) questionnaire
timeFrame: Once at screening visit
measure: Female Sexual Functioning Index (FSFI) questionnaire
timeFrame: Once at screening visit
measure: Qualiveen questionnaire
timeFrame: Once at screening visit
measure: Lower Urinary Tract Symptoms Quality of Life (LUTS-qol) questionnaire
timeFrame: Once at screening visit
measure: Swiss German Overactive Bladder (OAB) questionnaire
timeFrame: Once at screening visit
measure: Hospital Anxiety and Depression Scale (HADS) questionnaire
timeFrame: Once at screening visit
measure: MoCA test
timeFrame: Once at screening visit
measure: 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)
timeFrame: Through study completion until two weeks after last measurement
measure: Mean oral fluid intake in mL
timeFrame: Once at screening visit
measure: Number of voids per 24 hours
timeFrame: Once at screening visit
measure: Number of daytime voids
timeFrame: Once at screening visit
measure: Number of nighttime voids
timeFrame: Once at screening visit
measure: Number of intermittent catheterizations per 24h
timeFrame: Once at screening visit
measure: Number of daytime, intermittent catheterizations per 24h
timeFrame: Once at screening visit
measure: Number of nighttime, intermittent catheterizations per 24h
timeFrame: Once at screening visit
measure: Mean voided volume in mL
timeFrame: Once at screening visit
measure: Mean catheterized post void residual volume in mL
timeFrame: Once at screening visit
measure: Pain level score (0 none - 10 worst possible)
timeFrame: Once at screening visit
measure: Level of urgency (0 none - 4 severe with incontinence)
timeFrame: Once at screening visit
measure: Number of leakages per 24 hours
timeFrame: Once at screening visit
measure: Urine leakage (none-heavy)
timeFrame: Once at screening visit
measure: Number of used pads per 24 hours
timeFrame: Once at screening visit
measure: Wetness of pads (dry-soaked)
timeFrame: Once at screening visit
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Balgrist University Hospital
Study officials:
References: