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

The Effect of Lower Urinary Tract Electrical Stimulation on Renal Urine Production (diuresis) - a Monocentric Basic Study

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.

Study Overview

• Status: Withdrawn
• Conditions: Diuresis Under Eletrical Stimulation
• Intervention / Treatment: Other: electrical stimulation (non painful) of the lower urinary tract to determine the current perception threshold and record sensory evoked potentials

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zürich, Switzerland
    • Balgrist University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of Zurich

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (Estimated): October 31, 2023
• Study Completion (Estimated): October 31, 2023

Study Registration Dates

• First Submitted: January 19, 2017
• First Submitted That Met QC Criteria: August 17, 2017
• First Posted (Actual): August 22, 2017

Study Record Updates

• Last Update Posted (Estimated): November 14, 2024
• Last Update Submitted That Met QC Criteria: November 12, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2016-01695

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• product manufactured in and exported from the U.S.: No