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

November 12, 2024 updated by: University of Zurich

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

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zürich, Switzerland
        • Balgrist University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change in urine output (ml/s)
Time Frame: 10 minutes
10 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Systolic and diastolic blood pressure
Time Frame: Immediately before, during and immediately after the intervention
Blood pressure is measured using Finometer® device (Finapres Medical Systems, the Netherlands). Unit: mmHg.
Immediately before, during and immediately after the intervention
Heart rate
Time Frame: Immediately before, during and immediately after the intervention
Finometer® device (Finapres Medical Systems, the Netherlands). Unit: beats per minute.
Immediately before, during and immediately after the intervention
Sympathetic skin response
Time Frame: Immediately before, during and immediately after the intervention
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
Time Frame: Immediately before, during and immediately after the intervention
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)
Time Frame: Once at screening visit
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)
Time Frame: Once at screening visit
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)
Time Frame: Once at screening visit
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
Time Frame: Once at screening visit
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
Time Frame: Once at screening visit
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
Time Frame: Once at screening visit
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
Time Frame: Once at screening visit
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
Time Frame: Once at screening visit
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
Time Frame: Once at screening visit
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
Time Frame: Once at screening visit
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)
Time Frame: Through study completion until two weeks after last measurement
Assessed by a 3-day bladder diary
Through study completion until two weeks after last measurement
Mean oral fluid intake in mL
Time Frame: Once at screening visit
Assessed by a 3-day bladder diary
Once at screening visit
Number of voids per 24 hours
Time Frame: Once at screening visit
Assessed by a 3-day bladder diary
Once at screening visit
Number of daytime voids
Time Frame: Once at screening visit
Assessed by a 3-day bladder diary
Once at screening visit
Number of nighttime voids
Time Frame: Once at screening visit
Assessed by a 3-day bladder diary
Once at screening visit
Number of intermittent catheterizations per 24h
Time Frame: Once at screening visit
Assessed by a 3-day bladder diary
Once at screening visit
Number of daytime, intermittent catheterizations per 24h
Time Frame: Once at screening visit
Assessed by a 3-day bladder diary
Once at screening visit
Number of nighttime, intermittent catheterizations per 24h
Time Frame: Once at screening visit
Assessed by a 3-day bladder diary
Once at screening visit
Mean voided volume in mL
Time Frame: Once at screening visit
Assessed by a 3-day bladder diary
Once at screening visit
Mean catheterized post void residual volume in mL
Time Frame: Once at screening visit
Assessed by a 3-day bladder diary
Once at screening visit
Pain level score (0 none - 10 worst possible)
Time Frame: Once at screening visit
Assessed by a 3-day bladder diary
Once at screening visit
Level of urgency (0 none - 4 severe with incontinence)
Time Frame: Once at screening visit
Assessed by a 3-day bladder diary
Once at screening visit
Number of leakages per 24 hours
Time Frame: Once at screening visit
Assessed by a 3-day bladder diary
Once at screening visit
Urine leakage (none-heavy)
Time Frame: Once at screening visit
Assessed by a 3-day bladder diary
Once at screening visit
Number of used pads per 24 hours
Time Frame: Once at screening visit
Assessed by a 3-day bladder diary
Once at screening visit
Wetness of pads (dry-soaked)
Time Frame: Once at screening visit
Assessed by a 3-day bladder diary
Once at screening visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Zurich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2017

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 19, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 22, 2017

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 14, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 12, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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