Diuresis Under Eletrical StimulationEFFLUENTNCT03256656
The Effect of Lower Urinary Tract Electrical Stimulation on Renal Urine Production (diuresis)
A study testing electrical stimulation (non painful) of the lower urinary tract to determine the current perception threshold and record sensory evoked potentials in people with Diuresis Under Eletrical Stimulation, run by University of Zurich at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Diuresis Under Eletrical Stimulation
- What is being tested?
- electrical stimulation (non painful) of the lower urinary tract to determine the current perception threshold and record sensory evoked potentials
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2017to 31 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers:
- Written informed consent
- Good mental and physical health
- Age >18 years
- Patients with SCI:
- Written informed consent
Show all 9Show fewer
- Good mental condition
- Age >18 years
- Complete spinal cord injury (AIS A)
Who cannot join
- Healthy volunteers:
- Any neurological or urological pathology
- Pregnancy or breast feeding
- Urinary tract infection (UTI), frequent UTIs
- Hematuria
- Any previous pelvic or spine surgery
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Diuresis Under Eletrical Stimulation
- Being tested
- electrical stimulation (non painful) of the lower urinary tract to determine the current perception threshold and record sensory evoked potentials
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electrical stimulation (non painful) of the lower urinary tract to determine the current perception threshold and record sensory evoked potentialsOther
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects | Experimental | Not described Receives: Other: electrical stimulation (non painful) of the lower urinary tract to determine the current perception threshold and record sensory evoked potentials |
| Patients with SCI | Active comparator | Not described Receives: Other: electrical stimulation (non painful) of the lower urinary tract to determine the current perception threshold and record sensory evoked potentials |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in urine output (ml/s)
Measured: 10 minutes
Secondary outcomes (30)
Systolic and diastolic blood pressure
Blood pressure is measured using Finometer® device (Finapres Medical Systems, the Netherlands). Unit: mmHg.
Measured: Immediately before, during and immediately after the intervention
Heart rate
Finometer® device (Finapres Medical Systems, the Netherlands). Unit: beats per minute.
Measured: 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.
Measured: Immediately before, during and immediately after the intervention
Renal restistance index
The resistive index (RI) is measured using Doppler ultrasound
Measured: 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.
Measured: 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
Measured: 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."
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Through study completion until two weeks after last measurement
Mean oral fluid intake in mL
Assessed by a 3-day bladder diary
Measured: Once at screening visit
Number of voids per 24 hours
Assessed by a 3-day bladder diary
Measured: Once at screening visit
Number of daytime voids
Assessed by a 3-day bladder diary
Measured: Once at screening visit
Number of nighttime voids
Assessed by a 3-day bladder diary
Measured: Once at screening visit
Number of intermittent catheterizations per 24h
Assessed by a 3-day bladder diary
Measured: Once at screening visit
Number of daytime, intermittent catheterizations per 24h
Assessed by a 3-day bladder diary
Measured: Once at screening visit
Number of nighttime, intermittent catheterizations per 24h
Assessed by a 3-day bladder diary
Measured: Once at screening visit
Mean voided volume in mL
Assessed by a 3-day bladder diary
Measured: Once at screening visit
Mean catheterized post void residual volume in mL
Assessed by a 3-day bladder diary
Measured: Once at screening visit
Pain level score (0 none - 10 worst possible)
Assessed by a 3-day bladder diary
Measured: Once at screening visit
Level of urgency (0 none - 4 severe with incontinence)
Assessed by a 3-day bladder diary
Measured: Once at screening visit
Number of leakages per 24 hours
Assessed by a 3-day bladder diary
Measured: Once at screening visit
Urine leakage (none-heavy)
Assessed by a 3-day bladder diary
Measured: Once at screening visit
Number of used pads per 24 hours
Assessed by a 3-day bladder diary
Measured: Once at screening visit
Wetness of pads (dry-soaked)
Assessed by a 3-day bladder diary
Measured: Once at screening visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2017
- Study startJan 2017
- Primary completion31 Oct 2023 (estimated)
- Study completion31 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diuresis Under Eletrical StimulationStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03256656
- Sponsor's protocol ID
- 2016-01695
- Other IDs
- 2016
- Acronym
- EFFLUENT
- Status last verified
- Nov 2024
- First submitted
- 19 Jan 2017
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Lower Urinary Tract Electrical Stimulation on Renal Urine Production (diuresis) - a Monocentric Basic Study
- ClinicalTrials.gov ID
- NCT03256656
- Acronym / sponsor ID
- EFFLUENT / 2016-01695
- Conditions
- Diuresis Under Eletrical Stimulation
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 31 Oct 2023 (estimated)
- First posted
- 22 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects | Experimental | Other: electrical stimulation (non painful) of the lower urinary tract to determine the current perception threshold and record sensory evoked potentials |
| Patients with SCI | Active comparator | Other: electrical stimulation (non painful) of the lower urinary tract to determine the current perception threshold and record sensory evoked potentials |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Written informed consent
- Good mental and physical health
- Age >18 years
- Written informed consent
- Good mental condition
Key exclusion criteria (20 listed)
- Any neurological or urological pathology
- Pregnancy or breast feeding
- Urinary tract infection (UTI), frequent UTIs
- Hematuria
- Any previous pelvic or spine surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electrical stimulation (non painful) of the lower urinary tract to determine the current perception threshold and record sensory evoked potentials | Other | Healthy subjects, Patients with SCI |
Primary outcome
Change in urine output (ml/s)
Time frame: 10 minutes
30 secondary outcomes
Systolic and diastolic blood pressure
Time frame: Immediately before, during and immediately after the intervention
Heart rate
Time frame: Immediately before, during and immediately after the intervention
Sympathetic skin response
Time frame: Immediately before, during and immediately after the intervention
Renal restistance index
Time frame: 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
International Consultation on Incontinence Questionnaire-Male Lower Urinary Tract Symptoms (ICIQ-MLUTS)
Time frame: Once at screening visit
International Prostate Symptom Score (IPSS)
Time frame: Once at screening visit
International Index of Erectile Function (IIEF) questionnaire
Time frame: Once at screening visit
Female Sexual Functioning Index (FSFI) questionnaire
Time frame: Once at screening visit
Qualiveen questionnaire
Time frame: Once at screening visit
Lower Urinary Tract Symptoms Quality of Life (LUTS-qol) questionnaire
Time frame: Once at screening visit
Swiss German Overactive Bladder (OAB) questionnaire
Time frame: Once at screening visit
Hospital Anxiety and Depression Scale (HADS) questionnaire
Time frame: Once at screening visit
MoCA test
Time frame: 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
Mean oral fluid intake in mL
Time frame: Once at screening visit
Number of voids per 24 hours
Time frame: Once at screening visit
Number of daytime voids
Time frame: Once at screening visit
Number of nighttime voids
Time frame: Once at screening visit
Number of intermittent catheterizations per 24h
Time frame: Once at screening visit
Number of daytime, intermittent catheterizations per 24h
Time frame: Once at screening visit
Number of nighttime, intermittent catheterizations per 24h
Time frame: Once at screening visit
Mean voided volume in mL
Time frame: Once at screening visit
Mean catheterized post void residual volume in mL
Time frame: Once at screening visit
Pain level score (0 none - 10 worst possible)
Time frame: Once at screening visit
Level of urgency (0 none - 4 severe with incontinence)
Time frame: Once at screening visit
Number of leakages per 24 hours
Time frame: Once at screening visit
Urine leakage (none-heavy)
Time frame: Once at screening visit
Number of used pads per 24 hours
Time frame: Once at screening visit
Wetness of pads (dry-soaked)
Time frame: Once at screening visit
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electrical stimulation (non painful) of the lower urinary tract to determine the current perception threshold and record sensory evoked potentials in people with Diuresis Under Eletrical Stimulation, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in urine output (ml/s) (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2024.