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

NCT ID: NCT03256656

Last Updated: 2024-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2023-10-31

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.

Detailed Description

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Conditions

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Diuresis Under Eletrical Stimulation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Study Groups

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Healthy subjects

Group Type EXPERIMENTAL

electrical stimulation (non painful) of the lower urinary tract to determine the current perception threshold and record sensory evoked potentials

Intervention Type OTHER

Patients with SCI

Group Type ACTIVE_COMPARATOR

electrical stimulation (non painful) of the lower urinary tract to determine the current perception threshold and record sensory evoked potentials

Intervention Type OTHER

Interventions

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electrical stimulation (non painful) of the lower urinary tract to determine the current perception threshold and record sensory evoked potentials

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Balgrist University Hospital

Zurich, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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2016-01695

Identifier Type: -

Identifier Source: org_study_id

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