Neurophysiological Assessment of Healthy and Impaired Human Lower Urinary Tract Function

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

COMPLETED

Clinical Phase

NA

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2023-12-31

Brief Summary

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Study part 1 will consist of sensory evoked cortical potential (SEP) measurements of the lower urinary tract (LUT) in healthy subjects using different stimulation frequencies from 0.25 to 3Hz to find the most effective frequency in regard to acquisition time for reliable SEP response rates. Study part 2 will consist of a series of consecutive SEP measurements in patients with LUT symptoms during low bladder volume and maximum cystometric capacity to assess reliability of measurements and influence of potential concomitant LUTS treatments.

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Detailed Description

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Conditions

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Lower Urinary Tract Symptoms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Healthy volunteers

Group Type EXPERIMENTAL

EEG and EP measurement

Intervention Type PROCEDURE

Patients with LUTS

Group Type EXPERIMENTAL

EEG and EP measurement

Intervention Type PROCEDURE

Patients with LUTS and treatment

Group Type EXPERIMENTAL

EEG and EP measurement

Intervention Type PROCEDURE

Interventions

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EEG and EP measurement

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

healthy volunteers:

* Written informed consent,
* good mental and physical health,
* age \>18y,

Patients with LUTS and Patients with LUTS and treatment:

* Written informed consent,
* age \>18y,
* prior urodynamic investigation,
* LUTS since \>6months with or without detrusor overactivity

Exclusion Criteria

healthy volunteers:

* any neurological or urological pathology,
* current pregnancy or lactation,
* urinary tract infection,
* hematuria,
* any previous pelvic or spine or craniocerebral surgery,
* any anatomical anomaly of the LUT or genitalia,
* any metabolic disease,
* any LUT malignancy,
* bladder capacity \<150mL,
* SDV at 60mL;

Patients with LUTS and Patients with LUTS and treatment:

* current pregnancy or lactation,
* urinary tract infection,
* gross hematuria

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes