Neurophysiological Assessment of Healthy and Impaired Human Lower Urinary Tract Function

Ulrich Mehnert

Status: Completed

Conditions: Lower Urinary Tract Symptoms

Treatments: Procedure: EEG and EP measurement

Study type: Interventional

Funder types: Other

Identifiers

NCT02272309

KEK-ZH_2013-0518/PB_2016-00498

Details and patient eligibility

About

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.

Enrollment: 124 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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124 participants in 3 patient groups

Healthy volunteers

Experimental group

Description:

Healthy volunteers

Treatment:

Procedure: EEG and EP measurement

Patients with LUTS

Experimental group

Description:

Patients with LUTS

Treatment:

Procedure: EEG and EP measurement

Patients with LUTS and treatment

Experimental group

Description:

Patients with LUTS and treatment

Treatment:

Procedure: EEG and EP measurement