Neurophysiological Assessment of Healthy and Impaired Human Lower Urinary Tract Function

Not Applicable

Completed

• Conditions: Lower Urinary Tract Symptoms
• Interventions: Procedure: EEG and EP measurement

• Registration Number: NCT02272309
• Lead Sponsor: Ulrich Mehnert

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-10-20
• Study First Submitted QC: 2014-10-21
• Study First Posted: 2014-10-22
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-07
• Last Update Posted: 2025-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with LUTS and treatment	EEG and EP measurement	Patients with LUTS and treatment
Healthy volunteers	EEG and EP measurement	Healthy volunteers
Patients with LUTS	EEG and EP measurement	Patients with LUTS

Primary Outcome Measures

Name	Time	Method
N1latency of LUT SEPs	2-3 measurements within 4-16 weeks from first exam

Trial Locations

Locations (1)

Universitätsklinik Balgrist; 🇨🇭 Zurich, Switzerland