Neurophysiological Assessment of Healthy and Impaired Human Lower Urinary Tract Function

January 7, 2025 updated by: Ulrich Mehnert
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

124

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zurich, Switzerland, 8008
        • Universitätsklinik Balgrist

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Healthy volunteers
Procedure: EEG and EP measurement
Experimental: Patients with LUTS
Procedure: EEG and EP measurement
Experimental: Patients with LUTS and treatment
Procedure: EEG and EP measurement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
N1latency of LUT SEPs
Time Frame: 2-3 measurements within 4-16 weeks from first exam
2-3 measurements within 4-16 weeks from first exam

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ulrich Mehnert

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2014

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

October 20, 2014

First Submitted That Met QC Criteria

October 21, 2014

First Posted (Estimated)

October 22, 2014

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 7, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KEK-ZH_2013-0518/PB_2016-00498

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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