Study of Electroencephalogram (EEG) Measurement During Different Stimulations of the Lower Urinary Tract

July 19, 2019 updated by: Ulrich Mehnert

Investigation of Lower Urinary Tract Afferent and Cortical Brain Activity During Lower Urinary Tract Stimulation Using Electroencephalogram Measurements

The purpose of this study is to investigate afferent and cortical activities during bladder filling under different stimulations of the lower urinary tract. The participants of the study are healthy test persons and patients with overactive bladder.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

83

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
      • Zürich, Switzerland, 8008
        • Spinal Cord Injury & Research, University of Zürich, Balgrist University Hospital

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Right-handed
  • Written informed consent

Exclusion Criteria:

  • Any psychological diseases
  • Any renal, cardiac, and pulmonary diseases
  • Pregnancy or breastfeeding
  • Problems keeping calm for 60 minutes in the sitting position
  • Medication influencing EEG or bladder function

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: healthy testpersons
Electroencephalography recording during electrical stimulation of different locations of the lower urinary tract as well as during electrical and heat stimulation at the tibial and pudendal nerve and S3 dermatome.
Other: Electroencephalography
Standard electroencephalography investigation according to the ICS standard Current recording of latency and amplitude of evoked potentials
Experimental: patients with non-neurogenic OAB
Electroencephalography recording during electrical stimulation of different locations of the lower urinary tract as well as during electrical and heat stimulation at the tibial and pudendal nerve and S3 dermatome.
Other: Electroencephalography
Standard electroencephalography investigation according to the ICS standard Current recording of latency and amplitude of evoked potentials
Other: patients with neurogenic OAB
Electroencephalography recording during electrical stimulation of different locations of the lower urinary tract as well as during electrical and heat stimulation at the tibial and pudendal nerve and S3 dermatome
Other: Electroencephalography
Standard electroencephalography investigation according to the ICS standard Current recording of latency and amplitude of evoked potentials

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Establishment of somatosensory evoked potentials of lower urinary tract stimulations
Time Frame: 3 times on an average period of three months
EEG recording during electrical stimulation of different locations of the lower urinary tract as well as during electrical and heat stimulation at the tibial and pudendal nerve and S3 dermatome.
3 times on an average period of three months

Collaborators and Investigators

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

Sponsor

Ulrich Mehnert

Collaborators

NCCR (National Center of Competence in Resaerch, Switzerland)

Investigators

  • Principal Investigator: Ulrich Mehnert, Dr., Neuro-Urology, Spinal Cord Injury Center & Research, University of Zürich, Balgrist University Hospital

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

February 1, 2011

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

June 28, 2011

First Submitted That Met QC Criteria

July 7, 2011

First Posted (Estimate)

July 8, 2011

Study Record Updates

Last Update Posted (Actual)

July 23, 2019

Last Update Submitted That Met QC Criteria

July 19, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25/2009

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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