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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01389921
First Posted: July 8, 2011
Last Update Posted: March 23, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
NCCR (National Center of Competence in Resaerch, Switzerland)
Information provided by (Responsible Party):
Ulrich Mehnert, University of Zurich
  Purpose
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.

Condition Intervention
Healthy Nonneurogenic Neurogenic Bladder Dysfunction Neurogenic Bladder Dysfunction Nos Other: Electroencephalography

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Investigation of Lower Urinary Tract Afferent and Cortical Brain Activity During Lower Urinary Tract Stimulation Using Electroencephalogram Measurements

Further study details as provided by Ulrich Mehnert, University of Zurich:

Primary Outcome Measures:
  • 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.


Enrollment: 83
Study Start Date: February 2011
Study Completion Date: April 2014
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01389921


Locations
Switzerland
Spinal Cord Injury & Research, University of Zürich, Balgrist University Hospital
Zürich, Switzerland, 8008
Sponsors and Collaborators
Ulrich Mehnert
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
  More Information

Publications:
Responsible Party: Ulrich Mehnert, executive physician, University of Zurich
ClinicalTrials.gov Identifier: NCT01389921     History of Changes
Other Study ID Numbers: 25/2009
First Submitted: June 28, 2011
First Posted: July 8, 2011
Last Update Posted: March 23, 2016
Last Verified: March 2016

Keywords provided by Ulrich Mehnert, University of Zurich:
lower urinary tract
sensory evoked potential
contact heat evoked potential stimulation
electroencephalogram
cortical processing
bladder sensations
lower urinary tract dysfunction
overactive bladder

Additional relevant MeSH terms:
Urinary Bladder, Neurogenic
Neurologic Manifestations
Nervous System Diseases
Urinary Bladder Diseases
Urologic Diseases
Signs and Symptoms