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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
June 28, 2011
July 8, 2011
March 23, 2016
February 2011
September 2011   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01389921 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Study of Electroencephalogram (EEG) Measurement During Different Stimulations of the Lower Urinary Tract
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.
Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
  • Healthy
  • Nonneurogenic Neurogenic Bladder Dysfunction
  • Neurogenic Bladder Dysfunction Nos
Other: Electroencephalography
Standard electroencephalography investigation according to the ICS standard Current recording of latency and amplitude of evoked potentials
  • 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.
    Intervention: Other: Electroencephalography
  • 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.
    Intervention: Other: Electroencephalography
  • 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
    Intervention: Other: Electroencephalography

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
83
April 2014
September 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
 
NCT01389921
25/2009
No
Not Provided
Not Provided
Ulrich Mehnert, University of Zurich
Ulrich Mehnert
NCCR (National Center of Competence in Resaerch, Switzerland)
Principal Investigator: Ulrich Mehnert, Dr. Neuro-Urology, Spinal Cord Injury Center & Research, University of Zürich, Balgrist University Hospital
University of Zurich
March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP