Trial record 3 of 11 for:    Open Studies | "Urinary Bladder, Neurogenic"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of Zurich
Sponsor:
Collaborator:
NCCR (National Centers of Competence in Research, Switzerland)
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01389921
First received: June 28, 2011
Last updated: March 7, 2014
Last verified: March 2014
  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: 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 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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 60
Study Start Date: February 2011
Estimated 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01389921

Contacts
Contact: Thomas M. Kessler, PD Dr. med. +41 44 386 38 45 thomas.kessler@balgrist.ch
Contact: Martina Liechti, Dr. +41 44 386 37 39 m.liechti@paralab.balgrist.ch

Locations
Switzerland
Spinal Cord Injury & Research, University of Zürich, Balgrist University Hospital Recruiting
Zürich, Switzerland, 8008
Contact: Thomas M Kessler, PD Dr. med.    +41 44 386 38 45    thomas.kessler@balgrist.ch   
Contact: Martina Liechti, Dr. med.    +41 44 386 37 39    mliechti@paralab.balgrist.ch   
Principal Investigator: Stefanie Knüpfer         
Sponsors and Collaborators
University of Zurich
NCCR (National Centers of Competence in Research, Switzerland)
Investigators
Principal Investigator: Ulrich Mehnert, Dr. Neuro-Urology, Spinal Cord Injury Center & Research, University of Zürich, Balgrist University Hospital
  More Information

No publications provided

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01389921     History of Changes
Other Study ID Numbers: 25/2009
Study First Received: June 28, 2011
Last Updated: March 7, 2014
Health Authority: Switzerland: Ethikkommission

Keywords provided by 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

ClinicalTrials.gov processed this record on September 16, 2014