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

This study is ongoing, but not recruiting participants.
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 27, 2013
Last verified: March 2013
  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 women and women 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.


Enrollment: 48
Study Start Date: February 2011
Estimated Study Completion Date: November 2013
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: healthy women
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.
Other: Electroencephalography
Standard electroencephalography investigation according to the ICS standard Current recording of latency and amplitude of evoked potentials
Experimental: women with non-neurogenic OAB
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.
Other: Electroencephalography
Standard electroencephalography investigation according to the ICS standard Current recording of latency and amplitude of evoked potentials
women with neurogenic OAB
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
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:   Female
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01389921

Locations
Switzerland
Spinal Cord Injury & Research, University of Zürich, Balgrist University Hospital
Zürich, Switzerland, 8008
Sponsors and Collaborators
University of Zurich
NCCR (National Centers of Competence in Research, Switzerland)
Investigators
Study Chair: 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 27, 2013
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 May 23, 2013