Study of Electroencephalogram (EEG) Measurement During Different Stimulations of the Lower Urinary Tract
This study is ongoing, but not recruiting participants.
Sponsor:
University of Zurich
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
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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