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

Primary Purpose

Healthy, Nonneurogenic Neurogenic Bladder Dysfunction, Neurogenic Bladder Dysfunction Nos

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Electroencephalography
Sponsored by
Ulrich Mehnert
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Healthy focused on measuring lower urinary tract, sensory evoked potential, contact heat evoked potential stimulation, electroencephalogram, cortical processing, bladder sensations, lower urinary tract dysfunction, overactive bladder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Spinal Cord Injury & Research, University of Zürich, Balgrist University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

healthy testpersons

patients with non-neurogenic OAB

patients with neurogenic OAB

Arm Description

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.

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.

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

Outcomes

Primary Outcome Measures

Establishment of somatosensory evoked potentials of lower urinary tract stimulations
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.

Secondary Outcome Measures

Full Information

First Posted
June 28, 2011
Last Updated
July 19, 2019
Sponsor
Ulrich Mehnert
Collaborators
NCCR (National Center of Competence in Resaerch, Switzerland)
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1. Study Identification

Unique Protocol Identification Number
NCT01389921
Brief Title
Study of Electroencephalogram (EEG) Measurement During Different Stimulations of the Lower Urinary Tract
Official Title
Investigation of Lower Urinary Tract Afferent and Cortical Brain Activity During Lower Urinary Tract Stimulation Using Electroencephalogram Measurements
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ulrich Mehnert
Collaborators
NCCR (National Center of Competence in Resaerch, Switzerland)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Nonneurogenic Neurogenic Bladder Dysfunction, Neurogenic Bladder Dysfunction Nos
Keywords
lower urinary tract, sensory evoked potential, contact heat evoked potential stimulation, electroencephalogram, cortical processing, bladder sensations, lower urinary tract dysfunction, overactive bladder

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
83 (Actual)

8. Arms, Groups, and Interventions

Arm Title
healthy testpersons
Arm Type
Experimental
Arm Description
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.
Arm Title
patients with non-neurogenic OAB
Arm Type
Experimental
Arm Description
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.
Arm Title
patients with neurogenic OAB
Arm Type
Other
Arm Description
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 Type
Other
Intervention Name(s)
Electroencephalography
Intervention Description
Standard electroencephalography investigation according to the ICS standard Current recording of latency and amplitude of evoked potentials
Primary Outcome Measure Information:
Title
Establishment of somatosensory evoked potentials of lower urinary tract stimulations
Description
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.
Time Frame
3 times on an average period of three months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulrich Mehnert, Dr.
Organizational Affiliation
Neuro-Urology, Spinal Cord Injury Center & Research, University of Zürich, Balgrist University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Spinal Cord Injury & Research, University of Zürich, Balgrist University Hospital
City
Zürich
ZIP/Postal Code
8008
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
25626360
Citation
Gregorini F, Knupfer SC, Liechti MD, Schubert M, Curt A, Kessler TM, Mehnert U. Sensory evoked potentials of the bladder and urethra in middle-aged women: the effect of age. BJU Int. 2015 Apr;115 Suppl 6:18-25. doi: 10.1111/bju.13066.
Results Reference
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PubMed Identifier
26773330
Citation
Knupfer SC, Liechti MD, Gregorini F, De Wachter S, Kessler TM, Mehnert U. Sensory function assessment of the human male lower urinary tract using current perception thresholds. Neurourol Urodyn. 2017 Feb;36(2):469-473. doi: 10.1002/nau.22956. Epub 2016 Jan 15.
Results Reference
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PubMed Identifier
23206421
Citation
Gregorini F, Wollner J, Schubert M, Curt A, Kessler TM, Mehnert U. Sensory evoked potentials of the human lower urinary tract. J Urol. 2013 Jun;189(6):2179-85. doi: 10.1016/j.juro.2012.11.151. Epub 2012 Nov 30.
Results Reference
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Study of Electroencephalogram (EEG) Measurement During Different Stimulations of the Lower Urinary Tract

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