HealthyNCT01389921
Study of Electroencephalogram (EEG) Measurement During Different Stimulations of the Lower Urinary Tract
A study testing Electroencephalography in people with Healthy and Nonneurogenic Neurogenic Bladder Dysfunction, run by Ulrich Mehnert at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy, Nonneurogenic Neurogenic Bladder Dysfunction, Neurogenic Bladder Dysfunction Nos
- What is being tested?
- Electroencephalography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2011to Apr 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Right-handed
- Written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Spinal Cord Injury & Research, University of Zürich, Balgrist University Hospital
Zurich, 8008
About this study
Official title: 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.
- Being tested
- Electroencephalography
- Keywords
- lower urinary tract, sensory evoked potential, contact heat evoked potential stimulation, electroencephalogram, cortical processing, bladder sensations, lower urinary tract dysfunction, overactive bladder
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectroencephalographyOther
Standard electroencephalography investigation according to the ICS standard Current recording of latency and amplitude of evoked potentials
| Study group | Role | What they receive |
|---|---|---|
| healthy testpersons | Experimental | 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. Receives: Other: Electroencephalography |
| patients with non-neurogenic OAB | Experimental | 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. Receives: Other: Electroencephalography |
| patients with neurogenic OAB | Other | 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 Receives: Other: Electroencephalography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 times on an average period of three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2011 (estimated)
- Study startFeb 2011
- Primary completionSep 2011
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ulrich Mehnert
- Sponsor type
- University, hospital or other
- Collaborators
- NCCR (National Center of Competence in Resaerch, Switzerland)
- Responsible party
- Sponsor-investigator, Ulrich Mehnert, University of Zurich
- Investigators
- Ulrich Mehnert, Dr., Principal investigator, Neuro-Urology, Spinal Cord Injury Center & Research, University of Zürich, Balgrist University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01389921
- Sponsor's protocol ID
- 25/2009
- Status last verified
- Jul 2019
- First submitted
- 28 Jun 2011
- Last updated
- 23 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25626360Knupfer 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.
PubMed 26773330Gregorini 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.
PubMed 23206421
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Lower Urinary Tract Afferent and Cortical Brain Activity During Lower Urinary Tract Stimulation Using Electroencephalogram Measurements
- ClinicalTrials.gov ID
- NCT01389921
- Acronym / sponsor ID
- 25/2009
- Keywords
- lower urinary tract, sensory evoked potential, contact heat evoked potential stimulation, electroencephalogram, cortical processing, bladder sensations, lower urinary tract dysfunction, overactive bladder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Ulrich MehnertUniversity, hospital or other
- Collaborators
- NCCR (National Center of Competence in Resaerch, Switzerland)
- Study start
- Feb 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 8 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| healthy testpersons | Experimental | Other: ElectroencephalographyElectroencephalography 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. |
| patients with non-neurogenic OAB | Experimental | Other: ElectroencephalographyElectroencephalography 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. |
| patients with neurogenic OAB | Other | Other: ElectroencephalographyElectroencephalography 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Right-handed
- Written informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElectroencephalographyStandard electroencephalography investigation according to the ICS standard Current recording of latency and amplitude of evoked potentials | Other | healthy testpersons, patients with neurogenic OAB, patients with non-neurogenic OAB |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2019.
- Background: PubMed 25626360Gregorini 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.
- Background: PubMed 26773330Knupfer 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.
- Background: PubMed 23206421Gregorini 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulrich Mehnert, Dr. principal investigator
Neuro-Urology, Spinal Cord Injury Center & Research, University of Zürich, Balgrist University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroencephalography in people with Healthy and Nonneurogenic Neurogenic Bladder Dysfunction, run by Ulrich Mehnert at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establishment of somatosensory evoked potentials of lower urinary tract stimulations (time frame: 3 times on an average period of three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01389921, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2019.