Lower Urinary Tract SymptomsNCT02272309
Neurophysiological Assessment of Healthy and Impaired Human Lower Urinary Tract Function
A study testing EEG and EP measurement in people with Lower Urinary Tract Symptoms, run by Ulrich Mehnert at 1 site in Switzerland.
Trial summary
Study part 1 will consist of sensory evoked cortical potential (SEP) measurements of the lower urinary tract (LUT) in healthy subjects using different stimulation frequencies from 0.25 to 3Hz to find the most effective frequency in regard to acquisition time for reliable SEP response rates. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Lower Urinary Tract Symptoms
- What is being tested?
- EEG and EP measurement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2014to 31 Dec 2023
- 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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy volunteers:
- Written informed consent,
- good mental and physical health,
- age >18y,
- Patients with LUTS and Patients with LUTS and treatment:
- Written informed consent,
Show all 9Show fewer
- age >18y,
- prior urodynamic investigation,
- LUTS since >6months with or without detrusor overactivity
Who cannot join
- healthy volunteers:
- any neurological or urological pathology,
- current pregnancy or lactation,
- urinary tract infection,
- hematuria,
- any previous pelvic or spine or craniocerebral surgery,
Show all 15Show fewer
- any anatomical anomaly of the LUT or genitalia,
- any metabolic disease,
- any LUT malignancy,
- bladder capacity <150mL,
- SDV at 60mL;
- Patients with LUTS and Patients with LUTS and treatment:
- current pregnancy or lactation,
- urinary tract infection,
- gross hematuria
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Universitätsklinik Balgrist
Zurich, Canton of Zurich, 8008
About this study
Study part 1 will consist of sensory evoked cortical potential (SEP) measurements of the lower urinary tract (LUT) in healthy subjects using different stimulation frequencies from 0.25 to 3Hz to find the most effective frequency in regard to acquisition time for reliable SEP response rates. Study part 2 will consist of a series of consecutive SEP measurements in patients with LUT symptoms during low bladder volume and maximum cystometric capacity to assess reliability of measurements and influence of potential concomitant LUTS treatments.
- Conditions
- Lower Urinary Tract Symptoms
- Being tested
- EEG and EP measurement
- Medical subject headings
- Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEG and EP measurementProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Experimental | Healthy volunteers Receives: Procedure: EEG and EP measurement |
| Patients with LUTS | Experimental | Patients with LUTS Receives: Procedure: EEG and EP measurement |
| Patients with LUTS and treatment | Experimental | Patients with LUTS and treatment Receives: Procedure: EEG and EP measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
N1latency of LUT SEPs
Measured: 2-3 measurements within 4-16 weeks from first exam
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2014 (estimated)
- Study startMay 2014
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lower Urinary Tract SymptomsStudies 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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ulrich Mehnert
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ulrich Mehnert, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02272309
- Sponsor's protocol ID
- KEK-ZH_2013-0518/PB_2016-00498
- Status last verified
- Jan 2025
- First submitted
- 20 Oct 2014
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Liechti MD, van der Lely S, Knupfer SC, Abt D, Kiss B, Leitner L, Mordasini L, Tornic J, Wollner J, Mehnert U, Bachmann LM, Burkhard FC, Engeler DS, Pannek J, Kessler TM. Sacral Neuromodulation for Neurogenic Lower Urinary Tract Dysfunction. NEJM Evid. 2022 Nov;1(11):EVIDoa2200071. doi: 10.1056/EVIDoa2200071. Epub 2022 Jul 7.
PubMed 38319849van der Lely S, Stefanovic M, Schmidhalter MR, Pittavino M, Furrer R, Liechti MD, Schubert M, Kessler TM, Mehnert U. Protocol for a prospective, randomized study on neurophysiological assessment of lower urinary tract function in a healthy cohort. BMC Urol. 2016 Nov 25;16(1):69. doi: 10.1186/s12894-016-0188-9.
PubMed 27887601
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurophysiological Assessment of Healthy and Impaired Human Lower Urinary Tract Function
- ClinicalTrials.gov ID
- NCT02272309
- Acronym / sponsor ID
- KEK-ZH_2013-0518/PB_2016-00498
- Conditions
- Lower Urinary Tract Symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Ulrich MehnertUniversity, hospital or other
- Study start
- May 2014 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 22 Oct 2014 (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.
Study part 1 will consist of sensory evoked cortical potential (SEP) measurements of the lower urinary tract (LUT) in healthy subjects using different stimulation frequencies from 0.25 to 3Hz to find the most effective frequency in regard to acquisition time for reliable SEP response rates. Study part 2 will consist of a series of consecutive SEP measurements in patients with LUT symptoms during low bladder volume and maximum cystometric capacity to assess reliability of measurements and influence of potential concomitant LUTS treatments.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | Experimental | Procedure: EEG and EP measurementHealthy volunteers |
| Patients with LUTS | Experimental | Procedure: EEG and EP measurementPatients with LUTS |
| Patients with LUTS and treatment | Experimental | Procedure: EEG and EP measurementPatients with LUTS and treatment |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Written informed consent,
- good mental and physical health,
- age >18y,
- Written informed consent,
- age >18y,
Key exclusion criteria (15 listed)
- any neurological or urological pathology,
- current pregnancy or lactation,
- urinary tract infection,
- hematuria,
- any previous pelvic or spine or craniocerebral surgery,
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 |
|---|---|---|
| EEG and EP measurement | Procedure or surgery | Healthy volunteers, Patients with LUTS, Patients with LUTS and treatment |
Primary outcome
N1latency of LUT SEPs
Time frame: 2-3 measurements within 4-16 weeks from first exam
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 9 Jan 2025.
- Results publication: PubMed 38319849Liechti MD, van der Lely S, Knupfer SC, Abt D, Kiss B, Leitner L, Mordasini L, Tornic J, Wollner J, Mehnert U, Bachmann LM, Burkhard FC, Engeler DS, Pannek J, Kessler TM. Sacral Neuromodulation for Neurogenic Lower Urinary Tract Dysfunction. NEJM Evid. 2022 Nov;1(11):EVIDoa2200071. doi: 10.1056/EVIDoa2200071. Epub 2022 Jul 7.
- Derived from this study: PubMed 27887601van der Lely S, Stefanovic M, Schmidhalter MR, Pittavino M, Furrer R, Liechti MD, Schubert M, Kessler TM, Mehnert U. Protocol for a prospective, randomized study on neurophysiological assessment of lower urinary tract function in a healthy cohort. BMC Urol. 2016 Nov 25;16(1):69. doi: 10.1186/s12894-016-0188-9.
Related trials for Lower Urinary Tract Symptoms
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Active, not recruitingPhase 2/3
Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
Urinary Incontinence, Overactive Bladder Syndrome
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Recruiting
UCon Treatment of Overactive Bladder (OAB) in Males
Urinary Incontinence, Urge Incontinence
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EEG and EP measurement in people with Lower Urinary Tract Symptoms, 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 9 inclusion and 15 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 9 Jan 2025. 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?
N1latency of LUT SEPs (time frame: 2-3 measurements within 4-16 weeks from first exam). 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 NCT02272309, which also lists 2 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 9 Jan 2025.