Neurogenic Lower Urinary Tract DysfunctionNCT01768910
Supraspinal Control of Lower Urinary Tract Function in Healthy Controls and Patients With Bladder Dysfunction
A study testing fMRI, bladder filling and bladder cooling in people with Neurogenic Lower Urinary Tract Dysfunction and Multiple Sclerosis, run by University of Zurich at 2 sites in Switzerland.
Trial summary
The purpose of this study is to provide profound insight into the supraspinal neuronal mechanisms and networks responsible for lower urinary tract (LUT) control and to verify, amend or adjust neuronal circuitry models established from findings in healthy subjects in the context of neurogenic and non-neurogenic LUT… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Neurogenic Lower Urinary Tract Dysfunction, Multiple Sclerosis, Overactive Bladder
- What is being tested?
- fMRI, bladder filling and bladder cooling
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 2 sitesSwitzerland
- Study dates
- Dec 2011to Dec 2018
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy controls
- Right handed
- MR suitability
- Written informed consent
- unimpaired LUT function
- MS patients with OAB
Show all 37Show fewer
- Right handed
- MR suitability
- Written informed consent
- diagnosis of MS according to the McDonald criteria
- Expanded Disability Status Scale (EDSS) ≤ 6
- OAB symptoms since > 6 months
- ≥ 3 episodes of urinary urgency
- frequency > 8/24h
- with or without detrusor overactivity
- MS patients without OAB
- Right handed
- MR suitability
- Written informed consent
- diagnosis of MS according to the McDonald criteria
- Expanded Disability Status Scale (EDSS) ≤ 6
- Patients with NNOAB
- Right handed
- MR suitability
- Written informed consent
- idiopathic OAB symptoms since > 6 months
- ≥ 3 episodes of urinary urgency
- frequency > 8/24h
- refractory to antimuscarinic treatment for ≥ 1 month
- indication for intradetrusor injections of Botulinumtoxin Type A
- willingness and ability to perform self-catheterization
- SCI patients with neurogenic detrusor overactivity
- Right handed
- MR suitability
- Written informed consent
- neurogenic detrusor overactivity due to SCI
- indication for intradetrusor injections of botulinum toxin type A
Who cannot join
- Healthy controls
- impaired LUT function
- pregnancy or breast feeding
- no informed consent
- any craniocerebral injury or surgery
- any permanent ferromagnetic implant
Show all 67Show fewer
- any previous surgery of the LUT or genitalia
- any anatomical anomaly of the LUT or genitalia
- any LUT malignancy
- postvoid residual urine volume (PVR) > 150ml
- current urinary tract infection
- any LUT symptoms
- ≥ 3 episodes of urinary urgency
- frequency > 8/24h
- MS patients with OAB
- pregnancy or breast feeding
- any permanent ferromagnetic implant
- any neurological or psychological disease despite MS
- any craniocerebral injury or surgery
- any previous surgery of the LUT or genitalia
- any anatomical anomaly or malignancy of the LUT or genitalia
- any metabolic disease
- PVR > 150ml
- any concomitant treatment for the LUT (e.g. neuromodulation)
- Stress urinary incontinence
- any condition other than MS that might explain OAB symptoms
- current urinary tract infection
- indwelling catheters or the necessity to perform self-catheterization
- MS patients without OAB
- pregnancy or breast feeding
- any permanent ferromagnetic implant
- any neurological or psychological disease despite MS
- any craniocerebral injury or surgery
- any previous surgery of the LUT or genitalia
- any anatomical anomaly or malignancy of the LUT or genitalia
- any metabolic disease
- PVR > 150ml
- any concomitant treatment for the LUT (e.g. neuromodulation)
- Stress urinary incontinence
- any LUT symptoms
- ≥ 3 episodes of urinary urgency
- frequency > 8/24h
- indwelling catheters or the necessity to perform self-catheterization
- detrusor overactivity
- current urinary tract infection
- Patients with NNOAB
- pregnancy or planned within next 8 months, breast feeding
- any permanent ferromagnetic implant
- any neurological, psychological, metabolic or cardiovascular disease
- any craniocerebral injury or surgery
- any previous surgery of the LUT or genitalia within the last year or that is related to the OAB symptoms
- any anatomical anomaly or malignancy of the LUT or genitalia
- PVR > 150ml
- Stress urinary incontinence
- indwelling catheters or the necessity to perform self-catheterization
- any concomitant treatment for the LUT (e.g. neuromodulation)
- current urinary tract infection
- SCI patients with neurogenic detrusor overactivity
- pregnancy or breast feeding
- any permanent ferromagnetic implant
- any neurological or psychological disease despite SCI
- any craniocerebral injury or surgery
- any previous surgery of LUT of genitalia
- any anatomical anomaly or malignancy of the LUT or genitalia
- any metabolic disease
- any concomitant treatment for the LUT (e.g. neuromodulation)
- current urinary tract infection
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Neuro-Urology, Spinal Cord Injury Center & Research, University of Zürich, Balgrist University Hospital
Zurich, 8008
University Hospital Zürich
Zurich, 8008
About this study
Official title: The Bladder and the Brain - Investigation of the Supraspinal Neural Control of Lower Urinary Tract Function in Healthy Subjects and Patients With Neurogenic and Non-neurogenic Bladder Dysfunction Using Advanced Neuroimaging Techniques
The purpose of this study is to provide profound insight into the supraspinal neuronal mechanisms and networks responsible for lower urinary tract (LUT) control and to verify, amend or adjust neuronal circuitry models established from findings in healthy subjects in the context of neurogenic and non-neurogenic LUT dysfunction.
Read the detailed description
The subject recruitment will be performed within the Neuro-Urology outpatient clinic at the Balgrist University Hospital and in collaboration with the Departments of Neurology, Urology and Gynecology at the University Hospital Zürich.
The following subject groups will be recruited: 1) healthy controls (n=22), Non-neurogenic overactive bladder (NNOAB) patients (n=20), multiple sclerosis (MS) patients with OAB (n=15), MS patients without OAB (n=15), spinal cord injury (SCI) patients with neurogenic detrusor overactivity (n=24).
After inclusion, all subjects and patients will undergo one to two functional magnetic resonance imaging (fMRI) sessions. NNOAB patients might undergo an additional fMRI session after receiving overactive bladder (OAB) treatment (such as antimuscarinics, intradetrusor injections of botulinum toxin type A). Spinal cord injury (SCI) patients with neurogenic detrusor overactivity will undergo an additional fMRI session 5-7 weeks after intradetrusor injections of botulinum toxin type A.
High-resolution anatomical images and functional blood-oxygen-level-dependent (BOLD)-signal sensitive images will be acquired. In addition to the fMRI, diffusion tensor imaging (DTI) sequences will be recorded after the anatomical scans to provide information about the structural supraspinal connectivity.
Study endpoints are changes of the BOLD signal in regard to location and intensity, structural and functional connectivity (FC) between previously described supraspinal centers involved in LUT control, and statistical differences of changes in BOLD signals, structural and functional connectivity between patients and healthy controls.
All acquired fMRI data will be transferred to an off-line workstation running BrainVoyager QX or Statistical Parametric Mapping (SPM) Version 8. The functional data will be pre-processed for motion correction, spatial smoothing, linear trend removal, and temporal high-pass filtering. With both programs statistical analysis and graphical presentation of the results can be performed.
The DTI records will be evaluated with SPM8, BrainVoyager QX or other programs like Functional Magnetic Resonance Imaging of the Brain (FMRIB) Software Library (FSL) and DTI-Studio. To estimate FC we will use SPM8 or the brain connectivity toolbox. Both softwares allow the estimation of rest- and task-related connectivity on single subject and group level with corrected statistical threshold.
Overall, 96 subjects for the main study are estimated to be sufficient to demonstrate significant differences between groups.
- Conditions
- Neurogenic Lower Urinary Tract Dysfunction, Multiple Sclerosis, Overactive Bladder, Spinal Cord Injury
- Being tested
- fMRI, bladder filling, bladder cooling, additional post-treatment fMRI scan
- Keywords
- lower urinary tract, bladder, supraspinal control, neuroimaging, functional magnetic resonance imaging, diffusion tensor imaging, functional connectivity, neurogenic lower urinary tract dysfunction, overactive bladder, multiple sclerosis, spinal cord injury
- Medical subject headings
- Multiple Sclerosis, Urinary Bladder, Overactive, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fMRIOther
2 measurements using functional magnetic resonance imaging in a 3T scanner
bladder fillingOther
Repetitive retrograde bladder filling via transurethral catheter with different filling volumes using body warm saline during each of the fMRI measurements.
bladder coolingOther
Retrograde bladder filling via transurethral catheter with 4-8°C saline during each of the fMRI measurements.
additional post-treatment fMRI scanOther
Should NNOAB or SCI patients receive a study independent OAB therapy by their treating physician after the 2nd fMRI scan, they will be invited for an additional third fMRI scan.
| Study group | Role | What they receive |
|---|---|---|
| Healthy controls | Experimental | Procedure: 1-2 fMRI measurements within 4 weeks from first exam. Measurements include repetitive retrograde bladder filling via transurethral catheter at different bladder volumes and temperatures (e.g. bladder cooling, body warm or room temperature)of the filling liquid. Receives: Other: fMRI; Other: bladder filling; Other: bladder cooling |
| MS with OAB | Experimental | Procedure: 1-2 fMRI measurements within 4 weeks from first exam. Measurements include repetitive retrograde bladder filling via transurethral catheter at different bladder volumes and temperatures of the filling liquid. Receives: Other: fMRI; Other: bladder filling; Other: bladder cooling |
| MS without OAB | Experimental | Procedure: 1-2 measurements within 4 weeks from first exam. Measurements include repetitive bladder filling via transurethral catheter at different bladder volumes and temperatures of the filling liquid. Receives: Other: fMRI; Other: bladder filling; Other: bladder cooling |
| NNOAB | Experimental | Procedure: 1-2 measurements within 4 weeks from first exam. Measurements include repetitive bladder filling via transurethral catheter at different bladder volumes and temperatures of the filling liquid plus additional post-treatment fMRI scan 5 to 7 weeks after OAB treatment (such as antimuscarinics, intradetrusor injections of botulinum toxin type A) Receives: Other: fMRI; Other: bladder filling; Other: bladder cooling; Other: additional post-treatment fMRI scan |
| SCI with neurogenic detrusor overactivity | Experimental | Procedure: 1-2 measurements within 4 weeks from first exam. Measurements include repetitive bladder filling via transurethral catheter at different bladder volumes and temperatures of the filling liquid plus 1 additional post-treatment fMRI scan 5 to 7 weeks after intradetrusor injections of botulinum toxin type A Receives: Other: fMRI; Other: bladder filling; Other: bladder cooling; Other: additional post-treatment fMRI scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bold signal
During fMRI measurements the changes of BOLD signal intensity in respect to certain supraspinal areas (e.g. pons, insula, anterior cingulate cortex, thalamus, supplementary motor area, prefrontal cortex) will be evaluated.
Variables are age, bladder volume, urgency and attention.
Measured: baseline and 4 weeks
Structural and functional connectivity
Acquired data from the above mentioned measurements will be used to analyze structural and functional connectivity between supraspinal areas involved in the LUT control, especially between prefrontal, thalamus, insula, and anterior cingulate cortex.
Variables are age, bladder volume, urgency and attention. Correlations of neuronal activity from the fMRI-data will be estimated using SPM8, brain connectivity tool box.
Measured: baseline and after potential OAB treatment
Secondary outcomes (1)
Side effects
Pain, Lower urinary tract infection
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2013 (estimated)
- Study startDec 2011
- Primary completion17 Jul 2015
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Neurogenic Lower Urinary Tract DysfunctionStudies 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss National Science Foundation, Balgrist University Hospital
- Responsible party
- Sponsor
- Investigators
- Ulrich Mehnert, MD, Principal investigator, Neuro-Urology, Spinal Cord Injury Center & Research, University of Zurich, Balgrist University Hospital, Forchstrasse 340, 8008 Zurich, SwitzerlandThomas M Kessler, MD, Principal investigator, Neuro-Urology, Spinal Cord Injury Center & Research, University of Zurich, Balgrist University Hospital, Forchstrasse 340, 8008 Zurich, SwitzerlandSpyros Kollias, MD, Principal investigator, Institute of Neuroradiology, University Hospital Zurich, Sternwartstrasse 6, 8091 Zurich, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01768910
- Sponsor's protocol ID
- KEK-ZH-2011-0346/PB_2016-00872
- Status last verified
- Mar 2019
- First submitted
- 8 Jan 2013
- Last updated
- 18 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Walter M, Michels L, Kollias S, van Kerrebroeck PE, Kessler TM, Mehnert U. Protocol for a prospective neuroimaging study investigating the supraspinal control of lower urinary tract function in healthy controls and patients with non-neurogenic lower urinary tract symptoms. BMJ Open. 2014 May 21;4(5):e004357. doi: 10.1136/bmjopen-2013-004357.
PubMed 24848086Leitner L, Walter M, Freund P, Mehnert U, Michels L, Kollias S, Kessler TM. Protocol for a prospective magnetic resonance imaging study on supraspinal lower urinary tract control in healthy subjects and spinal cord injury patients undergoing intradetrusor onabotulinumtoxinA injections for treating neurogenic detrusor overactivity. BMC Urol. 2014 Aug 18;14:68. doi: 10.1186/1471-2490-14-68.
PubMed 25132340Leitner L, Walter M, Jarrahi B, Wanek J, Diefenbacher J, Michels L, Liechti MD, Kollias SS, Kessler TM, Mehnert U. A novel infusion-drainage device to assess lower urinary tract function in neuro-imaging. BJU Int. 2017 Feb;119(2):305-316. doi: 10.1111/bju.13655. Epub 2016 Oct 20.
PubMed 27617867Walter M, Leitner L, Michels L, Liechti MD, Freund P, Kessler TM, Kollias S, Mehnert U. Reliability of supraspinal correlates to lower urinary tract stimulation in healthy participants - A fMRI study. Neuroimage. 2019 May 1;191:481-492. doi: 10.1016/j.neuroimage.2019.02.031. Epub 2019 Feb 15.
PubMed 30776530
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Bladder and the Brain - Investigation of the Supraspinal Neural Control of Lower Urinary Tract Function in Healthy Subjects and Patients With Neurogenic and Non-neurogenic Bladder Dysfunction Using Advanced Neuroimaging Techniques
- ClinicalTrials.gov ID
- NCT01768910
- Acronym / sponsor ID
- KEK-ZH-2011-0346/PB_2016-00872
- Conditions
- Neurogenic Lower Urinary Tract Dysfunction, Multiple Sclerosis, Overactive Bladder, Spinal Cord Injury
- Keywords
- lower urinary tract, bladder, supraspinal control, neuroimaging, functional magnetic resonance imaging, diffusion tensor imaging, functional connectivity, neurogenic lower urinary tract dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Swiss National Science Foundation, Balgrist University Hospital
- Study start
- Dec 2011 (actual)
- Primary completion
- 17 Jul 2015 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 16 Jan 2013 (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 provide profound insight into the supraspinal neuronal mechanisms and networks responsible for lower urinary tract (LUT) control and to verify, amend or adjust neuronal circuitry models established from findings in healthy subjects in the context of neurogenic and non-neurogenic LUT dysfunction.
Detailed description
The subject recruitment will be performed within the Neuro-Urology outpatient clinic at the Balgrist University Hospital and in collaboration with the Departments of Neurology, Urology and Gynecology at the University Hospital Zürich.
The following subject groups will be recruited: 1) healthy controls (n=22), Non-neurogenic overactive bladder (NNOAB) patients (n=20), multiple sclerosis (MS) patients with OAB (n=15), MS patients without OAB (n=15), spinal cord injury (SCI) patients with neurogenic detrusor overactivity (n=24).
After inclusion, all subjects and patients will undergo one to two functional magnetic resonance imaging (fMRI) sessions. NNOAB patients might undergo an additional fMRI session after receiving overactive bladder (OAB) treatment (such as antimuscarinics, intradetrusor injections of botulinum toxin type A). Spinal cord injury (SCI) patients with neurogenic detrusor overactivity will undergo an additional fMRI session 5-7 weeks after intradetrusor injections of botulinum toxin type A.
High-resolution anatomical images and functional blood-oxygen-level-dependent (BOLD)-signal sensitive images will be acquired. In addition to the fMRI, diffusion tensor imaging (DTI) sequences will be recorded after the anatomical scans to provide information about the structural supraspinal connectivity.
Study endpoints are changes of the BOLD signal in regard to location and intensity, structural and functional connectivity (FC) between previously described supraspinal centers involved in LUT control, and statistical differences of changes in BOLD signals, structural and functional connectivity between patients and healthy controls.
All acquired fMRI data will be transferred to an off-line workstation running BrainVoyager QX or Statistical Parametric Mapping (SPM) Version 8. The functional data will be pre-processed for motion correction, spatial smoothing, linear trend removal, and temporal high-pass filtering. With both programs statistical analysis and graphical presentation of the results can be performed.
The DTI records will be evaluated with SPM8, BrainVoyager QX or other programs like Functional Magnetic Resonance Imaging of the Brain (FMRIB) Software Library (FSL) and DTI-Studio. To estimate FC we will use SPM8 or the brain connectivity toolbox. Both softwares allow the estimation of rest- and task-related connectivity on single subject and group level with corrected statistical threshold.
Overall, 96 subjects for the main study are estimated to be sufficient to demonstrate significant differences between groups.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Healthy controls | Experimental | Other: fMRI, Other: bladder filling, Other: bladder coolingProcedure: 1-2 fMRI measurements within 4 weeks from first exam. Measurements include repetitive retrograde bladder filling via transurethral catheter at different bladder volumes and temperatures (e.g. bladder cooling, body warm or room temperature)of the filling liquid. |
| MS with OAB | Experimental | Other: fMRI, Other: bladder filling, Other: bladder coolingProcedure: 1-2 fMRI measurements within 4 weeks from first exam. Measurements include repetitive retrograde bladder filling via transurethral catheter at different bladder volumes and temperatures of the filling liquid. |
| MS without OAB | Experimental | Other: fMRI, Other: bladder filling, Other: bladder coolingProcedure: 1-2 measurements within 4 weeks from first exam. Measurements include repetitive bladder filling via transurethral catheter at different bladder volumes and temperatures of the filling liquid. |
| NNOAB | Experimental | Other: fMRI, Other: bladder filling, Other: bladder cooling, Other: additional post-treatment fMRI scanProcedure: 1-2 measurements within 4 weeks from first exam. Measurements include repetitive bladder filling via transurethral catheter at different bladder volumes and temperatures of the filling liquid plus additional post-treatment fMRI scan 5 to 7 weeks after OAB treatment (such as antimuscarinics, intradetrusor injections of botulinum toxin type A) |
| SCI with neurogenic detrusor overactivity | Experimental | Other: fMRI, Other: bladder filling, Other: bladder cooling, Other: additional post-treatment fMRI scanProcedure: 1-2 measurements within 4 weeks from first exam. Measurements include repetitive bladder filling via transurethral catheter at different bladder volumes and temperatures of the filling liquid plus 1 additional post-treatment fMRI scan 5 to 7 weeks after intradetrusor injections of botulinum toxin type A |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (37 listed)
- Healthy controls
- Right handed
- MR suitability
- Written informed consent
- unimpaired LUT function
Key exclusion criteria (67 listed)
- Healthy controls
- impaired LUT function
- pregnancy or breast feeding
- no informed consent
- any craniocerebral injury or 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 |
|---|---|---|
| fMRI2 measurements using functional magnetic resonance imaging in a 3T scanner | Other | Healthy controls, MS with OAB, MS without OAB, NNOAB, SCI with neurogenic detrusor overactivity |
| bladder fillingRepetitive retrograde bladder filling via transurethral catheter with different filling volumes using body warm saline during each of the fMRI measurements. | Other | Healthy controls, MS with OAB, MS without OAB, NNOAB, SCI with neurogenic detrusor overactivity |
| bladder coolingRetrograde bladder filling via transurethral catheter with 4-8°C saline during each of the fMRI measurements. | Other | Healthy controls, MS with OAB, MS without OAB, NNOAB, SCI with neurogenic detrusor overactivity |
| additional post-treatment fMRI scanShould NNOAB or SCI patients receive a study independent OAB therapy by their treating physician after the 2nd fMRI scan, they will be invited for an additional third fMRI scan. | Other | NNOAB, SCI with neurogenic detrusor overactivity |
Primary outcome
Bold signal
Time frame: baseline and 4 weeks
During fMRI measurements the changes of BOLD signal intensity in respect to certain supraspinal areas (e.g. pons, insula, anterior cingulate cortex, thalamus, supplementary motor area, prefrontal cortex) will be evaluated. Variables are age, bladder volume, urgency and attention.
Structural and functional connectivity
Time frame: baseline and after potential OAB treatment
Acquired data from the above mentioned measurements will be used to analyze structural and functional connectivity between supraspinal areas involved in the LUT control, especially between prefrontal, thalamus, insula, and anterior cingulate cortex. Variables are age, bladder volume, urgency and attention. Correlations of neuronal activity from the fMRI-data will be estimated using SPM8, brain connectivity tool box.
1 secondary outcome
Side effects
Time frame: 3 years
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 18 Mar 2019.
- Results publication: PubMed 24848086Walter M, Michels L, Kollias S, van Kerrebroeck PE, Kessler TM, Mehnert U. Protocol for a prospective neuroimaging study investigating the supraspinal control of lower urinary tract function in healthy controls and patients with non-neurogenic lower urinary tract symptoms. BMJ Open. 2014 May 21;4(5):e004357. doi: 10.1136/bmjopen-2013-004357.
- Results publication: PubMed 25132340Leitner L, Walter M, Freund P, Mehnert U, Michels L, Kollias S, Kessler TM. Protocol for a prospective magnetic resonance imaging study on supraspinal lower urinary tract control in healthy subjects and spinal cord injury patients undergoing intradetrusor onabotulinumtoxinA injections for treating neurogenic detrusor overactivity. BMC Urol. 2014 Aug 18;14:68. doi: 10.1186/1471-2490-14-68.
- Results publication: PubMed 27617867Leitner L, Walter M, Jarrahi B, Wanek J, Diefenbacher J, Michels L, Liechti MD, Kollias SS, Kessler TM, Mehnert U. A novel infusion-drainage device to assess lower urinary tract function in neuro-imaging. BJU Int. 2017 Feb;119(2):305-316. doi: 10.1111/bju.13655. Epub 2016 Oct 20.
- Results publication: PubMed 30776530Walter M, Leitner L, Michels L, Liechti MD, Freund P, Kessler TM, Kollias S, Mehnert U. Reliability of supraspinal correlates to lower urinary tract stimulation in healthy participants - A fMRI study. Neuroimage. 2019 May 1;191:481-492. doi: 10.1016/j.neuroimage.2019.02.031. Epub 2019 Feb 15.
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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, MD principal investigator
Neuro-Urology, Spinal Cord Injury Center & Research, University of Zurich, Balgrist University Hospital, Forchstrasse 340, 8008 Zurich, Switzerland
Thomas M Kessler, MD principal investigator
Neuro-Urology, Spinal Cord Injury Center & Research, University of Zurich, Balgrist University Hospital, Forchstrasse 340, 8008 Zurich, Switzerland
Spyros Kollias, MD principal investigator
Institute of Neuroradiology, University Hospital Zurich, Sternwartstrasse 6, 8091 Zurich, Switzerland
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fMRI, bladder filling and bladder cooling in people with Neurogenic Lower Urinary Tract Dysfunction and Multiple Sclerosis, run by University of Zurich at 2 sites 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 37 inclusion and 67 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 18 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Bold signal (time frame: baseline and 4 weeks). The study lists 2 primary outcomes in all. 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 NCT01768910, which also lists 4 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 18 Mar 2019; AzTrials last refreshed its copy on 26 Oct 2026.