Urinary Tract DiseaseNCT00610064
Brain Effects of Sacral Neuromodulation
A study testing Baseline neuroimaging and Neuroimaging during sacral neuromodulation in people with Urinary Tract Disease, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
Sacral neuromodulation (SNM) has become an accepted treatment for patients with refractory lower urinary tract dysfunction such as urgency frequency syndrome, urgency incontinence, non-obstructive chronic urinary retention and chronic pelvic pain syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Tract Disease
- What is being tested?
- Baseline neuroimaging and Neuroimaging during sacral neuromodulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2005to Jun 2009
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with refractory lower urinary tract dysfunction scheduled for sacral neuromodulation
Who cannot join
- Pregnancy
- Age <18 years
- Claustrophobia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Brain Effects of Sacral Neuromodulation in Patients With Refractory Lower Urinary Tract Dysfunction
Sacral neuromodulation (SNM) has become an accepted treatment for patients with refractory lower urinary tract dysfunction such as urgency frequency syndrome, urgency incontinence, non-obstructive chronic urinary retention and chronic pelvic pain syndrome. Modulation of central afferent activity is considered critical to this therapeutic effect but the neural mechanisms are poorly understood.
We hypothesize that SNM has a significant effect on brain activity detectable by positron emission tomography (PET).
- Conditions
- Urinary Tract Disease
- Being tested
- Baseline neuroimaging, Neuroimaging during sacral neuromodulation
- Keywords
- Refractory lower urinary tract dysfunction, Sacral neuromodulation, Brain effects, Neuroimaging, Neuromodulation
- Medical subject headings
- Urologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baseline neuroimagingRadiation
Baseline neuroimaging using PET and MRI of the brain in patients before sacral neuromodulation
Neuroimaging during sacral neuromodulationRadiation
Neuroimaging during sacral neuromodulation using PET
| Study group | Role | What they receive |
|---|---|---|
| A | Other | Baseline neuroimaging Receives: Radiation: Baseline neuroimaging |
| B | Other | Neuroimaging during sacral neuromodulation Receives: Radiation: Neuroimaging during sacral neuromodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of sacral neuromodulation on brain activity
Measured: 2-8 weeks
Secondary outcomes (1)
Differences in brain activity effects of sacral neuromodulation (SNM) in patients with successful compared to failed SNM testing
Measured: immediately and 2-8 weeks after study inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2008 (estimated)
- Study startOct 2005
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract DiseaseStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Investigators
- Thomas M Kessler, MD, Principal investigator, Department of Urology, University of Bern, 3010 Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00610064
- Sponsor's protocol ID
- KEK80_05
- Other IDs
- 1025
- Status last verified
- Feb 2010
- First submitted
- 24 Jan 2008
- Last updated
- 5 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Effects of Sacral Neuromodulation in Patients With Refractory Lower Urinary Tract Dysfunction
- ClinicalTrials.gov ID
- NCT00610064
- Acronym / sponsor ID
- KEK80_05
- Conditions
- Urinary Tract Disease
- Keywords
- Refractory lower urinary tract dysfunction, Sacral neuromodulation, Brain effects, Neuroimaging, Neuromodulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- Oct 2005
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 7 Feb 2008 (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.
Sacral neuromodulation (SNM) has become an accepted treatment for patients with refractory lower urinary tract dysfunction such as urgency frequency syndrome, urgency incontinence, non-obstructive chronic urinary retention and chronic pelvic pain syndrome. Modulation of central afferent activity is considered critical to this therapeutic effect but the neural mechanisms are poorly understood.
We hypothesize that SNM has a significant effect on brain activity detectable by positron emission tomography (PET).
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Other | Radiation: Baseline neuroimagingBaseline neuroimaging |
| B | Other | Radiation: Neuroimaging during sacral neuromodulationNeuroimaging during sacral neuromodulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with refractory lower urinary tract dysfunction scheduled for sacral neuromodulation
Key exclusion criteria (3 listed)
- Pregnancy
- Age <18 years
- Claustrophobia
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 |
|---|---|---|
| Baseline neuroimagingBaseline neuroimaging using PET and MRI of the brain in patients before sacral neuromodulation | Radiation | A |
| Neuroimaging during sacral neuromodulationNeuroimaging during sacral neuromodulation using PET | Radiation | B |
Primary outcome
Effect of sacral neuromodulation on brain activity
Time frame: 2-8 weeks
1 secondary outcome
Differences in brain activity effects of sacral neuromodulation (SNM) in patients with successful compared to failed SNM testing
Time frame: immediately and 2-8 weeks after study inclusion
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 5 Feb 2010.
Related trials for Urinary Tract Disease
RecruitingPhase 2
An Open-Label Phase 2 Study of N-Acetyl-D-Mannosamine (ManNAc) in Subjects With Podocyte Diseases
Focal Segmental Glomerulosclerosis, Minimal Change Disease
RecruitingObservational study
Study of Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
RecruitingPhase 2
Psilocybin-Assisted Psychotherapy in Cancer Patients With Adjustment Disorder
Adjustment Disorder, Adjustment Disorder With Anxious Mood
Recruiting
Diuretic Tuner Clinical Decision Support
Edema, Hypervolemia
RecruitingObservational study
En-bloc Transurethral Resection of Bladder Tumor (En-bloc TURBT) Specimens Using a Redesigned Surgical Resectoscope Device
Bladder Cancer
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.
Thomas M Kessler, MD principal investigator
Department of Urology, University of Bern, 3010 Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baseline neuroimaging and Neuroimaging during sacral neuromodulation in people with Urinary Tract Disease, run by Insel Gruppe AG, University Hospital Bern 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 1 inclusion and 3 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 5 Feb 2010. 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?
Effect of sacral neuromodulation on brain activity (time frame: 2-8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Feb 2010.