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| Tracking Information | |||||||||
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| First Received Date ICMJE | January 24, 2008 | ||||||||
| Last Updated Date | March 23, 2009 | ||||||||
| Start Date ICMJE | October 2005 | ||||||||
| Estimated Primary Completion Date | June 2009 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Effect of sacral neuromodulation on brain activity [ Time Frame: 2-8 weeks ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00610064 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Brain Effects of Sacral Neuromodulation | ||||||||
| Official Title ICMJE | Brain Effects of Sacral Neuromodulation in Patients With Refractory Lower Urinary Tract Dysfunction | ||||||||
| Brief 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. 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). |
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| Detailed Description | |||||||||
| Study Phase | |||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Basic Science, Non-Randomized, Open Label, Crossover Assignment, Efficacy Study | ||||||||
| Condition ICMJE | Urinary Tract Disease | ||||||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 30 | ||||||||
| Estimated Completion Date | June 2009 | ||||||||
| Estimated Primary Completion Date | June 2009 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Switzerland | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00610064 | ||||||||
| Responsible Party | Thomas M. Kessler, MD, Department of Urology, University of Bern, 3010 Bern | ||||||||
| Study ID Numbers ICMJE | KEK80_05, 1025 | ||||||||
| Study Sponsor ICMJE | University Hospital Inselspital, Berne | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | University Hospital Inselspital, Berne | ||||||||
| Verification Date | March 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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