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| Descriptive Information Fields | |||||||||
| Brief Title † | Brain Effects of Sacral Neuromodulation | ||||||||
| Official Title † | 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 † | Interventional | ||||||||
| Study Design † | Basic Science, Non-Randomized, Open Label, Crossover Assignment, Efficacy Study | ||||||||
| Primary Outcome Measure † | Effect of sacral neuromodulation on brain activity [ Time Frame: 2-8 weeks ] [ Designated as safety issue: No ] | ||||||||
| Secondary Outcome Measure † | 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 ] | ||||||||
| Condition † | Urinary Tract Disease | ||||||||
| Intervention † | Radiation: Baseline neuroimaging Radiation: Neuroimaging during sacral neuromodulation |
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 30 | ||||||||
| Start Date † | October 2005 | ||||||||
| Completion Date | June 2009 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | Switzerland | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00610064 | ||||||||
| Organization ID | KEK80_05 | ||||||||
| Secondary IDs †† | 1025 | ||||||||
| Study Sponsor † | University Hospital Inselspital, Berne | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | University Hospital Inselspital, Berne | ||||||||
| Verification Date | July 2008 | ||||||||
| First Received Date † | January 24, 2008 | ||||||||
| Last Updated Date | July 3, 2008 | ||||||||
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