Treatment of Neurogenic Detrusor Overactivity: Early Versus Late Pudendal Nerve Stimulation in Spinal Cord Injury (SCI) Patients
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| First Received Date ICMJE | January 6, 2010 | ||||||||
| Last Updated Date | January 25, 2013 | ||||||||
| Start Date ICMJE | December 2009 | ||||||||
| Primary Completion Date | October 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Videocystometry [ Time Frame: week 4, 12, 26, 38, 52 after SCI ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01043848 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Neurophysiological measurements (NCV, BCR, SSR) [ Time Frame: week 2, 4, 12, 26, 38, 52 after SCI ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Treatment of Neurogenic Detrusor Overactivity: Early Versus Late Pudendal Nerve Stimulation in Spinal Cord Injury (SCI) Patients | ||||||||
| Official Title ICMJE | Therapeutic Effects of Early and Late Onset Peripheral Pudendal Neurostimulation on Bladder Function and Autonomic Neuroplasticity in SCI - a Controlled European Multicenter Study | ||||||||
| Brief Summary | Background: Although a small group, special attention has to be given to lower urinary tract (LUT) dysfunctions in spinal cord injury (SCI) patients, as they also suffer under a loss of motor-sensory function and autonomic regulation next to the severe deficiencies in bladder and bowel control. Autonomic dysregulation linked with LUT dysfunction can cause autonomic dysreflexia with life threatening increases in blood pressure and there is still no concept for an early rehabilitation of bladder function after SCI. Hypothesis: We assume that inadequate reorganization of nerve fibres in SCI is a reason for spastic bladder dysfunction and vegetative dysregulation and that this can be positively influenced by early neuromodulation. We hypothesized that bladder dysfunction as well as autonomic dysreflexia will be positively affected. Specific aims: Evaluation, if external pudendal nerve stimulation (EPS) can positively influence LUT rehabilitation in SCI patients and if early initiation of stimulation is more effective compared to late initiation (after spinal shock). Experimental design: Prospective multicentre study in 36 SCI patients (24 treatment subjects, 12 control subjects). EPS will be started either within 10 days after SCI (early stim group) or after cessation of spinal shock (late stim group). Effects on spastic bladder function and autonomic disinhibition will be assessed by urodynamics, vegetative tests, and by electrophysiological techniques. Expected value: If early EPS is effective and complete SCI patients benefit from this intervention; and if early onset of EPS has better and longer lasting effects than late onset stimulation, the findings will be of utmost relevance not only for bladder function but also to alleviate adverse phenomena such as autonomic dysreflexia. Neurostimulation may bear the opportunity to early reshape maladaptive neuroplasticity. This would be proof of an effective modulation and promotion of neuroplasticity, thus opening up new treatment options in the field of paraplegiology. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Procedure: external electric pudendal nerve stimulation
intervention timing: twice daily for 20 minutes during 3 consecutive months. intervention procedure: electrodes will be placed around the penile shaft (in males) or clips will be directly placed on the clitoris (in females). intervention device: contic+ stimulation parameters: 10 Hz, 200μs pulse width, 10mA (or less, if too uncomfortable). Other Name: contic+, tic Medizintechnik GmbH, 46286 Dorsten, Germany |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Suspended | ||||||||
| Estimated Enrollment ICMJE | 36 | ||||||||
| Completion Date | Not Provided | ||||||||
| Primary Completion Date | October 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 85 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Spain, Switzerland | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01043848 | ||||||||
| Other Study ID Numbers ICMJE | EMSCI-NU-2/09 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| Responsible Party | University of Zurich | ||||||||
| Study Sponsor ICMJE | University of Zurich | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | University of Zurich | ||||||||
| Verification Date | January 2010 | ||||||||
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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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