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| Tracking Information | |||||
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| First Received Date ICMJE | September 24, 2007 | ||||
| Last Updated Date | September 24, 2007 | ||||
| Start Date ICMJE | September 2007 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
The objective of this study is to determine the efficacy of a sham for posterior tibial nerve stimulation (PTNS). [ Time Frame: Prospective ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Posterior Tibial Nerve Stimulation vs. Sham | ||||
| Official Title ICMJE | Posterior Tibial Nerve Stimulation vs. Sham | ||||
| Brief Summary | The overall goal of this research is to determine the efficacy of a sham for posterior tibial nerve stimulation (PTNS). This novel design is needed in order to have a sham treatment that is similar to the actual treatment. The PTNS is used to treat urgency and frequency in people with overactive bladder (OAB). Until research is done using a sham component, we are unable to ascertain if the current use of PTNS is due to a placebo effect. |
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| Detailed Description | Subjects will be healthy volunteers who are recruited by word of mouth. At their office visit with the Nurse Practitioner (NP), the subject's history and medication list will be reviewed. The NP will randomize subjects into groups: one group with the PTNS on the right and sham on the left; the other group with the PTNS on the left and sham on the right. There will be a maximum of 30 subjects tested, and up to 50 people screened. The subjects will have 1 session for the testing of the PTNS vs sham that will include 15 minutes of stimulation as noted below. All participants will be blinded to the therapy they receive as described below. |
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| Study Phase | Phase III | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Other, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment | ||||
| Condition ICMJE | Overactive Bladder | ||||
| 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 | Completed | ||||
| Enrollment ICMJE | 30 | ||||
| Completion Date | September 2007 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00534521 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | 2007-145 | ||||
| Study Sponsor ICMJE | William Beaumont Hospitals | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | William Beaumont Hospitals | ||||
| Verification Date | September 2007 | ||||
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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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