Outcomes of Pudendal InterStim
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|ClinicalTrials.gov Identifier: NCT00719589|
Recruitment Status : Completed
First Posted : July 21, 2008
Last Update Posted : March 24, 2010
|Condition or disease|
InterStim is a bladder pacemaker device that has been in use for over 10 years for patients with voiding dysfunction. Although standard of care is to place the lead at the sacral nerve, in some patients a better response is obtained by placing the lead at the pudendal nerve.
Data will be collected from the subjects medical records and a questionnaire will be mailed one time to assess patients perception of improvement and treatment satisfaction after pudendal Interstim.
|Study Type :||Observational|
|Actual Enrollment :||84 participants|
|Observational Model:||Case Control|
|Official Title:||Outcomes of Pudendal InterStim|
|Study Start Date :||July 2008|
|Actual Primary Completion Date :||January 2010|
|Actual Study Completion Date :||January 2010|
Patient who have had implantation of an interstim.
- To determine the outcomes of pudendal interstim in terms of number of failed sacral lead patients that can be salvaged with a pudendal lead, [ Time Frame: 2 years ]
- To determine the outcomes of pudendal interstim in terms of complications [ Time Frame: 2 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00719589
|United States, Michigan|
|William Beaumont Hospital-Royal Oak|
|Royal Oak, Michigan, United States, 48073|
|Principal Investigator:||Kenneth M Peters, MD||William Beaumont Hospital - Royal Oak|