Outcomes of Pudendal InterStim
The purpose of this study is to determine how many patients who have failed treatment with a sacral lead can achieve good results with a pudendal, patients satisfaction with the results of each lead, complication rates after pudendal lead placement, and how many patients have required reprogramming of their device with EMG testing( a more costly procedure).
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Outcomes of Pudendal 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 ] [ Designated as safety issue: No ]
- To determine the outcomes of pudendal interstim in terms of complications [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||July 2008|
|Study Completion Date:||January 2010|
|Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
Patient who have had implantation of an interstim.
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|