InterStim Prospective Database
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|ClinicalTrials.gov Identifier: NCT00441935|
Recruitment Status : Terminated (Shift in department's research interest)
First Posted : March 1, 2007
Last Update Posted : December 26, 2017
|Condition or disease||Intervention/treatment|
|Urinary Retention Urinary Incontinence Pelvic Pain||Device: Interstim Neuromodulation|
Men and women with urinary incontinence (leakage of urine), frequency, and bladder pain experience embarrassment, inconvenience, and a significant negative impact on their quality of life. Although traditional treatments such as medications, diet modification, and bladder training provide relief for some people, others do not experience improvement with these treatments. Recently, mechanical devices much like a heart pacemaker have been developed to stimulate the nerves (sacral and pudendal) responsible for controlling bladder function. During a two stage operation, a permanent electrical wire is implanted in the lower back and connected to a mechanical box (stimulator) implanted under the patients skin in the hip area.
Participants will be asked to complete a set of questionnaires (Intake Form, Urinary Incontinence Treatment Network (UITN) Sexual Activity Questionnaire, Interstitial Cystitis Symptom Index and Problem Index, voiding diary) within 60 days prior to the procedure. Preoperative clinical information such as primary diagnosis, history of failed therapies, and medical history will be collected from the physician office record, and operative information will be collected from the inpatient hospital record. After the two stage operation (3, 6, and 12 months, then yearly thereafter as long as the device is in place) participants will be sent questionnaires. Upon completion and return to the study site
|Study Type :||Observational|
|Actual Enrollment :||736 participants|
|Official Title:||InterStim Prospective Database for Outcomes Research|
|Study Start Date :||April 2004|
|Actual Primary Completion Date :||December 16, 2016|
|Actual Study Completion Date :||December 16, 2016|
Subjects undergoing implantation of an Interstim device for neuromodulation.
Device: Interstim Neuromodulation
Two stage procedure to implant an interstim device for neuromodulation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00441935
|United States, Michigan|
|William Beaumont Hospital|
|Royal Oak, Michigan, United States, 48073|
|Principal Investigator:||Kenneth Peters, MD||William Beaumont Hospitals|