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Patient Registry to Study the Tined Lead Used With the InterStim System For Urinary Control

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00225966
Recruitment Status : Terminated (Study design was changed and is now InSite trial #1634 - See NCT00547378)
First Posted : September 26, 2005
Last Update Posted : November 15, 2013
Sponsor:
Information provided by:
MedtronicNeuro

Brief Summary:
The purpose of this study is assess the long-term safety and effectiveness of the InterStim tined lead using a minimally invasive approach.

Condition or disease Intervention/treatment Phase
Urge Incontinence Urinary Retention Device: Device Medtronic InterStim Tined Leads Models 3889 and 3093 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Enrollment : 153 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Patient Registry to Study the Tined Lead Used With the InterStim System For Urinary Control
Study Start Date : August 2004
Study Completion Date : October 2007



Primary Outcome Measures :
  1. Incidence of adverse events requiring surgical intervention
  2. Incidence of lead migration

Secondary Outcome Measures :
  1. Incidence of infection


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Signed and dated informed consent
  • 16 years of age or greater
  • Willing and able to complete voiding diaries and questionnaires at various time points during the study
  • Located geographically near the physician, or willing and able to travel to the physician's site as necessary for all required visits
  • Failed or is not a candidate for more conservative treatment

Exclusion Criteria:

  • Severe or uncontrolled diabetes; or diabetes with peripheral nerve involvement
  • Pregnancy or planned pregnancy
  • Concomitant medical conditions which would limit the success of the procedure such as: pelvic pain with uncertain etiology, active degenerative disc disease, spinal cord injury less than six months old, bleeding complications, or a cerebrovascular accident (CVA) less than six months old.
  • Anatomical limitations that would prevent successful placement of an electrode
  • Neurological diseases such as multiple sclerosis, clinically significant peripheral neuropathy or complete spinal cord injury (e.g., paraplegia)
  • Subject characteristics indicating a poor understanding of the study or poor compliance with the study protocol (e.g. subjects with psychological and/or emotional problems, subjects unable to adequately operate equipment)
  • Subjects with knowledge of planned magnetic resonance imaging (MRI), diathermy, microwave, high output ultrasonics, ultrasound scanning, or radiofrequency (RF) energy
  • Mechanical obstruction such as benign prostatic hypertrophy, cancer, or urethral stricture
  • Symptomatic urinary tract infection (UTI). Upon completion of therapy for UTI, or if the subject is receiving prophylaxis for UTI, subjects can be considered for test stimulation or the full system implant (whichever is applicable) if symptom free for one month prior to the procedure.
  • Subjects with other implantable neurostimulators, pacemakers, or defibrillators
  • Primary stress incontinence or mixed incontinence where the stress component overrides the urge component
  • Active participation in another clinical study

Information from the National Library of Medicine

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): NCT00225966


Locations
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United States, California
Contact Medtronic for specific site information
Los Angeles, California, United States
United States, Minnesota
Contact Medtronic for site information
Minneapolis, Minnesota, United States
Sponsors and Collaborators
MedtronicNeuro
Investigators
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Principal Investigator: Medtronic Investigator Medtronic

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ClinicalTrials.gov Identifier: NCT00225966    
Other Study ID Numbers: MGU-003
First Posted: September 26, 2005    Key Record Dates
Last Update Posted: November 15, 2013
Last Verified: November 2013
Keywords provided by MedtronicNeuro:
Urinary urgency-frequency
Additional relevant MeSH terms:
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Urinary Retention
Urinary Incontinence, Urge
Urination Disorders
Urologic Diseases
Urinary Incontinence
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms