Patient Registry to Study the Tined Lead Used With the InterStim System For Urinary Control - Full Text View

Sponsored by:	MedtronicNeuro
Information provided by:	MedtronicNeuro
ClinicalTrials.gov Identifier:	NCT00225966

Purpose

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

Condition	Intervention
Urge Incontinence Urinary Retention	Device: Device Medtronic InterStim Tined Leads Models 3889 and 3093

MedlinePlus related topics: Urinary Incontinence

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Patient Registry to Study the Tined Lead Used With the InterStim System For Urinary Control

Further study details as provided by MedtronicNeuro:

Primary Outcome Measures:

Incidence of adverse events requiring surgical intervention
Incidence of lead migration

Secondary Outcome Measures:

Incidence of infection

Estimated Enrollment:	153
Study Start Date:	August 2004

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00225966

Locations

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

Principal Investigator:

Medtronic Investigator

Medtronic

More Information

Study ID Numbers:	MGU-003
Study First Received:	September 12, 2005
Last Updated:	May 29, 2008
ClinicalTrials.gov Identifier:	NCT00225966
Health Authority:	United States: Institutional Review Board

Keywords provided by MedtronicNeuro:

Urinary urgency-frequency

Study placed in the following topic categories:

Signs and Symptoms
Urologic Diseases
Urination Disorders

Urinary Incontinence
Urinary Incontinence, Urge
Urinary Retention

Additional relevant MeSH terms:

Urological Manifestations

ClinicalTrials.gov processed this record on January 16, 2009