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Sponsored by: |
MedtronicNeuro |
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Information provided by: | MedtronicNeuro |
ClinicalTrials.gov Identifier: | NCT00549094 |
The purposes of this study are:
Condition | Intervention | Phase |
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Urinary Bladder, Overactive |
Device: InterStim Therapy Drug: Standard Medical Therapy |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Prospective, Multicenter, Randomized, Parallel-Group Trial Comparing the Safety and Efficacy of InterStim® Therapy to Standard Medical Therapy for Subjects With Urgency-Frequency Symptoms of Overactive Bladder |
Estimated Enrollment: | 325 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | November 2015 |
Estimated Primary Completion Date: | August 2015 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1
InterStim Therapy
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Device: InterStim Therapy
drug therapy
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2: Active Comparator
Standard Medical Therapy
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Drug: Standard Medical Therapy
Oxybutynin 2.5mg, 5mg Oxybutynin extended release 5 mg, 10mg, 15mg Oxybutynin transdermal 3.9mg Solifenacin 5mg, 10mg Tolteradine 1mg, 2mg Tolteradine extended release 2mg, 4mg Trospium 20mg Darifenacin extended release 7.5mg, 15mg
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Approximately 30 million Americans meet the criteria for overactive bladder(OAB). Urinary voiding dysfunction symptoms impose a significant physical and psychosocial impact on individuals, including loss of self-esteem and a decrease in the ability to maintain an independent lifestyle. These symptoms can substantially affect a subject's daily activities.
Patients with OAB are managed with diet modification, bladder training or retraining, pelvic muscle rehabilitation, medication and biofeedback. Medications are used as the first-line therapy for urgency frequency and urinary urge incontinence.
InterStim Therapy utilizes sacral nerve stimulation and is indicated in the US for the treatment of urinary retention and the symptoms of OAB, including urinary urge incontinence and significant symptoms or urgency-frequency alone or in combination, in subjects who have failed or could not tolerate more conservative treatments.
This protocol will enroll approximately 325 subjects at up to 30 sites in the US and up to 5 sites in Western Europe to randomize 216 subjects to either InterStim or standard medical therapy for 6 months. At the end of the 6 months, subjects in the standard medical tehrapy arm would be eligible to try InterStim therapy.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: InSite Team | 763-514-9669 | medtronicneurotrials@medtronic.com |
United States, California | |
Recruiting | |
Culver City, California, United States, 90232 | |
Contact: InSite Team medtronicneurotrials@medtronic.com | |
United States, Florida | |
Recruiting | |
St. Petersburg, Florida, United States, 763-514-9669 | |
Contact: InSite Team medtronicneurotrials@medtronic.com | |
United States, Indiana | |
Recruiting | |
Carmel, Indiana, United States, 46032 | |
Contact: InSite Team medtronicneurotrials@medtronic.com | |
United States, Kansas | |
Recruiting | |
Kansas City, Kansas, United States, 66160 | |
Contact: InSite Team medtronicneurotrials@medtronic.com | |
United States, Louisiana | |
Recruiting | |
Shreveport, Louisiana, United States, 71106 | |
Contact: InSite Team medtronicneurotrials@medtronic.com | |
United States, Massachusetts | |
Recruiting | |
Southbridge, Massachusetts, United States, 01550 | |
Contact: InSite Team medtronicneurotrials@medtronic.com | |
United States, Michigan | |
Recruiting | |
Dearborn, Michigan, United States, 48124 | |
Contact: InSite Team medtronicneurotrials@medtronic.com | |
United States, Minnesota | |
Recruiting | |
Woodbury, Minnesota, United States, 55125 | |
Contact: InSite Team medtronicneurotrials@medtronic.com | |
United States, New Jersey | |
Recruiting | |
Lawrenceville, New Jersey, United States, 08648 | |
Contact: InSite Team medtronicneurotrials@medtronic.com | |
United States, New York | |
Recruiting | |
Albany, New York, United States, 12205 | |
Contact: InSite Team medtronicneurotrials@medtronic.com | |
United States, North Carolina | |
Recruiting | |
Gastonia, North Carolina, United States, 28054 | |
Contact: InSite Team medtronicneurotrials@medtronic.com | |
United States, Ohio | |
Recruiting | |
Cincinnati, Ohio, United States, 45212 | |
Contact: InSite Team medtronicneurotrials@medtronic.com | |
Recruiting | |
Cleveland, Ohio, United States, 44109 | |
Contact: InSite Team medtronicneurotrials@medtronic.com | |
United States, Tennessee | |
Recruiting | |
Nashville, Tennessee, United States, 37203 | |
Contact: InSite Team medtronicneurotrials@medtronic.com | |
United States, Texas | |
Recruiting | |
Temple, Texas, United States, 76508 | |
Contact: InSite Team medtronicneurotrials@medtronic.com | |
Recruiting | |
Dallas, Texas, United States, 75246 | |
Contact: InSite Team medtronicneurotrials@medtronic.com | |
Recruiting | |
Carrollton, Texas, United States, 75010 | |
Contact: InSite Team medtronicneurotrials@medtronic.com | |
Recruiting | |
McAllen, Texas, United States, 78503 | |
Contact: InSite Trial medtronicneurotrials@medtronic.com | |
United States, Washington | |
Recruiting | |
Seattle, Washington, United States, 98101 | |
Contact: InSite Team medtronicneurotrials@medtronic.com |
Study Chair: | InSite Team | Medtronic |
Responsible Party: | Medtronic Neuromodulation ( Lisa Draper ) |
Study ID Numbers: | Protocol 1635 |
Study First Received: | October 18, 2007 |
Last Updated: | July 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00549094 |
Health Authority: | United States: Institutional Review Board |
urgency-frequency, overactive bladder, urgency frequency |
Oxybutynin Signs and Symptoms Urinary Bladder, Overactive Cystocele Darifenacin |
Urologic Diseases Trospium chloride Quinuclidin-3'-yl-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate monosuccinate Urinary Bladder Diseases |
Urological Manifestations |