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InSite for Urinary Urgency-Frequency (InSite - UF)
This study is currently recruiting participants.
Verified by MedtronicNeuro, May 2008
Sponsored by: MedtronicNeuro
Information provided by: MedtronicNeuro
ClinicalTrials.gov Identifier: NCT00549094
  Purpose

The purposes of this study are:

  1. To provide evidence from a randomized controlled trial that InterStim Therapy provides better relief of symptoms of OAB than standard medical treatments in current use.
  2. To fulfill the requirements of the FDA-mandated post-approval study of the safety of the tined lead using a minimally invasive approach.

Condition Intervention Phase
Urinary Bladder, Overactive
Device: InterStim Therapy
Drug: Standard Medical Therapy
Phase IV

Drug Information available for: Solifenacin succinate Solifenacin Darifenacin Darifenacin hydrobromide Oxybutynin Oxybutynin chloride
U.S. FDA Resources
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

Further study details as provided by MedtronicNeuro:

Primary Outcome Measures:
  • Decrease in urinary frequency [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

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
1
InterStim Therapy
Device: InterStim Therapy
drug therapy
2: Active Comparator
Standard Medical Therapy
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have a diagnosis of OAB including urinary urgency-frequency
  • Be male or female at least 18 years of age or older
  • Be able to consent to participate by signing the Informed Consent
  • Be willing and able to attend visits and comply with the study protocol including adequate operation of equipment
  • Have failed or are not a candidate for more conservative treatment (e.g. pelvic floor training, biofeedback, behavioral modification)
  • Have failed or could not tolerate (stopped taking medication due to lack of efficacy or intolerable side effects) at least one anticholinergic or antimuscarinic medication AND have at least one anticholiergic or antimuscarinic medication not yet attempted

Exclusion Criteria:

  • Have severe or uncontrolled diabetes or diabetes with peripheral nerve involvement
  • Have concomitant medical conditions which would limit the success of the study procedure
  • Have skin, orthopedic or neurologic anatomical limitations that could prevent successful placement of an electrode
  • Have neurological diseases such as multiple sclerosis, clinically significant peripheral neuropathy or complete spinal cord injury (e.g., paraplegia)
  • Have knowledge of planned MRIs, diathermy, microwave exposure, high output ultrasonic exposure, or RF energy exposure
  • Have urinary tract mechanical obstruction such as benign prostatic hypertrophy, cancer, or urethral stricture
  • Have symptomatic urinary tract infection (UTI). Upon completion of therapy for UTI, or if the subject is receiving prophylaxis for UTI, the subject can be considered for study entry if he/she is symptom-free for one month prior to randomization.
  • Have implantable neurostimulators, pacemakers, or defibrillators
  • Have primary stress incontinence or mixed incontinence where the stress component overrides the urge component
  • Have a primary diagnosis of Interstitial Cystitis
  • Have had treatment of urinary symptoms with botulinum toxin therapy in the past 12 months
  • Be a woman who is pregnant or planning to become pregnant or are a woman of child-bearing potential who is not using a medically-acceptable method of birth control.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00549094

Contacts
Contact: InSite Team 763-514-9669 medtronicneurotrials@medtronic.com

Locations
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    
Sponsors and Collaborators
MedtronicNeuro
Investigators
Study Chair: InSite Team Medtronic
  More Information

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

Keywords provided by MedtronicNeuro:
urgency-frequency, overactive bladder, urgency frequency

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
Urological Manifestations

ClinicalTrials.gov processed this record on January 15, 2009