InSite for Urinary Urge Incontinence

Condition(s) targeted: Urinary Incontinence, Urge; Overactive Bladder

Intervention: InterStim (Device); Standard Medical Therapy (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: MedtronicNeuro

Official(s) and/or principal investigator(s):
InSite Team, Study Chair, Affiliation: Medtronic

Overall contact:
InSite Team, Email: medtronicneurotrials@medtronic.com

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.

Official title: Prospective, Multicenter, Randomized, Parallel-Group Trial, Comparing the Safety and Efficacy of InterStim® Therapy to Standard Medical Therapy for Subjects With Urinary Urge Incontinent Symptoms of Overactive Bladder

Study design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Improvement in urinary incontinence

Secondary outcome: Safety

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 of urgency-frequency alone or in combination, in subjects who have failed or could not tolerate more conservative treatments.

This protocol will enroll approximately 150 subjects at up to 30 sites in the US and up to 5 in Western Europe to randomize 100 subjects to either InterStim or standard medical therapy for 6 months. At the end of the 6 months, subjects in the standard medical therapy arm would be eligible to try InterStim therapy.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Have a diagnosis of OAB including urinary urge incontinence

- 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 anticholinergic 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 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.

InSite Team, Email: medtronicneurotrials@medtronic.com

Culver City, California 90232, United States; Recruiting
InSite Team, Email: medtronicneurotrials@medtronic.com

St. Petersburg, Florida 33710, United States; Recruiting
InSite Team, Email: medtronicneurotrials@medtronic.com

Carmel, Indiana 46032, United States; Recruiting
InSite Team, Email: medtronicneurotrials@medtronic.com

Kansas City, Kansas 66160, United States; Recruiting
InSite Team, Email: medtronicneurotrials@medtronic.com

Shreveport, Louisiana 71106, United States; Recruiting
InSite Team, Email: medtronicneurotrials@medtronic.com

Southbridge, Massachusetts 01550, United States; Recruiting
InSite Team, Email: medtronicneurotrials@medtronic.com

Dearborn, Michigan 48124, United States; Recruiting
InSite Team, Email: medtronicneurotrials@medtronic.com

Woodbury, Minnesota 55125, United States; Recruiting
InSite Team, Email: medtronicneurotrials@medtronic.com

Lawrenceville, New Jersey 08648, United States; Recruiting
InSite Team, Email: medtronicneurotrials@medtronic.com

Albany, New York 12205, United States; Recruiting
InSite Team, Email: medtronicneurotrials@medtronic.com

Gastonia, North Carolina 28054, United States; Recruiting
InSite Team, Email: medtronicneurotrials@medtronic.com

Cincinnati, Ohio 45212, United States; Recruiting
InSite Team, Email: medtronicneurotrials@medtronic.com

Cleveland, Ohio 44109, United States; Recruiting
InSite Team, Email: medtronicneurotrials@medtronic.com

Nashville, Tennessee 37203, United States; Recruiting
InSite Team, Email: medtronicneurotrials@medtronic.com

Temple, Texas 76508, United States; Recruiting
InSite Team, Email: medtronicneurotrials@medtronic.com

Dallas, Texas 75246, United States; Recruiting
InSite Team, Email: medtronicneurotrials@medtronic.com

Carrolton, Texas 75010, United States; Recruiting
InSite Team, Email: medtronicneurotrials@medtronic.com

McAllen, Texas 78503, United States; Recruiting
InSite Team, Email: medtronicneurotrials@medtronic.com

Seattle, Washington 98101, United States; Recruiting
InSite Team, Email: medtronicneurotrials@medtronic.com

Starting date: October 2007
Ending date: November 2015
Last updated: July 18, 2008