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InSite for Over Active Bladder

Information source: MedtronicNeuro
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Urinary Incontinence, Urgency-frequency,; Overactive Bladder

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

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: MedtronicNeuro

Official(s) and/or principal investigator(s):
Steven Siegel, MD, Study Chair, Affiliation: Metro Urology


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.

Clinical Details

Official title: Prospective, Multicenter Trial Evaluating the Safety and Efficacy of InterStim® Therapy in Subjects With Symptoms of Overactive Bladder (InSite OAB)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Improvement in OAB symptoms

Safety of the tined lead

Secondary outcome:

To estimate the suspected cumulative tined lead migration rate at 5 years in subjects with a full system implant.

To characterize the cumulative infection rate at 5 years associated with the tined lead in subjects with a full system implant.

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. InSite OAB Protocol 1634 consists of two phases; Phase I which is the randomized portion of the trail and Phase II the non-randomized portion. Phase 1: A minimum of 60 subjects randomized to InterStim and a minimum of 60 subjects randomized to SMT. Phase 2: Non-randomized, all qualified subjects will receive InterStim, approximately 297 enrolled Subjects previously enrolled in Protocol 1634 for Urinary Urge Incontinence and Protocol 1635 for Urgency-Frequency will be included in Phase I of the new Protocol 1634 of OAB.


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


Inclusion Criteria:

- Have a diagnosis of OAB including urinary urge incontinence or 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 anticholinergic or antimuscarinic medication not yet attempted

- Have been on current regiment of OAB medications or have not been on any OAB

medications, for at least 4 weeks prior to beginning the baseline voiding diary 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


- 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)

- Have implantable neurostimulators, pacemakers, or defibrillators

- Have primary stress incontinence or mixed incontinence where the stress component

overrides the urge component

- Have had treatment of urinary symptoms with botulinum toxin therapy in the past 12


- 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

- Have a life expectancy of less than one year

- Have plans to enroll in another investigation device or drug trial during their

participation in this trial, or currently enrolled in an investigational device or drug trial

Locations and Contacts

Birmingham, Alabama 35209, United States

Phoenix, Arizona 85032, United States

Stanford, California 94305, United States

Sarasota, Florida 34237, United States

St. Petersburg, Florida 33710, United States

Meridian, Idaho 83642, United States

Kansas City, Kansas 66160, United States

Uxbridge, Massachusetts 01569, United States

Grand Rapids, Michigan 49503, United States

Jackson, Michigan 49203, United States

Plymouth, Minnesota 55441, United States

Woodbury, Minnesota 55125, United States

Brick, New Jersey 08724, United States

Cleveland, Ohio 44109, United States

Columbus, Ohio 43221, United States

Oklahoma City, Oklahoma 73104, United States

Arlington, Texas 76017, United States

Carrolton, Texas 75010, United States

Dallas, Texas 75246, United States

Temple, Texas 76508, United States

Additional Information

Starting date: October 2007
Last updated: June 22, 2015

Page last updated: August 23, 2015

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