InSite for Over Active Bladder
Condition: Urinary Incontinence, Urgency-frequency; Overactive Bladder
MeSH terms: Urinary Incontinence; Enuresis; Urinary Bladder, Overactive
Intervention: InterStim; Standard Medical Therapy
Intervention description: Oxybutynin 2.5mg, 5mg Oxybutynin extended release 5 mg, 10mg, 15mg Oxybutynin transdermal 3.9mg Solifenacin 5mg, 10mg Tolterodine 1mg, 2mg Tolterodine extended release 2mg, 4mg Trospium 20mg Darifenacin extended release 7.5mg, 15mg fesoterodine Fumarate 4mg, 8mg
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 571.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: overactive bladder, urinary incontinence, incontinence,Urgency-frequency

Summary:

      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.
    

Eligibility criteria:

        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
             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)

          -  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
             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

          -  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