InSite for Over Active Bladder

• Status: Completed
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: MedtronicNeuro

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