InSite for Over Active Bladder (NCT00547378) | Clinical Trial Compass
CompletedPhase 4
InSite for Over Active Bladder
571 participantsStarted 2007-10
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 tr…
What they're measuring
1
Randomized Cohort: OAB Therapeutic Response
Timeframe: 6 months
2
All Implanted Cohort: Adverse Events Related to the Tined Lead That Require Surgery