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Prospective, Multicenter Trial Evaluating the Safety and Efficacy of InterStim® Therapy in Subjects With Symptoms of Overactive Bladder (InSite OAB) (InSite - OAB)
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.
Details
| Lead sponsor | MedtronicNeuro |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 571 |
| Start date | 2007-10 |
| Completion | 2016-08 |
Conditions
- Urinary Incontinence, Urgency-frequency
- Overactive Bladder
Interventions
- InterStim
- Standard Medical Therapy
Primary outcomes
- Randomized Cohort: OAB Therapeutic Response — 6 months
To demonstrate that the OAB therapeutic response rate at 6 months is greater for the InterStim therapy group than for the Standard Medical Therapy group. OAB therapeutic response rate was calculated as number of subjects with OAB therapeutic response divided by number of subjects included in the analysis. OAB therapeutic response was defined as: * at least 50% or greater improvement in average leaks/day from baseline for subjects with urinary incontinence at baseline or * at least 50% improvement in average voids/day from baseline or a return to normal voiding frequency (\<8 voids/day) for subjects with urgency-frequency at baseline. - All Implanted Cohort: Adverse Events Related to the Tined Lead That Require Surgery — 5 years
To demonstrate that the upper bound of the 95% CI for the cumulative five-year rate of adverse events related to the tined lead that require surgery is less than 0.33. Adverse events on or after neurostimulator implant with an etiology of lead and with an intervention of surgical intervention/revision are the event of interest.