drugset / Trial / NCT00547378
InSite for Over Active Bladder
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2007-10
- Primary completion
- 2016-08
- Completion
- 2016-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Darifenacin | Small molecule | 7.5 mg | — |
| Comparator | Darifenacin | Small molecule | 15 mg | — |
| Comparator | Oxybutynin | Small molecule | 2.5 mg | Other |
| Comparator | Oxybutynin | Small molecule | 3.9 mg | Other |
| Comparator | Oxybutynin | Small molecule | 5 mg | Other |
| Comparator | Oxybutynin | Small molecule | 10 mg | Other |
| Comparator | Oxybutynin | Small molecule | 15 mg | Other |
| Comparator | Solifenacin | Small molecule | 5 mg | — |
| Comparator | Solifenacin | Small molecule | 10 mg | — |
| Comparator | Standard Medical Therapy | Unknown | 4 mg | — |
| Comparator | Standard Medical Therapy | Unknown | 8 mg | — |
| Comparator | Tolterodine | Small molecule | 1 mg | — |
| Comparator | Tolterodine | Small molecule | 2 mg | — |
| Comparator | Tolterodine | Small molecule | 4 mg | — |
| Comparator | Trospium | Small molecule | 20 mg | — |