InSite for Over Active Bladder (InSite - OAB)
The purposes of this study are:
- 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.
- To fulfill the requirements of the FDA-mandated post-approval study of the safety of the tined lead using a minimally invasive approach.
Urinary Incontinence, Urgency-frequency
Drug: Standard Medical Therapy
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Prospective, Multicenter Trial Evaluating the Safety and Efficacy of InterStim® Therapy in Subjects With Symptoms of Overactive Bladder (InSite OAB)|
- Improvement in OAB symptoms [ Time Frame: 6 months ] [ Designated as safety issue: No ]To demonstrate that the OAB therapeutic success rate at 6 months is greater for the InterStim therapy group than for the Standard Medical Therapy group.
- Safety of the tined lead [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]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 33%.
- To estimate the suspected cumulative tined lead migration rate at 5 years in subjects with a full system implant. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
- To characterize the cumulative infection rate at 5 years associated with the tined lead in subjects with a full system implant. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2007|
|Study Completion Date:||August 2016|
|Primary Completion Date:||August 2016 (Final data collection date for primary outcome measure)|
Active Comparator: 2
Standard Medical Therapy
Drug: Standard Medical Therapy
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
Approximately 30 million Americans meet the criteria for overactive bladder (OAB). Urinary voiding dysfunction symptoms impose a significant physical and psychosocial impact on individuals, including loss of self-esteem and a decrease in the ability to maintain an independent lifestyle. These symptoms can substantially affect a subject's daily activities.
Patients with OAB are managed with diet modification, bladder training or retraining, pelvic muscle rehabilitation, medication and biofeedback. Medications are used as the first-line therapy for urgency frequency and urinary urge incontinence.
InterStim Therapy utilizes sacral nerve stimulation and is indicated in the US for the treatment of urinary retention and the symptoms of OAB, including urinary urge incontinence and significant symptoms of urgency-frequency alone or in combination, in subjects who have failed or could not tolerate more conservative treatments.
InSite OAB Protocol 1634 consists of two phases; Phase I which is the randomized portion of the trail and Phase II the non-randomized portion.
Phase 1: A minimum of 60 subjects randomized to InterStim and a minimum of 60 subjects randomized to SMT.
Phase 2: Non-randomized, all qualified subjects will receive InterStim, approximately 297 enrolled Subjects previously enrolled in Protocol 1634 for Urinary Urge Incontinence and Protocol 1635 for Urgency-Frequency will be included in Phase I of the new Protocol 1634 of OAB.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00547378
|Study Chair:||Steven Siegel, MD||Metro Urology|