InSite for Over Active Bladder (InSite - OAB)
|ClinicalTrials.gov Identifier: NCT00547378|
Recruitment Status : Completed
First Posted : October 22, 2007
Results First Posted : December 12, 2017
Last Update Posted : December 12, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Urinary Incontinence, Urgency-frequency Overactive Bladder||Device: InterStim Drug: Standard Medical Therapy||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||571 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective, Multicenter Trial Evaluating the Safety and Efficacy of InterStim® Therapy in Subjects With Symptoms of Overactive Bladder (InSite OAB)|
|Study Start Date :||October 2007|
|Actual Primary Completion Date :||August 2016|
|Actual Study Completion Date :||August 2016|
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
- Randomized Cohort: OAB Therapeutic Response [ Time Frame: 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 [ Time Frame: 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.
- All Implanted Cohort: Tined Lead Migration Rate [ Time Frame: 5 years ]To estimate the suspected cumulative tined lead migration rate at 5 years in subjects with a full system implant. Suspected tined lead migration resulting in an adverse event of lead migration/dislodgement meets the definition of this endpoint.
- All Implanted Cohort: Infection Rate Associated With the Tined Lead [ Time Frame: 5 years ]To characterize the cumulative infection rate at 5 years associated with the tined lead in subjects with a full system implant.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00547378
|Study Chair:||Steven Siegel, MD||Metro Urology|