Prospective, Multicenter Trial Evaluating the Safety and Efficacy of InterStim® Therapy in Subjects With Symptoms of Overactive Bladder (InSite OAB)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 571
- 主要终点
- Randomized Cohort: OAB Therapeutic Response
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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 tract mechanical obstruction such as benign prostatic hypertrophy, cancer, or urethral stricture
- •Have symptomatic urinary tract infection (UTI)
- •Have implantable neurostimulators, pacemakers, or defibrillators
- •Have primary stress incontinence or mixed incontinence where the stress component overrides the urge component
- •Have had treatment of urinary symptoms with botulinum toxin therapy in the past 12 months
- •Be a woman who is pregnant or planning to become pregnant or are a woman of child-bearing potential who is not using a medically-acceptable method of birth control
- •Have a life expectancy of less than one year
- •Have plans to enroll in another investigation device or drug trial during their participation in this trial, or currently enrolled in an investigational device or drug trial
研究组 & 干预措施
1
InterStim Therapy
干预措施: InterStim (Device)
2
Standard Medical Therapy
干预措施: Standard Medical Therapy (Drug)
结局指标
主要结局
Randomized Cohort: OAB Therapeutic Response
时间窗: 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
时间窗: 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.
次要结局
- All Implanted Cohort: Tined Lead Migration Rate(5 years)
- All Implanted Cohort: Infection Rate Associated With the Tined Lead(5 years)