Evaluation of InterStim Micro System Performance and Safety (ELITE) to Confirm Long-Term Outcomes - Post Market Clinical Follow-Up Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 148
- 试验地点
- 47
- 主要终点
- Change From Baseline for HRQL Total Score
研究概览
简要总结
Post-market clinical follow-up for continued assessment of safety and performance to confirm long-term outcomes of the InterStim Micro System for sacral neuromodulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 as demonstrated on a 3-day voiding diary with greater than or equal to 8 urgency frequency episodes per day and/or by having a minimum of 3 episodes of urinary urge incontinence in 72 hours
- •Subjects 18 years of age or older
- •Candidate for sacral neuromodulation therapy in accordance with the InterStim Micro System labeling
- •Willing and able to accurately complete study diaries, questionnaires, attend visits, device recharging and comply with the study protocol
- •Willing and able to provide signed and dated informed consent
排除标准
- •Have neurological conditions such as multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury (e.g., paraplegia)
- •Have primary stress incontinence or mixed incontinence where the stress component overrides the urge component
- •Current urinary tract mechanical obstruction (e.g. benign prostatic enlargement or urethral stricture)
- •Have had treatment of urinary symptoms with botulinum toxin therapy in the past 12 months
- •Have knowledge of planned shortwave diathermy, microwave diathermy, or therapeutic diathermy
- •Women who are pregnant or planning to become pregnant
- •Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements.
- •Concurrent participation in another clinical study that may add additional safety risks and/or confound study results.
- •Fecal Incontinence Cohort
- •Inclusion Criteria:
- •Have a diagnosis of fecal incontinence as demonstrated by a 7-day bowel diary as greater than or equal to 2 incontinent episodes of more than staining (i.e., either slight, moderate or severe soiling)
- •Subjects 18 years of age or older
- •Candidate for sacral neuromodulation therapy in accordance with the InterStim Micro System labeling
- •Willing and able to accurately complete study diaries, questionnaires, attend visits, device recharging and comply with the study protocol
- •Willing and able to provide signed and dated informed consent
- •Exclusion Criteria:
- •Have neurological conditions such as multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury (e.g., paraplegia)
- •Uncorrected high grade internal rectal prolapse
- •Have knowledge of planned shortwave diathermy, microwave diathermy, or therapeutic diathermy
- •Women who are pregnant or planning to become pregnant
- •Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements.
- •Concurrent participation in another clinical study that may add additional safety risks and/or confound study results.
- •Non-Obstructive Urinary Retention Cohort
- •Inclusion Criteria:
- •Have a diagnosis of non-obstructive urinary retention as demonstrated by a 7-day urinary voiding diary with a minimum of 5 clean intermittent self-catheterizations
- •Chronic non-obstructive urinary retention with an elevated post-void residual (PVR) that has persisted for at least six months and is documented on two or more separate occasions.
- •Subjects 18 years of age or older
- •Candidate for sacral neuromodulation therapy in accordance with the InterStim Micro System labeling
- •Willing and able to accurately complete study diaries, questionnaires, attend visits, device recharging and comply with the study protocol
- •Willing and able to provide signed and dated informed consent
- •Exclusion Criteria:
- •Have neurological conditions such as multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury (e.g., paraplegia)
- •Current urinary tract mechanical obstruction (e.g. benign prostatic enlargement or urethral stricture)
- •Have knowledge of planned shortwave diathermy, microwave diathermy, or therapeutic diathermy .
- •Women who are pregnant or planning to become pregnant
- •Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements.
- •Concurrent participation in another clinical study that may add additional safety risks and/or confound study results.
结局指标
主要结局
Change From Baseline for HRQL Total Score
时间窗: 3 months
The Overactive Bladder Quality of Life Questionnaire (OAB-q) is a 33-item validated questionnaire that was developed to assess symptom bother and the impact of overactive bladder (OAB) on health-related quality of life (HRQL).8 Specifically, The OAB-q consists of an 8-item symptom bother scale and 25-item HRQL scale with 4 domains: coping (8 items), concern/worry (7 items), sleep (5 items) and social interaction (5 items). The score for each of OAB-q domain are summed and transformed to a score ranging from zero to 100. We are reporting the change from baseline for HRQL total score. If the change is positive, it means a better quality of life. The higher the positive change is, the better the quality of life is.
Change From Baseline in CCIS Score
时间窗: 3 months
The Cleveland Clinic Incontinence Score (Wexner Score) is an established 5-item questionnaire that was developed to assess the frequency and severity of fecal incontinence. CCIS-Wexner score ranges between 0 and 20. Higher scores indicate worse incontinence. We are reporting the change from baseline for CCIS Score. If the change is negative, the quality of life improved from baseline. The more negative the score is, the better the quality of life is.
Change From Baseline in the Number of CISC/Day
时间窗: 3 months
Subjects reported the clean intermittent self-catheterizations on voiding diaries for 7 consecutive days. We are reporting the change from baseline. If the change is negative, the quality of life is improved from baseline.
次要结局
未报告次要终点