NCT03335761已完成不适用
InterStim® Amplitude Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 97
- 试验地点
- 35
- 主要终点
- Change in Urinary Urge Incontinence (UUI) Episodes Per Day From Baseline to 12 Weeks.
研究概览
简要总结
This feasibility study will explore the effects of three different InterStim amplitude settings on overactive bladder symptoms (OAB).
详细描述
This is a prospective, randomized, multicenter, single-blinded study to explore the efficacy and quality of life (QoL) of 3 different amplitude settings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Primary diagnosis of urinary urge incontinence (UUI) as demonstrated on a 3-day baseline voiding diary demonstrating at least 3 UUI episodes
- •Female subjects 18 years of age or older
- •Candidate for InterStim Lead Placement
- •Willing and able to accurately complete voiding diaries, questionnaires, attend visits, and comply with the study protocol (which includes maintenance of InterStim II programming settings over the course of the study)
- •Willing and able to provide signed and dated informed consent
- •Willing to maintain current regimen (dosage and frequency) of any overactive bladder (OAB) medication
排除标准
- •Have neurological conditions such as multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury
- •History of diabetes unless the diabetes is well-controlled through diet and/or medications
- •Symptomatic urinary tract infection (UTI)
- •Have primary stress incontinence or mixed incontinence where the stress component overrides the urge component
- •Treatment of urinary symptoms with botulinum toxin in the past 9 months or any plan to have botulinum toxin treatment during the study
- •Implanted with a neurostimulator, pacemaker, or defibrillator
- •Have knowledge of planned MRIs, diathermy, microwave exposure, high output ultrasonic exposure, or radio frequency (RF) energy exposure not included within the scanning conditions provided with the MRI Guidelines for InterStim Therapy
- •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.
- •Currently enrolled or planning to enroll in a potentially confounding clinical study during the course of the study (co-enrollment in concurrent studies is only allowed when documented pre-approval is obtained from the Medtronic study manager (or designee).
结局指标
主要结局
Change in Urinary Urge Incontinence (UUI) Episodes Per Day From Baseline to 12 Weeks.
时间窗: 12 weeks
Symptoms related to OAB were evaluated using paper voiding diaries. Subjects were trained to complete the urinary voiding diaries for 3-days.
次要结局
- Change in QoL Using ICIQ-OAB QOL From Baseline to 12 Weeks.(12 weeks)
研究者
研究点 (35)
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