InterStim® Sacral Nerve Modulation Cycling Study

MedtronicNeuro3 个研究点分布在 1 个国家目标入组 30 人开始时间: 2013年9月1日最近更新: 2017年12月12日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: MedtronicNeuro
入组人数: 30
试验地点: 3
主要终点: Number of Urinary Urge Incontinent (UUI) Episodes Per Day - Randomized Portion

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The study will assess the effects of different InterStim cycling settings on urinary urge incontinence.

详细描述

This feasibility study will assess the following outcomes:

Voiding diaries
Patient reported assessments of response or satisfaction
Adverse events

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
主要目的: Treatment
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

•Implanted with either Neurostimulator Model 3023 (InterStim) or Neurostimulator Model 3058 (InterStim II) for at least 3 months
•Implanted with tined lead models 3889 or 3093
•Tined lead is located at S3 as determined by sensory or motor responses or x-ray or fluoroscopy
•Currently showing some efficacy with an InterStim device but has the potential to be optimized per the opinion of the Investigator
•Primary diagnosis before InterStim implant is urinary urge incontinence.
•Must be willing to maintain her current regimen (dosage and frequency) of any overactive bladder (OAB) medication (anticholinergic, antimuscarinic or Myrbetriq (Mirabegron)) or tricyclic antidepression medication over the study duration, if applicable.
•Female subject 18 years of age or older
•Willing and able to accurately complete voiding diaries and questionnaires, attend visits (within the visit windows +7 days), and comply with the study protocol that includes maintenance of InterStim programming settings over the course of the study
•Have had no more than one (InterStim) reprogramming at or within 28 days at or prior to randomization
•Able to consent to participate by signing the Informed Consent Form

排除标准

•History of Multiple sclerosis
•History of Reiter's syndrome
•History of spinal cord injury or a cerebral vascular accident (CVA)
•History of diabetes unless the diabetes is well-controlled through diet and/or medications
•Active symptomatic urinary tract infection (UTI)
•Stress incontinence as the primary diagnosis
•Urgency frequency as a primary diagnosis
•Pelvic pain of uncertain etiology that is not associated with a voiding dysfunction or where pelvic pain is the primary diagnosis
•Interstitial cystitis as the primary diagnosis
•Urinary retention as the primary diagnosis
•Treatment of urinary symptoms with botulinum toxin in the past 12 months or any plan to have botulinum toxin treatment during the study
•Bilateral lead placement
•Have other implantable neurostimulator, pacemaker, or defibrillator
•Have knowledge of planned diathermy, microwave exposure, high output ultrasonic exposure, RF energy exposure, or MRI scans not included within the scanning conditions provided within the MRI Guidelines for InterStim Therapy neurostimulation systems.
•Have an anticipated system modification within the next 5 months
•Women who are pregnant or planning to become pregnant (women of child-bearing potential must undergo a pregnancy test, with a clear negative result, no more than 7 days prior to randomization visit)
•Subjects who frequently use the patient programmer to change device program settings ("frequently" is defined as at least once a day and does not include shutting off the device for safety purposes)
•Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol.
•Study site personnel will contact the Medtronic Study Manager (or designee) to determine if a potential subject who plans to enroll in an investigational device or drug trial, or is currently enrolled in an investigational device or drug trial is eligible for this study