Direct Full-stage Implantation of Sacral Neuromodulation
赞助:
Loma Linda University
合作者:
信息的提供 (责任方):
Andrea Staack，Loma Linda University
| 追踪信息 | |||
|---|---|---|---|
| 首次提交日期 ICMJE | October 4, 2018 | ||
| 首次发布日期e ICMJE | October 5, 2018 | ||
| 最后更新发布日期 | October 5, 2018 | ||
| 预计研究开始日期 ICMJE | October 2018 | ||
| 预计主要完成日期 | November 2019 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
Improvement in overactive bladder symptoms[ Time Frame: 1 year ] measured using overactive bladder questionnaire |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | Direct Full-stage Implantation of Sacral Neuromodulation | ||
| 正式标题 ICMJE | Direct Full-stage Implantation of Sacral Neuromodulation | ||
| 简要概况 | The purpose of this investigator-initiated study is to investigate the efficacy and costs of direct full stage sacral neuromodulation in patients with overactive bladder. Patients with refractory OAB and urge urinary incontinence will undergo direct full stage implantation and be followed for a period of 6 months to monitor symptom improvement with voiding diaries and validated questionnaires preoperatively and postoperatively. Therapeutic and adverse outcomes will be evaluated. The use of medical resources and time off of work will be analyzed as well. This will be a descriptive study with no additional arms or randomization. |
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| 详细说明 | |||
| 研究类型 ICMJE | Observational | ||
| 研究阶段 | |||
| 研究设计 ICMJE | 分配: 干预模型: 干预模型描述: 盲法: Observational 盲法描述: 主要目的: |
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| 适用条件 ICMJE | |||
| 干预项目 ICMJE |
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| 研究工具 |
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| 招募信息 | |||
| 招募状态 ICMJE | Not yet recruiting | ||
| 预计入组 ICMJE |
30 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | November 2019 | ||
| 预计主要完成日期 | November 2019 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: - Patients >18 years of age - Female gender - Refractory overactive bladder: wet failing treatment with two or more anticholinergic and/or beta-3 agonist agents - Willing to stop treatment with anticholingeric and/or beta-3 agonist agents during the study period (2 week washout period preoperatively and 6 months postoperative) - Willing and able to complete study questionnaires, use Medtronic device programmer, return for scheduled follow-up appointments - Surgical candidate able to hold antiplatelet or anticoagulation prior to surgery - Health insurance provider that will cover full-stage implantation Exclusion Criteria: - Age <18 - Pregnant or planning to become pregnant - Male gender - Unable or unwilling to stop anticholingeric and/or beta-3 agonist agents during the study period - Treatment with botulinum toxin within last 6 months - Recent surgery for stress urinary incontinence or pelvic organ prolapse within last 6 months - Severe pelvic organ prolapse - Post-void residual >150 ml - Symptomatic or recurrent urinary tract infection - Neurologic disorders: cerebrovascular accident with neurologic deficits, Parkinson's, multiple sclerosis, spinal cord injury, significant peripheral neuropathy - Cognitive disorders, e.g. dementia - Interstitial cystitis or chronic pelvic pain syndrome - Poorly controlled diabetes mellitus (HbA1c >10%) - History of bladder malignancy, pelvic radiation, urinary retention requiring catheterization - Anticipated or known need for MRI at the trunk - History of or anticipated surgery at the lower back - Unable to hold antiplatelet or anticoagulation prior to surgery - Life expectancy <1 year | ||
| 性别 |
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| 年龄 | 最小年龄：18 Years ，最大年龄：100 Years | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | United States | ||
| 管理信息 | 数据检测委员会 | ||
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: Yes |
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| IPD 共享声明 |
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| 责任方 | Andrea Staack，Loma Linda University | ||
| 研究赞助商 ICMJE | Loma Linda University | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
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| PRS 账户 | Loma Linda University | ||
| 验证日期 | October 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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