适应症
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 性别
- All
入选标准
- •1. Aged 18 years or older
- •2. Provides written informed consent
- •3. Primary indication of UUI (with or without UF) or chronic FI who failed or could not tolerate more conservative treatments and implanted with the Axonics F15 SNM System and who have reached 1-year or greater, post-implant
- •4. Completion of a baseline pre-PNE 3-day bladder diary for UUI or a minimum of 7-day pre-PNE bowel diary for FI
- •5. English speaking
排除标准
- •1. Any significant medical condition that is likely to interfere with trial procedures, device operation, or likely to confound evaluation of trial endpoints (i.e., exclusion of neurological conditions such as multiple sclerosis)
- •2. Any psychiatric or personality disorder that is likely to interfere with trial procedures at the discretion of the participating physician; this may include poor understanding or compliance with trial requirements
- •3. A female who is breastfeeding
- •4. A female with a positive urine pregnancy test
- •5. Intradetrusor chemodenervation with OnabotulinumtoxinA (Botox) injections within 6 months prior to study follow-up visit
- •6. Prior history of pelvic or rectal cancer
- •7. Prior history of pelvic radiation
研究者
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