JPRN-jRCT2032210323进行中（未招募）3 期
Prospective, multi-center, randomized, double-blind sham-controlled trial of the urinary dysfunction treatment device O-NES in patients with refractory overactive bladder with urinary incontinence (pivotal trial)
Mukai Yoichi0 个研究点目标入组 180 人开始时间: 2021年9月16日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 180
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •They are aged 20 years or older at the time they give their informed consent.
- •-They have been treated with anticholinergic drugs and beta3 receptor agonists in the past, but the symptoms of overactive bladder are persisting or they cannot use therapeutic drugs of overactive bladder due to certain reasons such as contraindications.
- •-They have 2 points or higher of urinary urgency score (question 3) and 2 points or higher of urgency urinary incontinence score (question 4) in OABSS.
- •-Their mean urinary incontinence with urinary urgency per day is 1 time or more and their mean urinary frequency per day is 8 times or more.
- •-They have will and able to accurately record the urinary diary and complete the questionnaire throughout the trial period.
排除标准
- •-They wear any implantable electronic device (e.g. pacemaker).
- •-They have been treated with neuromodulation therapy (electrical stimulation, magnetic stimulation, etc.) for overactive bladder.
- •-They have a history of treatment with botulinum toxin for the bladder.
- •-They started treatment with the following drugs within 4 weeks prior to informed consent (including new, resumption, or drug switching): Alternatively, the dosage and administration were changed or discontinued.
- •1) Anticholinergic drugs or beta3 receptor agonists used for the purpose of improving the symptoms of overactive bladder
- •2) alpha1-blockers or PDE-5 inhibitors used to improve the symptoms of benign prostatic hyperplasia.
- •-They were diagnosed with stress urinary incontinence as the main symptom of urinary incontinence.
- •-They have urinary dysfunction, nocturnal enuresis, inflammatory diseases of the lower urinary tract (interstitial cystitis, bacterial cystitis, prostatitis, etc.), urinary stone (urethral stone, bladder stone, ureteral stone).
- •-They have a history of surgery to remove a malignant tumor in the pelvis.
- •-They have treatment-requiring pelvic organ prolapse or have a history of pelvic organ prolapse surgery within 6 months before informed consent.
- •-They have residual urine volume of exceeding 100 mL or have mechanical (organic) obstruction in the lower urinary tract or have clinically problematic lower urinary tract obstruction disease (such as benign prostatic hyperplasia).
- •-They are carrying out indwelling catheterization or intermittent self-catheterization.
- •-They have symptoms of overactive bladder of neurological cause.
研究者
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