NCT00448175已完成4 期
Overactive Bladder Innovative Therapy Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Frequency of Voids at 12 Weeks
研究概览
简要总结
The purpose of this study is to compare percutaneous tibial nerve stimulation (PTNS) to drug therapy for the treatment of symptoms of overactive bladder (OAB).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is at least 18 years of age
- •Experiences OAB with a voiding frequency of at least 8 times per day
- •Is ambulatory and able to use a toilet independently and without difficulty
排除标准
- •On OAB pharmacotherapy within the previous month
- •Primary complaint is stress urinary incontinence
- •Has pacemaker or implantable defibrillator
- •Has history of heart problems
- •Has nerve damage or neuropathy
- •Has gastric or urinary retention
- •Has uncontrolled narrow-angle glaucoma
- •Has known sensitivity to drug ingredients
- •Is pregnant or planning to become pregnant during the trial
研究组 & 干预措施
Urgent PC treatment arm
Experimental
干预措施: Urgent PC Neuromodulation System (Device)
Urgent PC treatment arm
Experimental
干预措施: Tolterodine (Drug)
结局指标
主要结局
Frequency of Voids at 12 Weeks
时间窗: Baseline to 12 weeks
To demonstrate that the Urgent PC system is as effective as or more effective (noninferior) than tolterodine (Detrol LA) in changing the frequency of urinary voids per day after 12 weeks of therapy. The voiding diaries completed at 12 weeks were compared to the baseline voiding diaries.
次要结局
- Urge Incontinence Episodes at 12 Weeks(12 weeks)
- Volume Voided at 12 Weeks(12 weeks)
- OAB Quality of Life at 12 Weeks(12 weeks)
- Known Side Effects Through 12 Weeks(12 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Effects of Transcutaneous Tibial Nerve Stimulation for Overactive Bladder Symptoms in AdultsUrge IncontinenceNocturiaOveractive BladderNCT05464589Dow University of Health Sciences60
Unknown
2 期
Percutaneous Tibial Nerve Stimulation in the Treatment of Anterior Resection Syndrome After Rectal Cancer SurgeryRectal CancerLow Anterior Resection SyndromeNCT02177084IRCCS Azienda Ospedaliero-Universitaria di Bologna12
已完成
不适用
A Trial of Transcutaneous Nerve Stimulation for OABOveractive BladderNCT02511717Lawson Health Research Institute20
已完成
不适用
Percutaneous posterior tibial nerve stimulation (PTNS) and biofeedback for treating faecal incontinenceFaecal IncontinenceOral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colonACTRN12616000056493orthern Sydney Local Health District13
已完成
不适用
Utilization of the BIOWAVE Device to Treat Overactive BladderOveractive BladderNCT01848366Kenneth Peters, MD8