A Study to Compare the Efficacy and Safety of Ultrasound Guided Lead Implantation for Sacral Neuromodulation (SNM) in Subjects With Overactive Bladder (OAB)With X-Ray Guided Technique
试验速览
- 阶段
- 1 期
- 入组人数
- 30
- 主要终点
- Successful rate
研究概览
简要总结
Overactive bladder(OAB,Urgency) was determined by International Continence Society as Urinary urgency, usually accompanied by frequency and nocturia, with or without urgency urinary incontinence, in the absence of urinary tract infection (UTI) or other obvious pathology.The SNM treatment involves a two-stage surgical procedure performed under local anesthesia. The device include IPG (implantable programme generator) and lead. In the initial test phase, 1st stage, electrode is placed near the sacral nerve and requires a 2 weeks assessment. This allows your doctors and you to assess your initial response according to your voiding dairy and satisfaction. In 2nd stage, SNM procedure is implantation of the IPG.
X ray guidance is harmful to both patients and doctors, while ultrasound guidance is real time visual guidance ,easy to operate by doctors and a radiation free option to challenge anatomy. Urologists are skilled in both ultrasound operations and anatomy basics and dedicating to developing better guidance technique in surgery.
The study here compare the efficacy and safety of ultrasound versus X ray guidance technique in SNM.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 16 years;
- •Subjects suitable for SNM surgery;
- •Normal upper urinary tract function;
- •Bladder volume > 100 mL;
- •Good compliance and able to complete the follow-up assessments.
排除标准
- •Psychiatric or neurologic disabilities on neurologic evaluation such as multiple sclerosis, spinal cord injury, epilepsy, Parkinson's disease, stroke;
- •Bladder lithiasis or tumor (cystoscopy or ultrasonography);
- •Stress urinary incontinence;
- •Bladder outlet obstruction;
- •Diuresis > 3 liters per 24 hours;
- •Negative at the test period or previous treatment with SNM;
- •Pregnancy and plan to be pregnancy in 2 years.
结局指标
主要结局
Successful rate
时间窗: 6 months post -IPG implantation
Successful rate is the percentage of patients who experienced a successful result (≥50% improvements in baseline symptoms ) as recorded in voiding dairies.
次要结局
- Adverse effect(During operation, 2 weeks post-lead implantation, 3 and 6 months post -IPG implantation)
- Guidance technique performance time(From beginning operation until successful lead placement is completed)
- Overactive bladder symptom score (OABSS)(pre-operation baseline, 2 weeks post-lead implantation, 3 and 6 months post -IPG implantation)
- Quality of Life (QoL) scores(pre-operation baseline, 2 weeks post-lead implantation, 3 and 6 months post -IPG implantation)
- Times of X-ray radiation(During operation)