Direct Full-stage Implantation of Sacral Neuromodulation
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Improvement in overactive bladder symptoms
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Improvement in overactive bladder symptoms
时间窗: 1 year
measured using overactive bladder questionnaire
次要结局
未报告次要终点
研究者
Andrea Staack
MD PhD
Loma Linda University