NCT00878176已完成不适用
Sacral Neuromodulation Test With Bilateral First Stage Tined Lead Procedure in Patients With Non-obstructive Urinary Retention: A Pilot Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- The primary endpoint is the eligibility for SNM therapy. This is defined as yes or no. A patient is eligible for the therapy when he or she can void again or the volume increased with at least 50%, and the catheterized volume is less then 100ml.
研究概览
简要总结
The objective of this study is to determine whether bilateral sacral nerve stimulation with First stage tined lead placement test is more effective than unilateral stimulation, among patients with non obstructive urinary retention.
研究设计
- 研究类型
- Interventional
- 干预模型
- Crossover
- 主要目的
- Screening
- 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
- •Patients who signed the informed consent
- •Patients (male and female), aged between 18-70 years, with non obstructive urinary retention.
- •Two specific subcategories of retention are included
- •Incomplete voiding or incomplete retention (>100 cc residual) such as hesitancy or intermittency, that are due to an acontractile detrusor or due to urethral sphincter overactivity. The overactivity of the sphincter may occur in absence of detrusor contraction and may be the cause of the lack of detrusor activity.
- •Complete retention. These individuals are completely unable to void.
- •All patients must have the potential for storing an adequate volume of urine:
- •i.e., at least 100 ml
排除标准
- •Known psychiatric disorders
- •Current or plans of pregnancy
- •Known neurologic diseases or impairment; including DM (severe or uncontrolled diabetes; or diabetes with peripheral nerve involvement), spinal cord injury, MS
- •Reiter's syndrome
- •Concomitant medical conditions that would limit the success of the procedure such as: active degenerative disc disease, spinal cord injury< 6 months old, bleeding complications, CVA< 6 months old etc.
- •Extra urethral incontinence
- •Pelvic pain of uncertain etiology that is not associated with a voiding dysfunction or where pelvic pain is the primary complaint/ diagnosis.
- •Anatomic obstructive voiding disorders
- •Current urinary tract infection
- •Malignancy of urinary tract
- •Severe grade III/ IV pelvic prolapse, cystocele, urethrocele, enterocele
- •Proven interstitial cystitis or clinical symptoms of interstitial cystitis
研究组 & 干预措施
1
Experimental
(Crossover study)
干预措施: First stage tined lead procedure (Procedure)
结局指标
主要结局
The primary endpoint is the eligibility for SNM therapy. This is defined as yes or no. A patient is eligible for the therapy when he or she can void again or the volume increased with at least 50%, and the catheterized volume is less then 100ml.
时间窗: 3 weeks
次要结局
- Complete or incomplete urinary retention(3 weeks)
研究者
研究点 (2)
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