NCT02856022已完成不适用
A Comparison of the Efficacy of Electrical Ilioinguinal Nerve Stimulation and Intravesical Irrigation in Treating Patients With Bladder Pain Syndrome in Women
Shanghai Institute of Acupuncture, Moxibustion and Meridian1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2014年7月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Bladder Pain/ Interstitial Cystitis Symptom Score (BPIC-SS)
研究概览
简要总结
The purpose of this study is to determine whether electrical ilioinguinal nerve stimulation (EINS) is more effective than intravesical irrigation (II) in treating bladder pain syndrome.
详细描述
The purpose of this study is to determine whether electrical ilioinguinal nerve stimulation (EINS) is more effective than intravesical irrigation (II) in treating bladder pain syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnostic Criteria:
- •Complaint of suprapubic pain related to bladder filling, accompanied by other symptoms such as increased daytime and night-time frequency, in the absence of proven urinary infection or other obvious pathology.
- •Negative in urine routine test or urine cultivation.
- •Urinating at least 7 times per day or having some urgency or pain (measured on linear analog scales)
- •Inclusion Criteria:
- •Providing informed consent to participate in the study;
- •Willing to undergo a cystoscopy under general or regional anesthesia when indicated during the course of the study;
- •Female patients meeting the diagnostic criteria;
- •Age ≥18 years and ≤80 years.
- •Disease course ≥ 6 months
排除标准
- •Bladder capacity of greater than 350 mL on awake cystometry;
- •Absence of an intense urge to void with the bladder is filled to 150 mL of liquid filling medium;
- •The demonstration of phasic involuntary bladder contractions on cystometry using the fill rate just described;
- •Duration of symptoms less than 9 months;
- •Absence of nocturia;
- •Symptoms relieved by antimicrobial agents, urinary antiseptic agents, anticholinergic agents, or antispasmodic agents;
- •A frequency of urination while awake of less than 8 times per day;
- •A diagnosis of bacterial cystitis or prostatitis within a 3-month period;
- •Bladder or ureteral calculi;
- •Active genital herpes;
- •Uterine, cervical, vaginal, or urethral cancer;
- •Urethral diverticulum;
- •Cyclophosphamide or any type of chemical cystitis;
- •Tuberculous cystitis;
- •Radiation cystitis;
- •Benign or malignant bladder tumors;
- •Age younger than 18 years.
研究组 & 干预措施
Electrical ilioinguinal nerve stimulation
Experimental
干预措施: Electrical ilioinguinal nerve stimulation (Device)
Intravesical Irrigation
Active Comparator
干预措施: Intravesical Irrigation (Procedure)
结局指标
主要结局
Bladder Pain/ Interstitial Cystitis Symptom Score (BPIC-SS)
时间窗: 4 weeks
次要结局
- SF-36 questionnaire(4 weeks)
研究者
研究点 (1)
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