NCT01558856已完成不适用
Prospective Randomized Trial Comparing Unilateral and Bilateral Neuromodulation Tests in the Treatment of Refractory Idiopathic Overactive Bladder
Centre Hospitalier Universitaire de Nīmes12 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2012年10月23日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 12
- 主要终点
- Success rate
研究概览
简要总结
The primary objective of this study is to compare the efficacy of unilateral and bilateral neuromodulation tests at 1 month.
详细描述
The secondary objectives of this study are to compare the following elements between a group of patients undergoing unilater modulation tests (standard procedure) and a group of patients undergoing bilateral neuromodulation tests (experimental procedure) (at 1 month): Pollakiuria, pad use, urge incontinence, symptom severity, % of patients not eligible for an implant, debimetry, tolerance, complications, quality of life.
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
- •The patient must have given his/her informed and signed consent
- •The patient must be insured or beneficiary of a health insurance plan
- •The patient is available for 1 month of follow-up
- •The patient understands and reads French
- •The patient has symptoms of overactive bladder resistant to first-line treatments (physiotherapy, anticholinergics)
- •The patient suffers from an overactive bladder confirmed by a urodynamic panel
- •The patient suffers from an overactive bladder unassociated with bladder obstruction as confirmed by flowmetry
- •The patient has primary (idiopathic) overactive bladder primary with normal urinalysis, abdominal and pelvic ultrasound, urine cytology + / - cystoscopy
- •The patient has no bleeding disorders, or the disorder is properly controlled after treatment
排除标准
- •The patient is participating in another study
- •The patient is in an exclusion period determined by a previous study
- •The patient is under judicial protection, under tutorship or curatorship
- •The patient refuses to sign the consent
- •It is impossible to correctly inform the patient
- •The patient is pregnant, parturient, or breastfeeding
- •Overactive bladder associated with bladder obstruction as determined by flowmetry
- •Overactive bladder unconfirmed by urodynamic panel
- •Overactive bladder secondary to another condition:
- •vesical: urolithiasis, bladder polyp, interstitial cystitis
- •pelivienne: tumor or inflammatory
- •neurological: multiple sclerosis, brain tumor, epilepsy
- •the patient has an uncorrectable bleeding disorder
结局指标
主要结局
Success rate
时间窗: 1 month
"Success" is defined as a \>= 50% improvement in at least one of the following symtoms: pollakiuria, number of urge incontinence episodes with incontinence, number of urge incontinence episodes.
次要结局
- Presence/absence of infection of the implant or electrode(1 month)
- presence/absence: 50% reduction in the number of urge incontinence episodes per day(1 month)
- debimetry: urinary volume per voiding(1 month)
- presence/absence: 50% reduction in the number of daily mictions(1 month)
- Symptom severity as measured by the MHU score(1 month)
- Visual analog scale for pain due to neuro stimulation (pain in legs or buttocks)(1 month)
- Change in quality of life: IQoL score(baseline to 1 month)
- presence/absence: 50% reduction in the number of urge incontinence episodes with incontinence per day(1 month)
- debimetry: flow rate per voiding(1 month)
- Change in quality of life: SF 36 score(baseline to 1 month)
- presence/absence: 50% reduction in the number of pads/protections used per day(1 month)
- Yes/no: the patient was eligible for an implant(1 month)
- Visual analog scale for pain at the implantation site(1 month)
- Change in quality of life: KHQ score(baseline to 1 month)
研究者
研究点 (12)
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