DRKS00021250尚未招募4 期
Prospective, randomized, placebo controlled trial to evaluate the efficacy of transcutaneous stimulation of n. tibialis posterior in treatment of idiopathic overactive bladder - TNT-Trial
niversitätsklinikum Münster0 个研究点目标入组 116 人开始时间: 2021年10月4日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 116
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 75 Years(—)
- 性别
- All
入选标准
- •Idiopathic overactive bladder
- •Age 18 to 70 years
- •Ability to give consent
- •Oral drug treatment of OAB should be discontinued 4 weeks before the start of treatment or continued for the duration of the study
排除标准
- •Children <18 LJ.
- •Age> 80.LJ
- •Taking psychotropic drugs, antiepileptics, antidepressants
- •Interruption of antimuscarinergics within the last 4 weeks before entering the study
- •Presence of a any pacemaker
- •recent other neuromodulative procedures (sacral neuromodulation, percutaneous tibial nerve stimulation) Sacral neuromodulation
- •recent Injection treatment with botox in the detrusor
- •Neurogenic genesis of urinary symptoms (e.g. apoplex, multiple sclerosis, Parkinson disease, paraplegia)
- •? obstructive micturition complaints
- •TRUS: prostate size> 40 cc, uroflowmetry: maximum urine flow <15 ml / s
- •? urogenital descensus> 2 °, any symptomatic urogenital descensus
- •Stress incontinence> 1 °
- •Bladder pain syndrome / interstitial cystitis
- •any history of bladder tumor
- •recurrent urinary tract infections (> 3 / year or> 2 / half year)
- •anatomical abnormalities of the urinary bladder and urethra such as Bladder diverticulum, bladder wall thickening (> 2.5mm with 250 ml bladder filling), urethral stricture
- •residual urine over 20% of the micturition volume or> 100 ml
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