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临床试验/DRKS00021250
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

研究者

发起方
niversitätsklinikum Münster

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