Efficacy of Transcutaneous Nerve Stimulation on Improvement of Overactive Bladder Symptoms
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Change in a number of urgency and urge incontinence episodes
研究概览
简要总结
Overactive bladder (OAB) is a very common problem that impairs the quality of life of about 17% of adult population in USA above the age of 40. The issues becomes more prominent with getting older. OAB was determined by International Continence Society as urgency (immediate desire to urinate that could not be postponed) with or without incontinence usually associated with increased frequency and nocturia (urination at night). In 2012, American Urologic Association published clinical guidelines for the treatment of OAB of non neurogenic origin. Neuromodulation was proposed as the third line of treatment and two treatments were recommended: sacral nerve neuromodulation (SNM) and posterior tibial nerve stimulation (PTNS). Each of above mentioned procedures are invasive. SNM involves lead implantation in operating room using X-ray guidance and anesthesia. PTNS involves needle insertion on the low extremity.
The investigators would like to examine the efficacy of transcutaneous nerve stimulation (TENS) in refractory to the first two lines of OAB treatment patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •male and female patients
- •age above 18
- •OAB symptoms more than 6 months before run into the study
- •OAB symptoms refractory to medical oral and cognitive treatments
- •Adverse events or unwillingness to continue with abovementioned treatments
- •patients with OAB symptoms with no evidence of neuropathic nature
- •patients who signed informed consent fully understanding the treatment and study design
排除标准
- •patients who unable or did not sign an informed consent or do not understand the study design and the treatment
- •patients who have implanted electric devices (eg. cardiac stimulators etc.)
- •patients who have post voiding residual more than 100ml
- •patients who have neuropathic OAB or pelvic ongoing malignancy or prior pelvic radiation
- •patients who were treated in the last 6 months with SNM, PTNS or intravesical Botox injections
- •patients with denovo OAB after recent implantation of tension-free vaginal tape (TVT) procedure
- •stress urinary incontinence predominant complaints in mixed incontinence patients
- •significant pelvic organ prolapse in women or an evidence of significant bladder outlet obstruction in male patients
- •patients with a history of recurrent urinary tract infections (UTIs) during the last 2 years
- •any medical condition that involves skin on the lower extremity
- •bilateral leg amputation
- •any medical condition that on investigator's mind could have an adverse impact on the patient during the study
- •participation in a clinical study at the last 6 months
研究组 & 干预措施
TENS 1
TENS at posterior tibial nerve area
干预措施: Sports TENS 2 (Device)
TENS 2
TENS at shoulder area
干预措施: Sports TENS 2 (Device)
结局指标
主要结局
Change in a number of urgency and urge incontinence episodes
时间窗: 12 weeks
change in OAB-q (overactive bladder questionnaire) score bladder diary: change in a number of urgency and urge incontinence episodes
Change in day and night-time frequency of micturitions
时间窗: 12 weeks
change in OAB-q (overactive bladder questionnaire) score bladder diary: change in a frequency of micturitions during the day and night. change in a mean volume of micturitions.
次要结局
- Change in quality of life in patients with overactive bladder syndrome at the end of TENS treatment(12 weeks)
研究者
MICHAEL VAINRIB
M.D.
Meir Medical Center