Transcutaneous Medial Plantar Nerve Stimulation in Women With Idiopathic Overactive Bladder: A Prospective Randomized Double-blind Placebo Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Improvement in incontinence episodes
研究概览
简要总结
The investigators conducted a prospective, randomized double-blind, placebo-controlled study based on a placebo technique to evaluate the efficacy of T-MPNS vs placebo in women with idiopathic OAB.
The main questions aimed to be answered are:
What are the effects of Transcutaneous Medial Plantar Nerve Stimulation (T-MPSS) on clinical parameters related to incontinence and quality of life compared to the placebo group in women with idiopathic overactive bladder (OAB)? Participants (n:40) with idiopathic OAB who meet the exclusion and inclusion criteria will be divided into 2 groups using a randomization table. The first group will receive T-MPSS (n:20) and the second group will receive placebo T-MPSS (n:20). Measurements will be performed twice in total, before and at the end of treatment (6th week).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women over the age of 18 with clinical diagnosis of idiopathic OAB
- •Not tolerated or unresponsive to antimuscarinics and discontinued at least 4 weeks
- •Able to understand the procedures, advantages and possible side effects
- •Willing and able to complete the voiding diary and QoL questionnaire
- •The strength of pelvic floor muscles 3/5 and more
排除标准
- •Women with stress urinary incontinence
- •History of conservative therapy (T-MPNS and Transcutaneous Tibial Nerve Stimulation/PTNS) within 6 months
- •Pregnancy or intention to become pregnant during the study
- •Current vulvovaginitis or urinary tract infections or malignancy
- •Anatomic or posttraumatic malformations/skin disorders of medial plantar nerve region on inner foot that cannot allow to apply the electrodes
- •More than stage 2 according to the pelvic organ prolapse quantification (POP-Q)
- •Cardiac pacemaker, implanted defibrillator
- •Previous urogynecological surgery within 3 months
- •Neurogenic bladder, signs of neurologic abnormalities at objective examination; history of the peripheral or central neurologic pathology
- •Ultrasonographic evidence of post-void residual volume more than 100 ml
结局指标
主要结局
Improvement in incontinence episodes
时间窗: Change from baseline Improvement in incontinence episodes at the 6th week after the treatment
Reduction in incontinence episodes will be collected. Women with ≥50% reduction in incontinence episodes will be considered positive responders
次要结局
- Anxiety and Depression level(Change from baseline anxiety and Depression level at the 6th week after the treatment)
- Cure and improvement rates(Change from baseline cure and improvement rates at the 6th week after the treatment)
- Frequency of voiding, nocturia, number of pads(Change from baseline Frequency of voiding, nocturia, number of pads at the 6th week after the treatment)
- The severity of incontinence(Change from baseline the severity of incontinence at the 6th week after the treatment)
- Symptom severity(Change from baseline symptom severity at the 6th week after the treatment)
- The Quality of Life(Change from baseline the Quality of Life at the 6th week after the treatment)
- Assessment of sexual functions Assessment of sexual functions(Change from baseline assessment of sexual functions at the 6th week after the treatment)
- Treatment Satisfaction Level(Change from baseline Treatment Satisfaction Level at the 6th week after the treatment)
研究者
Necmettin Yildiz
Professor Doctor
Pamukkale University