Comparison of the Efficacy of Transcutaneos Medial Plantar Nerve and Tibial Nerve Stimulation in Women With Idiopathic Overactive Bladder: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Improvement in incontinence episodes (positive response rate)
研究概览
简要总结
Our study is the first prospective randomized controlled trial that compares the effectiveness of transcutaneous medial plantar nerve stimulation (T-MPNS) and transcutaneous tibial nerve stimulation (TTNS) added to bladder training (BT) in women with idiopathic overactive bladder (OAB). İn this study, we aimed to assess the efficacy of T-MPNS and TTNS added to BT on quality of life (QoL) and clinical parameters asssociated with idiopathic OAB. In addition, preparation time for stimulation, treatment satisfaction and discomfort levels of the patients were evaluated.
The main questions we aim to answer are:
Is T-MPNS as effective as TTNS in the treatment of idiopathic OAB? For this purpose, we planned to compare transcutaneous applications of the tibial and plantar medial nerve in women with idiopathic OAB. 60 women with OAB will be randomized to 3 groups by using random number generator: BT program alone to Group 1 (n=20), BT plus T-MPNS to Group 2 (n=20), BT plus TTNS to Group 3 (n=20) will be applied.
详细描述
The main questions we aim to answer are:
Is T-MPNS as effective as TTNS in the treatment of idiopathic OAB? For this purpose, we planned to compare transcutaneous applications of the tibial and plantar medial nerve in women with idiopathic OAB. 60 women with OAB will be randomized to 3 groups by using random number generator: BT program alone to Group 1 (n=20), BT plus T-MPNS to Group 2 (n=20), BT plus TTNS to Group 3 (n=20) will be applied.
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 complate the voiding diary and QoL questionnaire
- •The strength of PFM 3/5 and more
排除标准
- •Women with stress urinary incontinence
- •History of conservative therapy (BT, T-MPNS and TTNS/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/tibial nerve region on inner foot/ankle 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 urogyneceological surgery within 3 months
- •Neurogenic bladder, signs of neurologic abnormalities at objective examination; history of the peripheral or central neurologic pathology
- •Ultrasonographic evidence of PVR volume more than 100 ml
结局指标
主要结局
Improvement in incontinence episodes (positive response rate)
时间窗: Change from baseline positive response rate at the 6th week after the treatment
Reduction in incontinence episodes will be collected from the 3-day bladder diary. Woman with ≥50% reduction in incontinence episodes were considered positive responders
次要结局
- The severity of incontinence(Change from baseline the 24-hour pad test at the 6th week after the treatment)
- Treatment satisfaction(Change from baseline of their urinary incontinence on a 5-point Likert scale at the 6th week after the treatment)
- Symptom severity(Change from baseline Overactive Bladder Questionnaire (OAB-V8) at the 6th week after the treatment)
- Quality of life (IIQ7)(Change from baseline point of The Quality of Life-Incontinence Impact Questionnaire at the 6th week after the treatment)
- Frequency of voiding, nocturia, number of pads(Change from baseline voiding, nocturia, and the number of pads used will be collected from the 3-day bladder diary at the 6th week after the treatment)
- FSFI(Change from baseline point of FSFI at the 6th week after the treatment)
- Cure-improvement rates(Change from baseline cure and improvements at the 6th week after the treatment)
- The Hospital Anxiety and Depression Scale (HAD)(Change from baseline point of The Hospital Anxiety and Depression Scale (HAD) at the 6th week after the treatment)
研究者
Necmettin Yildiz
Professor Doctor
Pamukkale University