Comparison of the Efficacy of Transcutaneous Peroneal Electrical Neuromodulation and Pelvic Floor Exercises in the Treatment of Idiopathic Overactive Bladder
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Change in Overactive Bladder Symptom Score from baseline to 3 months
研究概览
简要总结
Overactive bladder (OAB) is a common condition characterized by urinary urgency, usually accompanied by increased urinary frequency and nocturia, with or without urgency urinary incontinence. Several non-invasive treatment options are available, including pelvic floor exercises and neuromodulation.
This prospective, randomized study aims to compare the effectiveness and safety of transcutaneous peroneal electrical neuromodulation and pelvic floor exercises in adults with idiopathic OAB. Participants will be randomly assigned in a 1:1 ratio to receive either transcutaneous peroneal neuromodulation or pelvic floor exercise therapy for 3 months.
Treatment outcomes will be assessed using bladder diary parameters and OAB symptom scores at baseline and at 1 and 3 months after treatment initiation. Treatment adherence and treatment-related adverse events will also be evaluated. The study aims to determine whether transcutaneous peroneal neuromodulation provides comparable or improved clinical outcomes compared with pelvic floor exercises in patients with idiopathic OAB.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Adults aged 18 years or older.
- •Diagnosis of idiopathic overactive bladder (OAB) based on clinical evaluation.
- •Presence of urinary urgency, with or without urgency urinary incontinence, usually accompanied by increased urinary frequency and/or nocturia.
- •OAB symptoms present for at least 3 months.
- •Ability to complete bladder diaries and symptom questionnaires.
- •Willingness to participate in the study and provide written informed consent.
- •Ability to comply with the assigned treatment protocol and scheduled follow-up visits.
排除标准
- •Neurogenic lower urinary tract dysfunction or a known neurological disease affecting bladder function.
- •Active urinary tract infection at the time of enrollment.
- •Significant pelvic organ prolapse.
- •Predominant stress urinary incontinence or mixed urinary incontinence with predominant stress symptoms.
- •Clinically significant bladder outlet obstruction or urinary retention.
- •History of major pelvic surgery or pelvic radiotherapy that may affect lower urinary tract function.
- •Previous treatment with botulinum toxin injection or neuromodulation within the predefined washout period.
- •Current use of OAB medications that cannot be discontinued or appropriately washed out before enrollment.
- •Pregnancy.
- •Presence of a cardiac pacemaker, implanted defibrillator, or another implanted electrical device incompatible with electrical stimulation.
- •Any condition that, in the investigator's judgment, would prevent safe participation or adherence to the study protocol.
结局指标
主要结局
Change in Overactive Bladder Symptom Score from baseline to 3 months
时间窗: Baseline to 3 months
The change in overactive bladder symptom severity will be assessed using the validated Overactive Bladder Questionnaire (OAB-V8). Scores will be recorded at baseline and at 3 months after initiation of treatment. A greater reduction in score indicates greater improvement in overactive bladder symptoms.
次要结局
未报告次要终点
研究者
Tarik Emre Sener
Associated Professor
Marmara University