Evaluation of Transcutaneous Posterior Tibial Nerve Electro Stimulation With or Without Low Dose Trospium Chloride in the Management of Overactive Bladder in Females
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Patient satisfaction
研究概览
简要总结
This study was done to verify whether the combination of transcutaneous posterior tibial nerve stimulation (TPTNS) with low dose trospium chloride in the treatment of females with overactive bladder (OAB) would be more effective than TPTNS alone after failure of behavioral therapy.
详细描述
The investigators randomized 30 women with OAB, in two groups: G I (15 patients) received 30 minutes TPTNS, three times a week; GII (15 patients) received TPTNS plus Low dose trospium chloride (20 mg once daily); all for 8 weeks. Patients were evaluated using Overactive Bladder Symptom Score questionnaire (OABSS), Incontinence Impact Questionnaire-short form 7 (IIQ-7), 3 day voiding diary and urodynamics at weeks 0 and 8.
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
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Thirty adult female patients having OAB symptoms (wet type) and proved to have detrusor overactivity by urodynamics
排除标准
- •Patients having urinary tract infection or bladder outlet obstruction.
- •Patients having neurological diseases.
- •Patients having gynecological problems as genital infection, pelvic organ prolapse or genital tumors.
- •Patients with electronic implants such as heart pacemakers.
- •During pregnancy
- •Patients subject to seizures
结局指标
主要结局
Patient satisfaction
时间窗: 1 year
Improvement in the questionnaire scores and associated willingness of the patient to continue treatment
次要结局
未报告次要终点
研究者
Amr Gaber Abdulfattah Ali Abulseoud
Urology Specialist
Alexandria University