Effect Of Transcutaneous Tibial Nerve Stimulation Technique Combined With Exercise on High Post-Void Residual Urine Volume in Post-Menopausal Women: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Volume of post- void residue of urine in bladder
研究概览
简要总结
Objective of the study is to explore effect of combining transcutaneous tibial nerve stimulation with exercise on high post-void residual urine volume in post-menopausal women. The main question to be answered by this study:
Does transcutaneous tibial nerve stimulation technique combined with exercise have effect on high post-void residual urine in post-menopausal women? Researchers will compare 2 groups of 60 post-menopausal women. Group A participants will attend 12-week physiotherapy sessions composed of transcutaneous tibial nerve stimulation with exercise program and advice. While, control participants will take the same advice and routine care as group A participants.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •a total of 60 women will be recruited from Out- Patient Gynecology Clinic of Beni- Suef University Hospital, Beni-Suef, Egypt. Their ages will be ranged from 45-65 years and their body mass index (BMI) will not exceed 30 kg/m2.
排除标准
- •Women will be excluded from the study, if they were diagnosed with a history of irradiation and/or hormonal therapy in the last six months; the presence of neurological diseases (multiple sclerosis, Alzheimer's disease, stroke and Parkinson's disease); the use of anticholinergic drugs, calcium antagonists, b-antagonists, and dopamine antagonists; the presence of pelvic organ prolapse (POP), as measured by a score greater than III by the POP-Q system, predominantly neurogenic or predominantly mixed urinary incontinence populations, chronic physical or mental illness, or failed to complete an informed consent form.
研究组 & 干预措施
Placebo Group
routine pelvic floor strengthening exercises at home as well as advice
Intervention group
participants attended 12-week physiotherapy sessions composed of transcutaneous tibial nerve stimulation with pelvic floor, behavioral bladder exercises and advice.
干预措施: Transcutaneous Tibial Nerve Stimulation Technique (Device)
结局指标
主要结局
Volume of post- void residue of urine in bladder
时间窗: 5 months
Estimation of the amount of post void residual urine in millilitres was conducted by using a transabdominal ultrasound scanner (Toshiba Xario100, 8-12 MHz linear transducer).
次要结局
未报告次要终点
研究者
Eman Awad
Associate professor of physical therapy for woman's health, Physical Therapy Department for Woman and Child Health, Faculty of Physical Therapy, Beni-Suef University, Beni-Suef , Egypt
Beni-Suef University