Effects of Transcutaneous Tibial Nerve Stimulation for Overactive Bladder Symptoms in Adults: A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Change in Overactive Bladder Symptom Score from baseline at sixth week
研究概览
简要总结
For overactive bladder symptoms, there are numerous physiotherapy techniques have been found to be beneficial. Transcutaneous electrical stimulation of the tibial nerve is one of those treatment options, that is entirely a non-invasive, easy to apply, and cost-effective technique.
Transcutaneous stimulation of the tibial nerve targets the sacral nerve plexus that contracts the pelvic floor muscles and controls the bladder function.
This research aims to study the effectiveness of transcutaneous tibial nerve stimulation in adults with overactive bladder symptoms along with the conventional physiotherapy for overactive bladder (pelvic floor muscle training through Kegel's exercises) among 60 patients with overactive bladder symptoms on the basis of non-probability purposive sampling technique with screening for study criteria through a consultant urologist. After taking informed consent, all participants will be randomly allocated into two groups. Group A will receive pelvic floor muscles training through Kegels exercises along with transcutaneous electrical stimulation of the tibial nerve and Group B will receive pelvic floor muscles training through Kegels exercises. The treatment duration will of six weeks. Outcomes will be assessed before the start of the treatment and after the end of the treatment sessions.
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 (Outcomes Assessor)
盲法说明
The outcome accessor involved in the clinical trial will be prevented from having knowledge of the interventions to the individual participants of each group.
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically diagnosed overactive bladder
- •A total OABSS score of 3 or more and an urgency score of 2 or more
- •30-65 years old
排除标准
- •Pregnancy
- •Acute urinary tract infection (within 15 days)
- •Any surgical procedure for urinary incontinence
- •Genito-urinary cancer history
- •Stage II pelvic organ prolapse according to pelvic organ prolapse-quantification system
- •Lesion on the site of stimulation or around it
- •Pelvic pacemakers
- •Lower limbs prostheses
- •Patients who will not be able to perform Kegel's exercises
- •An impaired sensation at the site of stimulation.
- •Patients receiving any treatment other than the prescribed medications by the referring physician (that will be the same for all patients of both groups) will be excluded.
结局指标
主要结局
Change in Overactive Bladder Symptom Score from baseline at sixth week
时间窗: At baseline and after 6 weeks
OABSS is a validated instrument which evaluates the four cardinal symptoms (day and nighttime frequency, urgency, and urge incontinence) of OAB in a one score. A total OABSS score of 3 or more and an urgency score of 2 or more is the recommended cut-off for diagnosing OAB, and the severity is further divided into mild (total score of 3-5 points), moderate (6-11 points) and severe (12 or more points). Patients will be evaluated at baseline and 6 weeks after the intervention through OABSS.
次要结局
未报告次要终点
研究者
Sana Subhan
Principal Investigator
Dow University of Health Sciences