Darifenacin Versus Parasacral Transcutaneous Electric Nerve Stimulation for Overactive Bladder Syndrome in Patients Infected With Human T-Lymphotropic Virus 1 - Randomized Open Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Overactive Bladder Symptom Score
研究概览
简要总结
In this study the investigators compare the parasacral transcutaneous electric nerve stimulation (PTENS) treatment with Darifenacin to improve OAB symptoms in patients infected with HTLV-1.
详细描述
Subjects presenting OAB according to ICS, associated with the HTLV-1 infection were invited by the investigators to participate in the study according inclusion criteria . Participants who accepted were randomly allocated to two groups (G1 and G2) by the free randomization website. Group 1 was treated with Darifenacin, and group 2 with the PTENS protocol.
Drug Treatment Protocol:
The anticholinergic Fenazic (Adium) was used in a single dose of 15mg/day for 2 months.
PTENS Protocol:
The treatment consisted of PTENS with the Neurodyn Portable TENS FES(21) neuromuscular stimulation device in an outpatient clinic. Two self-adhesive electrodes (5x9cm) were used, positioned one in each gluteal region, below the iliac spine to apply low-frequency biphasic current with 10 Hz. Pulse duration of 0.5 milliseconds was applied for 40 minutes with continuous stimulation, 3 times a week, for 20 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
- None
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
- •HTLV-1 infection
- •Overactive bladder symptom
- •18 years of age or older
排除标准
- •HTLV-1 infected subjects with HAM
- •Parkinson
- •HIV infection
- •Prostatic hyperplasia
- •Pacemaker use
- •Genitourinary tract infection
研究组 & 干预措施
Darifenacin Group
Anticholinergic treatment for OAB
干预措施: Darifenacin (Drug)
PTENS Group
Neuromodulation using transcutaneous electrical sacral nerves stimulation
干预措施: Neuromodulation - Sacral nerve stimulation (Device)
结局指标
主要结局
Overactive Bladder Symptom Score
时间窗: 2 months or 20 sessions
Whether higher scores mean worse outcome
次要结局
未报告次要终点
研究者
Tatiane Souza Soares de Oliveira
Physiotherapist
Hospital Universitário Professor Edgard Santos