JPRN-jRCTs032190043已完成未知
Single blinded randomized control study of low-reactive level laser therapy for overactive bladder - LLLT study for overactive bladder
Tomoyuki Uchiyama0 个研究点目标入组 15 人开始时间: 2019年6月20日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 15
研究概览
简要总结
The purpose was to evaluate the safety and efficacy of low-reactive level laser therapy of the sacral nerve roots in patients with overactive bladder. There was no significant difference in the urination frequency(primary endpoint). There were significant improvements in urinary urgency, bladder capacity, OABSS, and I-PSS. There were no adverse events in the laser group and there were no safety issues.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1. Urination frequency is 8 or more times per day on average
- •2. Falls under any of the following
- •Urinary incontinence frequency is 1 or more times per day on average
- •Urinary urgency frequency is 1 or more times per day on average
- •3. Inadequate or inappropriate effect of behavioral therapy or drug therapy
- •4. 20 years old and older at IC
- •5. Outpatient
- •6. Contraception possible
排除标准
- •1. Severe cardiovascular disease
- •2. Severe liver disease
- •3. Severe kidney disease
- •4. Received intervention treatments in other clinical trials within 3 months
- •5. Pregnant, or have a plan
- •6. Tattoo, pigmentation, accessories, implantation equipment at the laser irradiation point
- •7. Malignant tumor
- •8. Bleeding tendency
- •9. Physically weak due to aging, disease, etc
- •10. Treatment of organic disease is prior
- •11. Urinary output over 3000ml per day
- •12. Cognitive impairment, mental illness, etc
- •13. Judged as ineligible by principle investigator or sub investigator
研究者
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