KCT0003202尚未招募未知
The efficacy combined therapy with silodosin and solifenasin in female overactive bladder patients with voiding symptom
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 338
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 79(Year)（—）
- 性别
- Female
入选标准
- •1. Women aged 19 ~79 years
- •2. OAB patients planned treat with solifenacin
- •3. OABSS total score = 3,OABSS subscore (Q3)=2 and more than 6 points of Voiding sx subscore (sum of 1,3,5,6 items) on IPSS
- •4. =3 urgency episodes per 24 h in a 3-day voiding diary
- •5. Those who have symptoms of overactive bladder symptom for more than 3 months before screening
- •6. Those who have the ability to write the voiding diary and the questionnaire accurately
- •7. A person who voluntarily participates in the observation study and agrees in writing to the subject consent form.
排除标准
- •1. Patients with acute cystitis.
- •2. Patients with undergoing alphablocker or anticholinergics.
- •3. Patients who do not agree with this study.
- •4. Pregnant and lactating women.
- •5. Patient with hypersensitivity of TruPass 8 mg or Vesicare 5 mg.
- •6. Patients with residual urine >200cc
- •7. Those with a history of acute urinary retention.
- •8. Patients with acute myocardiac infarction, angina, arrythemia or cardiac pacemaker
- •9. Those who underwent surgery that could affect urinary function within 24 hours of screening
- •10. Severe gastrointestinal disease or myasthenia gravis
- •11. Patients with narrow angle glaucoma
- •12. patients who treated with hemodialysis
- •13. Patients with severe renal impairment (CCr <30 ml / min) who have moderate hepatic impairment and are co-administered with potent CYP3A4 inhibitors (eg, ketoconazole, clarithromycin, itraconazole, ritonavir)
- •14. Those who participated in other interventional clinical trials within 3 months of screening
- •15. A person who has or has a history of a malignant tumor.
- •16. Patients with genetic problems such as galactose intolerance, Lapp lactose dehydrogenase deficiency, glucose-galactose uptake disorder
- •17. Any other person who is ineligible to participate in the observational study when the examiner or the examiner judges
研究者
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