Prospective study with Multicenter to compare the efficacy of Desmopressin alone and Imidafenacin combined treatment for symptom improvement in patients with nocturia with irritable bladder symptoms
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 48
研究概览
简要总结
This study was conducted with the group taking alpha blocker (tamsulosin 0.2 mg) + desmopressin 0.1 mg and alpha blocker (tamsulosin 0.2 mg) + desmo This is a prospective randomized study conducted to compare and evaluate the clinical effects of the pressin 0.1mg + imidafenacin 0.1mg combination group. was carried out over A total of 68 questionnaires were collected from 3 institutions, but 8 were excluded due to non-conformity with the selection exclusion criteria, and a total of 60 subjects were included in the efficacy evaluation subject group. The primary purpose of this study is to evaluate the improvement of symptoms of nocturia, and the secondary objective is to evaluate the quality of life according to the improvement of symptoms of nocturia. For this purpose, the subjects of each control and test group after administration of alpha blocker (tamsulosin 0.2mg) + desmopressin 0.1mg and alpha blocker (tamsulosin 0.2mg) + desmopressin 0.1mg + imidafenacin 0.1mg The frequency of nocturia, the amount of nocturia, the frequency of urination during the week, and the quality of life were evaluated. As a result of examining the changes in the 72-hour voiding diary, OABSS, IPSS, and N-QoL, at 8 weeks at the end of the test, both the control group and the test group showed a statistically significant improvement in nocturia symptoms. A better improvement effect could be confirmed. However, there was no significant difference between the control group and the test group in changes in the number of daytime urine and N-QoL. Both the alpha blocker (tamsulosin 0.2 mg) + desmopressin 0.1 mg and the alpha blocker (tamsulosin 0.2 mg) + desmopressin 0.1 mg + imidafenacin 0.1 mg combined administration showed improvement in the nocturia symptoms of the subjects. and the improvement effect was greater when imidafenacin was administered in combination. Therefore, alpha blocker (tamsulosin 0.2mg) + desmopressin 0.1mg + imidafenacin Concomitant administration of 0.1 mg is considered to be effective in improving the symptoms of nocturia in patients with benign prostatic hyperplasia.
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 50(Year) 至 o Limit（—）
- 性别
- Male
入选标准
- •For inclusion in the study, all of the following inclusion criteria must be fulfilled:
- •1) Male subjects aged = 50 years
- •2) Overactive bladder symptoms (4 = OABSS & 2 = Question 3)
- •3) Maximum flow rate (Qmax) 4 ml / sec or more and 20 ml / sec or less
- •4) Minimum urine volume more than 125 ml
- •5) Residual urine volume less than 100 ml
- •6) urination One or more times of nocturnal nighttime urine, nocturnal polyuria index (NPi) 30% or more
- •7) Be willing and able to provide written informed consent for the study
排除标准
- •The subjects must be excluded from participating in the study if the subject:
- •1) Acute urinary retention anamnesis within 3 months
- •2) Serum total PSA > 10 ng / ml (if more than 4 ng / ml, less than 10 ng / ml, you can participatie in the study
- •only if prostate cancer is excluded form the prostate biopsy within 6 months before screening)
- •3) Anatomical abnormality of lower urinary tract (urethral stricture, diverticulum, bladder neck contraction, etc.)
- •4) Clinical conditions affecting urination (neurogenic bladder, CP / CPPS, urinary tract infection, etc.)
- •5) Unstable and significant medical conditions, including:
- •- Within 6 months before screening Unstable angina, myocardial infarction, cerebrovascular disease
- •- Previous malignant tumors including skin basal cell carcinoma within the last 5 years
- •- diabetes, peptic ulcer disease not controlled by medical management
- •- Severe liver disease
- •- Renal insufficiency history, renal disease (when serum creatinine exceeds 1.4 mg / dl)
- •- Conditions that are expected to cause serious adverse reactions due to the clinical trial drug
- •6) If participation is impossible due to the judgment of principal Investigatior