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

Category Primary study
Registry of TrialsKorean Clinical Trials Database
Year 2019
INTERVENTION: Drug : 1.Assignment to arms > Control arm: alpha‐blocker + desmopressin 0.1 mg > Treatment arm: alpha‐blocker + desmopressin 0.1 mg + imidapfenacin 0.1 mg ? Alpha‐blocker: Tamsurosin 0.2mg 2. Randomization > Envelope proceeding: Enclose the prepared random assignment table and distribute it to each institution. The distributed randomized placeholder will be released at the time of enrollment and The target person is registered according to the assignment table. 3. The difference between the test group and the control group was as shown in item 1, the treatment Group was treated with imidafenacin, and the control group combination therapy CONDITION: Diseases of The genitoruinary system PRIMARY OUTCOME: The effect of improving the nighttime urine (the number of nocturnal urine decreases and the difference in urine volume can be compared) SECONDARY OUTCOME: Evaluation of frequency of urination and improvement of weekly urinary symptoms Evaluation of quality of life according to the effect of improving nighttime urine INCLUSION CRITERIA: 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
Epistemonikos ID: 4eda6b18171ff40916ebcb62d301c605b3100ac4
First added on: Aug 25, 2024