Effects of Desmopressin OD Tablets on Improvement of Nocturia in Early Phase of Treatment - EDION study

Hatakeyama Shingo0 个研究点目标入组 50 人开始时间: 2023年12月11日最近更新: 2024年4月1日

试验速览

暂无简介。

•Patients are eligible for enrollment if they meet all of the following;
•1) Male patients 65 years of age or older complaining of frequent urination at night more than twice
•2) Patients who can record a voiding diary
•3) Nocturnal polyuria index of 33% or higher in the voiding diary
•4) No improvement after at least 2 weeks of lifestyle interventions and behavioral therapy such as fluid restriction
•5) No hyponatremia (<135 mEq/L)
•6) No other contraindications.

•Exclude patients with any one of the following
•1) Patients with habitual or psychogenic polydipsia
•2) Patients with a history or suspected history of heart failure requiring diuretic therapy
•3) Patients with the syndrome of inappropriate antidiuretic hormone secretion (SIADH)
•4) Patients with renal dysfunction of moderate severity or greater (creatinine clearance less than 50 mL/min) [prolonged blood half-life and increased blood concentration are observed].
•5) Hyponatremia (<135 mEq/L)
•6) Administration of corticosteroids (injection, oral, inhalation, enema, suppository dosage)
•7) Previous hyponatremia (<135 mEq/L) due to desmopressin
•8) Patients diagnosed with hypopituitarism, enuresis, or adrenal insufficiency
•9) Patients with a nocturnal bladder capacity index (NBCi) greater than 2 on all 3 days of the voiding diary (to avoid registration of primary bladder disorders such as bladder outlet obstruction, orthostatic dysregulation, sensory urgency, infection or malignancy, and so on, to be excluded)
•10) Patients with a history of hypersensitivity to the components of this drug
•11) Patients with active urinary tract malignancies and those with a life expectancy of less than 6 months (however, if there is no recurrence after treatment, it is acceptable)
•12) Patients with safety concerns in the physician's clinical judgment

发起方

Hatakeyama Shingo