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

JRCT ID: jRCTs021230045

Registered date:11/12/2023

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Nocturia
• Date of first enrollment: 11/12/2023
• Target sample size: 50
• Study type: Interventional
• Intervention(s): Desmopressin OD tablet 25 micro g orally once daily before bedtime for 4 weeks

Outcome(s)

• Primary Outcome: Frequent urination at night on 28+2 days after administration of desmopressin OD 25 micro g tablets (if unavoidable due to vacations or other reasons, or if there is a long vacation due to Golden Week or year-end vacations, the weekday closest to 28+7 days is acceptable)

Secondary Outcome

Compared to baseline.
Nocturia on Day 4+/-1 after desmopressin OD tablets (key secondary endpoint)
Nocturia on Day 4+/-1 and Day 28+2 post-dose
Sleep time from bedtime to first voiding on 4+/-1 and 28+2 days post-dose
The sleep quality on post-treatment days 4+/-1 and 28+2
IPSS scores on days 4+/-1 and 28+2 post-treatment

Key inclusion & exclusion criteria

• Age minimum: >= 65age old
• Age maximum: Not applicable
• Gender: Male

Include criteria

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 criteria

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

Related Information

• Primary Sponsor: Hatakeyama Shingo
• Source(s) of Monetary Support: Ferring Pharmaceuticals Co., Ltd