Clinical Trial: Desmopressin in the Treatment of Mixed Nocturia With Nocturnal Polyuria and Low Nocturnal Bladder Capacity

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Desmopressin in the Treatment of Mixed Nocturia With Nocturnal Polyuria and Low Nocturnal Bladder Capacity

Brief Summary:

Nocturia is defined as waking one or more times to void during the period between going to bed with the intention of sleeping and waking with the intention of arising.The pathophysiology of nocturia is multifactorial and can be complex. Therefore it is important to adopt a systematic approach to identify the possible causal factors of nocturia and to treat them accordingly. Patients with nocturia can be categorized as having one of the following three disorders: (1) nocturnal polyuria (NP) in which the voided urine volume during the hours of sleep exceeds 35% of the 24-hr output, (2) low nocturnal bladder capacity (NBC) causing a nocturnal urinary volume greater than the bladder capacity, (3) or mixed nocturia, a combination of the preceding two categories.

Desmopressin, a synthetic analogue of the antidiuretic hormone (ADH), has been used for many years to treat diabetes insipidus and primary nocturnal enuresis.More recently, it is also known to be effective against nocturia with NP by decreasing night-time urine production.However, it may be associated with an increased risk of developing hyponatremia due to water retention, especially in elderly patients.In the present study, we investigated the safety and efficacy of oral desmopressin for the treatment of mixed nocturia in patients with both NP and a low NBC.


Detailed Summary:

  1. Open label, prospective, multicenter study

  2. Study design

    • screening (1-week), dose titration (1-3 weeks) and 4-weeks of treatment period
    • open-label dose-titration periods of up to 3 wk; the patients' optimum oral desmopressin dose (0.1, 0.2 and 0.4 mg) was determined as the dose that decreased the number of nocturnal voids by ≥50% and NUV decreased by ≥20% without hyponatremia.
    • If the patients did not meet the above criteria during dose titration period, they received the maximum tolerable dose instead of the optimum dose. -- 4-weeks of treatment period; Eligible patients were treated with the determined optimum desmopressin dose for 4-weeks.

  3. Measurements

    • 3-day frequency-volume charts
    • sleep questionnaire
    • body weight, blood and urine analysis,serum sodium monitoring
    • adverse event

Sponsor: Samsung Medical Center

Current Primary Outcome: Proportion of patients with a 50% or greater reduction in the mean number of nocturnal voids compared with baseline levels. [ Time Frame: after 4-weeks of treatment phase ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in the mean number of nocturnal voids. [ Time Frame: after 4-weeks of treatment phase ]
  • Change in the mean duration of the period from bedtime to the first nocturnal void. [ Time Frame: after 4-weeks of treatment phase ]
  • Change in the proportion of patients that felt they had a good sleep experience. [ Time Frame: after 4-weeks of treatment phase ]
  • Body weight gain. [ Time Frame: after 4-weeks of treatment phase ]


Original Secondary Outcome: Same as current

Information By: Samsung Medical Center

Dates:
Date Received: May 14, 2009
Date Started: April 2004
Date Completion:
Last Updated: May 14, 2009
Last Verified: May 2009