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

This study has been completed.
Sponsor:
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT00902655
First received: May 14, 2009
Last updated: NA
Last verified: May 2009
History: No changes posted

May 14, 2009
May 14, 2009
April 2004
December 2005   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • Change in the mean number of nocturnal voids. [ Time Frame: after 4-weeks of treatment phase ] [ Designated as safety issue: Yes ]
  • Change in the mean duration of the period from bedtime to the first nocturnal void. [ Time Frame: after 4-weeks of treatment phase ] [ Designated as safety issue: Yes ]
  • Change in the proportion of patients that felt they had a good sleep experience. [ Time Frame: after 4-weeks of treatment phase ] [ Designated as safety issue: Yes ]
  • Body weight gain. [ Time Frame: after 4-weeks of treatment phase ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Desmopressin in the Treatment of Mixed Nocturia With Nocturnal Polyuria and Low Nocturnal Bladder Capacity
Desmopressin in the Treatment of Mixed Nocturia With Nocturnal Polyuria and Low Nocturnal Bladder Capacity

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.

  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
Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Nocturia
Drug: Desmopressin
Desmopressin 0.1,0.2 or 0.4 mg once daily for 3-weeks of dose titration phase and 4-weeks of treatment phase
Other Name: Minirin
Experimental: Desmopressin
Intervention: Drug: Desmopressin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
103
December 2005
December 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • aged ≥18 yr
  • nocturia ≥2 voids/night
  • nocturnal polyuria index (NPi) >33%
  • nocturnal bladder capacity index (NBCi) >1

Exclusion Criteria:

  • nocturia due to other defined causes of increased urinary frequency
  • primary polydipsia (>40mL/kg/24 h)
  • neurogenic bladder dysfunction
  • significant bladder outlet obstruction
  • urge incontinence
  • continued post-voiding residual urine >150mL
  • serum sodium levels <135mmol/L
  • uncontrolled hypertension characterized by fluid and/or electrolyte imbalance
  • use of diuretics
  • actual or planned pregnancy
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00902655
2004-04-05
No
Kyu-Sung Lee/Professor, Samsung Medical Center
Samsung Medical Center
Not Provided
Principal Investigator: Kyu-Sung Lee, Ph.D Samsung Medical Center
Samsung Medical Center
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP