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

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ClinicalTrials.gov Identifier: NCT00902655
Recruitment Status : Completed
First Posted : May 15, 2009
Last Update Posted : May 15, 2009
Sponsor:
Information provided by:
Samsung Medical Center

Tracking Information
First Submitted Date  ICMJE May 14, 2009
First Posted Date  ICMJE May 15, 2009
Last Update Posted Date May 15, 2009
Study Start Date  ICMJE April 2004
Actual Primary Completion Date December 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 14, 2009)
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 Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 14, 2009)
  • 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 Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Desmopressin in the Treatment of Mixed Nocturia With Nocturnal Polyuria and Low Nocturnal Bladder Capacity
Official Title  ICMJE 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 Description
  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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Nocturia
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Desmopressin
Intervention: Drug: Desmopressin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 14, 2009)
103
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2005
Actual Primary Completion Date December 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00902655
Other Study ID Numbers  ICMJE 2004-04-05
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kyu-Sung Lee/Professor, Samsung Medical Center
Study Sponsor  ICMJE Samsung Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kyu-Sung Lee, Ph.D Samsung Medical Center
PRS Account Samsung Medical Center
Verification Date May 2009

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