Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
Nocturia Drug: Desmopressin Phase 4

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Desmopressin in the Treatment of Mixed Nocturia With Nocturnal Polyuria and Low Nocturnal Bladder Capacity
Study Start Date : April 2004
Actual Primary Completion Date : December 2005
Actual Study Completion Date : December 2005

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Desmopressin 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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 ]

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

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00902655


Locations
Layout table for location information
Korea, Republic of
Keimyung University School of Medicine
Daegu, Korea, Republic of
College of Medicine Inha University
Inchon, Korea, Republic of
Pusan National University Hospital
Pusan, Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Korea University Anam Hospital
Seoul, Korea, Republic of
Seoul National University College of Medicine
Seoul, Korea, Republic of
Sponsors and Collaborators
Samsung Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Kyu-Sung Lee, Ph.D Samsung Medical Center
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Kyu-Sung Lee/Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT00902655    
Other Study ID Numbers: 2004-04-05
First Posted: May 15, 2009    Key Record Dates
Last Update Posted: May 15, 2009
Last Verified: May 2009
Keywords provided by Samsung Medical Center:
Nocturnal polyuria
Nocturnal bladder capacity
Additional relevant MeSH terms:
Layout table for MeSH terms
Polyuria
Nocturia
Lower Urinary Tract Symptoms
Urological Manifestations
Urination Disorders
Urologic Diseases
 Deamino Arginine Vasopressin
Hemostatics
Coagulants
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs