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
  Purpose

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 Intervention Phase
Nocturia
Drug: Desmopressin
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Desmopressin in the Treatment of Mixed Nocturia With Nocturnal Polyuria and Low Nocturnal Bladder Capacity

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 103
Study Start Date: April 2004
Study Completion Date: December 2005
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00902655

Locations
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
Seoul National University College of Medicine
Seoul, Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Korea University Anam Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Kyu-Sung Lee, Ph.D Samsung Medical Center
  More Information

No publications provided

Responsible Party: Kyu-Sung Lee/Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT00902655     History of Changes
Other Study ID Numbers: 2004-04-05
Study First Received: May 14, 2009
Last Updated: May 14, 2009
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Samsung Medical Center:
Nocturnal polyuria
Nocturnal bladder capacity

Additional relevant MeSH terms:
Nocturia
Polyuria
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Urination Disorders
Urologic Diseases
Deamino Arginine Vasopressin
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs
Cardiovascular Agents

ClinicalTrials.gov processed this record on August 21, 2014