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

Primary Purpose

Nocturia

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Desmopressin
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nocturia focused on measuring Nocturnal polyuria, Nocturnal bladder capacity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Keimyung University School of Medicine
  • College of Medicine Inha University
  • Pusan National University Hospital
  • Asan Medical Center
  • Korea University Anam Hospital
  • Seoul National University College of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Desmopressin

Arm Description

Outcomes

Primary Outcome Measures

Proportion of patients with a 50% or greater reduction in the mean number of nocturnal voids compared with baseline levels.

Secondary Outcome Measures

Change in the mean number of nocturnal voids.
Change in the mean duration of the period from bedtime to the first nocturnal void.
Change in the proportion of patients that felt they had a good sleep experience.
Body weight gain.

Full Information

First Posted
May 14, 2009
Last Updated
May 14, 2009
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00902655
Brief Title
Desmopressin in the Treatment of Mixed Nocturia With Nocturnal Polyuria and Low Nocturnal Bladder Capacity
Official Title
Desmopressin in the Treatment of Mixed Nocturia With Nocturnal Polyuria and Low Nocturnal Bladder Capacity
Study Type
Interventional

2. Study Status

Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
December 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Samsung Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
Open label, prospective, multicenter study 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. Measurements 3-day frequency-volume charts sleep questionnaire body weight, blood and urine analysis,serum sodium monitoring adverse event

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nocturia
Keywords
Nocturnal polyuria, Nocturnal bladder capacity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
103 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Desmopressin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Desmopressin
Other Intervention Name(s)
Minirin
Intervention Description
Desmopressin 0.1,0.2 or 0.4 mg once daily for 3-weeks of dose titration phase and 4-weeks of treatment phase
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Change in the mean number of nocturnal voids.
Time Frame
after 4-weeks of treatment phase
Title
Change in the mean duration of the period from bedtime to the first nocturnal void.
Time Frame
after 4-weeks of treatment phase
Title
Change in the proportion of patients that felt they had a good sleep experience.
Time Frame
after 4-weeks of treatment phase
Title
Body weight gain.
Time Frame
after 4-weeks of treatment phase

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyu-Sung Lee, Ph.D
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Keimyung University School of Medicine
City
Daegu
Country
Korea, Republic of
Facility Name
College of Medicine Inha University
City
Inchon
Country
Korea, Republic of
Facility Name
Pusan National University Hospital
City
Pusan
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University College of Medicine
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

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

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