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.

Study Overview

• Status: Completed
• Conditions: Nocturia
• Intervention / Treatment: Drug: Desmopressin

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: Interventional
• Enrollment (Actual): 103
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: Minirin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients with a 50% or greater reduction in the mean number of nocturnal voids compared with baseline levels.	after 4-weeks of treatment phase

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Samsung Medical Center

Study record dates

Study Major Dates

• Study Start: April 1, 2004
• Primary Completion (Actual): December 1, 2005
• Study Completion (Actual): December 1, 2005

Study Registration Dates

• First Submitted: May 14, 2009
• First Submitted That Met QC Criteria: May 14, 2009
• First Posted (Estimate): May 15, 2009

Study Record Updates

• Last Update Posted (Estimate): May 15, 2009
• Last Update Submitted That Met QC Criteria: May 14, 2009
• Last Verified: May 1, 2009

More Information

Terms related to this study

• Keywords: Nocturnal polyuria; Nocturnal bladder capacity
• Additional Relevant MeSH Terms: Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Nocturia; Polyuria; Physiological Effects of Drugs; Natriuretic Agents; Hemostatics; Coagulants; Antidiuretic Agents; Deamino Arginine Vasopressin
• Other Study ID Numbers: 2004-04-05