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

NCT00902655 | Completed Phase 4

• 1 other identifier: 2004-04-05
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 6

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.

Conditions

Nocturia

Keywords

Nocturnal polyuria; Nocturnal bladder capacity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (1)

Desmopressin

EXPERIMENTAL

Drug: Desmopressin

Interventions

Desmopressin DRUG

Desmopressin 0.1,0.2 or 0.4 mg once daily for 3-weeks of dose titration phase and 4-weeks of treatment phase

Also known as: Minirin

Desmopressin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged ≥18 yr
• nocturia ≥2 voids/night
• nocturnal polyuria index (NPi) \>33%
• nocturnal bladder capacity index (NBCi) \>1

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (6)

Keimyung University School of Medicine

Daegu, South Korea

Location

College of Medicine Inha University

Inchon, South Korea

Location

Pusan National University Hospital

Pusan, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

Korea University Anam Hospital

Seoul, South Korea

Location

Seoul National University College of Medicine

Seoul, South Korea

Location

MeSH Terms

Conditions

Nocturia

Interventions

Deamino Arginine Vasopressin

Condition Hierarchy (Ancestors)

Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Arginine Vasopressin; Vasopressins; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Kyu-Sung Lee, Ph.D

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 14, 2009
• First Posted: May 15, 2009
• Study Start: April 1, 2004
• Primary Completion: December 1, 2005
• Study Completion: December 1, 2005
• Last Updated: May 15, 2009

Record last verified: 2009-05

Locations

KR (6)