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Trial · Interventional

CompletedPhase 4Registry data

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

NCTNCT00902655 (opens ClinicalTrials.gov in a new tab)Other id2004-04-05
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
103 participants (actual)
Sponsor
Samsung Medical Center · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

South Korea

Start
Apr 2004
Primary completion
Dec 2005
Completion
Dec 2005
First posted
15 May 2009 (estimated)
Last update posted
15 May 2009 (estimated)
Conditions
Nocturia

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200420052006
  1. Ph 4

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

    NCT00902655

    Apr 2004 to Dec 2005

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • DesmopressinDrug

Arms1

  • Experimental

    Desmopressin

Primary outcomes1

Outcomes the sponsor listed as primary.

  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 outcomes(4)

  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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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