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NCT Number: NCT00902655

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Keimyung University School of Medicine, Daegu, South Korea

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About this study

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Minirin

Primary outcomes

  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

  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

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
May 15, 2009
Registry last updated
May 15, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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