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Desmopressin in the Treatment of Mixed Nocturia With Nocturnal Polyuria and Low Nocturnal Bladder Capacity
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Nocturia | Drug: Desmopressin | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Desmopressin in the Treatment of Mixed Nocturia With Nocturnal Polyuria and Low Nocturnal Bladder Capacity |
- 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 ]
- Change in the mean number of nocturnal voids. [ Time Frame: after 4-weeks of treatment phase ]
- Change in the mean duration of the period from bedtime to the first nocturnal void. [ Time Frame: after 4-weeks of treatment phase ]
- Change in the proportion of patients that felt they had a good sleep experience. [ Time Frame: after 4-weeks of treatment phase ]
- Body weight gain. [ Time Frame: after 4-weeks of treatment phase ]
| Enrollment: | 103 |
| Study Start Date: | April 2004 |
| Study Completion Date: | December 2005 |
| Primary Completion Date: | December 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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 Name: Minirin
|
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
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00902655
| Korea, Republic of | |
| Keimyung University School of Medicine | |
| Daegu, Korea, Republic of | |
| College of Medicine Inha University | |
| Inchon, Korea, Republic of | |
| Pusan National University Hospital | |
| Pusan, Korea, Republic of | |
| Asan Medical Center | |
| Seoul, Korea, Republic of | |
| Korea University Anam Hospital | |
| Seoul, Korea, Republic of | |
| Seoul National University College of Medicine | |
| Seoul, Korea, Republic of | |
| Principal Investigator: | Kyu-Sung Lee, Ph.D | Samsung Medical Center |
More Information
| Responsible Party: | Kyu-Sung Lee/Professor, Samsung Medical Center |
| ClinicalTrials.gov Identifier: | NCT00902655 History of Changes |
| Other Study ID Numbers: |
2004-04-05 |
| Study First Received: | May 14, 2009 |
| Last Updated: | May 14, 2009 |
Keywords provided by Samsung Medical Center:
|
Nocturnal polyuria Nocturnal bladder capacity |
Additional relevant MeSH terms:
|
Nocturia Polyuria Lower Urinary Tract Symptoms Urological Manifestations Signs and Symptoms Urination Disorders Urologic Diseases |
Deamino Arginine Vasopressin Hemostatics Coagulants Antidiuretic Agents Natriuretic Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 23, 2017