Ignite Creation Date:
2024-05-05 @ 9:31 PM
Last Modification Date:
2024-10-26 @ 10:05 AM
Study NCT ID:
NCT00902655
Status:
COMPLETED
Last Update Posted:
2009-05-15
First Post:
2009-05-14
Brief Title:
Desmopressin in the Treatment of Mixed Nocturia With Nocturnal Polyuria and Low Nocturnal Bladder Capacity
Sponsor:
Samsung Medical Center
Organization:
Samsung Medical Center
Study Overview
Official Title:
Desmopressin in the Treatment of Mixed Nocturia With Nocturnal Polyuria and Low Nocturnal Bladder Capacity
Status:
COMPLETED
Status Verified Date:
2009-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 arisingThe 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 enuresisMore recently it is also known to be effective against nocturia with NP by decreasing night-time urine productionHowever it may be associated with an increased risk of developing hyponatremia due to water retention especially in elderly patientsIn 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
Desmopressin a synthetic analogue of the antidiuretic hormone ADH has been used for many years to treat diabetes insipidus and primary nocturnal enuresisMore recently it is also known to be effective against nocturia with NP by decreasing night-time urine productionHowever it may be associated with an increased risk of developing hyponatremia due to water retention especially in elderly patientsIn 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
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 01 02 and 04 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 analysisserum sodium monitoring
adverse event
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 01 02 and 04 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 analysisserum sodium monitoring
adverse event
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None