Status:
COMPLETED
Desmopressin in the Treatment of Mixed Nocturia With Nocturnal Polyuria and Low Nocturnal Bladder Capacity
Lead Sponsor:
Samsung Medical Center
Conditions:
Nocturia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 i...
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;...
Eligibility Criteria
Inclusion
- aged ≥18 yr
- nocturia ≥2 voids/night
- nocturnal polyuria index (NPi) \>33%
- nocturnal bladder capacity index (NBCi) \>1
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2005
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT00902655
Start Date
April 1 2004
End Date
December 1 2005
Last Update
May 15 2009
Active Locations (6)
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1
Keimyung University School of Medicine
Daegu, South Korea
2
College of Medicine Inha University
Inchon, South Korea
3
Pusan National University Hospital
Pusan, South Korea
4
Asan Medical Center
Seoul, South Korea