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

• ClinicalTrials.gov Identifier: NCT00902655
• Recruitment Status: Completed
• First Posted: May 15, 2009
• Last Update Posted: May 15, 2009
• Sponsor: Samsung Medical Center
• Information provided by: Samsung Medical Center

Tracking Information

• First Submitted Date: May 14, 2009
• First Posted Date: May 15, 2009
• Last Update Posted Date: May 15, 2009
• Study Start Date: April 2004
• Actual Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: May 14, 2009): 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 ]
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: May 14, 2009)

• 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 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Desmopressin in the Treatment of Mixed Nocturia With Nocturnal Polyuria and Low Nocturnal Bladder Capacity
• Official Title: Desmopressin in the Treatment of Mixed Nocturia With Nocturnal Polyuria and Low Nocturnal Bladder Capacity

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 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.

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 (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.

3. Measurements

   • 3-day frequency-volume charts
   • sleep questionnaire
   • body weight, blood and urine analysis,serum sodium monitoring
   • adverse event

• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Nocturia

Intervention

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

Study Arms

Experimental: Desmopressin

Intervention: Drug: Desmopressin

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 14, 2009): 103
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: December 2005
• Actual Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Korea, Republic of

Administrative Information

• NCT Number: NCT00902655
• Other Study ID Numbers: 2004-04-05
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Kyu-Sung Lee/Professor, Samsung Medical Center
• Study Sponsor: Samsung Medical Center
• Collaborators: Not Provided

Investigators

• Principal Investigator: Kyu-Sung Lee, Ph.D; Samsung Medical Center

• PRS Account: Samsung Medical Center
• Verification Date: May 2009