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

Nocturia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00902655
• Other study ID #: 2004-04-05
• Status: Completed
• Phase: Phase 4
• First received: May 14, 2009
• Last updated: May 14, 2009
• Start date: April 2004
• Est. completion date: December 2005

Study information

• Verified date: May 2009
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: December 2005
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nocturia
• Polyuria

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

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with a 50% or greater reduction in the mean number of nocturnal voids compared with baseline levels.		after 4-weeks of treatment phase	No
Secondary	Change in the mean number of nocturnal voids.		after 4-weeks of treatment phase	Yes
Secondary	Change in the mean duration of the period from bedtime to the first nocturnal void.		after 4-weeks of treatment phase	Yes
Secondary	Change in the proportion of patients that felt they had a good sleep experience.		after 4-weeks of treatment phase	Yes
Secondary	Body weight gain.		after 4-weeks of treatment phase	Yes