NocturiaPhase 4NCT00902655
Desmopressin in the Treatment of Mixed Nocturia With Nocturnal Polyuria and Low Nocturnal Bladder Capacity
A Phase 4 study testing Desmopressin in people with Nocturia, run by Samsung Medical Center at 6 sites in South Korea.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nocturia
- What is being tested?
- Desmopressin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 6 sitesSouth Korea
- Study dates
- Apr 2004to Dec 2005
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged ≥18 yr
- nocturia ≥2 voids/night
- nocturnal polyuria index (NPi) >33%
- nocturnal bladder capacity index (NBCi) >1
Who cannot join
- 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
Show all 10Show fewer
- serum sodium levels <135mmol/L
- uncontrolled hypertension characterized by fluid and/or electrolyte imbalance
- use of diuretics
- actual or planned pregnancy
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
South Korea6 sites
Keimyung University School of Medicine
Daegu
College of Medicine Inha University
Inchon
Pusan National University Hospital
Pusan
Asan Medical Center
Seoul
Korea University Anam Hospital
Seoul
Seoul National University College of Medicine
Seoul
About this study
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.
Read the 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
- Conditions
- Nocturia
- Being tested
- Desmopressin
- Keywords
- Nocturnal polyuria, Nocturnal bladder capacity
- Medical subject headings
- Nocturia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DesmopressinDrug
Also called Minirin
Desmopressin 0.1,0.2 or 0.4 mg once daily for 3-weeks of dose titration phase and 4-weeks of treatment phase
| Study group | Role | What they receive |
|---|---|---|
| Desmopressin | Experimental | Not described Receives: Drug: Desmopressin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with a 50% or greater reduction in the mean number of nocturnal voids compared with baseline levels.
Measured: after 4-weeks of treatment phase
Secondary outcomes (4)
Change in the mean number of nocturnal voids.
Measured: after 4-weeks of treatment phase
Change in the mean duration of the period from bedtime to the first nocturnal void.
Measured: after 4-weeks of treatment phase
Change in the proportion of patients that felt they had a good sleep experience.
Measured: after 4-weeks of treatment phase
Body weight gain.
Measured: after 4-weeks of treatment phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2009 (estimated)
- Study startApr 2004
- Primary completionDec 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NocturiaStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Kyu-Sung Lee, Ph.D, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00902655
- Sponsor's protocol ID
- 2004-04-05
- Status last verified
- May 2009
- First submitted
- 14 May 2009
- Last updated
- 15 May 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Desmopressin in the Treatment of Mixed Nocturia With Nocturnal Polyuria and Low Nocturnal Bladder Capacity
- ClinicalTrials.gov ID
- NCT00902655
- Acronym / sponsor ID
- 2004-04-05
- Conditions
- Nocturia
- Keywords
- Nocturnal polyuria, Nocturnal bladder capacity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Apr 2004
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 15 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Desmopressin | Experimental | Drug: Desmopressin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- aged ≥18 yr
- nocturia ≥2 voids/night
- nocturnal polyuria index (NPi) >33%
- nocturnal bladder capacity index (NBCi) >1
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DesmopressinAlso: MinirinDesmopressin 0.1,0.2 or 0.4 mg once daily for 3-weeks of dose titration phase and 4-weeks of treatment phase | Drug | Desmopressin |
Primary outcome
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
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2009.
Related trials for Nocturia
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Recruiting
UCon Treatment of Overactive Bladder (OAB) in Males
Urinary Incontinence, Urge Incontinence
Active, not recruiting
APPROVE Trial: Evaluating a Prescription Digital Therapeutic for Treatment of OAB in Women
Overactive Bladder (OAB), Urinary Urgency
Active, not recruitingPhase 1/2
An Acupuncture Study for Prostate Cancer Survivors With Urinary Issues
Survivorship, Prostate Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyu-Sung Lee, Ph.D principal investigator
Samsung Medical Center
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Desmopressin in people with Nocturia, run by Samsung Medical Center at 6 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2009.