NocturiaNCT01576900
The Effect of Combined Systematized Behavioural Modification Education Program (SyBeMeP) With DDAVP in Patients With Nocturia
An observational study of Nocturia, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
In patients with nocturia, combinational treatment of DDAVP and SyBeMeP might show better outcomes. Systemic video instruction might prove to be beneficial by helping patients have better understanding on treatment and replacing healthcare personnel. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Nocturia
- What is being tested?
- SyBeMeP (Systemized Behavioural Modification education Program)
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- How many people
- 124 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2012to Oct 2014
- Phase
- Observational
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Korean patients with nocturia regardless of age and gender
Who may be able to join
- A patient with nocturia, who visited department of urology as outpatient
- Have not been treated with desmopressin for at least 6 months before
Who cannot join
- Sleep disorder,
- history of medication for voiding,
- diabetes insipidus,
- diabetes mellitus,
- cardiovascular disease,
- voiding difficulties (including residual urine of more than 100ml),
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- small bladder capacity,
- overactive bladder,
- illiteracy,
- psychiatric disorder and having no intention to be enrolled by written agreement
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital
Seoul, Seoul, 110-744
About this study
In patients with nocturia, combinational treatment of DDAVP and SyBeMeP might show better outcomes.
Systemic video instruction might prove to be beneficial by helping patients have better understanding on treatment and replacing healthcare personnel.
Read the detailed description
One of main reason of nocturia is known as nocturnal polyuria. For the treatment of nocturia caused by overactive bladder, the combined therapy of anticholinergics plus behavioural modification has been established as the first line therapy. However, nocturia mainly comes from polyuria has been treated with desmopressin pharmacotherapy and the effect of behaviour modification education has not yet evaluated. Therefore, in this study, short term synergistic effect of combinational treatment of desmopressin and SyBeMeP (Systemized Behavioral Modification education Program) comparing desmopressin monotherpy will be evaluated in patients with nocturia.
Control group: Desmopressin (Minirin Tablet 0.1-0.4mg/day) + simple instruction Study group: Desmopressin (Minirin Tablet 0.1-0.4mg/day) + SyBeMeP. Patients will be randomized and assigned to each group at the ratio of 1:1. At screening visit, flowmetry and residual urine measurement, Complete Blood Count (CBC), atypical diabetes mellitus (ADM), electrolytes, urinalysis micro, urine concentration, and demographic examination will be done. Voiding diary will be distributed. At 2nd visit, patients will be randomized and each treatment will be initiated. IPSS, ICIQ-nocturia, and PPTB will be completed. Voiding diary will be distributed. At 3rd visit (2 weeks after from 2nd visit): IPSS, ICIQ-nocturia, and PPTB will be completed. Assess the treatment outcome including voiding diary analysis.
- Conditions
- Nocturia
- Being tested
- SyBeMeP (Systemized Behavioural Modification education Program)
- Keywords
- behavior therapy, nocturia, polyuria
- Medical subject headings
- Nocturia, Polyuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SyBeMeP (Systemized Behavioural Modification education Program)Behavioural
- Standard video material will be developed to minimize variation of outcomes caused by differences in contents at each trial site.
- Video material will be self-study program for PC with running time around 20 minutes. Contents will cover pathophysiology, diagnosis and treatment process, and be easy to understand for everyone with variety of examples. In treatment part, it will describe general principles of behavioural therapy (Adjustment of timing of fluid intake, Reducing alcohol and caffeine, Improving sleep hygiene including moderate exercise, room temperature, noise and lighting. if necessary, compressive stocking, late afternoon nap and leg elevation would be added)
- During trial, patients will watch SYBeMeP at a specially prepared separate room with computer.
- After watching the video, check-list on take-home message will be recorded by patients at the site to confirm patients' awareness after education.
| Study group | Role | What they receive |
|---|---|---|
| Desmopressin monotherapy | Control group: Desmopressin (Minirin Tablet 0.1-0.4mg/day) + simple instruction | |
| Combination group | Study group: Desmopressin (Minirin Tablet 0.1-0.4mg/day) + SyBeMeP
* Patients will be randomized and assigned to each group at the ratio of 1:1. Receives: Behavioral: SyBeMeP (Systemized Behavioural Modification education Program) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in urinary frequency (No. of nocturia)
Measured: baseline, 2 week, 1 month, and 3 months
Secondary outcomes (5)
Voiding diary indices
Measured: baseline, 2 weeks, 1 month and 3 months
IPSS
Measured: baseline, 2 weeks, 1 month and 3 months
ICIQ-nocturia
Measured: baseline, 2 weeks, 1 month and 3 months
patient's perception of bladder condition (PPTB)
Measured: baseline, 2 weeks, 1 month and 3 months
patient's satisfaction on the education
Measured: baseline, 2 weeks, 1 month and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NocturiaStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ferring Pharmaceuticals
- Responsible party
- Principal investigator, Seung-June Oh, Seoul National University Hospital
- Investigators
- Sung Yong Cho, M.D.,Ph.D., Study director, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01576900
- Sponsor's protocol ID
- Nocturia-SBMP
- Status last verified
- Nov 2014
- First submitted
- 13 Feb 2012
- Last updated
- 20 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cho SY, Lee SL, Kim IS, Koo DH, Kim HJ, Oh SJ. Short-term effects of systematized behavioral modification program for nocturia: a prospective study. Neurourol Urodyn. 2012 Jan;31(1):64-8. doi: 10.1002/nau.21186. Epub 2011 Aug 8.
PubMed 21826726
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Combined Systematized Behavioural Modification Education Program (SyBeMeP) With DDAVP in Patients With Nocturia
- ClinicalTrials.gov ID
- NCT01576900
- Acronym / sponsor ID
- Nocturia-SBMP
- Conditions
- Nocturia
- Keywords
- behavior therapy, nocturia, polyuria
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Ferring Pharmaceuticals
- Study start
- Apr 2012
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 13 Apr 2012 (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.
In patients with nocturia, combinational treatment of DDAVP and SyBeMeP might show better outcomes.
Systemic video instruction might prove to be beneficial by helping patients have better understanding on treatment and replacing healthcare personnel.
Detailed description
One of main reason of nocturia is known as nocturnal polyuria. For the treatment of nocturia caused by overactive bladder, the combined therapy of anticholinergics plus behavioural modification has been established as the first line therapy. However, nocturia mainly comes from polyuria has been treated with desmopressin pharmacotherapy and the effect of behaviour modification education has not yet evaluated. Therefore, in this study, short term synergistic effect of combinational treatment of desmopressin and SyBeMeP (Systemized Behavioral Modification education Program) comparing desmopressin monotherpy will be evaluated in patients with nocturia.
Control group: Desmopressin (Minirin Tablet 0.1-0.4mg/day) + simple instruction Study group: Desmopressin (Minirin Tablet 0.1-0.4mg/day) + SyBeMeP. Patients will be randomized and assigned to each group at the ratio of 1:1. At screening visit, flowmetry and residual urine measurement, Complete Blood Count (CBC), atypical diabetes mellitus (ADM), electrolytes, urinalysis micro, urine concentration, and demographic examination will be done. Voiding diary will be distributed. At 2nd visit, patients will be randomized and each treatment will be initiated. IPSS, ICIQ-nocturia, and PPTB will be completed. Voiding diary will be distributed. At 3rd visit (2 weeks after from 2nd visit): IPSS, ICIQ-nocturia, and PPTB will be completed. Assess the treatment outcome including voiding diary analysis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Desmopressin monotherapy | – | –Control group: Desmopressin (Minirin Tablet 0.1-0.4mg/day) + simple instruction |
| Combination group | – | Behavioral: SyBeMeP (Systemized Behavioural Modification education Program)Study group: Desmopressin (Minirin Tablet 0.1-0.4mg/day) + SyBeMeP * Patients will be randomized and assigned to each group at the ratio of 1:1. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Korean patients with nocturia regardless of age and gender
Key inclusion criteria (2 listed)
- A patient with nocturia, who visited department of urology as outpatient
- Have not been treated with desmopressin for at least 6 months before
Key exclusion criteria (10 listed)
- Sleep disorder,
- history of medication for voiding,
- diabetes insipidus,
- diabetes mellitus,
- cardiovascular disease,
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 |
|---|---|---|
| SyBeMeP (Systemized Behavioural Modification education Program)* Standard video material will be developed to minimize variation of outcomes caused by differences in contents at each trial site. * Video material will be self-study program for PC with running time around 20 minutes. Contents will cover pathophysiology, diagnosis and treatment process, and be easy to understand for everyone with variety of examples. In treatment part, it will describe general principles of behavioural therapy (Adjustment of timing of fluid intake, Reducing alcohol and caffeine, Improving sleep hygiene including moderate exercise, room temperature, noise and lighting. if necessary, compressive stocking, late afternoon nap and leg elevation would be added) * During trial, patients will watch SYBeMeP at a specially prepared separate room with computer. * After watching the video, check-list on take-home message will be recorded by patients at the site to confirm patients' awareness after education. | Behavioural | Combination group |
Primary outcome
Decrease in urinary frequency (No. of nocturia)
Time frame: baseline, 2 week, 1 month, and 3 months
5 secondary outcomes
Voiding diary indices
Time frame: baseline, 2 weeks, 1 month and 3 months
IPSS
Time frame: baseline, 2 weeks, 1 month and 3 months
ICIQ-nocturia
Time frame: baseline, 2 weeks, 1 month and 3 months
patient's perception of bladder condition (PPTB)
Time frame: baseline, 2 weeks, 1 month and 3 months
patient's satisfaction on the education
Time frame: baseline, 2 weeks, 1 month and 3 months
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 20 Nov 2014.
- Background: PubMed 21826726Cho SY, Lee SL, Kim IS, Koo DH, Kim HJ, Oh SJ. Short-term effects of systematized behavioral modification program for nocturia: a prospective study. Neurourol Urodyn. 2012 Jan;31(1):64-8. doi: 10.1002/nau.21186. Epub 2011 Aug 8.
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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.
Sung Yong Cho, M.D.,Ph.D. study director
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nocturia, run by Seoul National University Hospital at 1 site 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 2 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 20 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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?
Decrease in urinary frequency (No. of nocturia) (time frame: baseline, 2 week, 1 month, and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01576900, which also lists 1 linked publication.
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 20 Nov 2014.