Clinical trial NCT01576900: The Effect of Combined Systematized Behavioural Modification Education Program (SyBeMeP) With DDAVP in Patients With Nocturia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nocturia
Keywords: behavior therapy
nocturia
polyuria
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Ferring Pharmaceuticals
First posted: 2012-04-13
Enrollment: 124
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Korean patients with nocturia regardless of age and gender

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* A patient with nocturia, who visited department of urology as outpatient
* Have not been treated with desmopressin for at least 6 months before

Exclusion Criteria:

* Sleep disorder,
* history of medication for voiding,
* diabetes insipidus,
* diabetes mellitus,
* cardiovascular disease,
* voiding difficulties (including residual urine of more than 100ml),
* small bladder capacity,
* overactive bladder,
* illiteracy,
* psychiatric disorder and having no intention to be enrolled by written agreement

Primary outcomes:
measure: Decrease in urinary frequency (No. of nocturia)
timeFrame: baseline, 2 week, 1 month, and 3 months
Secondary outcomes:
measure: Voiding diary indices
timeFrame: baseline, 2 weeks, 1 month and 3 months
measure: IPSS
timeFrame: baseline, 2 weeks, 1 month and 3 months
measure: ICIQ-nocturia
timeFrame: baseline, 2 weeks, 1 month and 3 months
measure: patient's perception of bladder condition (PPTB)
timeFrame: baseline, 2 weeks, 1 month and 3 months
measure: patient's satisfaction on the education
timeFrame: baseline, 2 weeks, 1 month and 3 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Sung Yong Cho, M.D.,Ph.D.
role: STUDY_DIRECTOR
References:
citation: 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.