The Effect of Combined Systematized Behavioural Modification Education Program (SyBeMeP) With DDAVP in Patients With Nocturia

Seoul National University

Status: Completed

Conditions: Nocturia

Treatments: Behavioral: SyBeMeP (Systemized Behavioural Modification education Program)

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01576900

Nocturia-SBMP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 124 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

124 participants in 2 patient groups

Desmopressin monotherapy

Description:

Control group: Desmopressin (Minirin Tablet 0.1-0.4mg/day) + simple instruction

Combination group

Description:

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.

Treatment:

Behavioral: SyBeMeP (Systemized Behavioural Modification education Program)