NIPH Clinical Trials Search

JRCT ID: jRCT1070230013

Registered date:30/04/2023

A clinical study of non-invasive diagnostic criteria for detrusor underactivity

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedUAB syndrome
Date of first enrollment11/05/2023
Target sample size186
Countries of recruitment
Study typeObservational


Primary OutcomeDiagnostic predictive value based on noninvasive diagnostic criteria for DU.(%)
Secondary Outcome-PFS parameters (urine collection period) -PFS parameters (voiding phase) -Uroflowmetry parameters -Ultrasonographic PVR -BVE(%) -International Prostate Symptom Score -Major lower urinary tract symptom-score (CLSS). -ICIQ-UAB Score -Adverse events -BCI (men) and PIP1 (women) tabulation Summarized statistics of BCI (men) and PIP1 (women). -Urinary micro RNA analysis (only in collaborating laboratories where micro RNA analysis is feasible)

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximumNot applicable
Include criteria-Written consent was given for participation in the study. - Age at the time of informed consent is 18 years or older. - Willingness to adhere to the visit schedule and procedures specified in this study, and compliance is possible -Of the three voiding symptoms of UAB's syndrome as defined by ICS (hypovolemia, delayed voiding, abdominal pressure voiding), having any two or more symptoms for at least 12 weeks
Exclude criteria-Researchers and others judged the participation of this study to be inappropriate.

Related Information


Public contact
Name Ken Tsukamoto
Address 1-27 Kandanishikicho, Chiyoda-ku, Tokyo To Tokyo Japan 101-8444
Telephone +81-6-7176-5731
Affiliation Taiho Pharmaceutical Company
Scientific contact
Name Masaki Yoshida
Address 11-1-1, Miyukikibe, Kumamoto Shi Minami Ku, Kumamoto Ken Kumamoto Japan 861-4173
Telephone +81-96-378-1111
Affiliation Sakura Jyuji Hospital