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

JRCT ID: jRCT1070230013

Registered date:30/04/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: UAB syndrome
• Date of first enrollment: 11/05/2023
• Target sample size: 186
• Study type: Observational

Outcome(s)

• Primary Outcome: Diagnostic 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 maximum: Not applicable
• Gender: Both

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

• Primary Sponsor: Yoshida Masaki
• Secondary Sponsor: TAIHO PHARMACEUTICAL CO., LTD.