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Japanese

April. 30, 2023

Feb. 20, 2025

jRCT1070230013

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

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

Yoshida Masaki

Sakura Jyuji Hospital

11-1-1, Miyukikibe, Kumamoto Shi Minami Ku, Kumamoto Ken

+81-96-378-1111

masa.yoshida@sakurajyuji.jp

Tsukamoto Ken

Taiho Pharmaceutical Company

1-27 Kandanishikicho, Chiyoda-ku, Tokyo To

+81-6-7176-5731

k-tsukamoto@taiho.co.jp

Not Recruiting

Mar. 13, 2023

May. 11, 2023
186

Observational

diagnostic purpose

-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

-Researchers and others judged the participation of this study to be inappropriate.

18age 0month 0week old over
No limit

Both

UAB syndrome

Diagnostic predictive value based on noninvasive diagnostic criteria for DU.(%)

-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)

TAIHO PHARMACEUTICAL CO., LTD.
TAIHO PHARMACEUTICAL CO., LTD.
Applicable
Sakurajyuji Hospital Ethics Review Committee
11-1-1, Miyukikibe, Kumamoto Shi Minami Ku, Kumamoto Ken, Kumamoto

+81-96-378-1111

a.kato@sakurajyuji.jp
Approval

Mar. 13, 2023

No

none

History of Changes

No Publication date
8 Feb. 20, 2025 (this page) Changes
7 July. 09, 2024 Detail Changes
6 April. 02, 2024 Detail Changes
5 Nov. 11, 2023 Detail Changes
4 Sept. 04, 2023 Detail Changes
3 July. 25, 2023 Detail Changes
2 June. 24, 2023 Detail Changes
1 April. 30, 2023 Detail