Tokyo, Oct. 26 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059515) titled 'Clinical trial of a new urinary flow measurement system using urination sounds' on Oct. 25.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - International University of Health and Welfare
Condition:
Condition - Lower urinary tract symptoms
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To examine the clinical usefulness of a system that estimates urine flow measurement results from urination sounds.
Basic objectives2 - Others
Intervention:
Interventions/Control_1 - Uroloflowmetry
Eligibility:
Age-lower limit - 18
years-old
1. Individuals without urinary disorders (International Prostate Symptom Score [IPSS] total of less than 8 points, Overactive Bladder Symptpm Score [OABSS] total of less than 3 points)
2. Individuals who can provide written consent for participation in the study willingly
3. Individuals aged 18 years or older
4. Gender: Male and Female
1. Patients with LUTS (IPSS total of 8 points or more, OABSS total of 3 points or more
2. Patients who can provide written consent for research participation voluntarily
3. Patients aged 18 years or older at the time of consent
4. Gender: Male and female
Key exclusion criteria - If the urine volume is less than 20 mL. If the urine flow test could not be completed.
Target Size - 120
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 10 Month 01 Day
Date of IRB - 2025 Year 09 Month 17 Day
Anticipated trial start date - 2025 Year 10 Month 27 Day
Last follow-up date - 2028 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067244
Disclaimer: Curated by HT Syndication.
