Tokyo, June 22 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061949) titled 'Non-invasive Evaluation of Urinary Flow Dynamics and Fine Anatomical Structures of the Seminal Tract Using Magnetic Resonance Imaging Techniques' on June 22.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Institute of Science Tokyo

Condition: Condition - Urolithiasis, hydronephrosis, benign prostatic hyperplasia, lower urinary tract obstruction, and oligozoospermia Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The objective of this study is to non-invasively evaluate urinary flow dynamics and fine anatomical structures of the seminal tract using magnetic resonance imaging (MRI) techniques. Specifically, urinary flow dynamics in the renal pelvis and urinary bladder will be visualized using cine magnetic resonance urography (MRU) combined with motion-sensitized driven-equilibrium (MSDE) imaging. In addition, fine structures of the seminal tract, including the vas deferens and seminal vesicles, will be evaluated using Dual artificial intelligence (AI)-assisted two-dimensional magnetic resonance cholangiopancreatography (2D MRCP)-based imaging. The study also aims to investigate the relationship between MRI-derived imaging findings and clinical parameters related to urolithiasis, lower urinary tract obstruction, and male infertility. Basic objectives2 - Others

Intervention: Interventions/Control_1 - As part of this observational study, participants will undergo a single non-invasive MRI examination. For urinary tract evaluation, cine magnetic resonance urography (MRU) combined with motion-sensitized driven-equilibrium (MSDE) imaging will be used to assess urinary flow dynamics in the renal pelvis and urinary bladder. For seminal tract evaluation, pelvic MRI will be performed under imaging conditions equivalent to Dual artificial intelligence (AI)-assisted two-dimensional magnetic resonance cholangiopancreatography (2D MRCP) to evaluate fine anatomical structures of the seminal tract, including the vas deferens and seminal vesicles. MRI examinations will be performed once per participant at Takahara Clinic Innovative Scan using a 1.5-T MRI scanner (Philips Ingenia Ambition X). The examination will require approximately 30 to 45 minutes and will not involve contrast agents or ionizing radiation.

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Healthy adult volunteers aged 20 years or older without a history of urolithiasis, benign prostatic hyperplasia, or oligozoospermia. 2. Patients aged 20 years or older with any of the following conditions: history of urolithiasis hydronephrosis lower urinary tract obstruction, including benign prostatic hyperplasia oligozoospermia 3. Participants who understand the study and provide written informed consent. Key exclusion criteria - 1. Contraindications to MRI, including pacemaker implantation or ferromagnetic implants. 2. Pregnancy or possible pregnancy. 3. Difficulty undergoing MRI due to claustrophobia or other reasons. 4. Conditions likely to cause significant MRI artifacts or missing imaging data. 5. Insufficient information required for the primary outcome assessment. 6. Individuals judged inappropriate for participation by the principal investigator or co-investigators. Target Size - 40

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 07 Month 01 Day Anticipated trial start date - 2026 Year 08 Month 01 Day Last follow-up date - 2031 Year 02 Month 28 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070888

Disclaimer: Curated by HT Syndication.