UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061949 |
|---|---|
| Receipt number | R000070888 |
| Scientific Title | Non-invasive Evaluation of Urinary Flow Dynamics and Fine Anatomical Structures of the Seminal Tract Using Magnetic Resonance Imaging Techniques |
| Date of disclosure of the study information | 2026/06/22 |
| Last modified on | 2026/06/17 20:50:07 |
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Basic information
Public title
Non-invasive Evaluation of Urinary Flow Dynamics and Fine Anatomical Structures of the Seminal Tract Using Magnetic Resonance Imaging Techniques
Acronym
MRI-UroSem Study
Scientific Title
Non-invasive Evaluation of Urinary Flow Dynamics and Fine Anatomical Structures of the Seminal Tract Using Magnetic Resonance Imaging Techniques
Scientific Title:Acronym
MRI-UroSem Study
Region
| Japan |
Condition
Condition
Urolithiasis, hydronephrosis, benign prostatic hyperplasia, lower urinary tract obstruction, and oligozoospermia
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Evaluation of imaging biomarkers and anatomical/functional characteristics
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
MRI-derived imaging parameters of urinary flow dynamics and seminal tract morphology.
Specific parameters include:
1. Frequency and spatial distribution of urinary flow-related signal changes in the renal pelvis.
2. Frequency and spatial distribution of urinary flow-related signal changes in the urinary bladder.
3. Morphological findings of the seminal tract, including the vas deferens and seminal vesicles.
Key secondary outcomes
1. Association between renal pelvic morphology and stone size or number.
2. Association between renal pelvic morphology and recurrence of urolithiasis.
3. Association between prostatic morphology and severity of lower urinary tract symptoms.
4. Association between prostatic morphology and treatment response in benign prostatic hyperplasia.
5. Association between seminal tract morphology and semen analysis findings.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
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.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
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 sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Kobayashi |
Organization
Institute of Science Tokyo
Division name
Urology
Zip code
113-8510
Address
Yushima 1-5-45, Bunkyo-ku, Tokyo
TEL
03-5803-5295
koba.uro@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Kobayashi |
Organization
Institute of Science Tokyo
Division name
Urology
Zip code
113-8510
Address
Yushima 1-5-45, Bunkyo-ku, Tokyo
TEL
03-5803-5295
Homepage URL
koba.uro@tmd.ac.jp
Sponsor or person
Institute
Institute of Science Tokyo
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institute of Science Tokyo
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
Tel
03-5803-5295
koba.uro@tmd.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2031 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 06 | Month | 17 | Day |
Last modified on
| 2026 | Year | 06 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070888
