UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055479 |
|---|---|
| Receipt number | R000063391 |
| Scientific Title | Ultrasound-based urodynamic measurements during transurethral prostate surgery |
| Date of disclosure of the study information | 2024/09/11 |
| Last modified on | 2024/09/11 12:17:24 |
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Basic information
Public title
Ultrasound-based urodynamic measurements during transurethral prostate surgery
Acronym
Ultrasound-based urodynamic measurements during transurethral prostate surgery
Scientific Title
Ultrasound-based urodynamic measurements during transurethral prostate surgery
Scientific Title:Acronym
Ultrasound-based urodynamic measurements during transurethral prostate surgery
Region
| Japan |
Condition
Condition
Benign prostatic hyperplasia
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to measure urodynamics by ultrasonography during transurethral prostate surgery performed under general anesthesia.
Basic objectives2
Others
Basic objectives -Others
The aim is to collect intraoperative urodynamic data.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
In benign prostatic hyperplasia surgery, we are creating an ideal lower urinary tract lumen image for efficient urinary drainage.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 50 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male
Key inclusion criteria
1) Patients diagnosed with benign prostatic hyperplasia
2) Patients with a prostate volume of 30 cc or more
3) Patients who have given written consent to participate in the study from themselves, their guardians, or surrogates.
Key exclusion criteria
1) Patients who cannot undergo general anesthesia
2) Patients with allergy or hypersensitivity to ultrasound contrast media
3) Patients who have requested not to participate in this study by themselves, their parents or guardians
4) Patients judged by the investigators or others to be unsuitable to participate in this study.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kanya |
| Middle name | |
| Last name | Kaga |
Organization
Chiba Prefectural Sawara Hospital
Division name
Department of Urology
Zip code
2870003
Address
E2285, Sawara, Katori, Chiba, Japan
TEL
0478541231
robert_chibariyo0072@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Kanya |
| Middle name | |
| Last name | Kaga |
Organization
Chiba Prefectural Sawara Hospital
Division name
Department of Urology
Zip code
2870003
Address
E2285, Sawara, Katori, Chiba, Japan
TEL
0478541231
Homepage URL
robert_chibariyo0072@yahoo.co.jp
Sponsor or person
Institute
Chiba Prefectural Sawara Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee of Chiba Prefectural Sawara Hospital
Address
E2285, Sawara, Katori, Chiba, Japan
Tel
0478541231
d.szk18@pref.chiba.lg.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
| 2024 | Year | 09 | Month | 11 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 03 | Month | 13 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 13 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 13 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Urodynamics during transurethral prostate surgery under general anesthesia measured with a transrectal echoprobe.
Management information
Registered date
| 2024 | Year | 09 | Month | 11 | Day |
Last modified on
| 2024 | Year | 09 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063391
