UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039731 |
|---|---|
| Receipt number | R000045313 |
| Scientific Title | Prospective randomized study of the evaluation of the efficacy and the invasiveness in the treatment of benign prostatic hyperplasia with transurethral thulium laser surgery and transurethral resection of the prostate |
| Date of disclosure of the study information | 2020/03/09 |
| Last modified on | 2020/03/07 12:10:19 |
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Basic information
Public title
Prospective randomized study of the evaluation of the efficacy and the invasiveness in the treatment of benign prostatic hyperplasia with transurethral thulium laser surgery and transurethral resection of the prostate
Acronym
Prospective randomized study of the evaluation of the efficacy and the invasiveness in the treatment of benign prostatic hyperplasia with transurethral thulium laser surgery and transurethral resection of the prostate
Scientific Title
Prospective randomized study of the evaluation of the efficacy and the invasiveness in the treatment of benign prostatic hyperplasia with transurethral thulium laser surgery and transurethral resection of the prostate
Scientific Title:Acronym
Prospective randomized study of the evaluation of the efficacy and the invasiveness in the treatment of benign prostatic hyperplasia with ThuLEP and TUR-P
Region
| Japan |
Condition
Condition
Benign Prostatic Hyperplasia
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and the invasiveness in the treatment of benign prostatic hyperplasia with transurethral thulium laser surgery and transurethral resection of the prostate in prospective randomized study
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Influence to the urinary function
2. Ocurrence of complications
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Transurethral thulium laser surgery, about 2 hours
Interventions/Control_2
Transurethral resection of the prostate, about 2 hours
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
| 90 | years-old | > |
Gender
Male
Key inclusion criteria
1. Age with and larget than 50 years old, less than 90 years old
2. Patient who were diagnosed with benign prostatic hyperplasia
3. Patient who has blodder outlet obstruction due to benign prostatic hyperplasia
4. Patient who who underwent this procedure provided informed consent
Key exclusion criteria
1. Patient who has other disease which has effect to the urinary function
2. Patient who has influence due to pre-operative treatment
3. Patients who was regarded as inadequacy for the present study
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Shoji |
| Middle name | |
| Last name | Sunao |
Organization
Tokai University School of Medicine
Division name
Department of Urology
Zip code
259-1193
Address
Shimokasuya 143, Isehara, Kanagawa
TEL
0463-93-1121
sunashoj@mail.goo.ne.jp
Public contact
Name of contact person
| 1st name | Sunao |
| Middle name | |
| Last name | Shoji |
Organization
Tokai University School of Medicine
Division name
Department of Urology
Zip code
259-1193
Address
Shimokasuya 143, Isehara, Kanagawa
TEL
0463-93-1121
Homepage URL
sunashoj@mail.goo.ne.jp
Sponsor or person
Institute
Tokai University school of medicine
Institute
Department
Personal name
Funding Source
Organization
Tokai University school of medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board for Clinical Research, Tokai University
Address
143 Shimokasuya, Isehara, Kanagawa
Tel
0463-93-1121
tokai-rinsho@ml.tokai-u.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
東海大学医学部
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 03 | Month | 09 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 03 | Month | 07 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 07 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 07 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 03 | Month | 07 | Day |
Last modified on
| 2020 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045313
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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