UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031399 |
|---|---|
| Receipt number | R000035849 |
| Scientific Title | The effect of transurethral enucleation with bipolar on erectile dysfunction |
| Date of disclosure of the study information | 2018/02/21 |
| Last modified on | 2022/08/26 15:01:35 |
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Basic information
Public title
The effect of transurethral enucleation with bipolar on erectile dysfunction
Acronym
The effect of transurethral enucleation with bipolar on erectile dysfunction
Scientific Title
The effect of transurethral enucleation with bipolar on erectile dysfunction
Scientific Title:Acronym
The effect of transurethral enucleation with bipolar on erectile dysfunction
Region
| Japan |
Condition
Condition
benign prostatic hyperplasia
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The effect of transurethral enucleation with bipolar on erectile dysfunction
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Assesment of Erectile Function by use of IIEF5 preoperative, 3months and 12 months after TUEB
Key secondary outcomes
Assesment of UFM/RU, IPSS preoperative, 3months and 12 months after TUEB
Assesment of PSA preoperative and 12 months after TUEB
Assesment of pelvic MRI preoperatively
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
1) Patients aged 20 years or older.
2) Patients with benign prostatic hyperplasia will receive TUEB.
Key exclusion criteria
1) Patients who are judged to be inappropriate.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuyuki Kobayashi |
Organization
Kinki Central Hospital of Mutual Aid Association of Public Teachers
Division name
Department of Urology
Zip code
Address
3-1 Kurumazuka, Itami, Hyogo 664-8533, Japan
TEL
072-781-3712
ya_su_koba@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuyuki Kobayashi |
Organization
Kinki Central Hospital of Mutual Aid Association of Public Teachers
Division name
Department of Urology
Zip code
Address
3-1 Kurumazuka, Itami, Hyogo 664-8533, Japan
TEL
072-781-3712
Homepage URL
ya_su_koba@yahoo.co.jp
Sponsor or person
Institute
Departments of Urology, Kinki Central Hospital of Mutual Aid Association of Public Teachers, Hyogo, Japan
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
Address
Tel
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
| 2018 | Year | 02 | Month | 21 | 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
Completed
Date of protocol fixation
| 2016 | Year | 05 | Month | 23 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 23 | Day |
Anticipated trial start date
| 2016 | Year | 05 | Month | 30 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Completed
Management information
Registered date
| 2018 | Year | 02 | Month | 21 | Day |
Last modified on
| 2022 | Year | 08 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035849
