UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041240 |
|---|---|
| Receipt number | R000047097 |
| Scientific Title | The efficacy and safety of transurethral enucleation of the prostate for benign prostatic hyperplasia using King health questionnaire assessment |
| Date of disclosure of the study information | 2020/07/29 |
| Last modified on | 2022/07/31 15:26:50 |
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Basic information
Public title
The efficacy and safety of transurethral enucleation of the prostate for benign prostatic hyperplasia using King health questionnaire assessment
Acronym
The efficacy and safety of HoLEP using King health questionnaire assessment
Scientific Title
The efficacy and safety of transurethral enucleation of the prostate for benign prostatic hyperplasia using King health questionnaire assessment
Scientific Title:Acronym
The efficacy and safety of HoLEP using King health questionnaire assessment
Region
| Japan |
Condition
Condition
benign prostatic hyperplasia
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the efficacy and safety of transurethral enucleation of the prostate (HoLEP) for benign prostatic hyperplasia using the King Health Questionnaire.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Quality of life assessment using the King Health Study at 1, 3 and 6 months post-operatively
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
| 90 | years-old | > |
Gender
Male
Key inclusion criteria
1)Estimated prostate volume is 30 ml or more
2)Patients who will undergo Holmium laser enucleation of the prostate at our hospital
Key exclusion criteria
1)Patients who have severe incontinence before surgery due to severe cerebrovascular disorder or spinal cord injury
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Go |
| Middle name | |
| Last name | Anan |
Organization
Tohoku Medical and Pharmaceutical University Hospital
Division name
Department of Urology
Zip code
983-8536
Address
1-15-1 Fukumuro, Miyagino-ku, Sendai, Miyagi
TEL
022-234-4181
goanan@tohoku-mpu.ac.jp
Public contact
Name of contact person
| 1st name | Go |
| Middle name | |
| Last name | Anan |
Organization
Tohoku Medical and Pharmaceutical University Hospital
Division name
Department of Urology
Zip code
N/A
Address
1-15-1 Fukumuro, Miyagino-ku, Sendai, Miyagi
TEL
022-234-4181
Homepage URL
goanan@tohoku-mpu.ac.jp
Sponsor or person
Institute
Tohoku Medical and Pharmaceutical University
Institute
Department
Personal name
Funding Source
Organization
Tohoku Medical and Pharmaceutical University
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
Tohoku Medical and Pharmaceutical University
Address
1-15-1 Fukumuro, Miyagino-ku, Sendai, Miyagi
Tel
022-259-1221
tikenn@hosp.tohoku-mpu.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
| 2020 | Year | 07 | Month | 29 | Day |
Related information
URL releasing protocol
https://www.hosp.tohoku-mpu.ac.jp/center/cr_support_center/disclosure.html
Publication of results
Unpublished
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
100
Results
HoLEP could be safe and effective even for men aged more than 75 years, comparing complications, urinary condition, and KHQ scores.
Results date posted
| 2022 | Year | 07 | Month | 31 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
1)Estimated prostate volume is 30 ml or more
2)Patients who will undergo Holmium laser enucleation of the prostate at our hospital
Participant flow
Patients undergoing HOLEP surgery were asked to complete a preoperative and postoperative questionnaire and gave their consent.
Adverse events
non
Outcome measures
Quality of life assessment using the King Health Study at 1, 3 and 6 months post-operatively
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 07 | Month | 21 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 21 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 21 | 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
Quality of life assessment using the King Health Survey before and after surgery
Management information
Registered date
| 2020 | Year | 07 | Month | 29 | Day |
Last modified on
| 2022 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047097
