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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000041240
Receipt No. 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 2020/07/29

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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
Email 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
Email goanan@tohoku-mpu.ac.jp

Sponsor
Institute Tohoku Medical and Pharmaceutical University
Institute
Department

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
Email 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
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 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
2020 Year 07 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047097

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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