UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000015468
Receipt No. R000017584
Scientific Title Long-term outcomes of patients with benign prostatic hyperplasia undergoing transurethral resection of prostate, prospective observational study in single center
Date of disclosure of the study information 2014/10/18
Last modified on 2019/04/26

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Long-term outcomes of patients with benign prostatic hyperplasia undergoing transurethral resection of prostate, prospective observational study in single center
Acronym Long-term outcomes of patients undergoing transurethral resection of prostate
Scientific Title Long-term outcomes of patients with benign prostatic hyperplasia undergoing transurethral resection of prostate, prospective observational study in single center
Scientific Title:Acronym Long-term outcomes of patients undergoing transurethral resection of prostate
Region
Japan

Condition
Condition Benign prostatic hyperplasia
Classification by specialty
Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the lower urinary tract function in patients with undergoing transurethral resection of prostate in this long-term prospective study.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Subjective and objective assessment of lower urinary tract function in 5 years after transurethral resection of prostate
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Transurethral resection of prostate
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 A patient who are diagnosed as benign prostatic hyperplasia and undergoing transurethral resection of prostate
Key exclusion criteria (1)A patient with urological malignancy
(2)A patient with neurogenic bladder or urinary tract infection
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Naoya
Middle name
Last name Masumori
Organization Sapporo Medical University School of Medicine
Division name Department of Urology
Zip code 060-8543
Address S-1, W-16, Chuo-ku, Sapporo, Japan
TEL 011-611-2111
Email masumori@sapmed.ac.jp

Public contact
Name of contact person
1st name Kazuhiro
Middle name
Last name Nakane
Organization Sapporo Medical University School of Medicine
Division name Department of clinical reseach
Zip code 060-8543
Address S-1, W-16, Chuo-ku, Sapporo, Japan
TEL 011-611-2111
Homepage URL
Email k.nakane@sapmed.ac.jp

Sponsor
Institute Department of Urology, Sapporo Medical University School of Medicine
Institute
Department

Funding Source
Organization Department of Urology, Sapporo Medical University School of Medicine
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 Sapporo Medical University School of Medicine
Address S-1, W-16, Chuo-ku, Sapporo, Japan
Tel 011-611-2111
Email ji-rskk@sapmed.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
2014 Year 10 Month 18 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 60
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 No longer recruiting
Date of protocol fixation
2014 Year 09 Month 01 Day
Date of IRB
2014 Year 10 Month 09 Day
Anticipated trial start date
2014 Year 10 Month 18 Day
Last follow-up date
2023 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 10 Month 18 Day
Last modified on
2019 Year 04 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017584

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.