UMIN-CTR Clinical Trial

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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000047097