UMIN-CTR Clinical Trial

Basic information
Public title	Preoperative pelvic floor muscle exercise for early continence after holmium laser enucleation of the prostate : a randomised controlled study
Acronym	Preoperative pelvic floor muscle exercise for early continence after holmium laser enucleation of the prostate : a randomised controlled study
Scientific Title	Preoperative pelvic floor muscle exercise for early continence after holmium laser enucleation of the prostate : a randomised controlled study
Scientific Title:Acronym	Preoperative pelvic floor muscle exercise for early continence after holmium laser enucleation of the prostate : a randomised controlled study
Region	Japan

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

Objectives
Narrative objectives1	The aim of this study is to determine the benefit of preoperative and postoperative pelvic floor muscle exercise for early recovery of continence after HoLEP
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	urinary continent rate (no pad usage)
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Patients start preoperative pelvic floor muscle exercise preoperatively from 28 days before surgery and continue postoperatively.
Interventions/Control_2	Patients start preoperative pelvic floor muscle exercise postoperatively alone.
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 3)Patients who can continue pelvic floor muscle exercise on their own
Key exclusion criteria	1)Patients who can not continue pelvic floor muscle exercise on their own 2)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 Middle name Last name Go Anan
Organization	Tohoku Medical and Pharmaceutical UniversityHospital
Division name	Department of Urology
Zip code
Address	1-12-1 Fukumuro, Miyagino-ku, Sendai, Miyagi
TEL	022-259-1221
Email	goanan@tohoku-mpu.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Go Anan
Organization	Tohoku Medical and Pharmaceutical UniversityHospital
Division name	Department of Urology
Zip code
Address	1-12-1 Fukumuro, Miyagino-ku, Sendai, Miyagi
TEL	022-259-1221
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
Address
Tel
Email

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 10 Month 31 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	2017 Year 08 Month 14 Day
Date of IRB	2017 Year 08 Month 22 Day
Anticipated trial start date	2017 Year 09 Month 25 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

Management information
Registered date	2018 Year 10 Month 31 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=R000039459