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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034713
Receipt No. R000039459
Scientific Title Preoperative pelvic floor muscle exercise for early continence after holmium laser enucleation of the prostate : a randomised controlled study
Date of disclosure of the study information 2018/10/31
Last modified on 2018/10/31

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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 Open public recruiting
Date of protocol fixation
2017 Year 08 Month 14 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 25 Day
Last follow-up date
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
2018 Year 10 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039459

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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