UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034713 |
|---|---|
| Receipt number | 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 | 2020/07/29 19:28:49 |
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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
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
goanan@tohoku-mpu.ac.jp
Sponsor or person
Institute
Tohoku Medical and Pharmaceutical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039459
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| Registered date | File name |
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