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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000046560
Receipt No. R000052932
Scientific Title The effect of ultrasound-guided floor muscle training on urinary incontinence in patients after robot-assisted radical prostatectomy
Date of disclosure of the study information 2022/01/06
Last modified on 2022/01/06

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Basic information
Public title The effect of ultrasound-guided floor muscle training on urinary incontinence in patients after robot-assisted radical prostatectomy
Acronym The effect of ultrasound-guided floor muscle training on urinary incontinence in patients after robot-assisted radical prostatectomy
Scientific Title The effect of ultrasound-guided floor muscle training on urinary incontinence in patients after robot-assisted radical prostatectomy
Scientific Title:Acronym The effect of ultrasound-guided floor muscle training on urinary incontinence in patients after robot-assisted radical prostatectomy
Region
Japan

Condition
Condition Prostate cancer
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We will clarify whether the guidance of pelvic floor muscle exercises under abdominal ultrasonography, which could monitor the movement of pelvic floor muscles, contributes to the improvement of urinary incontinence rate in comparison with the paper-based pelvic floor muscle training guidance group.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Urinary incontinence rate during hospitalization and at 1,3,6 months after operation.
Key secondary outcomes (1)Mental burden of performing ultrasonic examination(2)Do you feel that pelvic floor muscle exercises contribute to the improvement of urinary incontinence? (questionnaire) (3)Whether they feel they are getting effective training. (questionnaire)(4)Whether pelvic floor muscle training is still being provided after discharge from the hospital (questionnaire)(5)How do you feel about the degree of urinary incontinence (questionnaire)?(6)Urinary incontinence rate in the nerve-sparing group(7)Urinary incontinence rate in the non-nerve-preserving group.

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Maneuver
Interventions/Control_1 The subjects were patients undergoing robot assisted radical prostatectomy(RARP). Fifty patients received pelvic floor muscle exercise instruction on ultrasound in addition to paper instruction. The survey will include measurements of daily urine volume and frequency, in-diaper urinary incontinence volume, and urinary incontinence rate, as well as a questionnaire on the implementation and effectiveness of the training. Allocation method: After obtaining consent to participate in the study, a distinction was made between groups of patients who underwent nerve-sparing and non-sparing techniques. Then the instructional method was assigned in each. Among the nerve-sparing/non-nerve sparing techniques, the age group was divided by decade. The odd numbers in the built-in order are divided into the instruction group under abdominal ultrasound, and the even numbers are divided into the instruction group on paper.
Instruct pelvic floor muscle training using pamphlets with/without abdominal ultrasonography before and after surgery. From the day after removal of the urethral catheter, daily urine volume and frequency, as well as the amount of urinary incontinence in the diaper, were measured. The urinary incontinence rate is calculated from the daily urine volume and the amount of urinary incontinence in the diaper. In addition, a questionnaire survey will be conducted in the period leading up to discharge from the hospital. At the outpatient visit 1 month, 3 months, and 6 months after discharge, the research members collect information on the daily urine volume and frequency, and the amount of urinary incontinence in the diaper from the urination diary. The urinary incontinence rate is calculated.
Interventions/Control_2 Fifty patients who underwent RARP, will be trained with only paper-based pelvic floor muscle exercise instruction.
In this group, as in the therapeutic intervention group, the groups were divided by the presence or absence of nerve preservation and stratified by age.
The content of the survey is the same as in the treatment intervention group.
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

Not applicable
Gender Male
Key inclusion criteria Patients who meet all of the following criteria are included.
(1) Robot-assisted radical prostatectomy patient.
(2) Age: At the time of obtaining consent, the age is 50 years or older.
(3) Gender: Male.
(4)Inpatient / Outpatient: Inpatient and outpatient.
(5) Patients who have fully understood the sufficient explanation of this study and have given written consent of their own free will.
Key exclusion criteria (1) Patients with cognitive decline who are judged by the principal investigator. And sub-investigators to be unsuitable as subjects, and patients who cannot understand the instruction and cannot perform pelvic floor muscle training on their own will.
(2) In addition, patients who are judged by the principal investigator to be inappropriate as research subjects.
(3) Patients who continue to take concomitantly prohibited or excluded drugs after surgery.
Banned drugs: Drugs that may reduce urinary incontinence.
1)Stress Urinary Incontinence Treatment.
2)Overactive bladder remedies.
Concomitant exclusions: Drugs that may reduce urinary incontinence.
1)Other anticholinergic agents.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Issei
Middle name
Last name Hirai
Organization University of Fukui Hospital
Division name Nursing Department
Zip code 910-1193
Address 23-3 Matsuoka Shimoaizuki,Eiheiji-cho,Yoshida-gun,Fukui 910-1193 Japan
TEL 0776-61-3111
Email isseihri@u-fukui.ac.jp

Public contact
Name of contact person
1st name Issei
Middle name
Last name Hirai
Organization University of Fukui Hospital
Division name Nursing Department
Zip code 910-1193
Address 23-3 Matsuoka Shimoaizuki,Eiheiji-cho,Yoshida-gun,Fukui 910-1193 Japan
TEL 0776-61-3111
Homepage URL
Email isseihri@u-fukui.ac.jp

Sponsor
Institute University of Fukui Hospital
Institute
Department

Funding Source
Organization None
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 Medical Research Support Center/University of Fukui Hospital
Address 23-3 Matsuoka Shimoaizuki,Eiheiji-cho,Yoshida-gun,Fukui 910-1193 Japan
Tel 0776-61-8529
Email chiken@ml.u-fukui.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
2022 Year 01 Month 06 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
2020 Year 09 Month 25 Day
Date of IRB
2020 Year 09 Month 25 Day
Anticipated trial start date
2020 Year 09 Month 25 Day
Last follow-up date
2022 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
2022 Year 01 Month 06 Day
Last modified on
2022 Year 01 Month 06 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052932

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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