UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046560 |
|---|---|
| Receipt number | 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 10:48:01 |
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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
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
isseihri@u-fukui.ac.jp
Sponsor or person
Institute
University of Fukui Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052932
