UMIN-CTR Clinical Trial

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