UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063386 |
|---|---|
| Receipt number | R000072554 |
| Scientific Title | Association between preoperative pelvic floor muscle strength and urinary incontinence after robot-assisted radical prostatectomy |
| Date of disclosure of the study information | 2026/10/24 |
| Last modified on | 2026/10/23 13:24:20 |
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Basic information
Public title
Association between preoperative pelvic floor muscle strength and urinary incontinence after robot-assisted radical prostatectomy
Acronym
RARP-PFM study
Scientific Title
Association between preoperative pelvic floor muscle strength and urinary incontinence after robot-assisted radical prostatectomy
Scientific Title:Acronym
RARP-PFM study
Region
| Japan |
Condition
Condition
Prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to objectively measure pelvic floor muscle strength before and after radical prostatectomy and to investigate its association with the occurrence of and recovery from postoperative urinary incontinence.
Basic objectives2
Others
Basic objectives -Others
Investigation of the association between pelvic floor muscle strength and the occurrence of and recovery from postoperative urinary incontinence
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Association between preoperative pelvic floor muscle strength and the incidence of urinary incontinence at 1, 3, 6, 9, and 12 months after robot-assisted radical prostatectomy.
Key secondary outcomes
Longitudinal changes in urinary incontinence volume assessed by pad tests.
Longitudinal changes in lower urinary tract symptom questionnaire scores.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 18 | years-old | < |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who meet all of the following criteria are eligible for inclusion:
Patients aged 18 years or older and younger than 100 years at the time of informed consent.
Patients diagnosed with prostate cancer.
Patients scheduled to undergo robot-assisted radical prostatectomy for localized prostate cancer at Fukushima Medical University Hospital.
Patients who have provided written informed consent to participate in this study.
Key exclusion criteria
Patients who meet any of the following criteria will be excluded:
Patients who are unable to undergo pelvic floor muscle strength measurement due to anatomical factors, such as severe anal disorders or pelvic organ prolapse, or due to pain.
Patients who are unable to understand the examination procedures or follow instructions during measurement because of cognitive impairment or psychiatric disorders.
Patients with severe voiding difficulty or urinary retention requiring an indwelling urethral catheter.
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Junya |
| Middle name | |
| Last name | Hata |
Organization
Fukushima medical university
Division name
Department of Urology
Zip code
9601295
Address
1 Hikarigaoka, Fukushima, Fukushima, Japan
TEL
0245471111
uroharry@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Harigane |
Organization
Fukushima medical university
Division name
Department of Urology
Zip code
9601295
Address
1 Hikarigaoka, Fukushima, Fukushima, Japan
TEL
0245471111
Homepage URL
uroharry@fmu.ac.jp
Sponsor or person
Institute
Fukushima medical university
Institute
Department
Personal name
Funding Source
Organization
Fukushima medical 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
Ethics Committee of Fukushima Medical University (General Ethics Committee)
Address
1 Hikarigaoka, Fukushima, Fukushima 960-1295, Japan
Tel
024-547-1111
fmurec@fmu.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
| 2026 | Year | 10 | Month | 24 | 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
| 2046 | Year | 12 | Month | 31 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 10 | Month | 24 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 27 | Day |
Anticipated trial start date
| 2026 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2027 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2027 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2028 | Year | 03 | Month | 31 | Day |
Other
Other related information
This is a single-center prospective cohort study investigating the association between pelvic floor muscle strength and the occurrence of and recovery from urinary incontinence after robot-assisted radical prostatectomy. Pelvic floor muscle strength will be objectively measured before surgery and at 1, 3, 6, 9, and 12 months after surgery.
Management information
Registered date
| 2026 | Year | 10 | Month | 23 | Day |
Last modified on
| 2026 | Year | 10 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072554
