UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057543 |
|---|---|
| Receipt number | R000065746 |
| Scientific Title | the effect of vibegron for the overactrive bladder after robot asisted radical prostatectomy |
| Date of disclosure of the study information | 2025/04/08 |
| Last modified on | 2025/04/07 19:25:09 |
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Basic information
Public title
the effect of vibegron for the overactrive bladder after robot asisted radical prostatectomy
Acronym
the effect of vibegron for OAB after RARP
Scientific Title
the effect of vibegron for the overactrive bladder after robot asisted radical prostatectomy
Scientific Title:Acronym
the effect of vibegron for OAB after RARP
Region
| Japan |
Condition
Condition
OAB
Classification by specialty
| Urology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine whether vivegron significantly improves OAB symptoms (urinary urgency, daytime frequency, nocturia, urge urinary incontinence, etc.) in male OAB patients after prostate cancer surgery, compared to the no-treatment (standard therapy only) group.In the case of this study, the standard treatment is precepted to be untreated and followed up.Postoperative prostate cancer patients have suffered from urinary incontinence and overactive bladder after removal of urinary catheters.However, since many patients spontaneously relieve their symptoms over a period of about one year, we urologists have so far been monitoring their progress without administering anticholinergic drugs or other beta3 agonists.Therefore, we decided to conduct this study in the hope that beta3 agonists could be administered immediately after surgery to shorten the period of suffering from overactive bladder symptoms as much as possible.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of OABSS (Overactive Bladder Symptom Score) improvement (change from baseline to end of treatment) between groups
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
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
administration of vibegron
Interventions/Control_2
non-administration of vibegron
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male
Key inclusion criteria
(1) Age: males aged 20 years and older; (2) patients who underwent robotic-assisted radical prostatectomy (RARP) for prostate cancer at our institution; (3) patients who meet the definition of OAB immediately after catheter removal (a total Overactive Bladder Symptom Score (OABSS ) score of at least 3 points and a "urinary urgency" question (usually question 3) with a score of at least 2).(4) Patients who can give written consent to the study
Key exclusion criteria
(1) Patients with severe cognitive impairment or psychiatric disorders that make it difficult for them to cooperate in this study (2) Patients with a history of serious adverse reactions to vivegron or its class of drugs (3) Patients who have serious hepatic or renal dysfunction, for whom treatment with vivegron is contraindicated or who are over 90 years of age (4) Patients who are already using other dysuria medications (anticholinergics, another beta3 agonist, etc.) preoperatively and for whom no change is possible.(4) Patients who are already using other medications for dysuria (e.g., anticholinergics, other beta3 agonists) preoperatively and cannot be switched to vivegron if possible (treatment group) or if they are already using other medications for lower urinary tract symptoms (anticholinergics, other beta 3 agonists) preoperatively and can be switched to vivegron (treatment group) or if they are already using other medications for lower urinary tract symptoms preoperatively (not treated group).(4) The possibility of discontinuation of the preoperative treatment of lower urinary tract symptoms (non-administered group).(5) Patients deemed inappropriate by the principal investigator
Target sample size
88
Research contact person
Name of lead principal investigator
| 1st name | Nobuhiro |
| Middle name | |
| Last name | Haga |
Organization
Fukuoka University Faculty of Medicine
Division name
Department of Urology
Zip code
814-0180
Address
Fukuoka city Jonan-ku Nanakuma 7-45-1
TEL
0928011011
nhaga@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | Nobuhiro |
| Middle name | |
| Last name | Haga |
Organization
Fukuoka University Faculty of Medicine
Division name
Department of Urology
Zip code
814-0180
Address
Fukuoka city Jonan-ku Nanakuma 7-45-1
TEL
0928011011
Homepage URL
nhaga@fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Fukuoka University Faculty of Medicine
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
IRB of Fukuoka University
Address
7-45-1 Nanakuma, Jonan-ku
Tel
0928011011
fumed-ethics@fukuoka-u.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
| 2025 | Year | 04 | Month | 08 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 04 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 04 | Month | 10 | Day |
Last follow-up date
| 2035 | 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
| 2025 | Year | 04 | Month | 07 | Day |
Last modified on
| 2025 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065746
