UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059810 |
|---|---|
| Receipt number | R000068391 |
| Scientific Title | Investigation of the Carry-over Effect after Discontinuation of Vibegron Therapy in Female Patients with Overactive Bladder |
| Date of disclosure of the study information | 2026/04/01 |
| Last modified on | 2025/11/18 11:52:58 |
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Basic information
Public title
Study on the Carry-over Effect of Vibegron Treatment in Women with Overactive Bladder
Acronym
Carry-over Effect of Vibegron Treatment
Scientific Title
Investigation of the Carry-over Effect after Discontinuation of Vibegron Therapy in Female Patients with Overactive Bladder
Scientific Title:Acronym
Investigation of the Carry-over Effect of Vibegron Therapy in Female Patients with Overactive Bladder
Region
| Japan |
Condition
Condition
Overactive bladder
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Among pharmacological treatments for overactive bladder (OAB), vibegron, a beta3-adrenoceptor agonist, has been reported to be associated with few adverse events and to be suitable for long-term administration. In clinical practice, however, many patients whose symptoms improve subsequently discontinue treatment, and we occasionally encounter cases in which symptoms do not immediately recur after discontinuation. This sustained symptom relief, hereafter referred to as a carry-over effect, has been reported for other agents, but there are no published data regarding vibegron. In particular, no study has prospectively evaluated the carry-over effect of beta3-adrenoceptor agonist therapy from the initiation of treatment.
The aim of the present study is to prospectively evaluate, in real-world clinical practice, the carry-over effect after discontinuation of vibegron therapy in female patients with OAB.
The findings of this study are expected to help establish evidence-based guidance to avoid unnecessary continuation of pharmacotherapy after symptom improvement and to contribute to reductions in healthcare expenditures.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
discontinuation maintenance rate at 4 weeks after drug withdrawal
Key secondary outcomes
discontinuation maintenance rate at 12 weeks after treatment discontinuation, percentage change in IPSS and OABSS, time to resumption of medication, incidence of adverse events
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
After completion of the initial assessment, oral vibegron will be started. After at least 12 weeks of treatment, patients will be re-evaluated, and if the OABSS has improved by 3 or more points, discontinuation of vibegron will be proposed. Patients will return 4 weeks after discontinuation, at which time the appropriateness of maintaining discontinuation will be assessed. If symptom recurrence is observed and the patient wishes to resume treatment, vibegron will be re-prescribed at that time.
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
| Not applicable |
Gender
Female
Key inclusion criteria
Patients with overactive bladder (OABSS total score 3 or more and question 3 score 2 or more)
Patients who are newly initiated on vibegron for OAB
Patients who have provided informed consent to participate in the study
Key exclusion criteria
Patients who are minors or who lack the capacity to provide consent
Patients with a history of prior pharmacological treatment for OAB
(e.g. anticholinergic agents, beta3-adrenergic agonists, intravesical botulinum toxin injection therapy, sacral neuromodulation, magnetic stimulation therapy, etc.)
Patients managed with intermittent catheterization or an indwelling urethral catheter
Patients with active cystitis (eligible after appropriate treatment)
Any other patients deemed inappropriate for inclusion by the treating physician
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Naoya |
| Middle name | |
| Last name | Masumori |
Organization
Sapporo Medical University
Division name
Department of Urology
Zip code
0608543
Address
16, minami 1 jo, chuo-ku, Sapporo
TEL
011-611-2111
masumori@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Kyoda |
Organization
Sapporo Medical University
Division name
Department of Urology
Zip code
0608543
Address
16, minami 1 jo, chuo-ku, Sapporo
TEL
011-611-2111
Homepage URL
kyohday@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sapporo Medical University
Address
16, minami 1 jo, chuo-ku, Sapporo
Tel
011-611-2111
wakakoyoro@sapmed.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 | 04 | Month | 01 | 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
| 2026 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2029 | 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 | 11 | Month | 18 | Day |
Last modified on
| 2025 | Year | 11 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068391
