UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055668 |
|---|---|
| Receipt number | R000057859 |
| Scientific Title | Efficacy and safety of vibegron in very elderly patients with overactive bladder |
| Date of disclosure of the study information | 2024/09/29 |
| Last modified on | 2025/11/07 00:03:46 |
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Basic information
Public title
Efficacy and safety of vibegron in patients with overactive bladder aged 80 years or over
Acronym
HOKUTO2 study
Scientific Title
Efficacy and safety of vibegron in very elderly patients with overactive bladder
Scientific Title:Acronym
HOKUTO2 study
Region
| Japan |
Condition
Condition
overactive bladder
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigating the efficacy and safety of vibegron in very elderly patients with overactive bladder.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overactive Bladder Symptom Score (OABSS) at 4, 8 and 12 weeks after starting treatment with vibegron.
Key secondary outcomes
Adverse events, International Prostate Symptom Score (IPSS), Overactive Bladder Questionnaire (OAB-q), Mini-Mental State Examination (MMSE), Vulnerable Elders Survey-13 (VES-13), uroflowmetry, and residual urine measurement at 4, 8 and 12 weeks after starting treatment with vibegron.
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
| 80 | years-old | <= |
Age-upper limit
| 110 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who meet all of the following.
Patients who visited the department of urology of the research collaborating hospitals from the date of approval by the head of the research institution to July 31,2025.
Over 80 years old.
Patients scheduled to receive vibegron.
Urinary urgency score 2 or over and total score 3 or over on the overactive bladder symptom score.
Patients who give written consent to participate in this study.
Key exclusion criteria
Patients with any of the following.
long QT syndrome.
Patients with a history of serious cardiac disease.
Patients with severe abdominal pressure incontinence.
Patients with residual urine volume over 100 mL, severe dysuria, active urinary tract infection, bladder stones, or urinary tract malignancy.
Patients scheduled to continue treatment with mirabegron.
Patients who are determined to be ineligible by a physician's judgment.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Shimura |
Organization
University of Yamanashi
Division name
Department of Urology
Zip code
409-3898
Address
1110 Shimokato, Chuo City, Yamanashi Prefecture, Japan
TEL
055-273-9643
shimurah@yamanashi.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Shimura |
Organization
University of Yamanashi
Division name
Department of Urology
Zip code
409-3898
Address
1110 Shimokato, Chuo City, Yamanashi Prefecture, Japan
TEL
055-273-9643
Homepage URL
shimurah@yamanashi.ac.jp
Sponsor or person
Institute
Department of Urology, University of Yamanashi
Institute
Department
Personal name
Funding Source
Organization
No funding organization
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
University of Yamanashi
Address
1110 Shimokato, Chuo City, Yamanashi Prefecture, Japan
Tel
055-273-9643
shimurah@yamanashi.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
| 2024 | Year | 09 | Month | 29 | 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
22
Results
Twenty patients (median: 83 years) were enrolled. Vibegron significantly improved in total score of the OABSS, including urgency and urge incontinence. The total IPSS, IPSS QOL index, and IPSS storage scores also significantly improved.
There were no significant changes in VES 13 score, the QTcF, or MMSE score. PVR was significantly increased.
Even though we should be careful of voiding dysfunction, vibegron is effective and does not worsen cognitive function or frailty in the very elderly.
Results date posted
| 2025 | Year | 11 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The median age was 83 years, with ages ranging from 80 to 93 years at registration. Among the 20 cases, 15 were male, indicating a higher male ratio. Of the male cases, 8 had received treatment for benign prostatic hyperplasia, with the maximum prostate volume being 70 mL. Pre-treatment median scores for OABSS, IPSS, IPSS QOL index, VES-13, and MMSE were 9, 10, 5, 3, and 28 points, respectively. The median maximum urinary flow rate was 9.6 mL/sec. The median residual urine volume was 11 mL, with a maximum residual volume of 70 mL. There were no cases of concomitant anticholinergic medication use. Five cases were switching from mirabegron, and 15 cases were new introductions of OAB treatment.
Participant flow
After collecting baseline data, oral administration of 50 mg of vibegron per day was initiated. Patients attended outpatient visits at weeks 4, 8, and 12 post-initiation for examination and data collection on various assessment items.
Adverse events
One case required hospitalization due to worsening heart failure one week after initiation of vibegron administration, and vibegron was discontinued because a urinary catheter was placed. The causal relationship between vibegron and heart failure is considered unclear.
A significant increase in residual urine volume was observed (median 12 mL before administration, median 33 mL at 12 weeks after administration). Four cases developed residual urine volumes exceeding 100 mL. However, as symptoms improved and no urinary retention or urinary tract infections were observed, close monitoring was implemented and administration was continued. Among these four cases, three had significant pre-existing benign prostatic hyperplasia, and one was a female patient who had a baseline residual urine volume of 70 mL.
No other observations were considered adverse events.
Outcome measures
OABSS: Total scores and subscores for urinary urgency and urge incontinence showed significant improvement at 4, 8, and 12 weeks compared to baseline.
IPSS: Total score, QOL index, and storage score showed significant improvement. However, the voiding score showed no change.
OABq: Significant improvement was observed in the domains of symptom bother, QOL, concern, and sleep. No change was observed in the domains of coping and social interaction.
VES-13: No significant change was observed at weeks 4, 8, or 12 in the VES-13, which assesses vulnerability.
MMSE: No significant changes were observed at weeks 4, 8, or 12 in the MMSE, used to assess dementia.
Cardiac function: No significant changes were observed in heart rate or QTcF on 12-lead ECG.
Residual urine: A significant increase was observed.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 12 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 13 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 11 | Month | 07 | Day |
Other
Other related information
Primary endpoint is Overactive Bladder Symptom Score (OABSS). Secondary endpoint are adverse events, International Prostate Symptom Score (IPSS), Overactive Bladder Questionnaire (OAB-q), Mini-Mental State Examination (MMSE), Vulnerable Elders Survey-13 (VES-13), uroflowmetry, and residual urine measurement. The above are evaluated before and 4, 8 and 12 weeks after the start of treatment with vibegron.
Management information
Registered date
| 2024 | Year | 09 | Month | 29 | Day |
Last modified on
| 2025 | Year | 11 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057859
