UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038194 |
|---|---|
| Receipt number | R000030364 |
| Scientific Title | The efficacy of Mirabegron for the treatment of neurogenic detrusor overactivity and/or low-compliance bladder |
| Date of disclosure of the study information | 2020/03/01 |
| Last modified on | 2021/10/03 10:43:39 |
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Basic information
Public title
The efficacy of Mirabegron for the treatment of neurogenic detrusor overactivity and/or low-compliance bladder
Acronym
The efficacy of Mirabegron for the treatment of neurogenic detrusor overactivity and/or low-compliance bladder
Scientific Title
The efficacy of Mirabegron for the treatment of neurogenic detrusor overactivity and/or low-compliance bladder
Scientific Title:Acronym
The efficacy of Mirabegron for the treatment of neurogenic detrusor overactivity and/or low-compliance bladder
Region
| Japan |
Condition
Condition
Neurogenic detrusor overactivity, Low compliance bladder
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The evaluation of the efficacy of Mirabegron in neurogenic detrusor overactivity and/or low compliance bladder.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change from baseline of the maximum cystmetric capacity in Urodynamic tests between before and after treatment.
Key secondary outcomes
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
Mirabegron should be taken orally once a day 25-50mg with 3-month intervention.
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with a known neurogenic disorder in a stable condition for more than 6 months and with storage dysfunction due to neurogenic detrusor overactivity or low compliance bladder
Key exclusion criteria
Genitourinary tract anomalies, acute infection of the genitourinary tract or clinical relevant diseases of the kidneys; and any condition that in the opinion of the investigator made the patient unsuitable for the study.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Tomonori |
| Middle name | |
| Last name | Yamanishi |
Organization
Dokkyo Medical University
Division name
Department of Urology, Continence Center
Zip code
3210293
Address
880, Kitakobayashi, Mibu, Shimotsuga, Tochigi
TEL
0282-86-1111
yamanish@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | Kanya |
| Middle name | |
| Last name | Kaga |
Organization
Dokkyo Medical University
Division name
Department of Urology, Continence Center
Zip code
3210293
Address
880, Kitakobayashi, Mibu, Shimotsuga, Tochigi
TEL
0282-86-1111
Homepage URL
k-kaga@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Dokkyo Medical University Hospital
Address
880, Kitakobayashi, Mibu, Shimotsuga, Tochigi
Tel
0282-86-1111
k-kaga@dokkyomed.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
| 2020 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
http://jcs2020.umin.jp/
Publication of results
Unpublished
Result
URL related to results and publications
http://jcs2020.umin.jp/
Number of participants that the trial has enrolled
45
Results
Maximum cystometric capacity, the primary endpoint, showed a slight increase from 271.9 ml before treatment to 289.7 ml at week 12, but the difference was not statistically significant (P = 0.4107).
Results date posted
| 2021 | Year | 10 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The age of the patients was 65.4 years, and 10 patients with self-catheterization were included. 40 patients had detrusor overactivity, and 5 patients had only low compliance bladder. The causative diseases of neurogenic bladder were brain lesions (e.g., cerebral hemorrhage) in 15 cases, spinal cord lesions (e.g., spinal cord injury) in 24 cases, and peripheral neuropathy (e.g., diabetes mellitus) in 6 cases.
Participant flow
Finally, 30 patients completed the study.
Adverse events
Adverse events were observed in three patients: dysuria, worsening of nocturnal urinary incontinence, and urinary tract infection. Of these, the first two patients dropped out due to adverse events. In addition, 13 patients dropped out for reasons such as discontinuation of hospital visits.
Outcome measures
Maximum cystometric capacity
Loss rate of detrusor overactivity
Bladder capacity at first desire
Bladder compliance
Bladder capacity at first involuntary contraction
Maximum involuntary pressure
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 10 | Month | 03 | Day |
Last modified on
| 2021 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030364
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
