UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038269 |
|---|---|
| Receipt number | R000043622 |
| Scientific Title | The efficacy of Fesoterodine for the treatment of neurogenic detrusor overactivity and/or low-compliance bladder |
| Date of disclosure of the study information | 2020/03/31 |
| Last modified on | 2020/09/02 20:52:55 |
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Basic information
Public title
The efficacy of Fesoterodine for the treatment of neurogenic detrusor overactivity and/or low-compliance bladder
Acronym
The efficacy of Fesoterodine for the treatment of neurogenic detrusor overactivity and/or low-compliance bladder
Scientific Title
The efficacy of Fesoterodine for the treatment of neurogenic detrusor overactivity and/or low-compliance bladder
Scientific Title:Acronym
The efficacy of Fesoterodine 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 Fesoterodine 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
Fesoterodine should be taken orally once a day 4-8mg 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
| 18 | 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
80
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
Pfizer Inc.
Organization
Division
Category of Funding Organization
Outside Japan
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 | 31 | Day |
Related information
URL releasing protocol
https://onlinelibrary.wiley.com/doi/full/10.1111/iju.14319
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/full/10.1111/iju.14319
Number of participants that the trial has enrolled
77
Results
A total of 17 patients withdrew because of adverse events and so on. 60 patients completed the study. Bladder capacity at first desire to void, maximum cystometric capacity and bladder compliance increased significantly. Neurogenic detrusor overactivity disappeared in 23.5%, and a significant increase was observed in bladder capacity at first involuntary contraction, and a significant decrease was observed in maximum detrusor contraction.
Results date posted
| 2020 | Year | 09 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients with NDO or LCB in a stable condition for >6 months were included.
Participant flow
Various assessments were performed before and after treatment, including urodynamic testing.
Adverse events
Adverse events were observed in 40 patients (51.9%): dry mouth (n = 20), constipation (n = 7), blurred vision (n = 3) and others in 10 patients (voiding difficulty, urinary retention, headache, sleepiness, urethral discomfort, urgency, nausea, shivering and reflux esophagitis.
Outcome measures
The primary end-point was change from baseline to the end of treatment in the MCC in V-UDS. The secondary end-points were the number of patients whose NDO disappeared, and changes in the following parameters from baseline to the post-treatment: bladder capacity at FDV, bladder capacity at FIC, maximum detrusor pressure and bladder compliance. If patients could void, Qmax, maximum detrusor pressure and PdetQmax were evaluated. Changes in OABSS, IPSS, ICIQ-SF and KHQ,18-20 and the changes in the number and the amount of voids, and the number of daily incontinence episodes in a 3-day FVC were evaluated from baseline to 4 and 12 weeks of treatment. In the SF-36, domains of physical functioning, physical role, body pain, general health, vitality, social functioning, role emotional and mental health were evaluated, with a minimum score of 0 (worst health), and the maximum score of 100 (best health).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2013 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2013 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2019 | 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
| 2019 | Year | 10 | Month | 10 | Day |
Last modified on
| 2020 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043622
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| Registered date | File name |
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