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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000038269
Receipt No. 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

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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
Email 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
Email k-kaga@dokkyomed.ac.jp

Sponsor
Institute Dokkyo Medical University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043622

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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