UMIN-CTR Clinical Trial

Basic information
Public title	Comparison of efficacy and safety of the secondary treatment with increased fesoterodine and with mirabegron combination with 4mg fesoterodine for those who still have moderate or more overactive bladder symptoms after the initial treatment with 4mg fesoterodine: preliminary study
Acronym	Comparison of efficacy and safety between increased fesoterodine and mirabegron combination for the overactive bladder resistant to the initial fesoterodine treatment.
Scientific Title	Comparison of efficacy and safety of the secondary treatment with increased fesoterodine and with mirabegron combination with 4mg fesoterodine for those who still have moderate or more overactive bladder symptoms after the initial treatment with 4mg fesoterodine: preliminary study
Scientific Title:Acronym	Comparison of efficacy and safety between increased fesoterodine and mirabegron combination for the overactive bladder resistant to the initial fesoterodine treatment.
Region	Japan

Condition
Condition	overactive bladder
Classification by specialty	Urology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the efficacy of the secondary treatment with increased fesoterodine 8mg and with 50mg mirabegron combination with 4mg fesoterodine for those who still have moderate or more overactive bladder symptoms after the initial treatment with 4mg fesoterodine.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Change of total overactive bladder symptom score.
Key secondary outcomes	1) Changes of parameters of questonnairs 2) Changes of parameters of urodynamic studies 3) Safety

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	For 8 weeks 8mg fesoterodine will be orally administered once a day after breakfast to the patients who have still moderate or more overactive bladder symptoms after 4mg fesoterodine treatment for more than 4 weeks.
Interventions/Control_2	For 8 weeks 50mg mirabegron combination with 4mg fesoterodine will be orally administered once a day after breakfast to the patients who have still moderate or more overactive bladder symptoms after 4mg fesoterodine treatment for more than 4 weeks.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Obtaining of written informed consent 2) Male and female, more than 20 years old 3) After 4 week or more administration of fesoterodine 4mg, more than 6 points of total IPSS, and more than 2 points of OABSS 3rd question 4) Patients who have not seen side effects 5) In case of the male patients who are suitable for the enrollment of this study but have any of the following symptoms; more than 7 points of total IPSS, less than 15ml/s of maximum urinary flow rate, and more than 50ml of residual urine volume, they need preceding BPH treatment with alpha 1 blocker for more than 4 weeks or dutasteride for more than 24 weeks or anti-androgenic agent for more than 16 weeks.
Key exclusion criteria	1) Patients with the practice of catheterization past or present. 2) Residual urine volume is more than 100ml. 3) Patients who can`t urine voluntarily. 4) Neurogenic bladder, urethral stricture, urinary tract infection, urinary tract calculi, interstitial cystitis, chronic prostatitis, prostate cancer, bladder cancer 5) Patients who are contraindicated for fesoterodine administration. 6) Patients who are contraindicated for mirabegron administration. 7) Patients who have the history of the administration of contraindicated agents within 2 weeks.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yasumasa Shichiri
Organization	Otsu Minicipal Hospital
Division name	Urology
Zip code
Address	2-9-9, Motomiya, Otsu city, Shiga
TEL	077-522-4607
Email	ysotsumhp@msn.com

Public contact
Name of contact person	1st name Middle name Last name Kimihiko Masui
Organization	Otsu Minicipal Hospital
Division name	Urology
Zip code
Address	2-9-9, Motomiya, Otsu city, Shiga
TEL	077-522-4607
Homepage URL
Email	k_m36@hotmail.com

Sponsor
Institute	Dept. of Urology, Otsu Minicipal Hospital
Institute
Department

Funding Source
Organization	none
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
Address
Tel
Email

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	2013 Year 09 Month 17 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	2013 Year 07 Month 29 Day
Date of IRB
Anticipated trial start date	2013 Year 09 Month 09 Day
Last follow-up date	2022 Year 08 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	2013 Year 09 Month 07 Day
Last modified on	2022 Year 09 Month 19 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013655