UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011677
Receipt number R000013655
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
Date of disclosure of the study information 2013/09/17
Last modified on 2022/09/19 08:55:55

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 or person

Institute

Dept. of Urology, Otsu Minicipal Hospital

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013655


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name