UMIN-CTR Clinical Trial

Public title

Study of the efficacy and safety of tadalafil and imidafenacin combination therapy for benign prostatic hyperplasia with overactive bladder

Acronym

Study of the efficacy and safety of tadalafil and imidafenacin combination therapy for benign prostatic hyperplasia with overactive bladder

Scientific Title

Study of the efficacy and safety of tadalafil and imidafenacin combination therapy for benign prostatic hyperplasia with overactive bladder

Scientific Title:Acronym

Study of the efficacy and safety of tadalafil and imidafenacin combination therapy for benign prostatic hyperplasia with overactive bladder

Region

Japan

Condition

Benign prostatic hyperplasia patients with overactive bladder despite tadalafil treatment

Classification by specialty

Urology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The aim of this study is to enhance the treatment options for benign prostatic hyperplasia patients with persisting overactive bladder even after treatment with tadalafil by investigating the efficacy and safety of adding imidafenacin

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The OABSS total score from baseline to 8 weeks

Key secondary outcomes

(1) OABSS subscore
(2) IPSS total, storage, voiding, QOL score
(3) BII
(4) Residual urine volume
(5) Maximum urinary flow rate
(6) Adverse events and side effects

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Intervention group: imidafenacin(0.1 mg twice a day) will be additionally prescribed for 8 weeks to patients currently taking tadalafil(5mg/day)

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

Age-lower limit

50

years-old

<=

Age-upper limit

Not applicable

Gender

Male

Key inclusion criteria

Patients must satisfy the following conditions at the first visit:
(1) 50 years old or above (at the time of obtaining consent)
(2) Overactive bladder despite taking tadalafil 5 mg per day for 4 weeks or more (OAB definition: 2 points or more for question 3 of the OABSS and 3 points or more for the OABSS total score)
(3) Prostate volume of at least 20 mL
(4) Outpatient
(5) Provided written consent for participation in this study

Key exclusion criteria

Patients who meet any of the following conditions at the first visit are excluded:
(1) Residual urine volume of 100 mL or more
(2) Suspicion of polyuria
(3) Currently have, or have a past history of, urinary retention
(4) Qmax of less than 5 mL/s
(5) Neoplasm of the lower urinary tract such as prostate or bladder cancer, neurogenic bladder, urethral stricture, chronic bacterial prostatitis, urinary tract infection, urinary tract stone, or interstitial cystitis
(6) Contraindication to the prescription of tadalafil or imidafenacin
(7) Severe liver dysfunction, kidney dysfunction, or heart disease
(8) Pyloric, duodenal, or other intestinal obstruction, decreased gastrointestinal motility or distention, paralytic ileus, closed angle glaucoma, or myasthenia gravis
(9) Taking a prohibited concurrent medication within 4 weeks prior to starting the study (5&alpha-reductase inhibitor, sex hormone agent within 6 months)
(10) Received a prohibited concurrent therapy within 8 weeks prior to starting the study
(11) Change in dose or regimen within 8 weeks prior to starting the study of a concurrent restricted medication or therapy
(12) Otherwise, determined to be inappropriate by the doctor

Target sample size

30

Name of lead principal investigator

1st name
Middle name
Last name	Kazuya Kawahara

Organization

Kawahara Clinic

Division name

Department of urolog

Zip code

Address

73-3,Nishimochida,Aira-city,Kagoshima 889-5431.Japan

TEL

099-564-5181

Email

kazi@kawahara.or.jp

Name of contact person

1st name
Middle name
Last name	Kazuya Kawahara

Organization

Kawahara Clinic

Division name

Department of urology

Zip code

Address

73-3,Nishimochida,Aira-city,Kagoshima 889-5431.Japan

TEL

099-564-5181

Homepage URL

Email

kazi@kawahara.or.jp

Institute

Kawahara Clinic

Institute

Department

Personal name

Organization

Kyorin Pharmaceutical Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

04

Month

19

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2016

Year

04

Month

12

Day

Date of IRB

Anticipated trial start date

2016

Year

04

Month

19

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2016

Year

04

Month

18

Day

Last modified on

2017

Year

03

Month

15

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025291