UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A randomized controlled study of the efficacy of Tadalafil monotherapy versus combination of Tadalafil and mirabegron for the treatment of overactive bladder (OAB) associated with benign prostatic hyperplasia (BPH)
Title of the study (Brief title)	CONTACT Study
Region	Japan

Condition
Condition	Benign prostatic hyperplasia
Classification by specialty	Urology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of add-on treatment of mirabegron (50mg/day) for OAB /BPH patients who were not satisfied with tadalafil (5mg/day) monotherapy for 8 weeks or longer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change from baseline to end of treatment in overactive bladder symptom score (OABSS) total score.
Key secondary outcomes	1) Changes in OABSS subscore (daytime frequency, night-time frequency, urgency, urgent incontinence). 2) Changes in international prostate symptom score (IPSS) total score and subscore (void, storage, postvoid, QOL). 3) Change in National Institute of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) total score and subscore (pain, urination, QOL). 4) Changes in the parameters in frequency volume chart (number of void/ 24 hour, number of night-time void, number of urgency episodes/24 hour, number of incontinence episodes/24 hour). 5) Changes in postvoid residual (PVR) volume. 6) Changes in urine volume, Qmax and Qave. 7) Frequency of adverse events.

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	Tadalafil monotherapy group: Group A Tadalafil at the dose of 5mg is orally administered once daily after breakfast for 12 weeks.
Interventions/Control_2	Tadalafil/mirabegron combination therapy group: Group B Tadalafil at the dose of 5mg and mirabegron at the dose of 50mg are orally administered once daily after breakfast for 12 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	50 years-old <=
Age-upper limit	90 years-old >
Gender	Male
Key inclusion criteria	1) Male patients with BPH. 2) Patients who meet the following criteria even after administering tadalafil 5mg/day for more than 8 weeks: OABSS total score >3 Urgency > once/week (OABSS urgency score >= 2) 3) Aged >=50 years and < 90 years 4) Patients who are able to give informed consent. 5) Patients from whom we have received written consent.
Key exclusion criteria	1) Patients with a history of hypersensitivity to tadalafil or mirabegron 2) Medication with anti-cholinergics, cholinergics,beta-agonists or antagonists, alpha-blocker and any other agents for treating pollakisuria/urinary incontinence during 8 weeks prior to the study. (Eligible if the medication was discontinued before tadalafil administration (before 8 weeks or more).5 alpha-reductase inhibitors or anti-androgen drugs can be included if they were administered > 6months and the patients had stable condition). 3) History or current condition of urinary retention or severe difficulty of urination 4) Patients with cancer in the part of lower urinary tract such as prostate or bladder, neurogenic bladder, urethra stricture, chronic bacterial prostatitis, symptomatic urinary tract infection, urinary tract stones and interstitial cystitis 5) Patients with serious cardiac disorder, serious cerebrovascular disease, serious liver dysfunction and serious kidney dysfunction 6) Qmax < 5 mL/sec 7) Postvoid residual volume (PVR) >150 mL 8) Any other patients who are regarded as unsuitable for this study by the investigator.
Target sample size	170

Research contact person
Name of lead principal investigator	Tomonori Yamanishi
Organization	Dokkyo Medical University
Division name	Department of Urology and Neurology, Continence Center
Address	880 Kita-Kobayashi, Mibu-machi, Shimotsuga-gun, Tochigi 321-0293, JAPAN
TEL	0282-86-1111
Email	yamanish@dokkyomed.ac.jp

Public contact
Name of contact person	Tomonori Yamanishi
Organization	Dokkyo Medical University
Division name	Department of Urology and Neurology, Continence Center
Address	880 Kita-Kobayashi, Mibu-machi, Shimotsuga-gun, Tochigi 321-0293, JAPAN
TEL	0282-86-1111
Homepage URL
Email	yamanish@dokkyomed.ac.jp

Sponsor
Institute	Clinical Research Support Center Kyushu
Institute
Department

Funding Source
Organization	Astellas Pharma Inc.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2016 Year 12 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 09 Month 01 Day
Anticipated trial start date	2016 Year 12 Month 08 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 12 Month 15 Day
Last modified on	2019 Year 02 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029077