UMIN-CTR Clinical Trial

Basic information
Public title	Study on the effect of combination therapy of alpha-1 blocker and transdermal oxybutynin hydrochloride in patients with overactive bladder due to benign prostatic hyperplasia
Acronym	Study on the combination therapy of alpha-1 blocker and transdermal oxybutynin in patients with overactive bladder due to benign prostatic hyperplasia
Scientific Title	Study on the effect of combination therapy of alpha-1 blocker and transdermal oxybutynin hydrochloride in patients with overactive bladder due to benign prostatic hyperplasia
Scientific Title:Acronym	Study on the combination therapy of alpha-1 blocker and transdermal oxybutynin in patients with overactive bladder due to benign prostatic hyperplasia
Region	Japan

Condition
Condition	Patients with overactive bladder due to benign prostatic hyperplasia
Classification by specialty	Urology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The efficacy of combination therapy of alpha-1 blocker and transdermal oxybutynin hydrochloride
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Change in total score of overactive bladder symptoms score(OABSS) 4weeks after the intervention
Key secondary outcomes	Change in each item of OABSS 4weeks after the intervention Change in International Prostate Symptoms Score 4weeks after the intervention

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	Pseudo-randomization

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Addition of transdermal oxybutynin hydrochloride 73.5mg once per day for 4weeks
Interventions/Control_2	Monotherapy of alpha-1 blocker
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	Not applicable
Gender	Male
Key inclusion criteria	Patients with LUTS/BPH who have urgency score of OABSS 2 or more, and total score of OABSS 3 or more after taking alpha-1 blocker for 4 weeks or more
Key exclusion criteria	Qmax on uroflowmetry 5ml/sec or less, postvoid residual urine 100ml or more, patients who underwent radiation to the prostate
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Middle name Last name Naoki Wada
Organization	Asahikawa Medical University
Division name	Department of Renal and Urologic Surgery
Zip code
Address	2-1-1-1 Midorigaoka-Higashi, Asahikawa, Japan
TEL	0166-68-2533
Email	nwada@asahikawa-med.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Naoki Wada
Organization	Asahikawa Medical University
Division name	Department of Renal and Urologic Surgery
Zip code
Address	2-1-1-1 Midorigaoka-Higashi, Asahikawa, Japan
TEL	0166-68-2533
Homepage URL
Email	nwada@asahikawa-med.ac.jp

Sponsor
Institute	Department of Renal and Urologic Surgery, Asahikawa Medical University
Institute
Department

Funding Source
Organization	Department of Renal and Urologic Surgery, Asahikawa Medical University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Inada urology clinic Fukagawa City Hospital Furano Hospital Asahikawa-Kosei Hospital Jinyukai urology clinic Kitasaito Hospital Ashibetsu City Hospital
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	2016 Year 04 Month 01 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	Completed
Date of protocol fixation	2016 Year 03 Month 14 Day
Date of IRB	2016 Year 03 Month 31 Day
Anticipated trial start date	2016 Year 04 Month 01 Day
Last follow-up date	2018 Year 03 Month 31 Day
Date of closure to data entry	2018 Year 05 Month 12 Day
Date trial data considered complete	2018 Year 05 Month 12 Day
Date analysis concluded	2018 Year 07 Month 01 Day

Other
Other related information

Management information
Registered date	2016 Year 03 Month 09 Day
Last modified on	2021 Year 03 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024703