臨床研究等提出・公開システム

Scientific Title	Comparison of efficacy and safety of tamsulosin and vibegron for male lower urinary tract symptoms - Multicenter randomized crossover study- (ALPHABET study)
Public Title	ALPHABET study (ALPHABET study)

Contact for Scientific Queries	Name	Wada Naoki
	Affiliation	Asahikawa Medical University
	Address	2-1 Higashi Midorigaoka Asahikawa
	Telephone	+81-166-68-2533
	E-mail	nwada@asahikawa-med.ac.jp
Contact for Public Queries	Name	Wada Naoki
	Affiliation	Asahikawa Medical University
	Address	2-1 Higashi Midorigaoka Asahikawa
	Telephone	+81-166-68-2533
	E-mail	nwada@asahikawa-med.ac.jp

Recruitment status	Pending

Anticipated date of first enrollment		Jan. 26, 2024
Actual date of first enrollment
Target sample size		60
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	active control
	assignment	crossover assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Age over 40 Prostate volume less than 30ml OAB Postvoid residual less than 100ml Patients who agree with the research
	Exclusion Criteria	Postvoid residual over 100ml suspected of prostate cancer any medicationfor LUTS within 8 weeks patients with neurogenic disease patients with active urinary infection patients with hypotension patients with severe heart disease patients with severe liver disease pateints with severe kidney disease patients with allergy with tamsulocin/vibegron
	Age Minimum	40age old over
	Age Maximum	No limit
	Gender	Male
Health Condition(s) or Problem(s) Studied		Overactive bladder with benign prostatic hyperplasia
Intervention(s)		tamusulocin vibegron
Health Condition(s) Keyword		OAB BPH
Intervention(s) Keyword		alpha blocker, be-ta3agonist
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		OABSS
Secondary Outcome(s)		IPSS postvoid residual

Primary Sponsor	none

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Asahikawa Medical University Research Ethics Committee
Address	2-1 Higashi Midorigaoka Asahikawa, Hokkaido
Telephone	+81-166-68-2297
E-Mail	rs-kp.g@asahikawa-med.ac.jp
Approval Status	Approval
Date of approval	Jan. 16, 2024

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none