UMIN-CTR Clinical Trial

Basic information
Public title	Tadalafil monotherapy versus tadalafil and solifenacin combined therapy for patients with lower urinary tract symptoms suggestive of benign prostate hyperplasia and overactive bladder: randomized controlled trial
Acronym	Tadalafil monotherapy versus tadalafil and solifenacin combined therapy for benign prostate hyperplasia with overactive bladder
Scientific Title	Tadalafil monotherapy versus tadalafil and solifenacin combined therapy for patients with lower urinary tract symptoms suggestive of benign prostate hyperplasia and overactive bladder: randomized controlled trial
Scientific Title:Acronym	Tadalafil monotherapy versus tadalafil and solifenacin combined therapy for benign prostate hyperplasia with overactive bladder
Region	Japan

Condition
Condition	benign prostate hyperplasia with overactive bladder
Classification by specialty	Urology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the efficacy for tadalafil monotherapy with tadalafil and solifenacin combined therapy in patients with benign prostate hyperplasia and overactive bladder, and to evaluate the safety of the combined therapy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change from baseline to end point for mean number of micturitions per 24 hours
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
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 5mg monotherapy (12 weeks)
Interventions/Control_2	tadalafil 5mg and solifenacin 5mg combined therapy (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	45 years-old <=
Age-upper limit	Not applicable
Gender	Male
Key inclusion criteria	1. male patients aged 45 or older 2. patients with lower urinary tract symptoms (IPSS: 13 points or more) 3. patients with overactive bladder (OABSS: Q3 2 points or more and total score 3 points or more) 4. patients with prostate volume 20mL or more 5. patients with informed consent
Key exclusion criteria	1. patients who developed urinary retention in the past 12 months 2. patients who had post voiding residual volume 100mL or more 3. patients strongly suspected of prostate cancer 4. patients with indwelling urethral catheter or intermittent self-catheterization 5. patients with acute urinary tract infection 6. patients with nocturnal polyuria 7. patients with daily urine volume over 3000mL 8. patients with mechanical abnormality of lower urinary tract (eg. urethral stricture, bladder tumor and bladder stone) 9. patients without desire to void 10. patients with pyloric, duodenal or intestinal obstruction 11. patients with angle-closure glaucoma 12. patients with myasthenia gravis 13. patients with severe heart disease, renal dysfunction or liver dysfunction 14. patients with severe constipation 15. patients tadalafil and solifenacin is contraindicated 16. patients who have been determined to be unsuitable as a subject by a physician
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Middle name Last name Mitsuhiro Tambo
Organization	Kyorin University School of Medicine
Division name	Department of Urology
Zip code
Address	6-20-2, Shinkawa, MIitaka, Tokyo
TEL	0422-47-5511
Email	tanbodes@ks.kyorin-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Mitsuhiro Tambo
Organization	Kyorin University School of Medicine
Division name	Department of Urology
Zip code
Address	6-20-2, Shinkawa, MIitaka, Tokyo
TEL	0422-47-5511
Homepage URL
Email	tanbodes@ks.kyorin-u.ac.jp

Sponsor
Institute	Department of Urology, Kyorin University School of Medicine
Institute
Department

Funding Source
Organization	Department of Urology, Kyorin University School of Medicine
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	2015 Year 03 Month 15 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	Terminated
Date of protocol fixation	2015 Year 02 Month 09 Day
Date of IRB	2020 Year 02 Month 08 Day
Anticipated trial start date	2015 Year 03 Month 01 Day
Last follow-up date	2020 Year 02 Month 08 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 03 Month 15 Day
Last modified on	2020 Year 03 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019503