UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016805 |
|---|---|
| Receipt number | R000019503 |
| 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 |
| Date of disclosure of the study information | 2015/03/15 |
| Last modified on | 2020/03/17 22:09:48 |
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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
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
tanbodes@ks.kyorin-u.ac.jp
Sponsor or person
Institute
Department of Urology, Kyorin University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019503
