Unique ID issued by UMIN | UMIN000024578 |
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Receipt number | R000028285 |
Scientific Title | Comparison of reduction effect on storage symptom between tadalafil and silodosin in men with benign prostate hyperplasia: A prospective randomized crossover study |
Date of disclosure of the study information | 2016/12/20 |
Last modified on | 2022/11/02 10:35:59 |
Comparison of reduction effect on storage symptom between tadalafil and silodosin in men with benign prostate hyperplasia: A prospective randomized crossover study
The RESTORE study
Comparison of reduction effect on storage symptom between tadalafil and silodosin in men with benign prostate hyperplasia: A prospective randomized crossover study
The RESTORE study
Japan |
Benign prostate hyperplasia
Urology |
Others
NO
To compare the reduction effect on storage symptom between tadalafil and silodosin in men with benign prostate hyperplasia
Safety
Confirmatory
Variations of overacrive bladder symptom score (OABSS) at 8-week after the administration of each drug
Variations of the items below at 4-week and 8-week after the administraion of each drug
- International prostate symptom score (IPSS): Total score, Storage subscore, and Voiding subscore
- International Index of Erectile Function (IIEF)
- Maximum urinary flow rate
- Post-void residual urine
- Mean voided volume
- Blood pressure on visits
Interventional
Cross-over
Randomized
Individual
Open -no one is blinded
Active
NO
NO
Institution is not considered as adjustment factor.
Numbered container method
2
Treatment
Medicine |
We will administer tadalafil 5mg/day for 8 weeks first and silodosin 8mg/day for 8 weeks second.
We will administer silodosin 8mg/day for 8 weeks first and tadalafil 5mg/day for 8 weeks second.
50 | years-old | <= |
Not applicable |
Male
- Prostate volume is 20 mL and over.
- OABSS is 6 and over.
- Prostate cancer
- Neurogenic bladder
- Under treatment with alpha1 blockers and/or OAB drugs
- Contraindication of tadalafil
30
1st name | Kazumasa |
Middle name | |
Last name | Torimoto |
Nara Medical University Hospital
Urology
634-8522
840 Shijo-cho, Kashihara, Nara, JAPAN
+81-744-22-3051
torimoto@naramed-u.ac.jp
1st name | Kazumasa |
Middle name | |
Last name | Torimoto |
Nara Medical University Hospital
Urology
634-8522
840 Shijo-cho, Kashihara, Nara, JAPAN
+81-744-22-3051
torimoto@naramed-u.ac.jp
Department of Urology, Nara Medical University
Department of Urology, Nara Medical University
Self funding
Nara Medical University Certified Review Board
840 Shijo-cho, Kashihara, Nara
+81-744-22-3051
ethics_nara@naramed-u.ac.jp
NO
奈良県立医科大学附属病院(奈良県)、平尾病院(奈良県)、高井病院(奈良県)、大阪暁明館病院(大阪府)
2016 | Year | 12 | Month | 20 | Day |
Unpublished
Completed
2016 | Year | 11 | Month | 28 | Day |
2016 | Year | 11 | Month | 24 | Day |
2016 | Year | 12 | Month | 20 | Day |
2020 | Year | 03 | Month | 31 | Day |
2016 | Year | 10 | Month | 26 | Day |
2022 | Year | 11 | Month | 02 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028285
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