Unique ID issued by UMIN | UMIN000014769 |
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Receipt number | R000017176 |
Scientific Title | Add-on effects of tadalafil for tamsulosin treated patients with benign prostatic hyperplasia suffering from residual lower urinary tract symptoms: a randomized, placebo-controlled, double-blind, crossover study |
Date of disclosure of the study information | 2014/10/01 |
Last modified on | 2019/06/01 15:12:19 |
Add-on effects of tadalafil for tamsulosin treated patients with benign prostatic hyperplasia suffering from residual lower urinary tract symptoms: a randomized, placebo-controlled, double-blind, crossover study
Add-on effects of tadalafil for tamsulosin treated patients with residual LUTS: a randomized, placebo-controlled, double-blind, crossover study
Add-on effects of tadalafil for tamsulosin treated patients with benign prostatic hyperplasia suffering from residual lower urinary tract symptoms: a randomized, placebo-controlled, double-blind, crossover study
Add-on effects of tadalafil for tamsulosin treated patients with residual LUTS: a randomized, placebo-controlled, double-blind, crossover study
Japan |
benign prostatic hyperplasia
Urology |
Others
NO
To investigate the add-on effects of tadalafil for tamsulosin treated patients with benign prostatic hyperplasia suffering from residual lower urinary tract symptoms by a randomized, placebo-controlled, double-blind, crossover study
Efficacy
Confirmatory
Pragmatic
Not applicable
Differences of total IPSS score from baseline to cross over treatment of tadalafil and placebo for 6 weeks each
1) Changes in questionnaire parameters (IPSS-QOL, IIEF)
2) Changes in uroflowmetry parameters (voided volume, Qmax, residual urine)
3) Changes in voiding diary (frequency per day, frequency at daytime, frequency at night, urine volume per day and average voided volume)
4) Safety, adverse events and side effects
Interventional
Cross-over
Randomized
Individual
Double blind -all involved are blinded
Placebo
NO
NO
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Medicine |
tadalafil for 6 weeks followed by placebo 6 weeks
tadalafil for 6 weeks following to placebo 6 weeks.
50 | years-old | <= |
Not applicable |
Male
1) Patients who agree with this study
2) 50 years old men and elder
3) Diagnosed as benign prostatic hyperplasia using a standard method
4) Prostatic volume is between 20ml and 40ml
5) Patients who have IPSS total score no less than 8 and QOL no less than 3 under treatment of tamsulosin 0.2mg for at least 4 weeks.
1) Patients with prostate cancer, neurogenic bladder, urethral stricture, chronic prostatitis, urinary tract infections, urinary tract stones or interstitial cystitis.
2) Patients with a contraindication for tadarafil
3) Patients taking silodosin or naftopidil, or in 2 weeks after stopping those two.
4) Patients taking dutasteride, or in 3 months after stopping dutasteride.
5) Patients taking anticholinergics, or in 2 weeks after stopping them.
6) Patients who are diagnosed as not applicable to this study by an attending doctor.
40
1st name | |
Middle name | |
Last name | Hiromitsu Negoro |
Kyoto University, Graduate School of Medicine
Urology
Shogoin kawahara-cho 54, Kyoto Sakyo-ku,
075-751-3337
hnegoro@kuhp.kyoto-u.ac.jp
1st name | |
Middle name | |
Last name | Hiromitsu Negoro |
Kyoto University, Graduate School of Medicine
Urology
Shogoin kawahara-cho 54, Kyoto Sakyo-ku,
075-751-3337
hnegoro@kuhp.kyoto-u.ac.jp
Department of Urology, Kyoto University, Graduate School of Medicine
donation money for research
Other
NO
京都大学医学部附属病院(京都府)
2014 | Year | 10 | Month | 01 | Day |
Unpublished
Completed
2014 | Year | 07 | Month | 15 | Day |
2014 | Year | 09 | Month | 19 | Day |
2014 | Year | 10 | Month | 01 | Day |
2018 | Year | 10 | Month | 31 | Day |
2014 | Year | 08 | Month | 05 | Day |
2019 | Year | 06 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017176
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