Unique ID issued by UMIN | UMIN000025282 |
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Receipt number | R000029077 |
Scientific Title | A randomized controlled study of the efficacy of Tadalafil monotherapy versus combination of Tadalafil and mirabegron for the treatment of overactive bladder (OAB) associated with benign prostatic hyperplasia (BPH) |
Date of disclosure of the study information | 2016/12/15 |
Last modified on | 2019/02/05 15:56:41 |
A randomized controlled study of the efficacy of Tadalafil monotherapy versus combination of Tadalafil and mirabegron for the treatment of overactive bladder (OAB) associated with benign prostatic hyperplasia (BPH)
CONTACT Study
A randomized controlled study of the efficacy of Tadalafil monotherapy versus combination of Tadalafil and mirabegron for the treatment of overactive bladder (OAB) associated with benign prostatic hyperplasia (BPH)
CONTACT Study
Japan |
Benign prostatic hyperplasia
Urology |
Others
NO
To evaluate the efficacy and safety of add-on treatment of mirabegron (50mg/day) for OAB /BPH patients who were not satisfied with tadalafil (5mg/day) monotherapy for 8 weeks or longer.
Safety,Efficacy
Change from baseline to end of treatment in overactive bladder symptom score (OABSS) total score.
1) Changes in OABSS subscore (daytime frequency, night-time frequency, urgency, urgent incontinence).
2) Changes in international prostate symptom score (IPSS) total score and subscore (void, storage, postvoid, QOL).
3) Change in National Institute of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) total score and subscore (pain, urination, QOL).
4) Changes in the parameters in frequency volume chart (number of void/ 24 hour, number of night-time void, number of urgency episodes/24 hour, number of incontinence episodes/24 hour).
5) Changes in postvoid residual (PVR) volume.
6) Changes in urine volume, Qmax and Qave.
7) Frequency of adverse events.
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
2
Treatment
Medicine |
Tadalafil monotherapy group: Group A
Tadalafil at the dose of 5mg is orally administered once daily after breakfast for 12 weeks.
Tadalafil/mirabegron combination therapy group: Group B
Tadalafil at the dose of 5mg and mirabegron at the dose of 50mg are orally administered once daily after breakfast for 12 weeks.
50 | years-old | <= |
90 | years-old | > |
Male
1) Male patients with BPH.
2) Patients who meet the following criteria even after administering tadalafil 5mg/day for more than 8 weeks:
OABSS total score >3
Urgency > once/week (OABSS urgency score >= 2)
3) Aged >=50 years and < 90 years
4) Patients who are able to give informed consent.
5) Patients from whom we have received written consent.
1) Patients with a history of hypersensitivity to tadalafil or mirabegron
2) Medication with anti-cholinergics, cholinergics,beta-agonists or antagonists, alpha-blocker and any other agents for treating pollakisuria/urinary incontinence during 8 weeks prior to the study. (Eligible if the medication was discontinued before tadalafil administration (before 8 weeks or more).5 alpha-reductase inhibitors or anti-androgen drugs can be included if they were administered > 6months and the patients had stable condition).
3) History or current condition of urinary retention or severe difficulty of urination
4) Patients with cancer in the part of lower urinary tract such as prostate or bladder, neurogenic bladder, urethra stricture, chronic bacterial prostatitis, symptomatic urinary tract infection, urinary tract stones and interstitial cystitis
5) Patients with serious cardiac disorder, serious cerebrovascular disease, serious liver dysfunction and serious kidney dysfunction
6) Qmax < 5 mL/sec
7) Postvoid residual volume (PVR) >150 mL
8) Any other patients who are regarded as unsuitable for this study by the investigator.
170
1st name | |
Middle name | |
Last name | Tomonori Yamanishi |
Dokkyo Medical University
Department of Urology and Neurology, Continence Center
880 Kita-Kobayashi, Mibu-machi, Shimotsuga-gun, Tochigi 321-0293, JAPAN
0282-86-1111
yamanish@dokkyomed.ac.jp
1st name | |
Middle name | |
Last name | Tomonori Yamanishi |
Dokkyo Medical University
Department of Urology and Neurology, Continence Center
880 Kita-Kobayashi, Mibu-machi, Shimotsuga-gun, Tochigi 321-0293, JAPAN
0282-86-1111
yamanish@dokkyomed.ac.jp
Clinical Research Support Center Kyushu
Astellas Pharma Inc.
Profit organization
Japan
NO
2016 | Year | 12 | Month | 15 | Day |
Unpublished
Completed
2016 | Year | 09 | Month | 01 | Day |
2016 | Year | 12 | Month | 08 | Day |
2016 | Year | 12 | Month | 15 | Day |
2019 | Year | 02 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029077
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