Unique ID issued by UMIN | UMIN000038803 |
---|---|
Receipt number | R000044241 |
Scientific Title | Study of silodosin and Vibegron combination therapy for overactive bladder patients with benign prostatic hyperplasia. |
Date of disclosure of the study information | 2019/12/06 |
Last modified on | 2019/12/05 20:13:44 |
Study of silodosin and Vibegron combination therapy for overactive bladder patients with benign prostatic hyperplasia.
Study of silodosin and Vibegron combination therapy for overactive bladder patients with benign prostatic hyperplasia.
Study of silodosin and Vibegron combination therapy for overactive bladder patients with benign prostatic hyperplasia.
Study of silodosin and Vibegron combination therapy for overactive bladder patients with benign prostatic hyperplasia.
Japan |
overactive bladder
Urology |
Others
NO
Efficacy and safety of combination therapy of Silodosin and Vibegron (50mg / day) for patients with overactive bladder with benign prostatic hyperplasia who cannot achieve symptom relief with single-dose silodosin (8mg / day) for 4 weeks consider.
Efficacy
Change in overactive bladder symptoms questionnaire (OABSS) total score.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Take Vibegron (50mg / day) for 4week.
50 | years-old | <= |
90 | years-old | > |
Male
1.Male patient diagnosed with BPH.
2.Patients receiving silodosin for 4 weeks at the time of registration.
3.Patients whose OABSS total score exceeds 3 points and urinary urgency exceeds 1 / week
(OABSS urgency score of 2 points or more).
4.Patients who are over 50 years old and under 90 years old when obtaining consent.
5.Patients who have obtained written consent for participation in this study.
1.Patients with a history of hypersensitivity to silodosin or Vibegron.
2.Patients who have started taking anticholinergic drugs, cholinergic drugs, beta3 agonists, beta antagonists, alpha-receptor blockers and other frequent urinary/urinary incontinence drugs within 8 weeks (excluding silodosin). In addition, a 5alpha-reductase inhibitor or an antiandrogen is administered 6months or more in advance and can be incorporated if the patient's condition is stable.
3.Patients with urinary retention or severe urination difficulty or patients with a history of urination.
4.Patients with neoplasms in the lower urinary tract such as bladder cancer and prostate cancer, neurogenic bladder, urethral stricture, chronic bacterial prostatitis, active urinary tract infection, urinary calculus, interstitial cystitis.
5.Patients who have more than 100mL of residual urine at the time of consent and registration.
6.Patients who are judged to be inappropriate as the subject of researcher.
54
1st name | HIROKI |
Middle name | |
Last name | ITO |
GIFU UNIVERSITY HOSPITAL
urology
501-1194
1-1 Yanagido, Gifu City
058-230-6341
rinri@gifu-u.ac.jp
1st name | HIROKI |
Middle name | |
Last name | ITO |
GIFU UNIVERSITY HOSPITAL
urology
501-1194
1-1 Yanagido, Gifu City
058-230-6341
rinri@gifu-u.ac.jp
GIFU UNIVERSITY
GIFU UNIVERSITY
Self funding
Gifu University graduate school of medicine / school of medicine
1-1 Yanagido, Gifu City
058-230-6059
rinri@gifu-u.ac.jp
NO
2019 | Year | 12 | Month | 06 | Day |
Unpublished
Open public recruiting
2019 | Year | 05 | Month | 31 | Day |
2019 | Year | 05 | Month | 31 | Day |
2019 | Year | 06 | Month | 01 | Day |
2020 | Year | 05 | Month | 31 | Day |
2019 | Year | 12 | Month | 05 | Day |
2019 | Year | 12 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044241
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