UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020040 |
|---|---|
| Receipt number | R000023146 |
| Scientific Title | The impact of the associated symptoms of other LUTS by tadalafil administration to patients with BPH |
| Date of disclosure of the study information | 2015/12/03 |
| Last modified on | 2021/06/10 08:35:06 |
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Basic information
Public title
The impact of the associated symptoms of other LUTS by tadalafil administration to patients with BPH
Acronym
The impact of the associated symptoms of other LUTS by tadalafil administration
Scientific Title
The impact of the associated symptoms of other LUTS by tadalafil administration to patients with BPH
Scientific Title:Acronym
The impact of the associated symptoms of other LUTS by tadalafil administration
Region
| Japan |
Condition
Condition
Benign prostatic hyperplasia
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we will evaluate the male lower urinary tract symptoms by tadalafil administration after alpha 1 blocker treatment failure. We will also confirm the effect of improving symptom score in tadalafil monotherapy in fresh cases. In our knowledge, there are no clinical studies evaluated erectile function, bladder storage symptoms and QOL by tadalafil.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Prostate volume, residual urine, IPSS, QOL score, OABSS, NIH Chronic Prostatitis Symptom Index (NIH-CPSI), and IIEF5 Questionnaire will be evaluated before and after additional administration and 4 weeks. In the possible case, voiding diary is also evaluated before and after administration. Also, the side effects will be evaluated by interview
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Prostate volume, residual urine, IPSS, QOL score, OABSS, NIH Chronic Prostatitis Symptom Index (NIH-CPSI), and IIEF5 Questionnaire will be evaluated before and after additional administration and 4 weeks.
Doses
Tadalafil 5mg/day
Duration
4weeks
Interventions/Control_2
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
Patients with diagnosed BPH
More than 40 years old
Key exclusion criteria
1. Patients with a history of hypersensitivity to components of tadalafil
2. Patients in the administration of nitrate agent or nitric oxide (NO) donating agent (nitroglycerin, amyl nitrite, nitrate Isozorubido)
3. Patients in the administration of soluble guanylate cyclase (sGC) stimulator (the Riociguat)
4. See the section of the patient ["Other notes" with the next listed cardiovascular system disorders. In addition, there is no experience for these patients. ]
(1) patients with unstable angina
(2)Patients with heart failure (NYHA classification 3 degrees or more)
(3)Patients with uncontrolled arrhythmias, hypotension (blood pressure <90 / 50mmHg), or uncontrolled hypertension (resting blood pressure> 170 / 100mmHg)
(4) Patients with a history of myocardial infarction is that within the last three months
(5) Patients with a history of cerebral infarction, cerebral hemorrhage that is within the last 6 months
5. Patients with patients
6. severe liver failure
7. with severe renal failure
8. Other, patients attending physician has determined that inadequate
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | UKIMURA OSAMU |
Organization
Kyoto Prefecturral University of Medicine
Division name
Urology
Zip code
Address
465 kaji-cho, Kamigyo-ku Kyoto, Japan, 602-8566
TEL
075-251-5595
ukimura@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | YASUHIRO YAMADA |
Organization
Kyoto Prefecturral University of Medicine
Division name
Urology
Zip code
Address
465 kaji-cho, Kamigyo-ku Kyoto, Japan, 602-8566
TEL
075-251-5595
Homepage URL
y-yamada@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefecturral University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyoto Prefecturral University 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 | 12 | Month | 03 | 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
Completed
Date of protocol fixation
| 2015 | Year | 12 | Month | 02 | Day |
Date of IRB
| 2015 | Year | 12 | Month | 10 | Day |
Anticipated trial start date
| 2015 | Year | 12 | Month | 30 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2021 | Year | 06 | Month | 10 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 12 | Month | 02 | Day |
Last modified on
| 2021 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023146
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