UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057227 |
|---|---|
| Receipt number | R000065371 |
| Scientific Title | Investigation of Background Factors Predicting the Efficacy of Therapeutic Agents for Benign Prostatic Hyperplasia |
| Date of disclosure of the study information | 2025/03/06 |
| Last modified on | 2026/03/07 12:41:21 |
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Basic information
Public title
Investigation of Background Factors Predicting the Efficacy of Therapeutic Agents for Benign Prostatic Hyperplasia
Acronym
Investigation of Background Factors Predicting the Efficacy of Therapeutic Agents for Benign Prostatic Hyperplasia
Scientific Title
Investigation of Background Factors Predicting the Efficacy of Therapeutic Agents for Benign Prostatic Hyperplasia
Scientific Title:Acronym
Investigation of Background Factors Predicting the Efficacy of Therapeutic Agents for Benign Prostatic Hyperplasia
Region
| Japan |
Condition
Condition
Benign prostatic hyperplasia
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether lifestyle-related diseases and obesity are predictors of the effectiveness of therapeutic agents for benign prostatic hyperplasia
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in IPSS from baseline for patients with and without obesity and lifestyle-related diseases for each treatment
Key secondary outcomes
(1) Parameter changes on questionnaires (QOL, OABSS, IIEF5)
(2) Change in parameters on urinary flow measurement (volume per void, Qmax, Qave, residual urine)
(3) Safety, adverse events, side effects
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
1. Age: 50 years old or older
2. Gender: Male
3. Outpatient only
4. Patients who have been fully informed about their participation in this study, and who have given written consent of their own free will based on sufficient understanding of the subject's condition.
5. Patients who visited a urologist with a chief complaint of lower urinary tract symptoms and were newly started on drug therapy, added a new drug to the existing drug therapy, or changed to a new drug after the diagnosis of benign prostatic hyperplasia. 6) Patients who were diagnosed with benign prostatic hyperplasia by abdominal ultrasonography.
6. Patients with a prostate volume of 20 ml or greater on abdominal ultrasonography.
7. Patients who meet the International Prostate Symptom Score (IPSS) total score of at least 8 points and QOL score of at least 3 points.
Key exclusion criteria
1. Patients with prostate cancer, bladder cancer, urethral stricture, urinary tract infection, or urinary calculus.
2. Patients with contraindication to any of the drugs for treatment of benign prostatic hyperplasia (BPH).
3. Patients within 3 months of starting treatment for benign prostatic hyperplasia or overactive bladder.
4. Patients with serious hepatic or renal dysfunction.
5. Patients with hypersensitivity to drugs such as allergy.
6. Patients who have participated in other clinical studies within 4 months.
7. Other patients who are deemed inappropriate as research subjects by the principal investigator.
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Terada |
Organization
University of Fukui
Division name
Urology
Zip code
910-1193
Address
23-3, Matsuoka Shimoaizuki, Eiheiji cho, Yoshida gun
TEL
0776613111
urokumura@gmail.com
Public contact
Name of contact person
| 1st name | Yoshinaga |
| Middle name | |
| Last name | Okumura |
Organization
University of Fukui
Division name
urology
Zip code
9101193
Address
23-3, Matsuoka Shimoaizuki, Eiheiji cho, Yoshida gun
TEL
0776613111
Homepage URL
urology@u-fukui.ac.jp
Sponsor or person
Institute
University of Fukui
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
The Research Ethics Committee of University of Fukui
Address
23-3, Matsuokashimoaizuki, Eiheijicho, Yoshigda gun, Fukui prefecture
Tel
0776618614
rinrisys@ml.u-fukui.ac.jp
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
福井県立病院,福井赤十字病院, 福井県済生会病院
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 03 | Month | 06 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 02 | Month | 21 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 21 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 21 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nothing
Management information
Registered date
| 2025 | Year | 03 | Month | 06 | Day |
Last modified on
| 2026 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065371
