Investigation of Background Factors Predicting the Efficacy of Therapeutic Agents for Benign Prostatic Hyperplasia

Investigation of Background Factors Predicting the Efficacy of Therapeutic Agents for Benign Prostatic Hyperplasia - Investigation of Background Factors Predicting the Efficacy of Therapeutic Agents for Benign Prostatic Hyperplasia

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000057227

Enrollment

600

Registered

2025-03-06

Start date

2025-02-21

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign prostatic hyperplasia

Interventions

None listed

Eligibility

Sex/Gender

Male

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Change in IPSS from baseline for patients with and without obesity and lifestyle-related diseases for each treatment	—

Secondary

Measure	Time frame
(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	—

Countries

Japan

Contacts

Public ContactYoshinaga Okumura

University of Fukui urology

urology@u-fukui.ac.jp0776613111

Outcome results