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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.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000038803
Enrollment
54
Registered
2019-12-06
Start date
2019-06-01
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

overactive bladder

Interventions

Take Vibegron (50mg / day) for 4week.

Sponsors

GIFU UNIVERSITY
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Change in overactive bladder symptoms questionnaire (OABSS) total score.

Countries

Japan

Contacts

Public ContactHIROKI ITO

GIFU UNIVERSITY HOSPITAL urology

rinri@gifu-u.ac.jp058-230-6341

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026