Treatment of Storage Symptoms Caused by Benign Prostatic Hyperplasia: Comparing Silodosin Monotherapy with Silodosin and Vibegron Combination Therapy

Silodosin Monotherapy versus Silodosin and Vibegron Combination Therapy for Storage Symptoms Associated with Benign Prostatic Hyperplasia

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1061240018

Enrollment

Registered

2024-05-30

Start date

2024-06-10

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

BPH, OAB BPH, OAB

Interventions

This study consists of a screening period after obtaining consent and a 12-week treatment period. Within 0-4 weeks before randomization, screening tests will be conducted. After confirming that the se

D011881

Multi-center, active-controlled, randomized, open-label, parallel-group study

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Male patients aged 50 years or older and less than 90 years at the time of consent. Patients with benign prostatic hyperplasia (BPH). Patients with an overactive bladder symptom score (OABSS) of 2 or higher for Question 3 and a total score of 3 or higher.

Exclusion criteria

Exclusion criteria: Patients with a residual urine volume of 100 ml or more as measured by abdominal ultrasound examination. Patients with a history of urinary retention. Patients with neurogenic bladder. Patients with severe bladder diverticulum or urethral stricture. Patients with malignant urogenital tumors. Patients who have undergone pelvic radiation therapy. Patients with severe heart disease, cerebrovascular disease, kidney disorder, or liver disorder. Patients who are already undergoing or have previously undergone monotherapy with silodosin (Silodosin) or vibegron (Beova), or combination therapy with silodosin (Silodosin) and vibegron (Beova). Patients deemed unsuitable for oral administration of silodosin (Silodosin) or vibegron (Beova) by the attending physician. Patients for whom the attending physician determines that a reduced dose of 2 mg per administration of silodosin (Urief) is necessary.

Design outcomes

Primary

Measure	Time frame
Change in total overactive bladder symptom score (OABSS) from baseline to 12 weeks post-treatment.	—

Secondary

Measure	Time frame
Changes in each OABSS score (daytime, nighttime, urgency, and urge incontinence). Changes in the total International Prostate Symptom Score (IPSS) and each subscore (voiding symptoms, storage symptoms, post-micturition symptoms, and QOL). Changes in the Overactive Bladder Quality of Life Questionnaire (OAB-q) scores. Changes in the Treatment Benefit Scale (TBS) scores. Changes in residual urine volume. Presence or absence of adverse events.	—

Measure

Time frame

Changes in each OABSS score (daytime, nighttime, urgency, and urge incontinence). Changes in the total International Prostate Symptom Score (IPSS) and each subscore (voiding symptoms, storage symptoms, post-micturition symptoms, and QOL). Changes in the Overactive Bladder Quality of Life Questionnaire (OAB-q) scores. Changes in the Treatment Benefit Scale (TBS) scores. Changes in residual urine volume. Presence or absence of adverse events.

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Contacts

Public ContactYusuke Kimura

Department of Urology, Tottori University Faculty of Medicine

k.yusuke@tottori-u.ac.jp+81-859-38-6607

Outcome results

None listed

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