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

JRCT ID: jRCT1061240018

Registered date:30/05/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: BPH, OAB
• Date of first enrollment: 10/06/2024
• Target sample size: 90
• Study type: Interventional

Intervention(s)

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 selection criteria are met and the exclusion criteria are not violated, registration will be performed. Subsequently, randomization will be carried out, and participants will be allocated to the following two groups.
Silodosin monotherapy group: Group A
Silodosin (Urief) 4mg will be taken orally twice daily after breakfast and dinner for 12 weeks.
Silodosin/vibegron combination therapy group: Group B
Silodosin (Urief) 4mg will be taken orally twice daily after breakfast and dinner, and vibegron (Beova) 50mg will be taken orally once daily after breakfast for 12 weeks.

Outcome(s)

• Primary Outcome: Change in total overactive bladder symptom score (OABSS) from baseline to 12 weeks post-treatment.

Secondary Outcome

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.

Key inclusion & exclusion criteria

• Age minimum: >= 50age old
• Age maximum: < 90age old
• Gender: Male

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Masashi Honda
• Secondary ID(s): Nil known