Study of additional vibegron in persistent overactive bladder

JRCT ID: jRCTs031230450

Registered date:17/11/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: overactive bladder
• Date of first enrollment: 12/12/2023
• Target sample size: 160
• Study type: Interventional
• Intervention(s): Study subjects are randomly assigned to the vibegron combination treatment group or the alpha1-blocker alone treatment group

Outcome(s)

• Primary Outcome: Intergroup difference in change from baseline (week 0) at week 12 in OABSS total score in the vibegron combination treatment group and alpha-1 blocker monotherapy group

Secondary Outcome

1. Intergroup differences in change from baseline (week 0) at week 12 between the vibegron combination treatment group and the alpha-1 blocker monotherapy group in the following evaluations;
1) Urinary parameters (average daily urinary frequency, average voided volume, urgency episodes, urgency urinary incontinence episodes, night-time frequency, and hours of undisturbed sleep) in bladder diary
2) Qmax and post-void residual urine volume
2. Intergroup differences in change from baseline (week 0) at each time points between the vibegron combination treatment group and the alpha-1 blocker monotherapy group for the following evaluations;
1) OABSS total score (at each time points except at week 12) and OABSS subscores
2) IPSS (total score, storage symptom score and voiding symptom score)
3) IPSS-QOL score
3. Intergroup difference in PGI at week 12
4. Proportion of patients who do not meet OAB criteria (OABSS Q3 score of 2 or more and OABSS total score of 3 or more) and proportion of normalization (proportion of patients with resolution of urinary incontinence, proportion of patients with resolution ofnocturia, etc.)

Key inclusion & exclusion criteria

• Age minimum: >= 50age old
• Age maximum: Not applicable
• Gender: Male

Include criteria

At the time of consent:
- Men patients 50 years of age or older at the date of consent
- Patients with BPH diagnosed by basic evaluation and other diagnostic methods
- Patients who agree to comply with the study settings for prohibited concomitant drugs/therapies and restricted concomitant drugs
- Patients who have been using the identical basic alpha-1 blocker (silodosin, tamsulosin or naftopidil) at the same dosage for at least 8 weeks prior to Visit 1
- Patients who gave written consent
Visit 1 (week 0):
- Patients who have been using the identical basic alpha-1 blocker (silodosin, tamsulosin, or naftopidil) at the same dosage for at least 8 weeks prior to Visit 1
- Prostate volume greater than or equal to 20 mL (either by transabdominal or transrectal ultrasonography within 6 months is eligible)
- Patients with an OABSS Q3 score of at least 2 points and an OABSS total score of at least 3 points
- Patients who have adequately completed a bladder diary

Exclude criteria

At the time of consent:
- Patients with neurogenic bladder (physician's discretion)
- Patients with a history of surgery for BPH
- Patients with urinary retention
- Patients with stress urinary incontinence only
- Patients with orthostatic hypotension
- Patients with prolonged catheterization or self-catheterization
- Patients with complications that present with symptoms similar to OAB (diabetes insipidus, urinary stone, urinary tract infection, interstitial cystitis, prostatitis) that, at the discretion of the principal investigator or subinvestigators, may affect the evaluation of this study
- Patients with a history of injury, surgery, or neurodegenerative disease (e.g., multiple sclerosis) affecting the lower urinary tract and innervation
- Patients with bladder or prostate cancer who are undergoing or will undergo treatment
- Patients with prior hypersensitivity to vibegron
- Patients with serious cardiac disease or severe hepatic dysfunction
- Patients who are judged unsuitable for inclusion in this trial by the principal investigator or subinvestigators.(e.g., patients diagnosed with dementia)
Visit1 (0 week):
- Patients with post-void residual urine volume greater than or equal to 100 mL
- Patients with a maximum urine flow rate (Qmax) of less than 5 mL/s (when a single voided volume of 100 mL or more is measured)
- Patients with polyuria (daily urine volume averaging more than 3000 mL per day)
- Patients who are unable to comply with study settings for prohibited concomitant drugs or therapies during the specified period
- Patients who started taking or changed the dosage of restricted concomitant drugs during the specified period

Related Information

• Primary Sponsor: Yoshida Masaki
• Secondary Sponsor: Kyorin Pharmaceutical Co., Ltd.,Kissei Pharmaceutical Co., Ltd.