Study to Evaluate the Efficacy, Safety and Tolerability of Vibegron in Men With Overactive Bladder (OAB) Symptoms on Pharmacological Therapy for Benign Prostatic Hyperplasia (BPH)
- Registration Number
- NCT03902080
- Lead Sponsor
- Urovant Sciences GmbH
- Brief Summary
This study will assess the efficacy of vibegron compared with placebo in men with overactive bladder (OAB) symptoms on pharmacological therapy for benign prostatic hyperplasia (BPH) as defined by micturition and urgency episodes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 1105
- Participant should have been on and agree to continue to stay on a stable dose of benign prostatic hyperplasia (BPH) treatment with either a) alpha blocker monotherapy or b) alpha blocker + 5 alpha reductase inhibitor.
- Participant has an International Prostate Symptom Score total score of ≥ 8
- Participant has a prostate-specific antigen level < 4 nanograms per milliliter (ng/mL), or if ≥ 4 ng/mL but ≤ 10 ng/mL, prostate cancer has been ruled out to the satisfaction of the investigator
- Participant must have both additional qualifications based on the 3-day Bladder Diary period: a) having an average of ≥ 8 but ≤ 20 micturition episodes per day over the 3-day diary period, and (b) having an average of ≥ 3 urgency episodes per day over the 3-day diary period
- Participant must have a post void residual volume value of < 100 mL
- Having at least 2 average nocturia episodes per night based on 3-day Bladder Diary at baseline. Nocturia is defined as waking to pass urine during the main sleep period.
- Participant has a history of 24-hour urine volume greater than 3,000 mL
- Has lower urinary tract pathology that could, in the opinion of the investigator, be responsible for urgency, frequency, or incontinence
- Has a history of prostate surgery, including minimally invasive transurethral or transrectal procedures, procedural treatments for BPH within 6 months of Screening or has a planned prostate surgery
- Has a history of urinary retention requiring an intervention (e.g., catheterization) for any reason
- Has maximum urinary flow (Qmax) < 5.0 mL/second with a minimum voided volume of 125 mL
- Has a history of or current nocturnal polyuria
- Has an active or recurrent (> 3 episodes per year) urinary tract infection by clinical symptoms or laboratory criteria (≥ 5 white blood cells/high power field [hpf] with presence of red blood cell [RBC] and/or a positive urine culture, defined as ≥ 10^5 colony forming units (CFU)/mL (i.e., 100 × 10^3 CFU/mL in a single specimen)
- Has uncontrolled hyperglycemia (defined as fasting blood glucose > 150 milligrams per deciliter (mg/dL) or 8.33 millimoles per liter (mmol/L) or non-fasting blood glucose > 200 mg/dL or 11.1 mmol/L) or, if in the opinion of the investigator, is uncontrolled
- Has uncontrolled hypertension (systolic blood pressure of ≥ 180 millimeters of mercury (mmHg) and/or diastolic blood pressure of ≥ 100 mmHg) or has a resting heart rate (by pulse) > 100 beats per minute (min)
- Has a history of cerebral vascular accident, transient ischemic attack, unstable angina, myocardial infarction, coronary artery interventions (e.g., coronary artery bypass grafting or percutaneous coronary interventions [e.g., angioplasty, stent insertion]), or neurovascular interventions (e.g., carotid artery stenting) within 6 months prior to the Screening Visit
- Has alanine aminotransferase or aspartate aminotransferase > 2.0 times the upper limit of normal (ULN), or bilirubin (total bilirubin) > 1.5 × ULN (or > 2.0 × ULN if secondary to Gilbert syndrome or pattern consistent with Gilbert syndrome)
- Has an estimated glomerular filtration rate < 30 mL/min/1.73 meters squared (m^2)
- Has a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstances that might, in the opinion of the investigator, confound the results of the study, interfere with the participant's ability to comply with the study procedure, or make participation in the study not in the participant's best interest
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Participants will receive matching placebo orally once daily for 24 weeks. Vibegron 75 mg Vibegron Participants will receive vibegron 75 milligrams (mg) orally once daily for 24 weeks.
- Primary Outcome Measures
Name Time Method Change From Baseline at Week 12 in the Average Number of Micturition Episodes Per Day Baseline; Week 12 Micturition was defined as the number of times a participant voided in the toilet as indicated on the Bladder Diary. Baseline was defined as the last non-missing result on or prior to the randomization date. Change from baseline was calculated as the post-baseline value minus the baseline value. Daily Averages were calculated as the sum of the event type on Complete Diary Days divided by the number of Complete Diary Days.
Change From Baseline at Week 12 in the Average Number of Urgency Episodes (Need to Urinate Immediately) Per Day Baseline; Week 12 Urgency was defined as the number of times a participant checked that they had the need to urinate immediately as indicated on the Bladder Diary. Baseline was defined as the last non-missing result on or prior to the randomization date. Change from baseline was calculated as the post-baseline value minus the baseline value. Daily Averages were calculated as the sum of the event type on Complete Diary Days divided by the number of Complete Diary Days.
- Secondary Outcome Measures
Name Time Method Change From Baseline at Week 12 in the Average Number of Nocturia Episodes Per Night Baseline; Week 12 Nocturia was defined as waking to pass urine during the main sleep period. Baseline was defined as the last non-missing result on or prior to the randomization date. Change from baseline was calculated as the post-baseline value minus the baseline value.
Change From Baseline at Week 12 in the Average Number of Urge Urinary Incontinence (UUI) Episodes Per Day for Participants With Urinary Incontinence at Baseline Baseline; Week 12 The number of UUI episodes was defined as the number of times a subject checked that they had "urge" as the main reason for leakage. Average UUI episodes per day at each study visit was calculated as total number of UUI episodes within the diary analysis visit windows divided by non-missing diary days. Change from baseline was calculated as the post-baseline value minus the baseline value. Daily Averages were calculated as the sum of the event type on Complete Diary Days divided by the number of Complete Diary Days.
Change From Baseline at Week 12 in the International Prostate Symptom Score (IPSS) Storage Score (1-week Recall) Baseline; Week 12 The IPSS is based on the responses to 7 questions concerning urinary symptoms and 1 question concerning quality of life. Each question concerning urinary symptoms allows the participant to choose 1 out of 6 answers indicating increasing severity of the particular symptom. The responses are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic). Higher numerical scores represent greater severity of symptoms. Decrease in IPSS storage score indicates improvement. Baseline was defined as the last non-missing result on or prior to the randomization date. Change from baseline was calculated as the post-baseline value minus the baseline value.
Change From Baseline at Week 12 in the Average Volume Voided Per Micturition Baseline; Week 12 Micturition was defined as the number of times a participant voided in the toilet as indicated on the Bladder Diary. Baseline was defined as the last non-missing result on or prior to the randomization date. Change from baseline was calculated as the post-baseline value minus the baseline value. Average volume voided per micturition at each study visit was calculated as the total volume voided over diary days within the analysis visit window divided by the total number of micturition episodes during non-missing diary days.
Trial Locations
- Locations (135)
Urology Centers of Alabama
🇺🇸Homewood, Alabama, United States
Private Practice
🇨🇦Brampton, Ontario, Canada
Coastal Clinical Research, Inc.
🇺🇸Mobile, Alabama, United States
Gen1 Research- Arizona Urology Specialists
🇺🇸Glendale, Arizona, United States
Urological Associates Of Southern Arizona
🇺🇸Tucson, Arizona, United States
California Research Medical Group, Inc.
🇺🇸Fullerton, California, United States
San Diego Clinical Trials
🇺🇸La Mesa, California, United States
Clinical Trials Research
🇺🇸Lincoln, California, United States
West Coast Urology
🇺🇸Los Alamitos, California, United States
American Institute of Research
🇺🇸Los Angeles, California, United States
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