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)
Boston Clinical Trials Inc - Urology
🇺🇸Boston, Massachusetts, United States
Advances In Health, Inc.
🇺🇸Houston, Texas, United States
Excel Clinical Research - Internal Medicine
🇺🇸Las Vegas, Nevada, United States
Meridian Clinical Research - Urology
🇺🇸Savannah, Georgia, United States
Quantum Clinical Trials
🇺🇸Miami, Florida, United States
Gen1 Research- Arizona Urology Specialists
🇺🇸Glendale, Arizona, United States
San Diego Clinical Trials
🇺🇸La Mesa, California, United States
Coastal Clinical Research, Inc.
🇺🇸Mobile, Alabama, United States
Skyline Urology
🇺🇸Torrance, California, United States
American Institute of Research
🇺🇸Los Angeles, California, United States
LCC Medical Research Institute
🇺🇸Miami, Florida, United States
First Urology
🇺🇸Jeffersonville, Indiana, United States
Medical Center for Clinical Research
🇺🇸San Diego, California, United States
Tri Valley Urology Medical Group
🇺🇸Murrieta, California, United States
Manhattan Research Associates
🇺🇸New York, New York, United States
Triad Clinical Trials
🇺🇸Greensboro, North Carolina, United States
Urological Surgeons of Long Island
🇺🇸Garden City, New York, United States
Western New York Urology Associates
🇺🇸Buffalo, New York, United States
Alliance Urology Specialists - Greensboro
🇺🇸Greensboro, North Carolina, United States
Seattle Urology Research Center
🇺🇸Burien, Washington, United States
Lowcountry Urology
🇺🇸North Charleston, South Carolina, United States
Uz Antwerpen
🇧🇪Edegem, Antwerpen, Belgium
Onze-Lieve-Vrouwziekenhuis VZW - Campus Aalst
🇧🇪Aalst, Oost-Vlaanderen, Belgium
New Jersey Urology, LLC
🇺🇸Voorhees, New Jersey, United States
Regional Urology, LLC
🇺🇸Shreveport, Louisiana, United States
Baylor Scott & White Medical Center
🇺🇸Temple, Texas, United States
University of Szeged
🇭🇺Szeged, Csongrád, Hungary
Centre Hospitalier Universitaire De Sherbrooke (CHUS)
🇨🇦Sherbrooke, Quebec, Canada
AZ Maria Middelares - Campus Maria Middelares
🇧🇪Gent, Oost-Vlaanderen, Belgium
Associated Urologists of North Carolina - Urology
🇺🇸Raleigh, North Carolina, United States
CHU de Liège - Domaine Universitaire du Sart Tilman - Urologie
🇧🇪Liège, Belgium
AZ Delta - Campus Wilgenstraat
🇧🇪Roeselare, West-Vlaanderen, Belgium
Columbia University Medical Center - Clinical Research
🇺🇸New York, New York, United States
Sunnybrook Health Sciences Center
🇨🇦Toronto, Ontario, Canada
Advanced Urology Centers of NY, A Division of Integrated Medical Professionals (IMP)
🇺🇸Plainview, New York, United States
Peters Medical Research
🇺🇸High Point, North Carolina, United States
Algemeen Stedelijk Ziekenhuis
🇧🇪Aalst, Oost-Vlaanderen, Belgium
Weill Cornell Medicine
🇺🇸New York, New York, United States
Toronto Western Hospital
🇨🇦Toronto, Ontario, Canada
H.U. Virgen de la Victoria
🇪🇸Málaga, Spain
Hospital Universitario Puerta de Hierro Majadahonda
🇪🇸Majadahonda, Madrid, Spain
UZ Leuven - Campus Gasthuisberg
🇧🇪Leuven, Vlaams Brabant, Belgium
Hospital Universitario Reina Sofia
🇪🇸Córdoba, Spain
Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókór
🇭🇺Nyiregyhaza, Hungary
NZOZ Specjalista
🇵🇱Kutno, Lódzkie, Poland
Hospital Universitario Infanta Sofía
🇪🇸San Sebastián de los Reyes, Madrid, Spain
Centrum Medyczne Linden
🇵🇱Krakow, Poland
Clínica Universitaria de Navarra
🇪🇸Madrid, Spain
Hospital del Mar
🇪🇸Barcelona, Spain
Hospital General Universitario Gregorio Marañón
🇪🇸Majadahonda, Madrid, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Hospital Universitario de Salamanca
🇪🇸Salamanca, Spain
Urology San Antonio
🇺🇸San Antonio, Texas, United States
Discovery Clinical Trials
🇺🇸San Antonio, Texas, United States
Szarka Ödön Egyesitett Egeszsegügyi es Szocialis Intezmeny
🇭🇺Csongrad, Hungary
JSC Saules seimos medicinos centras
🇱🇹Kaunas, Kauno Apskritis, Lithuania
Hospital of University of Health Sciences Kauno Klinikos
🇱🇹Kaunas, Kauno Apskritis, Lithuania
Klaipedos Universitetine Ligonine (Klaipeda Hospital)
🇱🇹Klaipeda, Klaipedos Apskritis, Lithuania
Hospital Garcia de Orta
🇵🇹Almada, Portugal
H. Santo António. Centro Hospitalar do Porto
🇵🇹Porto, Portugal
Semmelweis Egyetem
🇭🇺Budapest, Hungary
Uro-Clin Kft.
🇭🇺Pècs, Hungary
Uab "Vakk"
🇱🇹Kaunas, Kauno Apskritis, Lithuania
Wojewodzki Szpital Specjalist
🇵🇱Wroclaw, Dolnoslaskie, Poland
Nasz Lekarz Osrodek Badan Klinicznych
🇵🇱Bydgoszcz, Kujawsko-pomorskie, Poland
ETG Lodz
🇵🇱Lodz, Lódzkie, Poland
DRC Kft.
🇭🇺Sopron, Gyor-Moson-Sopron, Hungary
Szent Borbala Korhaz
🇭🇺Tatabanya, Hungary
Republican Vilnius University Hospital
🇱🇹Vilnius, Vilniaus Apskritis, Lithuania
Vilnius University Hospital Santariskiu Klinikos
🇱🇹Vilnius, Vilniaus Apskritis, Lithuania
Vilnius City Clinical Hospital
🇱🇹Vilnius, Vilniaus Apskritis, Lithuania
EuroMediCare Szpital Specjalistyczny z Przychodnia
🇵🇱Wroclaw, Dolnoslaskie Województwo, Poland
Szpital Specjalistyczny Slupsk
🇵🇱Slupsk, Pomorskie, Poland
Clinical Research Center Sp. z o.o., Medic-R Sp. K.
🇵🇱Poznan, Wielkopolskie, Poland
Nzoz Heureka
🇵🇱Piaseczno, Poland
Centro Clínico Académico Braga, Hospital de Braga
🇵🇹Braga, Portugal
Hospital Santiago Apostol
🇪🇸Miranda de Ebro, Burgos, Spain
Albany Medical College
🇺🇸Albany, New York, United States
Kaunas Hospital of Lithuanian Universoity of Health Sciences
🇱🇹Kaunas, Kauno Apskritis, Lithuania
Jahn Ferenc Dél-Pesti Kórház és Rendelointézet
🇭🇺Budapest, Hungary
National Cancer Institute
🇱🇹Vilnius, Vilniaus Apskritis, Lithuania
Centrum Medyczne PROMED
🇵🇱Krakow, Malopolskie Województwo, Poland
Centrum Urologiczne sp. z o.o.
🇵🇱Myslowice, Silesia, Poland
Medicome Sp. z o.o.
🇵🇱Oswiecim, Poland
Hospital Senhora de Oliveiro Guimaraes EPE
🇵🇹Guimaraes, Portugal
H. Egas Moniz. Centro Hospitalar Lisboa Ocidental
🇵🇹Lisboa, Portugal
Hospital de Santa Maria
🇵🇹Lisboa, Portugal
Urology Associates - Urology
🇺🇸Denver, Colorado, United States
Wasatch Clinical Research LLC
🇺🇸Salt Lake City, Utah, United States
Adult & Pediatric Urology P.C. - Urology
🇺🇸Omaha, Nebraska, United States
Urology Centers of Alabama
🇺🇸Homewood, Alabama, United States
Private Practice
🇨🇦Brampton, Ontario, Canada
California Research Medical Group, Inc.
🇺🇸Fullerton, California, United States
Clinical Trials Research
🇺🇸Lincoln, California, United States
Northern California Research Corp
🇺🇸Sacramento, California, United States
Urology Center Of Florida
🇺🇸Pompano Beach, Florida, United States
Imagine Research of Palm Beach County - Urology
🇺🇸Boynton Beach, Florida, United States
Tampa Bay Medical Research
🇺🇸Clearwater, Florida, United States
NorthShore University Health System
🇺🇸Glenview, Illinois, United States
Pinellas Urology, Inc.
🇺🇸Saint Petersburg, Florida, United States
Urological Research Network Corp
🇺🇸Hialeah, Florida, United States
The Iowa Clinic
🇺🇸West Des Moines, Iowa, United States
Chesapeake Urology Research Associates
🇺🇸Baltimore, Maryland, United States
Beaumont Hospital Royal Oak - Urology Research
🇺🇸Royal Oak, Michigan, United States
CentraCare Clinic - Adult & Pediatric Urology
🇺🇸Sartell, Minnesota, United States
Mens Health Boston - Urology
🇺🇸Chestnut Hill, Massachusetts, United States
Poplar Bluff Urology
🇺🇸Poplar Bluff, Missouri, United States
Premier Urology Group, LLC
🇺🇸Edison, New Jersey, United States
Duke Medical Center - Urology
🇺🇸Durham, North Carolina, United States
Carolina Institute for Clinical Research
🇺🇸Fayetteville, North Carolina, United States
Clinical Research Solutions
🇺🇸Middleburg Heights, Ohio, United States
Urology Clinics of North Texas
🇺🇸Dallas, Texas, United States
Urology of Virginia (UVA)
🇺🇸Virginia Beach, Virginia, United States
Bluewater Clinical Research Group Inc
🇨🇦Sarnia, Ontario, Canada
Diex Research Victoriaville Inc.
🇨🇦Victoriaville, Quebec, Canada
Diex Research Quebec Inc.
🇨🇦Quebec City, Quebec, Canada
Respublikine Klaipedos ligonine - Urology
🇱🇹Klaipeda, Klaipedos Apskritis, Lithuania
Lexmedica Hanna Durbajlo-Gradziel
🇵🇱Wroclaw, Poland
Hospital Universitario Fundación Alcorcón
🇪🇸Alcorcón, Madrid, Spain
Hospital Universitario HM Monteprincipe
🇪🇸Boadilla del Monte, Madrid, Spain
Hospital Universitari i Politecnic La Fe
🇪🇸Valencia, Spain
Precision Clinical Research
🇺🇸Sunrise, Florida, United States
Urological Associates Of Southern Arizona
🇺🇸Tucson, Arizona, United States
West Coast Urology
🇺🇸Los Alamitos, California, United States
Norris Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States
New Jersey Urology NJU
🇺🇸Englewood, New Jersey, United States
Diex Research Sherbrooke Inc.
🇨🇦Sherbrooke, Quebec, Canada
Florida Urology Partners, LLP
🇺🇸Tampa, Florida, United States
GU Research Network/Wichita Urology Group
🇺🇸Wichita, Kansas, United States
DelRicht Research
🇺🇸New Orleans, Louisiana, United States
Urology Specialists of Southern California (USSC)
🇺🇸Sherman Oaks, California, United States
Clinical Research of Central Florida
🇺🇸Winter Haven, Florida, United States
Idaho Urologic Institute
🇺🇸Meridian, Idaho, United States
Bay State Clinical Trials, Inc.
🇺🇸Watertown, Massachusetts, United States
AccuMed research Asociates
🇺🇸Garden City, New York, United States