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)
A Phase 3 Double-Blind, Randomized, Placebo-Controlled, Multi-Center 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)
2 other identifiers
interventional
1,105
8 countries
140
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2019
Typical duration for phase_3
140 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 26, 2019
CompletedFirst Submitted
Initial submission to the registry
April 1, 2019
CompletedFirst Posted
Study publicly available on registry
April 3, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 15, 2023
CompletedResults Posted
Study results publicly available
August 7, 2024
CompletedAugust 7, 2024
June 1, 2024
4.2 years
April 1, 2019
June 11, 2024
July 15, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change From Baseline at Week 12 in the Average Number of Micturition Episodes Per Day
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.
Baseline; Week 12
Change From Baseline at Week 12 in the Average Number of Urgency Episodes (Need to Urinate Immediately) Per Day
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.
Baseline; Week 12
Secondary Outcomes (4)
Change From Baseline at Week 12 in the Average Number of Nocturia Episodes Per Night
Baseline; Week 12
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
Change From Baseline at Week 12 in the International Prostate Symptom Score (IPSS) Storage Score (1-week Recall)
Baseline; Week 12
Change From Baseline at Week 12 in the Average Volume Voided Per Micturition
Baseline; Week 12
Study Arms (2)
Vibegron 75 mg
EXPERIMENTALParticipants will receive vibegron 75 milligrams (mg) orally once daily for 24 weeks.
Placebo
PLACEBO COMPARATORParticipants will receive matching placebo orally once daily for 24 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (140)
Urology Centers of Alabama
Homewood, Alabama, 35209, United States
Private Practice
Huntsville, Alabama, 35801, United States
Coastal Clinical Research, Inc.
Mobile, Alabama, 36608, United States
Gen1 Research- Arizona Urology Specialists
Glendale, Arizona, 85308, United States
Urological Associates Of Southern Arizona
Tucson, Arizona, 85741, United States
California Research Medical Group, Inc.
Fullerton, California, 92835, United States
San Diego Clinical Trials
La Mesa, California, 91942, United States
Clinical Trials Research
Lincoln, California, 95648, United States
West Coast Urology
Los Alamitos, California, 90720, United States
American Institute of Research
Los Angeles, California, 90017, United States
Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
Tri Valley Urology Medical Group
Murrieta, California, 92562, United States
Northern California Research Corp
Sacramento, California, 95821, United States
Medical Center for Clinical Research
San Diego, California, 92108, United States
Urology Specialists of Southern California (USSC)
Sherman Oaks, California, 91411, United States
Skyline Urology
Torrance, California, 90505, United States
Urology Associates - Urology
Denver, Colorado, 80220, United States
Imagine Research of Palm Beach County - Urology
Boynton Beach, Florida, 33435, United States
Tampa Bay Medical Research
Clearwater, Florida, 33761, United States
Urological Research Network Corp
Hialeah, Florida, 33016, United States
LCC Medical Research Institute
Miami, Florida, 33126, United States
Quantum Clinical Trials
Miami, Florida, 33140, United States
Private Practice
Orlando, Florida, 32808, United States
Urology Center Of Florida
Pompano Beach, Florida, 33060, United States
Pinellas Urology, Inc.
St. Petersburg, Florida, 33710, United States
Precision Clinical Research
Sunrise, Florida, 33351, United States
Florida Urology Partners, LLP
Tampa, Florida, 33615, United States
Clinical Research of Central Florida
Winter Haven, Florida, 33880, United States
Meridian Clinical Research - Urology
Savannah, Georgia, 31405, United States
Idaho Urologic Institute
Meridian, Idaho, 83642, United States
NorthShore University Health System
Glenview, Illinois, 60153, United States
First Urology
Jeffersonville, Indiana, 47130, United States
The Iowa Clinic
West Des Moines, Iowa, 50266, United States
GU Research Network/Wichita Urology Group
Wichita, Kansas, 67226, United States
DelRicht Research
New Orleans, Louisiana, 70115, United States
Regional Urology, LLC
Shreveport, Louisiana, 71106, United States
Chesapeake Urology Research Associates
Baltimore, Maryland, 21204, United States
Boston Clinical Trials Inc - Urology
Boston, Massachusetts, 02131, United States
Mens Health Boston - Urology
Chestnut Hill, Massachusetts, 02467, United States
Bay State Clinical Trials, Inc.
Watertown, Massachusetts, 02472, United States
Beaumont Hospital Royal Oak - Urology Research
Royal Oak, Michigan, 48703, United States
CentraCare Clinic - Adult & Pediatric Urology
Sartell, Minnesota, 56377, United States
Poplar Bluff Urology
Poplar Bluff, Missouri, 63901, United States
Adult & Pediatric Urology P.C. - Urology
Omaha, Nebraska, 68114, United States
Excel Clinical Research - Internal Medicine
Las Vegas, Nevada, 89109, United States
Private Practice
Las Vegas, Nevada, 89148, United States
Premier Urology Group, LLC
Edison, New Jersey, 08837, United States
New Jersey Urology NJU
Englewood, New Jersey, 07631, United States
New Jersey Urology, LLC
Mount Laurel, New Jersey, 08054, United States
New Jersey Urology, LLC
Voorhees Township, New Jersey, 08043, United States
Albany Medical College
Albany, New York, 12208, United States
Western New York Urology Associates
Buffalo, New York, 14203, United States
AccuMed research Asociates
Garden City, New York, 11530, United States
Urological Surgeons of Long Island
Garden City, New York, 11530, United States
Manhattan Research Associates
New York, New York, 10016, United States
Columbia University Medical Center - Clinical Research
New York, New York, 10032, United States
Weill Cornell Medicine
New York, New York, 10065, United States
Advanced Urology Centers of NY, A Division of Integrated Medical Professionals (IMP)
Plainview, New York, 11803, United States
Private Practice
Poughkeepsie, New York, 12603, United States
Duke Medical Center - Urology
Durham, North Carolina, 27710, United States
Carolina Institute for Clinical Research
Fayetteville, North Carolina, 27612, United States
Alliance Urology Specialists - Greensboro
Greensboro, North Carolina, 27403, United States
Triad Clinical Trials
Greensboro, North Carolina, 27410, United States
Peters Medical Research
High Point, North Carolina, 27262, United States
Associated Urologists of North Carolina - Urology
Raleigh, North Carolina, 27612, United States
Clinical Research Solutions
Middleburg Heights, Ohio, 44130, United States
Lowcountry Urology
North Charleston, South Carolina, 29406, United States
Urology Clinics of North Texas
Dallas, Texas, 75231, United States
Advances In Health, Inc.
Houston, Texas, 77030, United States
Urology San Antonio
San Antonio, Texas, 78229, United States
Discovery Clinical Trials
San Antonio, Texas, 78258, United States
Baylor Scott & White Medical Center
Temple, Texas, 76508, United States
Wasatch Clinical Research LLC
Salt Lake City, Utah, 84107, United States
Urology of Virginia (UVA)
Virginia Beach, Virginia, 23462, United States
Seattle Urology Research Center
Burien, Washington, 98166, United States
Uz Antwerpen
Edegem, Antwerpen, 02650, Belgium
Algemeen Stedelijk Ziekenhuis
Aalst, Oost-Vlaanderen, 09300, Belgium
Onze-Lieve-Vrouwziekenhuis VZW - Campus Aalst
Aalst, Oost-Vlaanderen, 09300, Belgium
AZ Maria Middelares - Campus Maria Middelares
Ghent, Oost-Vlaanderen, 09000, Belgium
UZ Leuven - Campus Gasthuisberg
Leuven, Vlaams Brabant, 03000, Belgium
AZ Delta - Campus Wilgenstraat
Roeselare, West-Vlaanderen, 08800, Belgium
CHU de Liège - Domaine Universitaire du Sart Tilman - Urologie
Liège, 04000, Belgium
Private Practice
Brampton, Ontario, L6T 4S5, Canada
Bluewater Clinical Research Group Inc
Sarnia, Ontario, N7T 4X3, Canada
Sunnybrook Health Sciences Center
Toronto, Ontario, M4N 3M5, Canada
Toronto Western Hospital
Toronto, Ontario, M5T 2S8, Canada
Diex Research Quebec Inc.
Québec, Quebec, G1N 4V3, Canada
Centre Hospitalier Universitaire De Sherbrooke (CHUS)
Sherbrooke, Quebec, J1H 5N4, Canada
Diex Research Sherbrooke Inc.
Sherbrooke, Quebec, J1L 0H8, Canada
Diex Research Victoriaville Inc.
Victoriaville, Quebec, G6P 6P6, Canada
University of Szeged
Szeged, Csongrád megye, 06725, Hungary
DRC Kft.
Sopron, Győr-Moson-Sopron, H-9400, Hungary
Semmelweis Egyetem
Budapest, 01082, Hungary
Jahn Ferenc Dél-Pesti Kórház és Rendelointézet
Budapest, 01204, Hungary
Szarka Ödön Egyesitett Egeszsegügyi es Szocialis Intezmeny
Csongrád, 06640, Hungary
Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókór
Nyíregyháza, 04400, Hungary
Uro-Clin Kft.
Pècs, 07621, Hungary
Szent Borbala Korhaz
Tatabánya, 02800, Hungary
Kaunas Hospital of Lithuanian Universoity of Health Sciences
Kaunas, Kaunas County, LT-47144, Lithuania
JSC Saules seimos medicinos centras
Kaunas, Kaunas County, LT-49449, Lithuania
Uab "Vakk"
Kaunas, Kaunas County, LT-50128, Lithuania
Hospital of University of Health Sciences Kauno Klinikos
Kaunas, Kaunas County, LT-50161, Lithuania
Respublikine Klaipedos ligonine - Urology
Klaipėda, Klaipėda County, LT-92231, Lithuania
Klaipedos Universitetine Ligonine (Klaipeda Hospital)
Klaipėda, Klaipėda County, LT-92288, Lithuania
National Cancer Institute
Vilnius, Vilnius County, LT-08660, Lithuania
Republican Vilnius University Hospital
Vilnius, Vilnius County, LT-08660, Lithuania
Vilnius University Hospital Santariskiu Klinikos
Vilnius, Vilnius County, LT-08661, Lithuania
Vilnius City Clinical Hospital
Vilnius, Vilnius County, LT-10207, Lithuania
EuroMediCare Szpital Specjalistyczny z Przychodnia
Wroclaw, Dolnoslaskie Województwo, 54-144, Poland
Clinical Research Center Sp. z o.o., Medic-R Sp. K.
Poznan, Greater Poland Voivodeship, 60-856, Poland
Nasz Lekarz Osrodek Badan Klinicznych
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-650, Poland
Wojewodzki Szpital Specjalist
Wroclaw, Lower Silesian Voivodeship, 51-124, Poland
NZOZ Specjalista
Kutno, Lódzkie, 99-300, Poland
ETG Lodz
Lodz, Lódzkie, 90-302, Poland
Centrum Medyczne PROMED
Krakow, Malopolskie Województwo, 31-513, Poland
Szpital Specjalistyczny Slupsk
Słupsk, Pomeranian Voivodeship, 76-200, Poland
Centrum Urologiczne sp. z o.o.
Mysłowice, Silesian Voivodeship, 41-400, Poland
Centrum Medyczne Linden
Krakow, 37-721, Poland
Medicome Sp. z o.o.
Oświęcim, 32-600, Poland
Nzoz Heureka
Piaseczno, 05-500, Poland
Lexmedica Hanna Durbajlo-Gradziel
Wroclaw, 53-114, Poland
Hospital Garcia de Orta
Almada, 2805-267, Portugal
Centro Clínico Académico Braga, Hospital de Braga
Braga, 4710-243, Portugal
Hospital Senhora de Oliveiro Guimaraes EPE
Guimarães, 4835-044, Portugal
H. Egas Moniz. Centro Hospitalar Lisboa Ocidental
Lisbon, 1349-019, Portugal
Hospital de Santa Maria
Lisbon, 1649-035, Portugal
H. Santo António. Centro Hospitalar do Porto
Porto, 4099-001, Portugal
Hospital Santiago Apostol
Miranda de Ebro, Burgos, 09200, Spain
Hospital Universitario Fundación Alcorcón
Alcorcón, Madrid, 28922, Spain
Hospital Universitario HM Monteprincipe
Boadilla del Monte, Madrid, 28660, Spain
Hospital General Universitario Gregorio Marañón
Majadahonda, Madrid, 28007, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, 28222, Spain
Hospital Universitario Infanta Sofía
San Sebastián de los Reyes, Madrid, 28702, Spain
Hospital del Mar
Barcelona, 08003, Spain
Hospital Universitario Reina Sofia
Córdoba, 14004, Spain
Clínica Universitaria de Navarra
Madrid, 28027, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
H.U. Virgen de la Victoria
Málaga, 29010, Spain
Hospital Universitario de Salamanca
Salamanca, 37007, Spain
Hospital Universitari i Politecnic La Fe
Valencia, 46026, Spain
Related Publications (1)
Rovner ES, Owens-Grillo J, Thomas E, Herschorn S, Peters KM, Staskin D, Mujais S. Bladder Function and Safety of Vibegron in Men With Overactive Bladder Receiving Treatment for Benign Prostatic Hyperplasia: Outcomes From the Phase 3 Randomized Controlled COURAGE Trial. Neurourol Urodyn. 2025 Dec 9. doi: 10.1002/nau.70199. Online ahead of print.
PMID: 41363221DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Information, Clinical Trial Results
- Organization
- Urovant Sciences
Study Officials
- STUDY DIRECTOR
Study Director
Urovant Sciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 1, 2019
First Posted
April 3, 2019
Study Start
March 26, 2019
Primary Completion
June 15, 2023
Study Completion
June 15, 2023
Last Updated
August 7, 2024
Results First Posted
August 7, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- The data will be made available within 24 months after study completion and will be accessible for a time frame appropriate for the approved proposal.
- Access Criteria
- Access to these clinical trial data can be requested by emailing medinfo@urovant.com and will be provided following Urovant review and approval of a research proposal and execution of a Data Sharing Agreement (DSA).
Urovant is committed to sharing patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Data requests will be reviewed and approved on the basis of scientific merit. All data provided will be anonymized according to applicable laws and regulations.