A Study to Examine the Safety and Efficacy of a New Drug in Patients With Symptoms of Overactive Bladder (OAB) (Empowur)

An International Phase 3, Randomized, Double-Blind, Placebo- and Active (Tolterodine)-Controlled Multicenter Study to Evaluate the Safety and Efficacy of Vibegron in Patients With Symptoms of Overactive Bladder

This study is designed to evaluate the safety, tolerability, and efficacy of vibegron administered once daily in patients with OAB.

Study Overview

• Status: Completed
• Conditions: Overactive Bladder
• Intervention / Treatment: Drug: vibegron; Drug: Tolterodine placebo; Drug: Vibegron placebo; Drug: Tolterodine Tartrate ER

• Study Type: Interventional
• Enrollment (Actual): 1530
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Red Deer, Alberta, Canada, T4N 6V7
      • Central Alberta Research Clinic
  • British Columbia
    • Victoria, British Columbia, Canada, V8T 2C1
      • Silverado Research Inc.
  • Ontario
    • Toronto, Ontario, Canada, M4S 1Y2
      • PrimeHealth Clinical Research
  • Quebec
    • Levis, Quebec, Canada, G6W 0M6
      • Manna Research (Quebec)
    • Montreal, Quebec, Canada, H1M 1B1
      • Recherche GCP Research
    • Montréal, Quebec, Canada, H9R 4S3
      • Manna Research (Montreal)
    • Sherbrooke, Quebec, Canada, J1L 0H8
      • Diex Research Sherbrooke Inc.
• Hungary
  • Budapest, Hungary, 1036
    • Obudai Egeszsegugyi Centrum Kft.
  • Csongrád, Hungary, 6640
    • Szarka Ödön Egyesitett Egeszsegügyi es Szocialis Intezmeny
  • Debrecen, Hungary, 4029
    • Szent Anna Private Surgery
  • Kecskemét, Hungary, 6000
    • Mediroyal Prevention Center
  • Pécs, Hungary, 7621
    • Uro-clin Ltd
• Latvia
  • Daugavpils, Latvia, LV-5417
    • Daugavpils Regional Hospital
  • Riga, Latvia, LV-1002
    • Pauls Stradins Clinical University Hospital
  • Riga, Latvia, LV-1001
    • URO Ltd.
• Lithuania
  • Klaipėda, Lithuania, 92231
    • Public Institution Republican Klaipda Hospital
  • Vilnius, Lithuania, LT-10207
    • Vilnius city clinical hospital
  • Vilnius, Lithuania, LT-09108
    • Vilnius
• Poland
  • Woj. Dolnoslaskie
    • Wrocław, Woj. Dolnoslaskie, Poland, 54-144
      • Poradnia Urologiczna EuroMediCare Szpital Specjalistyczny z Przychodnia
  • Woj. Lodzkie
    • Łódź, Woj. Lodzkie, Poland, 90-302
      • ETG Lodz
  • Woj. Lubelskie
    • Lublin, Woj. Lubelskie, Poland, 20-632
      • NZOZ NOVITA Specjalistyczne Gabinety Lekarskie
  • Woj. Mazowieckie
    • Piaseczno, Woj. Mazowieckie, Poland, 05-500
      • Nzoz Heureka
  • Woj. Podlaskie
    • Białystok, Woj. Podlaskie, Poland, 15-776
      • Klimed Marek Klimkiewicz
  • Woj. Slaskie
    • Mysłowice, Woj. Slaskie, Poland, 41-400
      • NZOZ Centrum Urologiczne sp. z o.o.
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35216
      • Achieve Clinical Research
    • Birmingham, Alabama, United States, 35209
      • Central Alabama Research
    • Gulf Shores, Alabama, United States, 36542-2856
      • Fundamental Research LLC
    • Huntsville, Alabama, United States, 35801
      • Longwood Research
    • Mobile, Alabama, United States, 36608
      • Coastal Clinical Research Inc.
  • Arizona
    • Tempe, Arizona, United States, 85283
      • Clinical Research Consortium
    • Tucson, Arizona, United States, 85704
      • Noble Clinical Research
    • Tucson, Arizona, United States, 85745
      • Eclipse Clinical Research
  • California
    • Anaheim, California, United States, 92801
      • Dream Team Clinical Research LLC
    • Canoga Park, California, United States, 91303
      • HOPE Clinical Research
    • Cerritos, California, United States, 90703
      • Core Healthcare Group
    • Fresno, California, United States, 93702
      • Research Center of Fresno Inc.
    • Hawaiian Gardens, California, United States, 90716
      • American Clinical Trials
    • Huntington Beach, California, United States, 92647
      • Marvel Clinical Research
    • La Mesa, California, United States, 91942
      • Grossmont Center for Clinical Research
    • Laguna Hills, California, United States, 92653
      • Prime-Care Clinical Research
    • Long Beach, California, United States, 90806
      • Long Beach Clinical Trials LLC
    • Long Beach, California, United States, 90806
      • Long Beach Clinical Trial Services Inc.
    • Los Angeles, California, United States, 90017
      • Urology Group of Southern California
    • Los Angeles, California, United States, 90017
      • Downtown L.A. Research Center Inc.
    • Murrieta, California, United States, 92562
      • Tri Valley Urology Medical Group
    • Sacramento, California, United States, 95821
      • Northern California Research
    • San Bernardino, California, United States, 92404-4816
      • San Bernadino Urological Associates
    • San Diego, California, United States, 92103
      • Artemis Institute for Clinical Research
    • San Diego, California, United States, 92108
      • WR MCCCR
    • San Marcos, California, United States, 92078
      • Artemis Institute for Clinical Research
    • Upland, California, United States, 91786
      • Empire Clinical Research
    • Valley Village, California, United States, 91607-3456
      • Bayview Research Group LLC
  • Colorado
    • Denver, Colorado, United States, 80220
      • Horizons Clinical Research Center
    • Denver, Colorado, United States, 80246
      • Lynn Institute of Denver
  • Connecticut
    • Milford, Connecticut, United States, 06460
      • Clinical Research Consulting LLC
    • New London, Connecticut, United States, 06320
      • Coastal Connecticut Research LLC
    • Waterbury, Connecticut, United States, 06708
      • Chase Medical Research, LLC
  • Florida
    • Aventura, Florida, United States, 33180-1151
      • Innovative Medical Research of South Florida Inc.
    • Brandon, Florida, United States, 33511
      • PAB Clinical Research
    • Clearwater, Florida, United States, 33756
      • Innovative Research of West FL Inc.
    • Coral Gables, Florida, United States, 33134
      • Universal Medical and Research Center LLC
    • Cutler Bay, Florida, United States, 33189
      • Top Medical Research Inc.
    • DeLand, Florida, United States, 32720
      • Avail Clinical Research
    • Delray Beach, Florida, United States, 33484
      • Jesscan Medical Research
    • Doral, Florida, United States, 33122
      • Revival Research
    • Edgewater, Florida, United States, 32132
      • Riverside Clinical Research
    • Fort Lauderdale, Florida, United States, 33316-2521
      • KO Clinical Research
    • Hialeah, Florida, United States, 33012
      • Indago Research Health Center
    • Hialeah, Florida, United States, 33016
      • Best Quality Research, Inc.
    • Hialeah, Florida, United States, 33012-3407
      • A.G.A Clinical Trials
    • Hialeah, Florida, United States, 33016
      • Vital Pharm Research Inc.
    • Jupiter, Florida, United States, 33458
      • Health Awareness, Inc.
    • Miami, Florida, United States, 33174
      • Advanced Medical Research Institute
    • Miami, Florida, United States, 33155
      • Miami Clinical Research
    • Miami, Florida, United States, 33015
      • San Marcus Research Clinic Inc.
    • Miami, Florida, United States, 33126
      • LCC Medical Research Institute Inc.
    • Miami, Florida, United States, 33144
      • Nuren Medical Research Center
    • Miami, Florida, United States, 33155
      • AppleMed Research Group LLC
    • New Port Richey, Florida, United States, 34652
      • Suncoast Clinical Research Inc.
    • New Port Richey, Florida, United States, 34655
      • Bayside Clinical Research
    • Orlando, Florida, United States, 32806
      • Compass Research LLC
    • Pembroke Pines, Florida, United States, 33027
      • South Broward Research LLC
    • Pompano Beach, Florida, United States, 33060
      • Clinical Research Center of Florida
    • Saint Petersburg, Florida, United States, 33710
      • Pinellas Urology
    • Spring Hill, Florida, United States, 34609
      • Meridien Research
    • Tampa, Florida, United States, 33603
      • Clinical Research of West Florida
    • The Villages, Florida, United States, 32162
      • Bioclinica Research
    • Weeki Wachee, Florida, United States, 34607
      • ASCLEPES Research Centers
    • Winter Haven, Florida, United States, 33880
      • Clinical Research of Central Florida
  • Georgia
    • Peachtree Corners, Georgia, United States, 30071
      • In-Quest Medical Research, LLC
    • Savannah, Georgia, United States, 31406
      • Meridian Clinical Research LLC
    • Stockbridge, Georgia, United States, 30281
      • Clinical Research Atlanta
    • Woodstock, Georgia, United States, 30189-4255
      • North Georgia Clinical Research
  • Idaho
    • Blackfoot, Idaho, United States, 83221
      • Elite Clinical Trials
    • Meridian, Idaho, United States, 83642
      • Advanced Clinical Research
  • Illinois
    • Evanston, Illinois, United States, 60201
      • Evanston Premier Healthcare Research
    • Gurnee, Illinois, United States, 60031
      • Clinical Investigation Specialists Inc.
  • Indiana
    • Brownsburg, Indiana, United States, 46112
      • Investigators Research Group LLC
    • Evansville, Indiana, United States, 47714
      • Medisphere Medical Research Center
  • Kansas
    • Wichita, Kansas, United States, 67205
      • Heartland Research Associates LLC
    • Wichita, Kansas, United States, 67207
      • Heartland Research Associates LLC
  • Kentucky
    • Lexington, Kentucky, United States, 40509
      • Central Kentucky Research Associates Inc.
    • Louisville, Kentucky, United States, 40213
      • L-MARC Research Center
  • Louisiana
    • Lake Charles, Louisiana, United States, 70601
      • Centex Studies Inc.
    • New Orleans, Louisiana, United States, 70115
      • DelRicht Research
    • Shreveport, Louisiana, United States, 71106
      • Regional Urology LLC
  • Maryland
    • Hanover, Maryland, United States, 21076
      • Chesapeake Urology Research Associates
  • Massachusetts
    • Boston, Massachusetts, United States, 02131
      • Boston Clinical Trials
    • New Bedford, Massachusetts, United States, 02740-2133
      • Btc of New Bedford
    • North Attleboro, Massachusetts, United States, 02760
      • Regeneris Medical
    • North Dartmouth, Massachusetts, United States, 02747
      • Infinity Medical Research Inc.
    • Quincy, Massachusetts, United States, 02169
      • Beacon Clinical Research
    • Watertown, Massachusetts, United States, 02472
      • Bay State Clinical Trials Inc.
  • Michigan
    • Rochester, Michigan, United States, 48307-1318
      • Remidica LLC
    • Saginaw, Michigan, United States, 48604
      • Saginaw Valley Medical Research
  • Minnesota
    • Sartell, Minnesota, United States, 56377
      • CentraCare Clinic Adult & Pediatric Urology
  • Missouri
    • Poplar Bluff, Missouri, United States, 63901-1908
      • Poplar Bluff Urology
  • Montana
    • Billings, Montana, United States, 59102
      • Montana Health Research Institute Inc.
    • Missoula, Montana, United States, 59808
      • Montana Medical Research
  • Nebraska
    • Bellevue, Nebraska, United States, 68005
      • Pioneer Clinical Research, LLC
    • La Vista, Nebraska, United States, 68128
      • Barrett Clinic P.C.
    • Lincoln, Nebraska, United States, 68510
      • Women's Clinic of Lincoln PC
    • Norfolk, Nebraska, United States, 68701
      • Meridian Clinical Research LLC
    • Omaha, Nebraska, United States, 68114
      • Quality Clinical Research Inc.
    • Omaha, Nebraska, United States, 68114
      • Adult and Pediatric Urology P.C.
  • Nevada
    • Las Vegas, Nevada, United States, 89119
      • Clinical Research Consortium
    • Las Vegas, Nevada, United States, 89109-6209
      • Excel Clinical Research
    • Las Vegas, Nevada, United States, 89144
      • Sheldon Freedman MD LTD
  • New Jersey
    • Berlin, New Jersey, United States, 08009
      • Hassman Research Institute
    • Edison, New Jersey, United States, 08837
      • Premier Urology Group LLC
    • Englewood, New Jersey, United States, 07631
      • Urologic Research and Consulting LLC
    • Lawrenceville, New Jersey, United States, 08648-2526
      • Lawrence OB-GYN Clinical Research LLC
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Albuquerque Clinical Trials, Inc.
    • Albuquerque, New Mexico, United States, 87109
      • AccumetRx Clinical Research - Division of Urology Group of New Mexico
  • New York
    • Binghamton, New York, United States, 13901
      • United Medical Associates
    • Endwell, New York, United States, 13760
      • Regional Clinical Research Inc.
    • Garden City, New York, United States, 11530-1664
      • AccuMed Research Associates
    • Hartsdale, New York, United States, 10530
      • Drug Trials America
    • Jackson Heights, New York, United States, 11372
      • Smart Medical Research Inc.
    • Port Jefferson, New York, United States, 11777
      • ProHealth Care AssociatesLLP
    • Rochester, New York, United States, 14609-3109
      • Rochester Clinical Research Inc.
    • Williamsville, New York, United States, 14221-6046
      • Upstate Clinical Research Associates LLC
  • North Carolina
    • Cary, North Carolina, United States, 27518
      • PMG Research of Cary
    • Charlotte, North Carolina, United States, 28209
      • PMG Research of Charlotte LLC
    • Greensboro, North Carolina, United States, 27408
      • PharmQuest
    • High Point, North Carolina, United States, 27262
      • Peters Medical Research
    • Raleigh, North Carolina, United States, 27612
      • Associated Urologists of North Carolina
    • Raleigh, North Carolina, United States, 27609-7245
      • Raleigh Medical Group PMG Research of Raleigh
    • Salisbury, North Carolina, United States, 28411
      • PMG Research of Salisbury
    • Wilmington, North Carolina, United States, 28401
      • PMG Research of Wilmington, LLC
    • Wilmington, North Carolina, United States, 28401
      • PMG Research
    • Winston-Salem, North Carolina, United States, 27103
      • PMG Research of Winston-Salem
    • Winston-Salem, North Carolina, United States, 27103-4109
      • Carolina Medical Trials LLC
  • Ohio
    • Cincinnati, Ohio, United States, 45236-2934
      • Sentral Clinical Research Services
    • Cleveland, Ohio, United States, 44122
      • Rapid Medical Research
    • Columbus, Ohio, United States, 43213-6523
      • Aventiv Research, Inc.
    • Columbus, Ohio, United States, 43207
      • Buckeye Health and Research
    • Dayton, Ohio, United States, 45439
      • Providence Health Partners
    • Englewood, Ohio, United States, 45322-2722
      • HWC Womens Research Center
    • Middleburg Heights, Ohio, United States, 44130
      • Clinical Research Solutions
    • Wadsworth, Ohio, United States, 44281
      • Family Practice Center of Wadsworth Inc. - New Venture Medical Research
    • Willoughby Hills, Ohio, United States, 44094
      • Ohio Clinical Research LLC
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112-4703
      • Lynn Health Science Institute
  • Pennsylvania
    • Indiana, Pennsylvania, United States, 15701
      • Leonard Maliver MD Antria, Inc.
    • Jenkintown, Pennsylvania, United States, 19046
      • The Clinical Trial Center LLC
    • Lansdale, Pennsylvania, United States, 19446
      • Green and Seidner Family Practice Associates P.C.
    • Philadelphia, Pennsylvania, United States, 19114
      • Clinical Research of Philadelphia LLC
    • Pittsburgh, Pennsylvania, United States, 15236
      • Preferred Primary Care Physicians Inc.
    • Pittsburgh, Pennsylvania, United States, 15243
      • Research Protocol Management Specialists Hills ObGyn Associates Inc
    • Pittsburgh, Pennsylvania, United States, 15243
      • Preferred Primary Care Physicians Inc.
    • Smithfield, Pennsylvania, United States, 15478
      • Frontier Clinical Research, LLC
    • Uniontown, Pennsylvania, United States, 15401
      • Preferred Primary Care Physicians Inc.
    • Upper Saint Clair, Pennsylvania, United States, 15241
      • Peak Research LLC
  • Rhode Island
    • East Providence, Rhode Island, United States, 02914
      • Greater Providence Clinical Research, LLC
    • Warwick, Rhode Island, United States, 02886-1689
      • Omega Medical Research
  • South Carolina
    • Charleston, South Carolina, United States, 29406-8106
      • Clinical Trials of South Carolina
    • Charleston, South Carolina, United States, 29412-2625
      • Pharmacorp Clinical Trials Inc.
    • Fort Mill, South Carolina, United States, 29707
      • Piedmont Research Partners
    • Greer, South Carolina, United States, 29651-1818
      • DeGarmo Institute of Medical Research
    • Moncks Corner, South Carolina, United States, 29461
      • PMG Research of Charleston LLC
    • Mount Pleasant, South Carolina, United States, 29464
      • Coastal Carolina Research Center
    • Mount Pleasant, South Carolina, United States, 29464
      • PMG Research of Charleston LLC
    • Myrtle Beach, South Carolina, United States, 29588
      • Family Medicine of SayeBrook LLC
    • Pelzer, South Carolina, United States, 29669
      • Palmetto Institute of Clinical Research Inc.
    • Simpsonville, South Carolina, United States, 29681
      • Hillcrest Clinical Research LLC
    • Summerville, South Carolina, United States, 29485
      • Palmetto Clinical Research
  • Tennessee
    • Bristol, Tennessee, United States, 37620
      • PMG Research of Bristol LLC
    • Chattanooga, Tennessee, United States, 37421
      • WR - ClinSearch LLC
    • Jackson, Tennessee, United States, 38301
      • The Jackson Clinic
    • Johnson City, Tennessee, United States, 37601
      • MultiSpecialty Clinical Research, Inc.
    • Knoxville, Tennessee, United States, 37920
      • Volunteer Research Group - NOCCR
    • Memphis, Tennessee, United States, 38120-2382
      • Adams Patterson Gynecology and Obstetrics
    • Nashville, Tennessee, United States, 37203-3005
      • Clinical Research Associates Inc.
  • Texas
    • Bryan, Texas, United States, 77802-2589
      • DiscoveResearch Inc.
    • DeSoto, Texas, United States, 75115-2052
      • WR Global Medical Research
    • Houston, Texas, United States, 77084
      • BI Research Center
    • Houston, Texas, United States, 77030
      • Advances in Health
    • Houston, Texas, United States, 77099
      • Pioneer Research Solutions
    • Houston, Texas, United States, 77058
      • Centex Studies Inc.
    • Houston, Texas, United States, 77061
      • Discovery MM Services Inc.
    • Hurst, Texas, United States, 76054
      • Protenium Clinical Research
    • Katy, Texas, United States, 77450-7587
      • Discovery MM Services Inc.
    • Missouri City, Texas, United States, 77459
      • Discovery MM Services Inc.
    • Plano, Texas, United States, 75024
      • Village Health Partners ACRC Trials
    • San Antonio, Texas, United States, 78249
      • Bandera Family Health Care
    • San Antonio, Texas, United States, 78229
      • Clinical Trials of Texas Inc.
    • Spring, Texas, United States, 77379
      • Clinova Clinical Trials
  • Utah
    • Bountiful, Utah, United States, 84010
      • Progressive Clinical Research
    • Salt Lake City, Utah, United States, 84107
      • Wasatch Clinical Research LLC
    • West Jordan, Utah, United States, 84088
      • Advanced Clinical Research
  • Virginia
    • Arlington, Virginia, United States, 22207
      • Millennium Clinical Trials
    • Newport News, Virginia, United States, 23606
      • Health Research of Hampton Roads Inc.
  • Washington
    • Burien, Washington, United States, 98166
      • Seattle Urology Research
    • Seattle, Washington, United States, 98105
      • Seattle Women's: Health, Research, Gynecology
    • Spokane, Washington, United States, 99207
      • North Spokane Womens Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Has a history of OAB for at least 3 months prior to the Screening Visit.
2. Meets either the OAB Wet or OAB Dry criteria.

Exclusion Criteria:

Urology Medical History

1. Patient had an average total daily urine volume > 3000 mL in the past 6 months or during the 14-day Run-in Period.
2. Has lower urinary tract pathology that could, in the opinion of the Investigator, be responsible for urgency, frequency, or incontinence.
3. Has a history of surgery to correct stress urinary incontinence, pelvic organ prolapse, or procedural treatments for BPH within 6 months of Screening.
4. Has current history or evidence of Stage 2 or greater pelvic organ prolapse (prolapse extends beyond the hymenal ring).
5. Patient is currently using a pessary for the treatment of pelvic organ prolapse.
6. Has a known history of elevated post-void residual volume defined as greater than 150 mL.
7. Has undergone bladder training or electrostimulation within 28 days prior to Screening or plans to initiate either during the study.
8. Has an active or recurrent (> 3 episodes per year) urinary tract infection by clinical symptoms or pre-defined laboratory criteria.
9. Has a requirement for an indwelling catheter or intermittent catheterization.
10. Has received an intradetrusor injection of botulinum toxin within 9 months prior to Screening.
11. Has uncontrolled hyperglycemia (defined as fasting blood glucose > 150 mg/dL or 8.33 mmol/L and/or non-fasting blood glucose > 200 mg/dL or 11.1 mmol/L) or, if in the opinion of the Investigator, is uncontrolled.
12. Has evidence of diabetes insipidus.
13. Is pregnant, breast-feeding, or is planning to conceive within the projected duration of the study.
14. Has a concurrent malignancy or history of any malignancy within 5 years prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
15. Has uncontrolled hypertension (systolic blood pressure of ≥ 180 mmHg and/or diastolic blood pressure of ≥ 100 mmHg) or has a resting heart rate (by pulse) > 100 beats per minute.
16. Has narrow angle glaucoma (primary open angle glaucoma is not excluded).
17. 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 a known history of liver disease.
18. Has a history of injury, surgery, or neurodegenerative diseases (e.g., multiple sclerosis, Parkinson's) that could affect the lower urinary tract or its nerve supply.
19. Has hematuria, including microscopic hematuria according to pre-defined criteria.
20. Has clinically significant electrocardiogram (ECG) abnormality.
21. Has alanine aminotransferase or aspartate aminotransferase > 2.0 times the upper limit of normal (ULN), or bilirubin (total bilirubin) > 1.5 x ULN (or > 2.0 x ULN if secondary to Gilbert syndrome or pattern consistent with Gilbert syndrome).
22. Has an estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2.
23. Has an allergy, intolerance, or a history of a significant clinical or laboratory adverse experience associated with any of the active or inactive components of the vibegron formulation or tolterodine formulation.
24. Is currently participating or has participated in a study with an investigational compound or device within 28 days prior to signing informed consent, or has participated in any previous study with vibegron.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vibegron + Placebo to match Tolterodine	Drug: vibegron; single daily oral dose of vibegron 75 mg for 12 weeks; Other Names: RVT-901; URO-901; MK4618; KRP114V; Drug: Tolterodine placebo; placebo to match tolterodine (active comparator)
Active Comparator: Tolterodine + Placebo to match vibegron	Drug: Vibegron placebo; placebo to match vibegron (experimental drug); Drug: Tolterodine Tartrate ER; single daily oral dose of tolterodine tartrate ER 4 mg for 12 weeks; Other Names: Mariosea XL
Placebo Comparator: Placebo to match vibegron + Placebo to match Tolterodine	Drug: Tolterodine placebo; placebo to match tolterodine (active comparator); Drug: Vibegron placebo; placebo to match vibegron (experimental drug)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline (CFB) at Week 12 in the Average Number of Micturitions Per 24 Hours in All Overactive Bladder (OAB) Participants	A micturition/void is defined as "Urinated in Toilet" as indicated on the Patient Voiding Diary (PVD). The number of micturitions is defined as the number of times a participant voided in the toilet as indicated on the PVD. The average daily number of micturitions was calculated using the daily entries in the PVD (which was to be completed prior to each study visit) as the total number of micturitions that occurred on a Complete Diary Day (CDD) divided by the number of CDDs in the PVD. CFB was calculated as the post-BL value minus the BL value. "Per 24 hours" corresponds to one Diary Day (i.e., time between when the participant got up for the day each morning and time the participant got up for the day the next morning as recorded in the PVD). Covariates included in the mixed model for repeated measures are study visit (Weeks 2, 4, 8, and 12), OAB type (wet/dry), sex, region (U.S./non-U.S.), BL number of micturitions, and treatment by study visit interaction. FAS=Full Analysis Set.	Baseline (BL); Week 12
CFB at Week 12 in the Average Number of Urge Urinary Incontinence (UUI) Episodes Per 24 Hours in OAB Wet Participants	The number of UUI episodes is defined as the number of times a participant had checked "urge" as the main reason for the leakage in the PVD, regardless of whether more than one reason for leakage in addition to "urge" was checked. The average daily number of UUI episodes was calculated using the daily entries in the PVD (which was to be completed prior to each study visit) as the total number of UUI episodes that occurred on a CDD divided by the number of CCDs in the PVD. CFB was calculated as the post-BL value minus the BL value. "Per 24 hours" corresponds to one Diary Day (i.e., time between when participant got up for the day each morning and time participant got up for the day the next morning as recorded in the PVD). Covariates included in the mixed model for repeated measures were study visit (Weeks 2, 4, 8, and 12), sex, region (U.S./non-U.S.), BL number of UUI episodes and treatment by study visit interaction. FAS-I=Full Analysis Set for Incontinence.	Baseline; Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CFB at Week 12 in the Average Number of Urgency Episodes Over 24 Hours in All OAB Participants	An urgency episode is defined as the "Need to Urinate Immediately" as indicated on the PVD. CFB is calculated as the post-BL value minus the BL value. "Over 24 hours" corresponds to one Diary Day (i.e., time between when the participant got up for the day each morning and time the participant got up for the day the next morning as recorded in the PVD). Covariates included in the mixed model for repeated measures were study visit (Weeks 2, 4, 8, and 12), OAB type (wet/dry), sex, region (U.S./non-U.S.), BL number of urgency episodes, and treatment by study visit interaction.	Baseline; Week 12
Percentage of OAB Wet Participants With at Least a 75% Reduction From Baseline in UUI Episodes Per 24 Hours at Week 12	The number of UUI episodes is defined as the number of times a participant had checked "urge" as the main reason for the leakage in the PVD, regardless of whether more than one reason for leakage in addition to "urge" was checked. The average daily number of UUI episodes was calculated using the daily entries in the PVD (which was to be completed prior to each study visit) as the total number of UUI episodes that occurred on a CDD divided by the number of CCDs in the PVD. CFB was calculated as the post-BL value minus the BL value. "Per 24 hours" corresponds to one Diary Day (i.e., time between when participant got up for the day each morning and time participant got up for the day the next morning as recorded in the PVD).	Baseline; Week 12
Percentage of OAB Wet Participants With a 100% Reduction From Baseline in UUI Episodes Per 24 Hours at Week 12	The number of UUI episodes is defined as the number of times a participant had checked "urge" as the main reason for the leakage in the PVD, regardless of whether more than one reason for leakage in addition to "urge" was checked. The average daily number of UUI episodes was calculated using the daily entries in the PVD (which was to be completed prior to each study visit) as the total number of UUI episodes that occurred on a CDD divided by the number of CCDs in the PVD. CFB was calculated as the post-BL value minus the BL value. "Per 24 hours" corresponds to one Diary Day (i.e., time between when participant got up for the day each morning and time participant got up for the day the next morning as recorded in the PVD).	Baseline; Week 12
Percentage of All OAB Participants With at Least a 50% Reduction From Baseline in Urgency Episodes Per 24 Hours at Week 12	An urgency episode is defined as the "Need to Urinate Immediately" as indicated on the PVD. CFB is calculated as the post-BL value minus the BL value. "Per 24 hours" corresponds to one Diary Day (i.e., time between when the participant got up for the day each morning and time the participant got up for the day the next morning as recorded in the PVD).	Baseline; Week 12
CFB at Week 12 in the Average Number of Total Incontinence Episodes Over 24 Hours in OAB Wet Participants	Total incontinence is defined as having any reason for "Accidental Urine Leakage" and/or "Accidental Urine Leakage" checked, as indicated on the PVD. It is assumed that if the participant recorded a reason for leakage then the accidental urine leakage occurred. CFB is calculated as the post-BL value minus the BL value. "Over 24 hours" corresponds to one Diary Day (i.e., time between when the par. got up for the day each morning and time the par. got up for the day the next morning as recorded in the PVD). Covariates included in the mixed model for repeated measures were study visit (Weeks 2, 4, 8, and 12), sex, region (U.S./non-U.S.), BL number of incontinence episodes, and treatment by study visit interaction. hr = hours.	Baseline; Week 12
CFB at Week 12 in the Coping Score From the Overactive Bladder Questionnaire Long Form (OAB-q LF, 1-week Recall) in All OAB Participants	The OAB-q LF is a validated patient-reported outcome. 8 questions of the OAB-q LF ask participants how well they have coped with their bladder symptoms during the previous week, as a measure of quality of life. Each question has a response ranging from "not coping" (= 1) to "coping well" (= 6). These questions make up the coping scale. The raw score (sum of question scores [ranging from 8 to 48]) is transformed to a unified score, ranging from 0 to 100. Higher scores correspond to a higher quality of life, and lower scores represent a lower quality of life. CFB is calculated as the post-BL value minus the BL value. Covariates included in the mixed model for repeated measures were study visit (Weeks 2, 4, 8, and 12), sex, region (U.S./non-U.S.), OAB type (wet/dry), BL score, and treatment by study visit interaction.	Baseline; Week 12
CFB at Week 12 in the Average Volume Voided Per Micturition in All OAB Participants	A micturition/void is defined as "Urinated in Toilet" as indicated on the PVD. The number of micturitions is defined as the number of times a participant voided in the toilet as indicated on the PVD. CFB is calculated as the post-BL value minus the BL value. Covariates included in the mixed model for repeated measures were study visit (Weeks 2, 4, 8, and 12), OAB type (wet/dry), sex, region (U.S./non-U.S.), BL volume (milliliters [mL]), and treatment by study visit interaction.	Baseline; Week 12
CFB at Week 12 in the Health-related Quality of Life (HRQL) Total Score From the OAB-q LF (1-week Recall) in All OAB Participants	The OAB-q LF is a validated patient-reported outcome. The 25 questions comprising the Coping, Concern, Sleep and Social Interaction subscales of the OAB-q LF ask participants how much their symptoms have affected their life over the last week. Each question has a response ranging from "None of the time" (= 1) to "All of the time" (= 6). The raw score (sum of question scores for the 4 subscales [ranging from 25 to 150]) is transformed to a unified score, ranging from 0 to 100. Higher scores correspond to a higher quality of life, and lower scores represent a lower quality of life. CFB is calculated as the post-BL value minus the BL value. Covariates included in the mixed model for repeated measures were study visit (Weeks 2, 4, 8, and 12), sex, region (U.S./non-U.S.), OAB type (wet/dry), BL score, and treatment by study visit interaction.	Baseline; Week 12
CFB at Week 12 in the Symptom Bother Score From the OAB-q LF (1-week Recall) in All OAB Participants	The OAB-q LF is a validated patient-reported outcome. The first 8 questions of the OAB-q LF ask participants how much they were bothered by their bladder symptoms during the previous week. Each question has a response ranging from "Not at all" (= 1) to "A very great deal" (= 6). These questions make up the symptom bother scale. The raw score (sum of question scores [ranging from 8 to 48]) is transformed to a unified score, ranging from 0 to 100. Higher scores correspond to the symptoms having a larger bother, and lower scores represent a lower amount of bother due to symptoms. CFB is calculated as the post-BL value minus the BL value. Covariates included in the mixed model for repeated measures were study visit (Weeks 2, 4, 8, and 12), sex, region (U.S./non-U.S.), OAB type (wet/dry), BL score, and treatment by study visit interaction.	Baseline; Week 12
Percentage of All OAB Participants With an Average Number of Micturitions < 8 Per 24 Hours at Week 12	A micturition/void is defined as "Urinated in Toilet" as indicated on the PVD. The number of micturitions is defined as the number of times a participant voided in the toilet as indicated on the PVD. A participant was defined as having an average of < 8 daily micturitions if the arithmetic mean of the number of micturitions per day in the PVD was less than 8 . "Per 24 hours" corresponds to one Diary Day (i.e., time between when the participant got up for the day each morning and time the participant got up for the day the next morning as recorded in the PVD).	Week 12
Percentage of OAB Wet Participants With at Least a 50% Reduction From Baseline in Total Incontinence Episodes Per 24 Hours at Week 12	Total incontinence is defined as having any reason for "Accidental Urine Leakage" and/or "Accidental Urine Leakage" checked, as indicated on the PVD. It is assumed that if the participant recorded a reason for leakage then the accidental urine leakage occurred. All events marked as having leakage, regardless of cause, or where "Accidental Leakage" was checked. were used in the analysis. "Per 24 hours" corresponds to one Diary Day (i.e., time between when the participant got up for the day each morning and time the participant got up for the day the next morning as recorded in the PVD.	Baseline; Week 12
CFB at Week 12 in Overall Bladder Symptoms Based on Patient Global Impression of Severity (PGI-Severity) in All OAB Participants	The Patient Global Impression (PGI) questions are designed to assess a participant's overall impression of OAB. For the PGI-Severity score, participants are asked to rate their OAB symptoms over the previous week with one of the following responses: 1 = none, 2 = mild, 3 = moderate, 4 = severe. CFB is calculated as the post-BL value minus the BL value. Covariates included in the mixed model for repeated measures were study visit (Weeks 2, 4, 8, and 12), OAB type (wet/dry), sex, region (U.S./non-U.S.), BL score, and treatment by study visit interaction.	Baseline; Week 12
CFB at Week 12 in Overall Control Over Bladder Symptoms Based on Patient Global Impression of Control (PGI-Control) in All OAB Participants	The Patient Global Impression (PGI) questions are designed to assess a participant's overall impression of OAB. For the PGI-Control score, participants were asked to rate how much control they had over their OAB symptoms over the previous week with one of the following responses: 1 = complete control, 2 = a lot of control, 3 = some control, 4 = only a little control, 5 = no control. CFB is calculated as the post-BL value minus the BL value. Covariates included in the mixed model for repeated measures were study visit (Weeks 2, 4, 8, and 12), OAB type (wet/dry), sex, region (U.S./non-U.S.), BL score, and treatment by study visit interaction.	Baseline; Week 12

Collaborators and Investigators

• Sponsor: Urovant Sciences GmbH

Publications and helpful links

General Publications

• Staskin D, Frankel J, Varano S, Kennelly M, Newman DK, Rosenberg MT, Shortino DD, Jankowich RA, Mudd PN Jr. Vibegron for the Treatment of Patients with Dry and Wet Overactive Bladder: A Subgroup Analysis from the EMPOWUR Trial. Int J Clin Pract. 2022 Apr 13;2022:6475014. doi: 10.1155/2022/6475014. eCollection 2022.
• Frankel J, Staskin D, Varano S, Kennelly M, Newman DK, Rosenberg MT, Jankowich RA, Shortino D, Mudd PN Jr, Girman CJ. Interpretation of the Meaningfulness of Symptom Reduction with Vibegron in Patients with Overactive Bladder: Analyses from EMPOWUR. Adv Ther. 2022 Feb;39(2):959-970. doi: 10.1007/s12325-021-01972-8. Epub 2021 Dec 18.
• Varano S, Staskin D, Frankel J, Shortino D, Jankowich R, Mudd PN Jr. Efficacy and Safety of Once-Daily Vibegron for Treatment of Overactive Bladder in Patients Aged >/=65 and >/=75 Years: Subpopulation Analysis from the EMPOWUR Randomized, International, Phase III Study. Drugs Aging. 2021 Feb;38(2):137-146. doi: 10.1007/s40266-020-00829-z. Epub 2021 Jan 20.
• Frankel J, Varano S, Staskin D, Shortino D, Jankowich R, Mudd PN Jr. Vibegron improves quality-of-life measures in patients with overactive bladder: Patient-reported outcomes from the EMPOWUR study. Int J Clin Pract. 2021 May;75(5):e13937. doi: 10.1111/ijcp.13937. Epub 2021 Jan 22.

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2018
• Primary Completion (Actual): January 10, 2019
• Study Completion (Actual): February 4, 2019

Study Registration Dates

• First Submitted: March 21, 2018
• First Submitted That Met QC Criteria: April 2, 2018
• First Posted (Actual): April 10, 2018

Study Record Updates

• Last Update Posted (Actual): March 4, 2021
• Last Update Submitted That Met QC Criteria: February 11, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Incontinence; Lower Urinary Tract Symptoms; Urologic Diseases; Urge urinary incontinence; OAB; Vibegron; Beta-3 adrenergic receptor (β3-AR) agonists; Urinary bladder, overactive; Urological Agents
• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder, Overactive; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Urological Agents; Tolterodine Tartrate
• Other Study ID Numbers: RVT-901-3003; 2017-003293-14 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No