AzTrials
AzTrials

Overactive BladderPhase 3EmpowurNCT03492281

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

A Phase 3 study testing vibegron and Tolterodine Tartrate ER in people with Overactive Bladder, run by Urovant Sciences GmbH at 215 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Overactive Bladder
What is being tested?
vibegron and Tolterodine Tartrate ER
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,530 participants
Where
215 sitesin 6 countries
Study dates
26 Mar 2018to 4 Feb 2019
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Urology Medical History
  • Patient had an average total daily urine volume > 3000 mL in the past 6 months or during the 14-day Run-in Period.
  • Has lower urinary tract pathology that could, in the opinion of the Investigator, be responsible for urgency, frequency, or incontinence.
  • Has a history of surgery to correct stress urinary incontinence, pelvic organ prolapse, or procedural treatments for BPH within 6 months of Screening.
  • Has current history or evidence of Stage 2 or greater pelvic organ prolapse (prolapse extends beyond the hymenal ring).
  • Patient is currently using a pessary for the treatment of pelvic organ prolapse.
Show all 25Show fewer
  • Has a known history of elevated post-void residual volume defined as greater than 150 mL.
  • Has undergone bladder training or electrostimulation within 28 days prior to Screening or plans to initiate either during the study.
  • Has an active or recurrent (> 3 episodes per year) urinary tract infection by clinical symptoms or pre-defined laboratory criteria.
  • Has a requirement for an indwelling catheter or intermittent catheterization.
  • Has received an intradetrusor injection of botulinum toxin within 9 months prior to Screening.
  • 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.
  • Has evidence of diabetes insipidus.
  • Is pregnant, breast-feeding, or is planning to conceive within the projected duration of the study.
  • 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.
  • 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.
  • Has narrow angle glaucoma (primary open angle glaucoma is not excluded).
  • 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.
  • 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.
  • Has hematuria, including microscopic hematuria according to pre-defined criteria.
  • Has clinically significant electrocardiogram (ECG) abnormality.
  • 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).
  • Has an estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2.
  • 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.
  • 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.

Trial locations and contacts

215 sites in 6 countries.

215 sites in 6 countries

United States191 sites

  • Albuquerque Clinical Trials, Inc.

    Albuquerque, New Mexico, 87102

  • AccumetRx Clinical Research - Division of Urology Group of New Mexico

    Albuquerque, New Mexico, 87109

  • Dream Team Clinical Research LLC

    Anaheim, California, 92801

  • Millennium Clinical Trials

    Arlington, Virginia, 22207

  • Innovative Medical Research of South Florida Inc.

    Aventura, Florida, 33180-1151

  • Pioneer Clinical Research, LLC

    Bellevue, Nebraska, 68005

  • Hassman Research Institute

    Berlin, New Jersey, 08009

  • Montana Health Research Institute Inc.

    Billings, Montana, 59102

  • United Medical Associates

    Binghamton, New York, 13901

  • Central Alabama Research

    Birmingham, Alabama, 35209

  • Achieve Clinical Research

    Birmingham, Alabama, 35216

  • Elite Clinical Trials

    Blackfoot, Idaho, 83221

  • Boston Clinical Trials

    Boston, Massachusetts, 02131

  • Progressive Clinical Research

    Bountiful, Utah, 84010

  • PAB Clinical Research

    Brandon, Florida, 33511

  • PMG Research of Bristol LLC

    Bristol, Tennessee, 37620

  • Investigators Research Group LLC

    Brownsburg, Indiana, 46112

  • DiscoveResearch Inc.

    Bryan, Texas, 77802-2589

  • Seattle Urology Research

    Burien, Washington, 98166

  • Hope Clinical Research

    Canoga Park, California, 91303

  • PMG Research of Cary

    Cary, North Carolina, 27518

  • Core Healthcare Group

    Cerritos, California, 90703

  • Clinical Trials of South Carolina

    Charleston, South Carolina, 29406-8106

  • Pharmacorp Clinical Trials Inc.

    Charleston, South Carolina, 29412-2625

  • PMG Research of Charlotte LLC

    Charlotte, North Carolina, 28209

  • WR - ClinSearch LLC

    Chattanooga, Tennessee, 37421

  • Sentral Clinical Research Services

    Cincinnati, Ohio, 45236-2934

  • Innovative Research of West FL Inc.

    Clearwater, Florida, 33756

  • Rapid Medical Research

    Cleveland, Ohio, 44122

  • Buckeye Health and Research

    Columbus, Ohio, 43207

  • Aventiv Research, Inc.

    Columbus, Ohio, 43213-6523

  • Universal Medical and Research Center LLC

    Coral Gables, Florida, 33134

  • Top Medical Research Inc.

    Cutler Bay, Florida, 33189

  • Providence Health Partners

    Dayton, Ohio, 45439

  • Avail Clinical Research

    DeLand, Florida, 32720

  • Jesscan Medical Research

    Delray Beach, Florida, 33484

  • Horizons Clinical Research Center

    Denver, Colorado, 80220

  • Lynn Institute of Denver

    Denver, Colorado, 80246

  • WR Global Medical Research

    DeSoto, Texas, 75115-2052

  • Revival Research

    Doral, Florida, 33122

  • Greater Providence Clinical Research, LLC

    East Providence, Rhode Island, 02914

  • Riverside Clinical Research

    Edgewater, Florida, 32132

  • Premier Urology Group LLC

    Edison, New Jersey, 08837

  • Regional Clinical Research Inc.

    Endwell, New York, 13760

  • Urologic Research and Consulting LLC

    Englewood, New Jersey, 07631

  • HWC Womens Research Center

    Englewood, Ohio, 45322-2722

  • Evanston Premier Healthcare Research

    Evanston, Illinois, 60201

  • MediSphere Medical Research Center

    Evansville, Indiana, 47714

  • KO Clinical Research

    Fort Lauderdale, Florida, 33316-2521

  • Piedmont Research Partners

    Fort Mill, South Carolina, 29707

  • Research Center of Fresno Inc.

    Fresno, California, 93702

  • AccuMed Research Associates

    Garden City, New York, 11530-1664

  • PharmQuest

    Greensboro, North Carolina, 27408

  • DeGarmo Institute of Medical Research

    Greer, South Carolina, 29651-1818

  • Fundamental Research LLC

    Gulf Shores, Alabama, 36542-2856

  • Clinical Investigation Specialists Inc.

    Gurnee, Illinois, 60031

  • Chesapeake Urology Research Associates

    Hanover, Maryland, 21076

  • Drug Trials America

    Hartsdale, New York, 10530

  • American Clinical Trials

    Hawaiian Gardens, California, 90716

  • A.G.A Clinical Trials

    Hialeah, Florida, 33012-3407

  • Indago Research Health Center

    Hialeah, Florida, 33012

  • Best Quality Research, Inc.

    Hialeah, Florida, 33016

  • Vital Pharm Research Inc.

    Hialeah, Florida, 33016

  • Peters Medical Research

    High Point, North Carolina, 27262

  • Advances in Health

    Houston, Texas, 77030

  • Centex Studies Inc.

    Houston, Texas, 77058

  • Discovery MM Services Inc.

    Houston, Texas, 77061

  • BI Research Center

    Houston, Texas, 77084

  • Pioneer Research Solutions

    Houston, Texas, 77099

  • Marvel Clinical Research

    Huntington Beach, California, 92647

  • Longwood Research

    Huntsville, Alabama, 35801

  • Protenium Clinical Research

    Hurst, Texas, 76054

  • Leonard Maliver MD Antria, Inc.

    Indiana, Pennsylvania, 15701

  • The Jackson Clinic

    Jackson, Tennessee, 38301

  • Smart Medical Research Inc.

    Jackson Heights, New York, 11372

  • The Clinical Trial Center LLC

    Jenkintown, Pennsylvania, 19046

  • MultiSpecialty Clinical Research, Inc.

    Johnson City, Tennessee, 37601

  • Health Awareness, Inc.

    Jupiter, Florida, 33458

  • Discovery MM Services Inc.

    Katy, Texas, 77450-7587

  • Volunteer Research Group - NOCCR

    Knoxville, Tennessee, 37920

  • Grossmont Center for Clinical Research

    La Mesa, California, 91942

  • Barrett Clinic P.C.

    La Vista, Nebraska, 68128

  • Prime-Care Clinical Research

    Laguna Hills, California, 92653

  • Centex Studies Inc.

    Lake Charles, Louisiana, 70601

  • Green and Seidner Family Practice Associates P.C.

    Lansdale, Pennsylvania, 19446

  • Excel Clinical Research

    Las Vegas, Nevada, 89109-6209

  • Clinical Research Consortium

    Las Vegas, Nevada, 89119

  • Sheldon Freedman MD Ltd

    Las Vegas, Nevada, 89144

  • Lawrence OB-GYN Clinical Research LLC

    Lawrenceville, New Jersey, 08648-2526

  • Central Kentucky Research Associates Inc.

    Lexington, Kentucky, 40509

  • Women's Clinic of Lincoln PC

    Lincoln, Nebraska, 68510

  • Long Beach Clinical Trial Services Inc.

    Long Beach, California, 90806

  • Long Beach Clinical Trials LLC

    Long Beach, California, 90806

  • Downtown L.A. Research Center Inc.

    Los Angeles, California, 90017

  • Urology Group of Southern California

    Los Angeles, California, 90017

  • L-MARC Research Center

    Louisville, Kentucky, 40213

  • Adams Patterson Gynecology and Obstetrics

    Memphis, Tennessee, 38120-2382

  • Advanced Clinical Research

    Meridian, Idaho, 83642

  • San Marcus Research Clinic Inc.

    Miami, Florida, 33015

  • LCC Medical Research Institute Inc.

    Miami, Florida, 33126

  • Nuren Medical Research Center

    Miami, Florida, 33144

  • AppleMed Research Group LLC

    Miami, Florida, 33155

  • Miami Clinical Research

    Miami, Florida, 33155

  • Advanced Medical Research Institute

    Miami, Florida, 33174

  • Clinical Research Solutions

    Middleburg Heights, Ohio, 44130

  • Clinical Research Consulting LLC

    Milford, Connecticut, 06460

  • Montana Medical Research

    Missoula, Montana, 59808

  • Discovery MM Services Inc.

    Missouri City, Texas, 77459

  • Coastal Clinical Research Inc.

    Mobile, Alabama, 36608

  • PMG Research of Charleston LLC

    Moncks Corner, South Carolina, 29461

  • Coastal Carolina Research Center

    Mt. Pleasant, South Carolina, 29464

  • PMG Research of Charleston LLC

    Mt. Pleasant, South Carolina, 29464

  • Tri Valley Urology Medical Group

    Murrieta, California, 92562

  • Family Medicine of SayeBrook LLC

    Myrtle Beach, South Carolina, 29588

  • Clinical Research Associates Inc.

    Nashville, Tennessee, 37203-3005

  • BTC of New Bedford

    New Bedford, Massachusetts, 02740-2133

  • Coastal Connecticut Research LLC

    New London, Connecticut, 06320

  • DelRicht Research

    New Orleans, Louisiana, 70115

  • Suncoast Clinical Research Inc.

    New Port Richey, Florida, 34652

  • Bayside Clinical Research

    New Port Richey, Florida, 34655

  • Health Research of Hampton Roads Inc.

    Newport News, Virginia, 23606

  • Meridian Clinical Research LLC

    Norfolk, Nebraska, 68701

  • Regeneris Medical

    North Attleboro, Massachusetts, 02760

  • Infinity Medical Research Inc.

    North Dartmouth, Massachusetts, 02747

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma, 73112-4703

  • Adult and Pediatric Urology P.C.

    Omaha, Nebraska, 68114

  • Quality Clinical Research Inc.

    Omaha, Nebraska, 68114

  • Compass Research LLC

    Orlando, Florida, 32806

  • In-Quest Medical Research, LLC

    Peachtree Corners, Georgia, 30071

  • Palmetto Institute of Clinical Research Inc.

    Pelzer, South Carolina, 29669

  • South Broward Research LLC

    Pembroke Pines, Florida, 33027

  • Clinical Research of Philadelphia LLC

    Philadelphia, Pennsylvania, 19114

  • Preferred Primary Care Physicians Inc.

    Pittsburgh, Pennsylvania, 15236

  • Preferred Primary Care Physicians Inc.

    Pittsburgh, Pennsylvania, 15243

  • Research Protocol Management Specialists Hills ObGyn Associates Inc

    Pittsburgh, Pennsylvania, 15243

  • Village Health Partners ACRC Trials

    Plano, Texas, 75024

  • Clinical Research Center of Florida

    Pompano Beach, Florida, 33060

  • Poplar Bluff Urology

    Poplar Bluff, Missouri, 63901-1908

  • ProHealth Care AssociatesLLP

    Port Jefferson, New York, 11777

  • Beacon Clinical Research

    Quincy, Massachusetts, 02169

  • Raleigh Medical Group PMG Research of Raleigh

    Raleigh, North Carolina, 27609-7245

  • Associated Urologists of North Carolina

    Raleigh, North Carolina, 27612

  • Remidica LLC

    Rochester, Michigan, 48307-1318

  • Rochester Clinical Research Inc.

    Rochester, New York, 14609-3109

  • Northern California Research

    Sacramento, California, 95821

  • Saginaw Valley Medical Research

    Saginaw, Michigan, 48604

  • PMG Research of Salisbury

    Salisbury, North Carolina, 28411

  • Wasatch Clinical Research LLC

    Salt Lake City, Utah, 84107

  • Clinical Trials of Texas Inc.

    San Antonio, Texas, 78229

  • Bandera Family Health Care

    San Antonio, Texas, 78249

  • San Bernadino Urological Associates

    San Bernardino, California, 92404-4816

  • Artemis Institute for Clinical Research

    San Diego, California, 92103

  • WR MCCCR

    San Diego, California, 92108

  • Artemis Institute for Clinical Research

    San Marcos, California, 92078

  • CentraCare Clinic Adult & Pediatric Urology

    Sartell, Minnesota, 56377

  • Meridian Clinical Research LLC

    Savannah, Georgia, 31406

  • Seattle Women's: Health, Research, Gynecology

    Seattle, Washington, 98105

  • Regional Urology LLC

    Shreveport, Louisiana, 71106

  • Hillcrest Clinical Research LLC

    Simpsonville, South Carolina, 29681

  • Frontier Clinical Research, LLC

    Smithfield, Pennsylvania, 15478

  • North Spokane Womens Health

    Spokane, Washington, 99207

  • Clinova Clinical Trials

    Spring, Texas, 77379

  • Meridien Research

    Spring Hill, Florida, 34609

  • Pinellas Urology

    St. Petersburg, Florida, 33710

  • Clinical Research Atlanta

    Stockbridge, Georgia, 30281

  • Palmetto Clinical Research

    Summerville, South Carolina, 29485

  • Clinical Research of West Florida

    Tampa, Florida, 33603

  • Clinical Research Consortium

    Tempe, Arizona, 85283

  • Bioclinica Research

    The Villages, Florida, 32162

  • Noble Clinical Research

    Tucson, Arizona, 85704

  • Eclipse Clinical Research

    Tucson, Arizona, 85745

  • Preferred Primary Care Physicians Inc.

    Uniontown, Pennsylvania, 15401

  • Empire Clinical Research

    Upland, California, 91786

  • PEAK Research LLC

    Upper Saint Clair, Pennsylvania, 15241

  • Bayview Research Group LLC

    Valley Village, California, 91607-3456

  • Family Practice Center of Wadsworth Inc. - New Venture Medical Research

    Wadsworth, Ohio, 44281

  • Omega Medical Research

    Warwick, Rhode Island, 02886-1689

  • Chase Medical Research, LLC

    Waterbury, Connecticut, 06708

  • Bay State Clinical Trials Inc.

    Watertown, Massachusetts, 02472

  • Asclepes Research Centers

    Weeki Wachee, Florida, 34607

  • Advanced Clinical Research

    West Jordan, Utah, 84088

  • Heartland Research Associates LLC

    Wichita, Kansas, 67205

  • Heartland Research Associates LLC

    Wichita, Kansas, 67207

  • Upstate Clinical Research Associates LLC

    Williamsville, New York, 14221-6046

  • Ohio Clinical Research LLC

    Willoughby Hills, Ohio, 44094

  • PMG Research of Wilmington, LLC

    Wilmington, North Carolina, 28401

  • PMG Research

    Wilmington, North Carolina, 28401

  • Carolina Medical Trials LLC

    Winston-Salem, North Carolina, 27103-4109

  • PMG Research of Winston-Salem

    Winston-Salem, North Carolina, 27103

  • Clinical Research of Central Florida

    Winter Haven, Florida, 33880

  • North Georgia Clinical Research

    Woodstock, Georgia, 30189-4255

Other trials in United States

Canada7 sites

  • Manna Research (Quebec)

    Lévis, Quebec, G6W 0M6

  • Recherche GCP Research

    Montreal, Quebec, H1M 1B1

  • Manna Research (Montreal)

    Montreal, Quebec, H9R 4S3

  • Central Alberta Research Clinic

    Red Deer, Alberta, T4N 6V7

  • Diex Research Sherbrooke Inc.

    Sherbrooke, Quebec, J1L 0H8

  • PrimeHealth Clinical Research

    Toronto, Ontario, M4S 1Y2

  • Silverado Research Inc.

    Victoria, British Columbia, V8T 2C1

Other trials in Canada

Poland6 sites

  • Klimed Marek Klimkiewicz

    Bialystok, Woj. Podlaskie, 15-776

  • ETG Lodz

    Lodz, Woj. Lodzkie, 90-302

  • NZOZ NOVITA Specjalistyczne Gabinety Lekarskie

    Lublin, Woj. Lubelskie, 20-632

  • NZOZ Centrum Urologiczne sp. z o.o.

    Mysłowice, Woj. Slaskie, 41-400

  • Nzoz Heureka

    Piaseczno, Woj. Mazowieckie, 05-500

  • Poradnia Urologiczna EuroMediCare Szpital Specjalistyczny z Przychodnia

    Wroclaw, Woj. Dolnoslaskie, 54-144

Other trials in Poland

Hungary5 sites

  • Obudai Egeszsegugyi Centrum Kft.

    Budapest, 1036

  • Szarka Ödön Egyesitett Egeszsegügyi es Szocialis Intezmeny

    Csongrád, 6640

  • Szent Anna Private Surgery

    Debrecen, 4029

  • Mediroyal Prevention Center

    Kecskemét, 6000

  • Uro-clin Ltd

    Pécs, 7621

Other trials in Hungary

Latvia3 sites

  • Daugavpils Regional Hospital

    Daugavpils, LV-5417

  • Uro Ltd.

    Riga, LV-1001

  • Pauls Stradins Clinical University Hospital

    Riga, LV-1002

Other trials in Latvia

Lithuania3 sites

  • Public Institution Republican Klaipda Hospital

    Klaipėda, 92231

  • Vilnius

    Vilnius, LT-09108

  • Vilnius city Clinical hospital

    Vilnius, LT-10207

Other trials in Lithuania

About this study

Official title: 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.

Being tested
vibegron, Vibegron placebo, Tolterodine Tartrate ER, Tolterodine placebo
Keywords
Beta-3 adrenergic receptor (β3-AR) agonists, Incontinence, OAB, Vibegron, Urge urinary incontinence, Urinary bladder, overactive, Urologic Diseases, Lower Urinary Tract Symptoms, Urological Agents
Medical subject headings
Urinary Bladder, Overactive, Urinary Incontinence, Urge, Urologic Diseases, Lower Urinary Tract Symptoms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • vibegronDrug

    Also called RVT-901, MK4618, KRP114V, URO-901

    single daily oral dose of vibegron 75 mg for 12 weeks

  • Vibegron placeboDrug

    placebo to match vibegron (experimental drug)

  • Tolterodine Tartrate ERDrug

    Also called Mariosea XL

    single daily oral dose of tolterodine tartrate ER 4 mg for 12 weeks

  • Tolterodine placeboDrug

    placebo to match tolterodine (active comparator)

Study groups in NCT03492281
Study groupRoleWhat they receive
Vibegron + Placebo to match TolterodineExperimentalNot described
Receives: Drug: vibegron; Drug: Tolterodine placebo
Placebo to match vibegron + Placebo to match TolterodinePlacebo comparatorNot described
Receives: Drug: Vibegron placebo; Drug: Tolterodine placebo
Tolterodine + Placebo to match vibegronActive comparatorNot described
Receives: Drug: Vibegron placebo; Drug: Tolterodine Tartrate ER

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline (BL); Week 12

  2. 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.

    Measured: Baseline; Week 12

Secondary outcomes (13)

  1. 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.

    Measured: Baseline; Week 12

  2. 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).

    Measured: Baseline; Week 12

  3. 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).

    Measured: Baseline; Week 12

  4. 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).

    Measured: Baseline; Week 12

  5. 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.

    Measured: Baseline; Week 12

  6. 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.

    Measured: Baseline; Week 12

  7. 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.

    Measured: Baseline; Week 12

  8. 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.

    Measured: Baseline; Week 12

  9. 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.

    Measured: Baseline; Week 12

  10. 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).

    Measured: Week 12

  11. 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.

    Measured: Baseline; Week 12

  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.

    Measured: Baseline; Week 12

  13. 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.

    Measured: Baseline; Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Apr 2018
  2. Study start26 Mar 2018
  3. Primary completion10 Jan 2019
  4. Study completion4 Feb 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,530 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03492281
Sponsor's protocol ID
RVT-901-3003
Other IDs
2017-003293-14, 2017
Acronym
Empowur
Status last verified
Feb 2021
First submitted
21 Mar 2018
Last updated
4 Mar 2021
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Staskin D, Frankel J, Gregg SG, Varano S, Owens-Grillo J. Plain language summary of safety and symptom improvement with vibegron in people with overactive bladder: results from the EMPOWUR study. J Comp Eff Res. 2023 Sep;12(9):CER. doi: 10.57264/cer-2023-0043. Epub 2023 Aug 10.

    PubMed 37586057

  • Frankel J, Staskin D, Varano S, Newman DK, Gregg SG, Owens-Grillo J. Plain language summary: does treatment with vibegron result in improvements in overactive bladder (OAB) symptoms that are meaningful to people with OAB? J Comp Eff Res. 2023 Sep;12(9):CER. doi: 10.57264/cer-2023-0049. Epub 2023 Aug 10.

    PubMed 37586052

  • Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3.

    PubMed 37160401

  • Newman DK, Thomas E, Greene H, Haag-Molkenteller C, Varano S. Efficacy and Safety of Vibegron for the Treatment of Overactive Bladder in Women: A Subgroup Analysis From the Double-Blind, Randomized, Controlled EMPOWUR Trial. Urogynecology (Phila). 2023 Jan 1;29(1):48-57. doi: 10.1097/SPV.0000000000001258. Epub 2022 Oct 21.

    PubMed 36384907

  • 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.

    PubMed 35685566

  • 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.

    PubMed 34921665

  • 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.

    PubMed 33469832

  • 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.

    PubMed 33332699

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing vibegron and Tolterodine Tartrate ER in people with Overactive Bladder, run by Urovant Sciences GmbH at 215 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 215 sites in United States, Canada, Poland, Hungary, Latvia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline (CFB) at Week 12 in the Average Number of Micturitions Per 24 Hours in All Overactive Bladder (OAB) Participants (time frame: Baseline (BL); Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03492281, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2021.

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