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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-003293-14 | EudraCT Number |
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This study is designed to evaluate the safety, tolerability, and efficacy of vibegron administered once daily in patients with OAB.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vibegron + Placebo to match Tolterodine | Experimental |
| |
| Placebo to match vibegron + Placebo to match Tolterodine | Placebo Comparator |
| |
| Tolterodine + Placebo to match vibegron | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vibegron | Drug | single daily oral dose of vibegron 75 mg for 12 weeks |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
Urology Medical History
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Alabama Research | Birmingham | Alabama | 35209 | United States | ||
| Achieve Clinical Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37586057 | Derived | 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. | |
| 37586052 | Derived | 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. |
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Of 3149 participants screened for this study, 1518 were randomized (after a 2-week, single-blind placebo Run-in Period), and 1515 received 1 dose of double-blind study drug in the Treatment Period (Safety Set: placebo, N = 540; vibegron, N = 545; tolterodine, N = 430).
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received matching placebo, orally, once daily for 12 weeks. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex. |
| FG001 | Vibegron 75 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 15, 2018 | Jan 11, 2021 |
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| Vibegron placebo | Drug | placebo to match vibegron (experimental drug) |
|
| Tolterodine Tartrate ER | Drug | single daily oral dose of tolterodine tartrate ER 4 mg for 12 weeks |
|
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| Tolterodine placebo | Drug | placebo to match tolterodine (active comparator) |
|
| 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 |
| Birmingham |
| Alabama |
| 35216 |
| United States |
| Fundamental Research LLC | Gulf Shores | Alabama | 36542-2856 | United States |
| Longwood Research | Huntsville | Alabama | 35801 | United States |
| Coastal Clinical Research Inc. | Mobile | Alabama | 36608 | United States |
| Clinical Research Consortium | Tempe | Arizona | 85283 | United States |
| Noble Clinical Research | Tucson | Arizona | 85704 | United States |
| Eclipse Clinical Research | Tucson | Arizona | 85745 | United States |
| Dream Team Clinical Research LLC | Anaheim | California | 92801 | United States |
| Hope Clinical Research | Canoga Park | California | 91303 | United States |
| Core Healthcare Group | Cerritos | California | 90703 | United States |
| Research Center of Fresno Inc. | Fresno | California | 93702 | United States |
| American Clinical Trials | Hawaiian Gardens | California | 90716 | United States |
| Marvel Clinical Research | Huntington Beach | California | 92647 | United States |
| Grossmont Center for Clinical Research | La Mesa | California | 91942 | United States |
| Prime-Care Clinical Research | Laguna Hills | California | 92653 | United States |
| Long Beach Clinical Trial Services Inc. | Long Beach | California | 90806 | United States |
| Long Beach Clinical Trials LLC | Long Beach | California | 90806 | United States |
| Downtown L.A. Research Center Inc. | Los Angeles | California | 90017 | United States |
| Urology Group of Southern California | Los Angeles | California | 90017 | United States |
| Tri Valley Urology Medical Group | Murrieta | California | 92562 | United States |
| Northern California Research | Sacramento | California | 95821 | United States |
| San Bernadino Urological Associates | San Bernardino | California | 92404-4816 | United States |
| Artemis Institute for Clinical Research | San Diego | California | 92103 | United States |
| WR MCCCR | San Diego | California | 92108 | United States |
| Artemis Institute for Clinical Research | San Marcos | California | 92078 | United States |
| Empire Clinical Research | Upland | California | 91786 | United States |
| Bayview Research Group LLC | Valley Village | California | 91607-3456 | United States |
| Horizons Clinical Research Center | Denver | Colorado | 80220 | United States |
| Lynn Institute of Denver | Denver | Colorado | 80246 | United States |
| Clinical Research Consulting LLC | Milford | Connecticut | 06460 | United States |
| Coastal Connecticut Research LLC | New London | Connecticut | 06320 | United States |
| Chase Medical Research, LLC | Waterbury | Connecticut | 06708 | United States |
| Innovative Medical Research of South Florida Inc. | Aventura | Florida | 33180-1151 | United States |
| PAB Clinical Research | Brandon | Florida | 33511 | United States |
| Innovative Research of West FL Inc. | Clearwater | Florida | 33756 | United States |
| Universal Medical and Research Center LLC | Coral Gables | Florida | 33134 | United States |
| Top Medical Research Inc. | Cutler Bay | Florida | 33189 | United States |
| Avail Clinical Research | DeLand | Florida | 32720 | United States |
| Jesscan Medical Research | Delray Beach | Florida | 33484 | United States |
| Revival Research | Doral | Florida | 33122 | United States |
| Riverside Clinical Research | Edgewater | Florida | 32132 | United States |
| KO Clinical Research | Fort Lauderdale | Florida | 33316-2521 | United States |
| A.G.A Clinical Trials | Hialeah | Florida | 33012-3407 | United States |
| Indago Research Health Center | Hialeah | Florida | 33012 | United States |
| Best Quality Research, Inc. | Hialeah | Florida | 33016 | United States |
| Vital Pharm Research Inc. | Hialeah | Florida | 33016 | United States |
| Health Awareness, Inc. | Jupiter | Florida | 33458 | United States |
| San Marcus Research Clinic Inc. | Miami | Florida | 33015 | United States |
| LCC Medical Research Institute Inc. | Miami | Florida | 33126 | United States |
| Nuren Medical Research Center | Miami | Florida | 33144 | United States |
| AppleMed Research Group LLC | Miami | Florida | 33155 | United States |
| Miami Clinical Research | Miami | Florida | 33155 | United States |
| Advanced Medical Research Institute | Miami | Florida | 33174 | United States |
| Suncoast Clinical Research Inc. | New Port Richey | Florida | 34652 | United States |
| Bayside Clinical Research | New Port Richey | Florida | 34655 | United States |
| Compass Research LLC | Orlando | Florida | 32806 | United States |
| South Broward Research LLC | Pembroke Pines | Florida | 33027 | United States |
| Clinical Research Center of Florida | Pompano Beach | Florida | 33060 | United States |
| Meridien Research | Spring Hill | Florida | 34609 | United States |
| Pinellas Urology | St. Petersburg | Florida | 33710 | United States |
| Clinical Research of West Florida | Tampa | Florida | 33603 | United States |
| Bioclinica Research | The Villages | Florida | 32162 | United States |
| Asclepes Research Centers | Weeki Wachee | Florida | 34607 | United States |
| Clinical Research of Central Florida | Winter Haven | Florida | 33880 | United States |
| In-Quest Medical Research, LLC | Peachtree Corners | Georgia | 30071 | United States |
| Meridian Clinical Research LLC | Savannah | Georgia | 31406 | United States |
| Clinical Research Atlanta | Stockbridge | Georgia | 30281 | United States |
| North Georgia Clinical Research | Woodstock | Georgia | 30189-4255 | United States |
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| Advanced Clinical Research | Meridian | Idaho | 83642 | United States |
| Evanston Premier Healthcare Research | Evanston | Illinois | 60201 | United States |
| Clinical Investigation Specialists Inc. | Gurnee | Illinois | 60031 | United States |
| Investigators Research Group LLC | Brownsburg | Indiana | 46112 | United States |
| MediSphere Medical Research Center | Evansville | Indiana | 47714 | United States |
| Heartland Research Associates LLC | Wichita | Kansas | 67205 | United States |
| Heartland Research Associates LLC | Wichita | Kansas | 67207 | United States |
| Central Kentucky Research Associates Inc. | Lexington | Kentucky | 40509 | United States |
| L-MARC Research Center | Louisville | Kentucky | 40213 | United States |
| Centex Studies Inc. | Lake Charles | Louisiana | 70601 | United States |
| DelRicht Research | New Orleans | Louisiana | 70115 | United States |
| Regional Urology LLC | Shreveport | Louisiana | 71106 | United States |
| Chesapeake Urology Research Associates | Hanover | Maryland | 21076 | United States |
| Boston Clinical Trials | Boston | Massachusetts | 02131 | United States |
| BTC of New Bedford | New Bedford | Massachusetts | 02740-2133 | United States |
| Regeneris Medical | North Attleboro | Massachusetts | 02760 | United States |
| Infinity Medical Research Inc. | North Dartmouth | Massachusetts | 02747 | United States |
| Beacon Clinical Research | Quincy | Massachusetts | 02169 | United States |
| Bay State Clinical Trials Inc. | Watertown | Massachusetts | 02472 | United States |
| Remidica LLC | Rochester | Michigan | 48307-1318 | United States |
| Saginaw Valley Medical Research | Saginaw | Michigan | 48604 | United States |
| CentraCare Clinic Adult & Pediatric Urology | Sartell | Minnesota | 56377 | United States |
| Poplar Bluff Urology | Poplar Bluff | Missouri | 63901-1908 | United States |
| Montana Health Research Institute Inc. | Billings | Montana | 59102 | United States |
| Montana Medical Research | Missoula | Montana | 59808 | United States |
| Pioneer Clinical Research, LLC | Bellevue | Nebraska | 68005 | United States |
| Barrett Clinic P.C. | La Vista | Nebraska | 68128 | United States |
| Women's Clinic of Lincoln PC | Lincoln | Nebraska | 68510 | United States |
| Meridian Clinical Research LLC | Norfolk | Nebraska | 68701 | United States |
| Adult and Pediatric Urology P.C. | Omaha | Nebraska | 68114 | United States |
| Quality Clinical Research Inc. | Omaha | Nebraska | 68114 | United States |
| Excel Clinical Research | Las Vegas | Nevada | 89109-6209 | United States |
| Clinical Research Consortium | Las Vegas | Nevada | 89119 | United States |
| Sheldon Freedman MD Ltd | Las Vegas | Nevada | 89144 | United States |
| Hassman Research Institute | Berlin | New Jersey | 08009 | United States |
| Premier Urology Group LLC | Edison | New Jersey | 08837 | United States |
| Urologic Research and Consulting LLC | Englewood | New Jersey | 07631 | United States |
| Lawrence OB-GYN Clinical Research LLC | Lawrenceville | New Jersey | 08648-2526 | United States |
| Albuquerque Clinical Trials, Inc. | Albuquerque | New Mexico | 87102 | United States |
| AccumetRx Clinical Research - Division of Urology Group of New Mexico | Albuquerque | New Mexico | 87109 | United States |
| United Medical Associates | Binghamton | New York | 13901 | United States |
| Regional Clinical Research Inc. | Endwell | New York | 13760 | United States |
| AccuMed Research Associates | Garden City | New York | 11530-1664 | United States |
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| Smart Medical Research Inc. | Jackson Heights | New York | 11372 | United States |
| ProHealth Care AssociatesLLP | Port Jefferson | New York | 11777 | United States |
| Rochester Clinical Research Inc. | Rochester | New York | 14609-3109 | United States |
| Upstate Clinical Research Associates LLC | Williamsville | New York | 14221-6046 | United States |
| PMG Research of Cary | Cary | North Carolina | 27518 | United States |
| PMG Research of Charlotte LLC | Charlotte | North Carolina | 28209 | United States |
| PharmQuest | Greensboro | North Carolina | 27408 | United States |
| Peters Medical Research | High Point | North Carolina | 27262 | United States |
| Raleigh Medical Group PMG Research of Raleigh | Raleigh | North Carolina | 27609-7245 | United States |
| Associated Urologists of North Carolina | Raleigh | North Carolina | 27612 | United States |
| PMG Research of Salisbury | Salisbury | North Carolina | 28411 | United States |
| PMG Research of Wilmington, LLC | Wilmington | North Carolina | 28401 | United States |
| PMG Research | Wilmington | North Carolina | 28401 | United States |
| Carolina Medical Trials LLC | Winston-Salem | North Carolina | 27103-4109 | United States |
| PMG Research of Winston-Salem | Winston-Salem | North Carolina | 27103 | United States |
| Sentral Clinical Research Services | Cincinnati | Ohio | 45236-2934 | United States |
| Rapid Medical Research | Cleveland | Ohio | 44122 | United States |
| Buckeye Health and Research | Columbus | Ohio | 43207 | United States |
| Aventiv Research, Inc. | Columbus | Ohio | 43213-6523 | United States |
| Providence Health Partners | Dayton | Ohio | 45439 | United States |
| HWC Womens Research Center | Englewood | Ohio | 45322-2722 | United States |
| Clinical Research Solutions | Middleburg Heights | Ohio | 44130 | United States |
| Family Practice Center of Wadsworth Inc. - New Venture Medical Research | Wadsworth | Ohio | 44281 | United States |
| Ohio Clinical Research LLC | Willoughby Hills | Ohio | 44094 | United States |
| Lynn Health Science Institute | Oklahoma City | Oklahoma | 73112-4703 | United States |
| Leonard Maliver MD Antria, Inc. | Indiana | Pennsylvania | 15701 | United States |
| The Clinical Trial Center LLC | Jenkintown | Pennsylvania | 19046 | United States |
| Green and Seidner Family Practice Associates P.C. | Lansdale | Pennsylvania | 19446 | United States |
| Clinical Research of Philadelphia LLC | Philadelphia | Pennsylvania | 19114 | United States |
| Preferred Primary Care Physicians Inc. | Pittsburgh | Pennsylvania | 15236 | United States |
| Preferred Primary Care Physicians Inc. | Pittsburgh | Pennsylvania | 15243 | United States |
| Research Protocol Management Specialists Hills ObGyn Associates Inc | Pittsburgh | Pennsylvania | 15243 | United States |
| Frontier Clinical Research, LLC | Smithfield | Pennsylvania | 15478 | United States |
| Preferred Primary Care Physicians Inc. | Uniontown | Pennsylvania | 15401 | United States |
| PEAK Research LLC | Upper Saint Clair | Pennsylvania | 15241 | United States |
| Greater Providence Clinical Research, LLC | East Providence | Rhode Island | 02914 | United States |
| Omega Medical Research | Warwick | Rhode Island | 02886-1689 | United States |
| Clinical Trials of South Carolina | Charleston | South Carolina | 29406-8106 | United States |
| Pharmacorp Clinical Trials Inc. | Charleston | South Carolina | 29412-2625 | United States |
| Piedmont Research Partners | Fort Mill | South Carolina | 29707 | United States |
| DeGarmo Institute of Medical Research | Greer | South Carolina | 29651-1818 | United States |
| PMG Research of Charleston LLC | Moncks Corner | South Carolina | 29461 | United States |
| Coastal Carolina Research Center | Mt. Pleasant | South Carolina | 29464 | United States |
| PMG Research of Charleston LLC | Mt. Pleasant | South Carolina | 29464 | United States |
| Family Medicine of SayeBrook LLC | Myrtle Beach | South Carolina | 29588 | United States |
| Palmetto Institute of Clinical Research Inc. | Pelzer | South Carolina | 29669 | United States |
| Hillcrest Clinical Research LLC | Simpsonville | South Carolina | 29681 | United States |
| Palmetto Clinical Research | Summerville | South Carolina | 29485 | United States |
| PMG Research of Bristol LLC | Bristol | Tennessee | 37620 | United States |
| WR - ClinSearch LLC | Chattanooga | Tennessee | 37421 | United States |
| The Jackson Clinic | Jackson | Tennessee | 38301 | United States |
| MultiSpecialty Clinical Research, Inc. | Johnson City | Tennessee | 37601 | United States |
| Volunteer Research Group - NOCCR | Knoxville | Tennessee | 37920 | United States |
| Adams Patterson Gynecology and Obstetrics | Memphis | Tennessee | 38120-2382 | United States |
| Clinical Research Associates Inc. | Nashville | Tennessee | 37203-3005 | United States |
| DiscoveResearch Inc. | Bryan | Texas | 77802-2589 | United States |
| WR Global Medical Research | DeSoto | Texas | 75115-2052 | United States |
| Advances in Health | Houston | Texas | 77030 | United States |
| Centex Studies Inc. | Houston | Texas | 77058 | United States |
| Discovery MM Services Inc. | Houston | Texas | 77061 | United States |
| BI Research Center | Houston | Texas | 77084 | United States |
| Pioneer Research Solutions | Houston | Texas | 77099 | United States |
| Protenium Clinical Research | Hurst | Texas | 76054 | United States |
| Discovery MM Services Inc. | Katy | Texas | 77450-7587 | United States |
| Discovery MM Services Inc. | Missouri City | Texas | 77459 | United States |
| Village Health Partners ACRC Trials | Plano | Texas | 75024 | United States |
| Clinical Trials of Texas Inc. | San Antonio | Texas | 78229 | United States |
| Bandera Family Health Care | San Antonio | Texas | 78249 | United States |
| Clinova Clinical Trials | Spring | Texas | 77379 | United States |
| Progressive Clinical Research | Bountiful | Utah | 84010 | United States |
| Wasatch Clinical Research LLC | Salt Lake City | Utah | 84107 | United States |
| Advanced Clinical Research | West Jordan | Utah | 84088 | United States |
| Millennium Clinical Trials | Arlington | Virginia | 22207 | United States |
| Health Research of Hampton Roads Inc. | Newport News | Virginia | 23606 | United States |
| Seattle Urology Research | Burien | Washington | 98166 | United States |
| Seattle Women's: Health, Research, Gynecology | Seattle | Washington | 98105 | United States |
| North Spokane Womens Health | Spokane | Washington | 99207 | United States |
| Central Alberta Research Clinic | Red Deer | Alberta | T4N 6V7 | Canada |
| Silverado Research Inc. | Victoria | British Columbia | V8T 2C1 | Canada |
| PrimeHealth Clinical Research | Toronto | Ontario | M4S 1Y2 | Canada |
| Manna Research (Quebec) | Lévis | Quebec | G6W 0M6 | Canada |
| Recherche GCP Research | Montreal | Quebec | H1M 1B1 | Canada |
| Manna Research (Montreal) | Montreal | Quebec | H9R 4S3 | Canada |
| Diex Research Sherbrooke Inc. | Sherbrooke | Quebec | J1L 0H8 | Canada |
| Obudai Egeszsegugyi Centrum Kft. | Budapest | 1036 | Hungary |
| Szarka Ödön Egyesitett Egeszsegügyi es Szocialis Intezmeny | Csongrád | 6640 | Hungary |
| Szent Anna Private Surgery | Debrecen | 4029 | Hungary |
| Mediroyal Prevention Center | Kecskemét | 6000 | Hungary |
| Uro-clin Ltd | Pécs | 7621 | Hungary |
| Daugavpils Regional Hospital | Daugavpils | LV-5417 | Latvia |
| Uro Ltd. | Riga | LV-1001 | Latvia |
| Pauls Stradins Clinical University Hospital | Riga | LV-1002 | Latvia |
| Public Institution Republican Klaipda Hospital | Klaipėda | 92231 | Lithuania |
| Vilnius | Vilnius | LT-09108 | Lithuania |
| Vilnius city Clinical hospital | Vilnius | LT-10207 | Lithuania |
| Poradnia Urologiczna EuroMediCare Szpital Specjalistyczny z Przychodnia | Wroclaw | Woj. Dolnoslaskie | 54-144 | Poland |
| ETG Lodz | Lodz | Woj. Lodzkie | 90-302 | Poland |
| NZOZ NOVITA Specjalistyczne Gabinety Lekarskie | Lublin | Woj. Lubelskie | 20-632 | Poland |
| Nzoz Heureka | Piaseczno | Woj. Mazowieckie | 05-500 | Poland |
| Klimed Marek Klimkiewicz | Bialystok | Woj. Podlaskie | 15-776 | Poland |
| NZOZ Centrum Urologiczne sp. z o.o. | Mysłowice | Woj. Slaskie | 41-400 | Poland |
| 37160401 | Derived | 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. |
| 36384907 | Derived | 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. |
| 35685566 | Derived | 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. |
| 34921665 | Derived | 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. |
| 33469832 | Derived | 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. |
| 33332699 | Derived | 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. |
Participants received vibegron 75 milligrams (mg), orally, once daily for 12 weeks. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex.
| FG002 | Tolterodine ER 4 mg | Participants received tolterodine extended release (ER) 4 mg, orally, once daily for 12 weeks. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex. |
| COMPLETED |
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| NOT COMPLETED |
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Baseline data are reported for members of the Safety Set, comprised of all participants who received at least 1 dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received matching placebo, orally, once daily for 12 weeks. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex. |
| BG001 | Vibegron 75 mg | Participants received vibegron 75 milligrams (mg), orally, once daily for 12 weeks. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex. |
| BG002 | Tolterodine ER 4 mg | Participants received tolterodine extended release (ER) 4 mg, orally, once daily for 12 weeks. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Average number of micturitions per 24 hours in all overactive bladder (OAB) participants | A micturition/void was defined as "Urinated in Toilet" as indicated on the Patient Voiding Diary (PVD). The number of micturitions was 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. | Only participants with available data were analyzed. | Mean | Standard Deviation | micturitions per 24 hours |
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| Average number of urge urinary incontinence (UUI) episodes per 24 hours in OAB Wet participants | The number of UUI episodes was 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. OAB Wet participants were those participants with an average of ≥8.0 micturitions per Diary Day (DD); with an average of ≥1.0 UUI episodes per DD; and, if stress urinary incontinence was present, with a total number of UUI episodes greater than the total number of stress urinary incontinence episodes from the previous visit diary. | Only participants with available data were analyzed. | Mean | Standard Deviation | UUI episodes |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | 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. | FAS: all randomized participants who took at least 1 dose of double-blind study treatment and had at least 1 evaluable CFB measurement. Only participants with evaluable data were analyzed. | Posted | Least Squares Mean | Standard Error | micturitions per 24 hours | Baseline (BL); Week 12 |
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| Primary | 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. | FAS-I: all randomized OAB Wet participants who took at least 1 dose of double-blind study treatment and had at least 1 evaluable CFB measurement. Only those participants with evaluable data were analyzed. | Posted | Least Squares Mean | Standard Error | UUI episodes per 24 hours | Baseline; Week 12 |
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| Secondary | 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. | FAS. Only participants with evaluable data were analyzed. | Posted | Least Squares Mean | Standard Error | urgency episodes over 24 hours | Baseline; Week 12 |
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| Secondary | 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). | FAS-I. The multiple imputation method was used for missing values. | Posted | Number | percentage of participants | Baseline; Week 12 |
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| Secondary | 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). | FAS-I. The multiple imputation method was used for missing values. | Posted | Number | percentage of participants | Baseline; Week 12 |
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| Secondary | 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). | FAS. The multiple imputation method was used for missing values. | Posted | Number | percentage of participants | Baseline; Week 12 |
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| Secondary | 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. | FAS-I. Only participants with evaluable data were analyzed. | Posted | Least Squares Mean | Standard Error | total incontinence episodes over 24 hr | Baseline; Week 12 |
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| Secondary | 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. | FAS. Only participants with evaluable data were analyzed. If < 50% of items were available, the subscore was regarded as missing; however, if ≥ 50% of items were available, the subscore included missing items imputed as the average of the remaining non-missing items for the subscore. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline; Week 12 |
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| Secondary | 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. | FAS. Only participants with evaluable data were analyzed. | Posted | Least Squares Mean | Standard Error | mL per micturition | Baseline; Week 12 |
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| Secondary | 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. | FAS. Only participants with evaluable data were analyzed. If < 50% of items were available, the subscore was regarded as missing; however, if ≥ 50% of items were available, the subscore included missing items imputed as the average of the remaining non-missing items for the subscore. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline; Week 12 |
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| Secondary | 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. | FAS. Only participants with evaluable data were analyzed. If < 50% of items were available, the subscore was regarded as missing; however, if ≥ 50% of items were available, the subscore included missing items imputed as the average of the remaining non-missing items for the subscore. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline; Week 12 |
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| Secondary | 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). | FAS. Only participants with evaluable data were analyzed. | Posted | Number | percentage of participants | Week 12 |
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| Secondary | 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. | FAS-I. Only participants with evaluable data were analyzed. The multiple imputation method was used for missing values. | Posted | Number | percentage of participants | Baseline; Week 12 |
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| Secondary | 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. | FAS. Only participants with evaluable data were analyzed. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline; Week 12 |
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| Secondary | 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. | FAS. Only participants with evaluable data were analyzed. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline; Week 12 |
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from the time the participant provided informed consent to participate in the study at the Screening Visit until completion of the Follow-up Visit (up to Day 113 or Early Withdrawal plus 28 days)
Treatment-emergent adverse events are reported for members of the Safety Set, comprised of all participants who received at least 1 dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants received matching placebo, orally, once daily for 12 weeks. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex. | 0 | 540 | 6 | 540 | 38 | 540 |
| EG001 | Vibegron 75 mg | Participants received vibegron 75 milligrams (mg), orally, once daily for 12 weeks. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex. | 0 | 545 | 8 | 545 | 36 | 545 |
| EG002 | Tolterodine ER 4 mg | Participants received tolterodine extended release (ER) 4 mg, orally, once daily for 12 weeks. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex. | 1 | 430 | 10 | 430 | 50 | 430 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Aortic valve incompetence | Cardiac disorders | MedDra 20.1 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
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| Coronary artery stenosis | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
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| Vertigo positional | Ear and labyrinth disorders | MedDRA 20.1 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Appendix disorder | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Colitis | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Chest pain | General disorders | MedDRA 20.1 | Systematic Assessment |
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| Non-cardiac chest pain | General disorders | MedDRA 20.1 | Systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA 20.1 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| Post procedural complication | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
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| Rib fracture | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
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| Ejection fraction decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
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| Lactic acidosis | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
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| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
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| Cholangiocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
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| Colorectal adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
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| Ovarian adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
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| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
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| Encephalopathy | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
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| Loss of consciousness | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Panic attack | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry mouth | Gastrointestinal disorders | MedDra 20.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
The Sponsor does not object to publication by Institution or Principal Investigator (PI) of results of the Trial based on information collected or generated by the Institution or PI. However, the Institution and PI are required to provide the Sponsor with an opportunity to review any proposed publication or other type of disclosure before it is submitted or otherwise disclosed to ensure against any inadvertent disclosure of Sponsor Confidential Information or unprotected Sponsor Inventions.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Information, Clinical Trial Results | Urovant Sciences | 949-226-6029 | info@urovant.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 6, 2019 | Jan 11, 2021 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| D053202 | Urinary Incontinence, Urge |
| D014570 | Urologic Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C000608232 | N-(4-((5-(hydroxy(phenyl)methyl)pyrrolidin-2-yl)methyl)phenyl)-4-oxo-4,6,7,8-tetrahydropyrrolo(1,2-a)pyrimidine-6-carboxamide |
| D000068737 | Tolterodine Tartrate |
| ID | Term |
|---|---|
| D010665 | Phenylpropanolamine |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D003408 | Cresols |
| D010636 | Phenols |
Not provided
Not provided
|
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| Asian |
|
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| Black or African American |
|
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| White |
|
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| Puerto Rican |
|
|
| White and Black or African American |
|
|
| Hispanic |
|
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| Filipino |
|
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| Morrocan |
|
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| Multiracial |
|
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| White, Black or African American |
|
|
|
|
| =0.0988 |
Comparisons between tolterodine ER and placebo are considered descriptive. |
| Least Squares Mean Difference |
| -0.3 |
| Standard Error of the Mean |
| 0.16 |
| 2-Sided |
| 95 |
| -0.6 |
| 0.1 |
| Superiority |
| OG001 | Vibegron 75 mg: OAB Wet | Participants who met the definition of OAB Wet at study entry (based on the PVD) received vibegron 75 milligrams (mg), orally, once daily for 12 weeks. OAB Wet participants were defined as those with an average of ≥8.0 micturitions per Diary Day; with an average of ≥1.0 UUI episodes per Diary Day; and, if stress urinary incontinence was present, with a total number of UUI episodes greater than the total number of stress urinary incontinence episodes from the previous visit diary. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex. |
| OG002 | Tolterodine ER 4 mg: OAB Wet | Participants who met the definition of OAB Wet at study entry (based on the PVD) received tolterodine extended release (ER) 4 mg, orally, once daily for 12 weeks. OAB Wet participants were defined as those with an average of ≥8.0 micturitions per Diary Day; with an average of ≥1.0 UUI episodes per Diary Day; and, if stress urinary incontinence was present, with a total number of UUI episodes greater than the total number of stress urinary incontinence episodes from the previous visit diary. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex. |
|
|
|
Participants received tolterodine extended release (ER) 4 mg, orally, once daily for 12 weeks. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex. |
|
|
|
| Vibegron 75 mg: OAB Wet |
Participants who met the definition of OAB Wet at study entry (based on the PVD) received vibegron 75 milligrams (mg), orally, once daily for 12 weeks. OAB Wet participants were defined as those with an average of ≥8.0 micturitions per Diary Day; with an average of ≥1.0 UUI episodes per Diary Day; and, if stress urinary incontinence was present, with a total number of UUI episodes greater than the total number of stress urinary incontinence episodes from the previous visit diary. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex. |
| OG002 | Tolterodine ER 4 mg: OAB Wet | Participants who met the definition of OAB Wet at study entry (based on the PVD) received tolterodine extended release (ER) 4 mg, orally, once daily for 12 weeks. OAB Wet participants were defined as those with an average of ≥8.0 micturitions per Diary Day; with an average of ≥1.0 UUI episodes per Diary Day; and, if stress urinary incontinence was present, with a total number of UUI episodes greater than the total number of stress urinary incontinence episodes from the previous visit diary. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex. |
|
|
|
| Vibegron 75 mg: OAB Wet |
Participants who met the definition of OAB Wet at study entry (based on the PVD) received vibegron 75 milligrams (mg), orally, once daily for 12 weeks. OAB Wet participants were defined as those with an average of ≥8.0 micturitions per Diary Day; with an average of ≥1.0 UUI episodes per Diary Day; and, if stress urinary incontinence was present, with a total number of UUI episodes greater than the total number of stress urinary incontinence episodes from the previous visit diary. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex. |
| OG002 | Tolterodine ER 4 mg: OAB Wet | Participants who met the definition of OAB Wet at study entry (based on the PVD) received tolterodine extended release (ER) 4 mg, orally, once daily for 12 weeks. OAB Wet participants were defined as those with an average of ≥8.0 micturitions per Diary Day; with an average of ≥1.0 UUI episodes per Diary Day; and, if stress urinary incontinence was present, with a total number of UUI episodes greater than the total number of stress urinary incontinence episodes from the previous visit diary. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex. |
|
|
|
|
|
|
| OG001 |
| Vibegron 75 mg: OAB Wet |
Participants who met the definition of OAB Wet at study entry (based on the PVD) received vibegron 75 milligrams (mg), orally, once daily for 12 weeks. OAB Wet participants were defined as those with an average of ≥8.0 micturitions per Diary Day; with an average of ≥1.0 UUI episodes per Diary Day; and, if stress urinary incontinence was present, with a total number of UUI episodes greater than the total number of stress urinary incontinence episodes from the previous visit diary. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex. |
| OG002 | Tolterodine ER 4 mg: OAB Wet | Participants who met the definition of OAB Wet at study entry (based on the PVD) received tolterodine extended release (ER) 4 mg, orally, once daily for 12 weeks. OAB Wet participants were defined as those with an average of ≥8.0 micturitions per Diary Day; with an average of ≥1.0 UUI episodes per Diary Day; and, if stress urinary incontinence was present, with a total number of UUI episodes greater than the total number of stress urinary incontinence episodes from the previous visit diary. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex. |
|
|
|
Participants received vibegron 75 milligrams (mg), orally, once daily for 12 weeks. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex. |
| OG002 | Tolterodine ER 4 mg | Participants received tolterodine extended release (ER) 4 mg, orally, once daily for 12 weeks. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex. |
|
|
|
|
|
|
Participants received vibegron 75 milligrams (mg), orally, once daily for 12 weeks. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex. |
| OG002 | Tolterodine ER 4 mg | Participants received tolterodine extended release (ER) 4 mg, orally, once daily for 12 weeks. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex. |
|
|
|
Participants received vibegron 75 milligrams (mg), orally, once daily for 12 weeks. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex. |
| OG002 | Tolterodine ER 4 mg | Participants received tolterodine extended release (ER) 4 mg, orally, once daily for 12 weeks. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex. |
|
|
|
Participants received tolterodine extended release (ER) 4 mg, orally, once daily for 12 weeks. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex.
|
|
|
Participants who met the definition of OAB Wet at study entry (based on the PVD) received vibegron 75 milligrams (mg), orally, once daily for 12 weeks. OAB Wet participants were defined as those with an average of ≥8.0 micturitions per Diary Day; with an average of ≥1.0 UUI episodes per Diary Day; and, if stress urinary incontinence was present, with a total number of UUI episodes greater than the total number of stress urinary incontinence episodes from the previous visit diary. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex. |
| OG002 | Tolterodine ER 4 mg: OAB Wet | Participants who met the definition of OAB Wet at study entry (based on the PVD) received tolterodine extended release (ER) 4 mg, orally, once daily for 12 weeks. OAB Wet participants were defined as those with an average of ≥8.0 micturitions per Diary Day; with an average of ≥1.0 UUI episodes per Diary Day; and, if stress urinary incontinence was present, with a total number of UUI episodes greater than the total number of stress urinary incontinence episodes from the previous visit diary. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex. |
|
|
|
Participants received tolterodine extended release (ER) 4 mg, orally, once daily for 12 weeks. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex. |
|
|
|
| Tolterodine ER 4 mg |
Participants received tolterodine extended release (ER) 4 mg, orally, once daily for 12 weeks. Participants were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex. |
|
|
|