A Phase 3 interventional study of vibegron and Vibegron placebo in Overactive Bladder, sponsored by Urovant Sciences GmbH. Completed at 215 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-04.
Sponsored by Urovant Sciences GmbH (part of Sumitomo Pharma Co., Ltd.) · Phase 3, Interventional, and Treatment
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Among 333 studies in Urinary Bladder, Overactive with a site in United States — 40 open to participants now, 48 under way, 2 of them phase 3. Urinary Bladder, Overactive · United States.
Among the 333 studies in Urinary Bladder, Overactive with a site in United States, this one is the 14th largest by enrollment of the 288 interventional ones that give a count, is one of 20 that started in 2018, is one of 49 in phase 3, and was the 189th registered.
858 studies on the registry are indexed under Urinary Bladder, Overactive; 126 are open to participants now.
Browse Urinary Bladder, Overactive studies →40 of the 333 studies in Urinary Bladder, Overactive with a site in United States are open now. Recruiting first, the newest first:
Mayo Clinic · Sites in United States
Ages 21+ · Women only
Vensica Therapeutics Ltd. · Sites in United States
Ages 18–80 · Women only
The Cleveland Clinic · Sites in United States
Ages 18+ · Women only
Loma Linda University · Sites in United States
Ages 18–89
Stimuli Technology · Sites in United States, Canada
Ages 22+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 73 Urinary Bladder, Overactive studies recruiting now, 44 (60%) set no upper age limit and 15 (21%) stop at 75 or younger; 6 take children under 18; 8 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
333 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 26 · Phase 2 35 · Phase 3 52 · Phase 4 71
First in 2002; this study’s year is marked. 20 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 1,530 is above the median of 70 across 649 interventional studies indexed under Urinary Bladder, Overactive.
Median enrollment 66 across the 288 interventional studies, 91 across the 43 observational. Of the 259 that completed or were terminated, 134 (52%) have results posted.
This tab as a report to print or save as PDF → With an account.
153 of 333 have an industry lead sponsor. The 10 most frequent:
This study is registered under Urovant Sciences GmbH, one of the names counted as Sumitomo Pharma Co., Ltd.. Under that name alone:
Urovant Sciences GmbH is the lead sponsor of 11 studies on the registry; 1 is open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
Sumitomo Pharma Co., Ltd. has 9 studies filed under Urinary Bladder, Overactive — fewer than ten, so there is no comparison to draw.
19 of the studies in Urinary Bladder, Overactive with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06797245Medstar Health Research InstituteAPPROVE Trial: Evaluating a Prescription Digital Therapeutic for Treatment of OAB in Women | 2026-11 |
| NCT07387315TriHealth Inc.A Randomized, Placebo-controlled Trial of Nitrous Oxide During In-office Bladder Botox Injections | 2026-11 |
| NCT07335484Axonics, Inc.Aquarius Pilot Study to Evaluate the New Axonics Trial System | 2026-11 |
| NCT07405554Endeavor HealthZinc Supplementation With Botulinum Toxin for Overactive Bladder | 2026-12 |
| NCT05200923MedtronicNeuroPelvic Health Electrically Evoked Recording (PEER) 2 Study | 2026-12-18 |
Add all 19 to your calendar (.ics) → With an account.
Among the 333 studies in Urinary Bladder, Overactive with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study is designed to evaluate the safety, tolerability, and efficacy of vibegron administered once daily in patients with OAB.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Urology Medical History
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: vibegron · Drug: Tolterodine placebo
Drug: Vibegron placebo · Drug: Tolterodine placebo
Drug: Vibegron placebo · Drug: Tolterodine Tartrate ER
single daily oral dose of vibegron 75 mg for 12 weeks
Also known as: RVT-901, MK4618, KRP114V, URO-901
placebo to match vibegron (experimental drug)
single daily oral dose of tolterodine tartrate ER 4 mg for 12 weeks
Also known as: Mariosea XL
placebo to match tolterodine (active comparator)
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.
Time frame: 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.
Time frame: Baseline; Week 12
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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline; Week 12
| Milestone | Placebo | Vibegron 75 mg | Tolterodine ER 4 mg |
|---|---|---|---|
| Started | 540 | 547 | 431 |
| Completed | 486 | 502 | 385 |
| Not completed | 54 | 45 | 46 |
| Withdrew: Withdrawal by subject | 21 | 14 | 13 |
| Withdrew: Lost to follow-up | 14 | 15 | 10 |
| Withdrew: Adverse event | 6 | 8 | 13 |
| Withdrew: Lack of efficacy | 3 | 0 | 1 |
| Withdrew: Physician decision | 1 | 0 | 3 |
| Withdrew: Protocol violation | 0 | 2 | 1 |
| Withdrew: Withdrawn due to sponsor | 1 | 0 | 1 |
| Withdrew: Death | 0 | 0 | 1 |
| Withdrew: Captured as other in database | 8 | 6 | 3 |
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.
| micturitions per 24 hours | Placebo | Vibegron 75 mg | Tolterodine ER 4 mg |
|---|---|---|---|
| Change From Baseline (CFB) at Week 12 in the Average Number of Micturitions Per 24 Hours in All Overactive Bladder (OAB) Participants | -1.3 ± 0.14 | -1.8 ± 0.14 | -1.6 ± 0.15 |
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.
| UUI episodes per 24 hours | Placebo: OAB Wet | Vibegron 75 mg: OAB Wet | Tolterodine ER 4 mg: OAB Wet |
|---|---|---|---|
| CFB at Week 12 in the Average Number of Urge Urinary Incontinence (UUI) Episodes Per 24 Hours in OAB Wet Participants | -1.4 ± 0.13 | -2.0 ± 0.13 | -1.8 ± 0.14 |
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.
| urgency episodes over 24 hours | Placebo | Vibegron 75 mg | Tolterodine ER 4 mg |
|---|---|---|---|
| CFB at Week 12 in the Average Number of Urgency Episodes Over 24 Hours in All OAB Participants | -2.0 ± 0.19 | -2.7 ± 0.19 | -2.5 ± 0.21 |
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).
| percentage of participants | Placebo: OAB Wet | Vibegron 75 mg: OAB Wet | Tolterodine ER 4 mg: OAB Wet |
|---|---|---|---|
| Unadjusted | 36.8 | 52.4 | 47.6 |
| Adjusted for sex | 32.8 | 49.3 | 42.2 |
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).
| percentage of participants | Placebo: OAB Wet | Vibegron 75 mg: OAB Wet | Tolterodine ER 4 mg: OAB Wet |
|---|---|---|---|
| Unadjusted | 22.5 | 28.8 | 26.6 |
| Adjusted for sex | 19.0 | 25.3 | 20.9 |
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).
| percentage of participants | Placebo | Vibegron 75 mg | Tolterodine ER 4 mg |
|---|---|---|---|
| Unadjusted | 38.3 | 43.2 | 41.2 |
| Adjusted for sex | 32.8 | 39.5 | 36.4 |
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.
| total incontinence episodes over 24 hr | Placebo: OAB Wet | Vibegron 75 mg: OAB Wet | Tolterodine ER 4 mg: OAB Wet |
|---|---|---|---|
| CFB at Week 12 in the Average Number of Total Incontinence Episodes Over 24 Hours in OAB Wet Participants | -1.6 ± 0.15 | -2.3 ± 0.15 | -2.0 ± 0.16 |
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.
| units on a scale | Placebo | Vibegron 75 mg | Tolterodine ER 4 mg |
|---|---|---|---|
| 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 | 12.9 ± 1.32 | 16.5 ± 1.31 | 16.0 ± 1.39 |
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.
| mL per micturition | Placebo | Vibegron 75 mg | Tolterodine ER 4 mg |
|---|---|---|---|
| CFB at Week 12 in the Average Volume Voided Per Micturition in All OAB Participants | 2.2 ± 3.28 | 23.5 ± 3.26 | 15.5 ± 3.52 |
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.
| units on a scale | Placebo | Vibegron 75 mg | Tolterodine ER 4 mg |
|---|---|---|---|
| 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 | 10.8 ± 1.13 | 14.6 ± 1.12 | 13.7 ± 1.19 |
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.
| units on a scale | Placebo | Vibegron 75 mg | Tolterodine ER 4 mg |
|---|---|---|---|
| CFB at Week 12 in the Symptom Bother Score From the OAB-q LF (1-week Recall) in All OAB Participants | -12.8 ± 1.25 | -19.6 ± 1.24 | -17.4 ± 1.31 |
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).
| percentage of participants | Placebo | Vibegron 75 mg | Tolterodine ER 4 mg |
|---|---|---|---|
| Unadjusted | 28.7 | 40.1 | 35.0 |
| Adjusted for sex | 24.8 | 37.2 | 31.6 |
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.
| percentage of participants | Placebo: OAB Wet | Vibegron 75 mg: OAB Wet | Tolterodine ER 4 mg: OAB Wet |
|---|---|---|---|
| Unadjusted | 53.8 | 64.0 | 66.5 |
| Adjusted for sex | 49.9 | 61.6 | 61.5 |
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.
| units on a scale | Placebo | Vibegron 75 mg | Tolterodine ER 4 mg |
|---|---|---|---|
| CFB at Week 12 in Overall Bladder Symptoms Based on Patient Global Impression of Severity (PGI-Severity) in All OAB Participants | -0.5 ± 0.04 | -0.8 ± 0.04 | -0.7 ± 0.04 |
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.
| units on a scale | Placebo | Vibegron 75 mg | Tolterodine ER 4 mg |
|---|---|---|---|
| CFB at Week 12 in Overall Control Over Bladder Symptoms Based on Patient Global Impression of Control (PGI-Control) in All OAB Participants | -0.7 ± 0.05 | -1.0 ± 0.05 | -0.9 ± 0.05 |
Collected over 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). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/540 (0%) | 6/540 (1.1%) | 38/540 (7%) |
| Vibegron 75 mg | 0/545 (0%) | 8/545 (1.5%) | 36/545 (6.6%) |
| Tolterodine ER 4 mg | 1/430 (0.2%) | 10/430 (2.3%) | 50/430 (11.6%) |
| Event | Placebo | Vibegron 75 mg | Tolterodine ER 4 mg |
|---|---|---|---|
| Vertigo positionalEar and labyrinth disorders | 0/540 | 0/545 | 1/430 |
| SepsisInfections and infestations | 0/540 | 0/545 | 1/430 |
| Urinary tract infectionInfections and infestations | 0/540 | 0/545 | 1/430 |
| Post procedural complicationInjury, poisoning and procedural complications | 0/540 | 0/545 | 1/430 |
| Muscular weaknessMusculoskeletal and connective tissue disorders | 0/540 | 0/545 | 1/430 |
| Ovarian adenomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/540 | 0/545 | 1/430 |
| Prostate cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/540 | 0/545 | 1/430 |
| Cerebrovascular accidentNervous system disorders | 0/540 | 1/545 | 1/430 |
| EncephalopathyNervous system disorders | 0/540 | 0/545 | 1/430 |
| Loss of consciousnessNervous system disorders | 0/540 | 0/545 | 1/430 |
| Event | Placebo | Vibegron 75 mg | Tolterodine ER 4 mg |
|---|---|---|---|
| Dry mouthGastrointestinal disorders | 5/540 | 9/545 | 28/430 |
| Urinary tract infectionInfections and infestations | 33/540 | 27/545 | 24/430 |
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.
| Age, Continuous(years) | Placebo | Vibegron 75 mg | Tolterodine ER 4 mg | Total |
|---|---|---|---|---|
| Mean | 59.9 ± 13.35 | 60.4 ± 13.49 | 59.8 ± 13.27 | 60.0 ± 13.37 |
| Sex: Female, Male(Participants) | Placebo | Vibegron 75 mg | Tolterodine ER 4 mg | Total |
|---|---|---|---|---|
| Female | 459 | 463 | 364 | 1286 |
| Male | 81 | 82 | 66 | 229 |
| Race/Ethnicity, Customized(Participants) | Placebo | Vibegron 75 mg | Tolterodine ER 4 mg | Total |
|---|---|---|---|---|
| American Indian or Alaska | 3 | 2 | 0 | 5 |
| Asian | 30 | 28 | 27 | 85 |
| Black or African American | 85 | 78 | 72 | 235 |
| White | 418 | 435 | 326 | 1179 |
| Puerto Rican | 1 | 1 | 1 | 3 |
| White and Black or African American | 1 | 0 | 0 | 1 |
| Hispanic | 2 | 1 | 0 | 3 |
| Filipino | 0 | 0 | 1 | 1 |
| Morrocan | 0 | 0 | 1 | 1 |
| Multiracial | 0 | 0 | 1 | 1 |
| White, Black or African American | 0 | 0 | 1 | 1 |
| Average number of micturitions per 24 hours in all overactive bladder (OAB) participants(micturitions per 24 hours) | Placebo | Vibegron 75 mg | Tolterodine ER 4 mg | Total |
|---|---|---|---|---|
| Mean | 11.72 ± 3.971 | 11.38 ± 3.508 | 11.53 ± 3.184 | 11.54 ± 3.595 |
| Average number of urge urinary incontinence (UUI) episodes per 24 hours in OAB Wet participants(UUI episodes) | Placebo | Vibegron 75 mg | Tolterodine ER 4 mg | Total |
|---|---|---|---|---|
| Mean | 2.80 ± 2.978 | 2.78 ± 3.105 | 2.72 ± 2.616 | 2.77 ± 2.926 |
Showing the first 100 of 215 sites across 6 countries. Choose a country and city above to see the rest.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Mar 2018 to primary completion in Jan 2019, 9 months.
Results were first posted in Mar 2021, 2 years 1 month after primary completion. A results delay was requested in Jan 2020.
Of 26 industry-sponsored phase 3 interventional studies under Urinary Bladder, Overactive, half reached primary completion within 16 months of starting (the median); a quarter within 11 and three quarters within 24. This study's 9 months is below that.
Counting every sponsor, half of 33 studies reached it within 18 months; a quarter within 11 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Vibegron