Trial · NCT03492281
A Study to Examine the Safety and Efficacy of a New Drug in Patients With Symptoms of Overactive Bladder (OAB)
NCT03492281, Phase 3, Completed, Urovant Sciences GmbH; results first posted 2021-03-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Examine the Safety and Efficacy of a New Drug in Patients With Symptoms of Overactive Bladder (OAB). Trials, record NCT03492281. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03492281
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Examine the Safety and Efficacy of a New Drug in Patients With Symptoms of Overactive Bladder (OAB)
- NCT number
- NCT03492281
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,530 participants, actual
- Lead sponsor
- Urovant Sciences GmbH
- Conditions
- Overactive Bladder
- Interventions
- vibegron, Vibegron placebo, Tolterodine Tartrate ER, Tolterodine placebo
- First posted
- 2018-04-10
- Last updated
- 2021-03-04
- Other registries' IDs
- eudract:2017-003293-14
- Results first posted
- 2021-03-04
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline (CFB) at Week 12 in the Average Number of Micturitions Per 24 Hours in All Overactive Bladder (OAB) Participants | Baseline (BL); Week 12 | 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. |
| Primary | CFB at Week 12 in the Average Number of Urge Urinary Incontinence (UUI) Episodes Per 24 Hours in OAB Wet Participants | Baseline; 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). 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. |
| Secondary | CFB at Week 12 in the Average Number of Urgency Episodes Over 24 Hours in All OAB Participants | Baseline; 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. "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. |
| Secondary | Percentage of OAB Wet Participants With at Least a 75% Reduction From Baseline in UUI Episodes Per 24 Hours at Week 12 | Baseline; 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). |
| Secondary | Percentage of OAB Wet Participants With a 100% Reduction From Baseline in UUI Episodes Per 24 Hours at Week 12 | Baseline; 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). |
| Secondary | Percentage of All OAB Participants With at Least a 50% Reduction From Baseline in Urgency Episodes Per 24 Hours at Week 12 | Baseline; 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). |
| Secondary | CFB at Week 12 in the Average Number of Total Incontinence Episodes Over 24 Hours in OAB Wet Participants | Baseline; 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. 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. |
| 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 | Baseline; Week 12 | 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. |
| Secondary | CFB at Week 12 in the Average Volume Voided Per Micturition in All OAB Participants | Baseline; 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. 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. |
| 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 | Baseline; Week 12 | 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. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline (CFB) at Week 12 in the Average Number of Micturitions Per 24 Hours in All Overactive Bladder (OAB) Participants | Baseline (BL); Week 12 | 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. | micturitions per 24 hours | LEAST_SQUARES_MEAN |
| PRIMARY | CFB at Week 12 in the Average Number of Urge Urinary Incontinence (UUI) Episodes Per 24 Hours in OAB Wet Participants | Baseline; Week 12 | 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. | UUI episodes per 24 hours | LEAST_SQUARES_MEAN |
| SECONDARY | CFB at Week 12 in the Average Number of Urgency Episodes Over 24 Hours in All OAB Participants | Baseline; Week 12 | FAS. Only participants with evaluable data were analyzed. | urgency episodes over 24 hours | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of OAB Wet Participants With at Least a 75% Reduction From Baseline in UUI Episodes Per 24 Hours at Week 12 | Baseline; Week 12 | FAS-I. The multiple imputation method was used for missing values. | percentage of participants | NUMBER |
| SECONDARY | Percentage of OAB Wet Participants With a 100% Reduction From Baseline in UUI Episodes Per 24 Hours at Week 12 | Baseline; Week 12 | FAS-I. The multiple imputation method was used for missing values. | percentage of participants | NUMBER |
| SECONDARY | Percentage of All OAB Participants With at Least a 50% Reduction From Baseline in Urgency Episodes Per 24 Hours at Week 12 | Baseline; Week 12 | FAS. The multiple imputation method was used for missing values. | percentage of participants | NUMBER |
| SECONDARY | CFB at Week 12 in the Average Number of Total Incontinence Episodes Over 24 Hours in OAB Wet Participants | Baseline; Week 12 | FAS-I. Only participants with evaluable data were analyzed. | total incontinence episodes over 24 hr | LEAST_SQUARES_MEAN |
| 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 | Baseline; Week 12 | 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. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | CFB at Week 12 in the Average Volume Voided Per Micturition in All OAB Participants | Baseline; Week 12 | FAS. Only participants with evaluable data were analyzed. | mL per micturition | LEAST_SQUARES_MEAN |
| 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 | Baseline; Week 12 | 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. | units on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group60
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline (CFB) at Week 12 in the Average Number of Micturitions Per 24 Hours in All Overactive Bladder (OAB) Participants | Placebo | -1.3 | Standard Error 0.14 | micturitions per 24 hours | |
| Change From Baseline (CFB) at Week 12 in the Average Number of Micturitions Per 24 Hours in All Overactive Bladder (OAB) Participants | Vibegron 75 mg | -1.8 | Standard Error 0.14 | micturitions per 24 hours | |
| Change From Baseline (CFB) at Week 12 in the Average Number of Micturitions Per 24 Hours in All Overactive Bladder (OAB) Participants | Tolterodine ER 4 mg | -1.6 | Standard Error 0.15 | micturitions per 24 hours | |
| CFB at Week 12 in the Average Number of Urge Urinary Incontinence (UUI) Episodes Per 24 Hours in OAB Wet Participants | Placebo: OAB Wet | -1.4 | Standard Error 0.13 | UUI episodes per 24 hours | |
| CFB at Week 12 in the Average Number of Urge Urinary Incontinence (UUI) Episodes Per 24 Hours in OAB Wet Participants | Vibegron 75 mg: OAB Wet | -2.0 | Standard Error 0.13 | UUI episodes per 24 hours | |
| CFB at Week 12 in the Average Number of Urge Urinary Incontinence (UUI) Episodes Per 24 Hours in OAB Wet Participants | Tolterodine ER 4 mg: OAB Wet | -1.8 | Standard Error 0.14 | UUI episodes per 24 hours | |
| CFB at Week 12 in the Average Number of Urgency Episodes Over 24 Hours in All OAB Participants | Placebo | -2.0 | Standard Error 0.19 | urgency episodes over 24 hours | |
| CFB at Week 12 in the Average Number of Urgency Episodes Over 24 Hours in All OAB Participants | Vibegron 75 mg | -2.7 | Standard Error 0.19 | urgency episodes over 24 hours | |
| CFB at Week 12 in the Average Number of Urgency Episodes Over 24 Hours in All OAB Participants | Tolterodine ER 4 mg | -2.5 | Standard Error 0.21 | urgency episodes over 24 hours | |
| Percentage of OAB Wet Participants With at Least a 75% Reduction From Baseline in UUI Episodes Per 24 Hours at Week 12 | Placebo: OAB Wet | Unadjusted | 36.8 | percentage of participants |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 540 | |
| Overall Study | STARTED | Vibegron 75 mg | 547 | |
| Overall Study | STARTED | Tolterodine ER 4 mg | 431 | |
| Overall Study | COMPLETED | Placebo | 486 | |
| Overall Study | COMPLETED | Vibegron 75 mg | 502 | |
| Overall Study | COMPLETED | Tolterodine ER 4 mg | 385 | |
| Overall Study | NOT COMPLETED | Placebo | 54 | |
| Overall Study | NOT COMPLETED | Vibegron 75 mg | 45 | |
| Overall Study | NOT COMPLETED | Tolterodine ER 4 mg | 46 |
Source ClinicalTrials.gov
Adverse events111
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Dry mouth | Gastrointestinal disorders | Placebo | 5 | 540 | |
| other | Dry mouth | Gastrointestinal disorders | Vibegron 75 mg | 9 | 545 | |
| other | Dry mouth | Gastrointestinal disorders | Tolterodine ER 4 mg | 28 | 430 | |
| other | Urinary tract infection | Infections and infestations | Placebo | 33 | 540 | |
| other | Urinary tract infection | Infections and infestations | Vibegron 75 mg | 27 | 545 | |
| other | Urinary tract infection | Infections and infestations | Tolterodine ER 4 mg | 24 | 430 | |
| serious | Aortic valve incompetence | Cardiac disorders | Placebo | 1 | 540 | |
| serious | Aortic valve incompetence | Cardiac disorders | Vibegron 75 mg | 0 | 545 | |
| serious | Aortic valve incompetence | Cardiac disorders | Tolterodine ER 4 mg | 0 | 430 | |
| serious | Atrial fibrillation | Cardiac disorders | Placebo | 0 | 540 |
1 to 10 of 111Source ClinicalTrials.gov
See all 111 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 540 |
| Total, all-cause mortality | Vibegron 75 mg | 0 | 545 |
| Total, all-cause mortality | Tolterodine ER 4 mg | 1 | 430 |
| Total, other adverse events | Placebo | 38 | 540 |
| Total, other adverse events | Vibegron 75 mg | 36 | 545 |
| Total, other adverse events | Tolterodine ER 4 mg | 50 | 430 |
| Total, serious adverse events | Placebo | 6 | 540 |
| Total, serious adverse events | Vibegron 75 mg | 8 | 545 |
| Total, serious adverse events | Tolterodine ER 4 mg | 10 | 430 |
Source ClinicalTrials.gov
Papers8
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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Read this trial from software.
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