Trial · NCT00911937
A Trial To Evaluate The Efficacy And Safety Of Fesoterodine In Patients With Symptoms Of Overactive Bladder Including Nocturnal Urinary Urgency
NCT00911937, Phase 4, Completed, Pfizer; results first posted 2012-08-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Trial To Evaluate The Efficacy And Safety Of Fesoterodine In Patients With Symptoms Of Overactive Bladder Including Nocturnal Urinary Urgency. Trials, record NCT00911937. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00911937
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Trial To Evaluate The Efficacy And Safety Of Fesoterodine In Patients With Symptoms Of Overactive Bladder Including Nocturnal Urinary Urgency
- NCT number
- NCT00911937
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 963 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Overactive Bladder
- Interventions
- Fesoterodine, Placebo
- First posted
- 2009-06-03
- Last updated
- 2018-12-04
- Results first posted
- 2012-08-14
Source ClinicalTrials.gov
Registered outcomes28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Number of Micturition-related Nocturnal Urgency Episodes Per 24 Hours | Baseline | Micturition-related nocturnal urgency episodes had urinary sensation scale (USS) rating of 3 or more that occurred between time participant went to bed and time he or she arose to start next day. Number of nocturnal micturition-related urgency episodes per 24 hours was calculated as sum of all nocturnal micturition-related urgency episodes divided by total number of diary days collected at that visit. |
| Primary | Change From Baseline in Mean Number of Micturition-related Nocturnal Urgency Episodes Per 24 Hours at Week 12 | Baseline and Week 12 | Micturition-related nocturnal urgency episodes had USS rating of 3 or more that occurred between time participant went to bed and time he or she arose to start next day. Number of nocturnal micturition-related urgency episodes per 24 hours was calculated as sum of all nocturnal micturition-related urgency episodes divided by total number of diary days collected at that visit. |
| Secondary | Change From Baseline in Mean Number of Micturition-related Nocturnal Urgency Episodes Per 24 Hours at Week 4 | Baseline and Week 4 | Micturition-related nocturnal urgency episodes had USS rating of 3 or more that occurred between time participant went to bed and time he or she arose to start next day. Number of micturition-related nocturnal urgency episodes per 24 hours was calculated as sum of all nocturnal micturition-related urgency episodes divided by total number of diary days collected at that visit. |
| Secondary | Percent Change From Baseline in Micturition-related Nocturnal Urgency Episodes Per 24 Hours at Week 4 and 12 | Baseline, Week 4 and 12 | Percent change of micturition-related nocturnal urgency episodes per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (100\*(Week 4 or 12 - baseline)/baseline). |
| Secondary | Number of Nocturnal Micturitions Per 24 Hours | Baseline | Nocturnal micturitions were defined as micturitions with USS rating 1-5 that occurred between the time the participant went to bed and the time he or she arose to start the next day. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. The mean number of nocturnal micturitions per 24 hours was calculated as the total number of nocturnal micturitions divided by the total number of diary days collected at that visit. |
| Secondary | Change From Baseline in Number of Nocturnal Micturitions Per 24 Hours at Week 4 and 12 | Baseline, Week 4 and 12 | Nocturnal micturitions were defined as micturitions with USS rating 1-5 that occurred between the time the participant went to bed and the time he or she arose to start the next day. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. The mean number of nocturnal micturitions per 24 hours was calculated as the total number of nocturnal micturitions divided by the total number of diary days collected at that visit. |
| Secondary | Percent Change From Baseline in Nocturnal Micturitions Per 24 Hours at Week 4 and 12 | Baseline, Week 4 and 12 | Percent change of nocturnal micturitions per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (100\*(Week 4 or 12 - baseline)/baseline). |
| Secondary | Mean Number of Micturitions Per 24 Hours | Baseline | Micturitions include episodes of voluntary micturition and episodes of Urgency Urinary Incontinence \[UUI\]. UUI episodes were defined as those micturitions with USS rating of 5 in the diary in participants with UUI at baseline. USS rating 5: Unable to hold; leak urine. |
| Secondary | Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 4 and 12 | Baseline, Week 4 and 12 | Micturitions include episodes of voluntary micturition and episodes of UUI. UUI episodes were defined as those micturitions with USS rating of 5 in the diary in participants with UUI at baseline. USS rating 5: Unable to hold; leak urine. |
| Secondary | Percent Change From Baseline in Micturitions Per 24 Hours at Week 4 and 12 | Baseline, Week 4 and 12 | Percent change of micturitions per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (100\*(Week 4 or 12 - baseline)/baseline). |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 registered outcomesOutcomes28
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Number of Micturition-related Nocturnal Urgency Episodes Per 24 Hours | Baseline | Full analysis set (FAS): all participants who received at least 1 dose of study drug and had at least baseline or a post-baseline efficacy assessment. Here, 'N'(number of participants analyzed) signifies those participants who had baseline nocturnal urgency episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12. | episodes per 24 hours | MEAN |
| PRIMARY | Change From Baseline in Mean Number of Micturition-related Nocturnal Urgency Episodes Per 24 Hours at Week 12 | Baseline and Week 12 | FAS population. Last observation carried forward (LOCF) method was used to impute missing data. Here, 'N' (number of participants analyzed) signifies those participants who had baseline nocturnal urgency episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12. | episodes per 24 hours | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Mean Number of Micturition-related Nocturnal Urgency Episodes Per 24 Hours at Week 4 | Baseline and Week 4 | FAS population included all participants who received at least 1 dose of study drug and had at least baseline or a post-baseline efficacy assessment. Here, 'N' (number of participants analyzed) signifies those participants who had baseline nocturnal urgency episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 4. | episodes per 24 hours | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Micturition-related Nocturnal Urgency Episodes Per 24 Hours at Week 4 and 12 | Baseline, Week 4 and 12 | FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had baseline nocturnal urgency episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12. | percent change | MEAN |
| SECONDARY | Number of Nocturnal Micturitions Per 24 Hours | Baseline | FAS population. Here, 'N' (number of participants analyzed) signifies those participants who had baseline nocturnal micturition frequency greater than 0 per 24 hours and non-missing change from baseline value at Week 12. | micturitions per 24 hours | MEAN |
| SECONDARY | Change From Baseline in Number of Nocturnal Micturitions Per 24 Hours at Week 4 and 12 | Baseline, Week 4 and 12 | FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had baseline nocturnal micturition frequency greater than 0 per 24 hours and non-missing change from baseline value at Week 12. | micturitions per 24 hours | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Nocturnal Micturitions Per 24 Hours at Week 4 and 12 | Baseline, Week 4 and 12 | FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had baseline nocturnal micturition frequency greater than 0 per 24 hours and non-missing change from baseline value at Week 12. | percent change | MEAN |
| SECONDARY | Mean Number of Micturitions Per 24 Hours | Baseline | FAS population included all participants who received at least 1 dose of study drug and had at least baseline or a post-baseline efficacy assessment. Here, 'N' (number of participants analyzed) signifies those participants who had baseline micturition frequency greater than 0 per 24 hours and non-missing change from baseline value at Week 12. | micturitions per 24 hours | MEAN |
| SECONDARY | Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 4 and 12 | Baseline, Week 4 and 12 | FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had baseline micturition frequency greater than 0 per 24 hours and non-missing change from baseline value at Week 12. | micturitions per 24 hours | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Micturitions Per 24 Hours at Week 4 and 12 | Baseline, Week 4 and 12 | FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had baseline micturition frequency greater than 0 per 24 hours and non-missing change from baseline value at Week 12. | percent change | MEAN |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 outcomesResults by group106
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Number of Micturition-related Nocturnal Urgency Episodes Per 24 Hours | Placebo | 2.93 | Standard Deviation 0.98 | episodes per 24 hours | |
| Mean Number of Micturition-related Nocturnal Urgency Episodes Per 24 Hours | Fesoterodine | 2.91 | Standard Deviation 0.90 | episodes per 24 hours | |
| Change From Baseline in Mean Number of Micturition-related Nocturnal Urgency Episodes Per 24 Hours at Week 12 | Placebo | -1.06 | Standard Error 0.06 | episodes per 24 hours | |
| Change From Baseline in Mean Number of Micturition-related Nocturnal Urgency Episodes Per 24 Hours at Week 12 | Fesoterodine | -1.29 | Standard Error 0.06 | episodes per 24 hours | |
| Change From Baseline in Mean Number of Micturition-related Nocturnal Urgency Episodes Per 24 Hours at Week 4 | Placebo | -0.70 | Standard Error 0.05 | episodes per 24 hours | |
| Change From Baseline in Mean Number of Micturition-related Nocturnal Urgency Episodes Per 24 Hours at Week 4 | Fesoterodine | -0.83 | Standard Error 0.06 | episodes per 24 hours | |
| Percent Change From Baseline in Micturition-related Nocturnal Urgency Episodes Per 24 Hours at Week 4 and 12 | Placebo | Change at Week 4 | -24.1 | Standard Deviation 38.1 | percent change |
| Percent Change From Baseline in Micturition-related Nocturnal Urgency Episodes Per 24 Hours at Week 4 and 12 | Fesoterodine | Change at Week 4 | -28.4 | Standard Deviation 38.7 | percent change |
| Percent Change From Baseline in Micturition-related Nocturnal Urgency Episodes Per 24 Hours at Week 4 and 12 | Placebo | Change at Week 12 | -36.2 | Standard Deviation 37.8 | percent change |
| Percent Change From Baseline in Micturition-related Nocturnal Urgency Episodes Per 24 Hours at Week 4 and 12 | Fesoterodine | Change at Week 12 | -44.5 | Standard Deviation 39.7 | percent change |
1 to 10 of 106Source ClinicalTrials.gov
See all 106 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 487 | |
| Overall Study | STARTED | Fesoterodine | 476 | |
| Overall Study | Treated | Placebo | 474 | |
| Overall Study | Treated | Fesoterodine | 463 | |
| Overall Study | COMPLETED | Placebo | 400 | |
| Overall Study | COMPLETED | Fesoterodine | 381 | |
| Overall Study | NOT COMPLETED | Placebo | 87 | |
| Overall Study | NOT COMPLETED | Fesoterodine | 95 |
Source ClinicalTrials.gov
Adverse events396
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 | Iron deficiency anaemia | Blood and lymphatic system disorders | Placebo | 1 | 474 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Fesoterodine | 0 | 463 | |
| other | Cardiomegaly | Cardiac disorders | Placebo | 1 | 474 | |
| other | Cardiomegaly | Cardiac disorders | Fesoterodine | 0 | 463 | |
| other | Mitral valve prolapse | Cardiac disorders | Placebo | 1 | 474 | |
| other | Mitral valve prolapse | Cardiac disorders | Fesoterodine | 0 | 463 | |
| other | Palpitations | Cardiac disorders | Placebo | 1 | 474 | |
| other | Palpitations | Cardiac disorders | Fesoterodine | 1 | 463 | |
| other | Otorrhoea | Ear and labyrinth disorders | Placebo | 0 | 474 | |
| other | Otorrhoea | Ear and labyrinth disorders | Fesoterodine | 1 | 463 |
1 to 10 of 396Source ClinicalTrials.gov
See all 396 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Fesoterodine | ||
| Total, other adverse events | Placebo | 148 | 474 |
| Total, other adverse events | Fesoterodine | 187 | 463 |
| Total, serious adverse events | Placebo | 9 | 474 |
| Total, serious adverse events | Fesoterodine | 5 | 463 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37160401 | DERIVED |
Source PubMed
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Fesoterodine vs Placebo: serious adverse events |
Source Trial comparisons
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00911937
GET https://conductscience.org/api/trials/v1/NCT00911937/registered?page=2