Trial · NCT00611026
Clinical Trial to Evaluate the Efficacy and Safety of Fesoterodine in Comparison to Tolterodine Extended Release(ER)in Patients With Overactive Bladder.
NCT00611026, Phase 3, Completed, Pfizer; results first posted 2011-01-12
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Clinical Trial to Evaluate the Efficacy and Safety of Fesoterodine in Comparison to Tolterodine Extended Release(ER)in Patients With Overactive Bladder. Trials, record NCT00611026. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00611026
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clinical Trial to Evaluate the Efficacy and Safety of Fesoterodine in Comparison to Tolterodine Extended Release(ER)in Patients With Overactive Bladder.
- NCT number
- NCT00611026
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,417 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Overactive Bladder
- Interventions
- Tolterodine ER, Placebo, Fesoterodine
- First posted
- 2008-02-08
- Last updated
- 2011-02-02
- Results first posted
- 2011-01-12
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12 | Baseline, Week 12 | UUI per 24 hours: total number of micturitions with Urinary Sensation Scale (USS) of 5 divided by total number of diary days collected at visit. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine). |
| Secondary | Change From Baseline in Mean Voided Volume Per Micturition | Baseline, Week 1, Week 4, Week 12 | Mean voided volume in milliliters (mL) calculated as sum of voided volume divided by the total number of micturition episodes with a recorded voided volume greater than 0 in the 3-day diary at that visit. |
| Secondary | Change From Baseline in Mean Number of Micturitions Per 24 Hours | Baseline, Week 1, Week 4, Week 12 | The mean number of micturitions was calculated as the total number of micturitions divided by the total number of diary days collected at that visit. |
| Secondary | Percent Change From Baseline of Micturitions Per 24 Hours | Baseline, Week 1, Week 4, Week 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 (ie, 100%\*(Week 1 or 4 or 12 - baseline)/baseline). |
| Secondary | Change From Baseline in Mean Number of Nocturnal Micturitions Per 24 Hours | Baseline, Week 1, Week 4, Week 12 | Mean number of nocturnal micturitions per 24 hours was calculated as the total number of all micturitions divided by the total number of diary days collected at that visit. Nocturnal micturitions are those recorded in the Bedtime section of the diary. Nocturnal (Bedtime) was defined as the time the participant went to bed until he/she arose to start the next day. |
| Secondary | Percent Change From Baseline of Nocturnal Micturitions Per 24 Hours | Baseline, Week 1, Week 4, Week 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 (ie, 100%\*(Week 1 or 4 or 12 - baseline)/baseline). Nocturnal micturitions are those recorded in the Bedtime section of the diary. Nocturnal (Bedtime) was defined as the time the participant went to bed until he/she arose to start the next day. |
| Secondary | Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 1 and Week 4 | Baseline, Week 1, Week 4 | UUI episodes per 24 hours calculated as total number of micturitions with Urinary Sensation Scale (USS) of 5 divided by total number of diary days collected at visit. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine). |
| Secondary | Percent Change From Baseline of UUI Episodes Per 24 Hours | Baseline, Week 1, Week 4, Week 12 | UUI episodes per 24 hours calculated as total number of micturitions with USS of 5 in diary. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change calculated as UUI episodes per 24 hours at observation divided by baseline number of UUI episodes per 24 hours, multiplied by 100. |
| Secondary | Change From Baseline in Mean Number of Urgency Urinary Episodes Per 24 Hours (Urinary Sensation Scale ≥3 in the Diary) | Baseline, Week 1, Week 4, Week 12 | Urgency Urinary episodes per 24 hours: total number of micturitions with Urinary Sensation Scale (USS) of ≥3 divided by total number of diary days collected at visit. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine). |
| Secondary | Percent Change From Baseline in Mean Number of Urgency Urinary Episodes Per 24 Hours (Urinary Sensation Scale ≥3 in the Diary) | Baseline, Week 1, Week 4, Week 12 | Percent change from baseline in mean number of Urgency Urinary episodes per 24 hours (Urinary Sensation Scale ≥3 in the diary). Change calculated as UUI episodes per 24 hours at observation divided by baseline number of UUI episodes per 24 hours, multiplied by 100. |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12 | Baseline, Week 12 | Full analysis set (FAS): at least 1 dose of assigned treatment, data for at least 1 baseline or post-baseline efficacy assessment, and excluded 77 participants from 3 study sites with Good Clinical Practices (GCP) deviations (Fesoterodine N=30, Tolterodine ER N=31, Placebo N=16). Decision to exclude that data was made while the study was blinded. | episodes per 24 hours | MEAN |
| SECONDARY | Change From Baseline in Mean Voided Volume Per Micturition | Baseline, Week 1, Week 4, Week 12 | FAS; (n)=number of participants with non-missing numerical change from baseline to the respective post-baseline value (Week 1, Week 4 \[Last Observation Carried Forward (LOCF)\], or Week 12 \[LOCF\]) for placebo, tolterodine ER, and fesoterodine, respectively. | mL | MEAN |
| SECONDARY | Change From Baseline in Mean Number of Micturitions Per 24 Hours | Baseline, Week 1, Week 4, Week 12 | FAS; (n)=number of participants with non-missing numerical change from baseline to the respective post-baseline value (Week 1, Week 4 \[LOCF\], or Week 12 \[LOCF\]) for placebo, tolterodine ER, and fesoterodine, respectively. | micturitions per 24 hours | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline of Micturitions Per 24 Hours | Baseline, Week 1, Week 4, Week 12 | FAS; (n)=number of participants with non-missing percent change from baseline to the respective post-baseline value (Week 1, Week 4 \[LOCF\], or Week 12 \[LOCF\]) for placebo, tolterodine ER, and fesoterodine, respectively. | percent change | MEDIAN |
| SECONDARY | Change From Baseline in Mean Number of Nocturnal Micturitions Per 24 Hours | Baseline, Week 1, Week 4, Week 12 | FAS; (n)=number of participants with baseline nocturnal micturitions \>0 per 24 hours and non-missing change from baseline to the respective post-baseline value (Week 1, Week 4 \[LOCF\], or Week 12 \[LOCF\]) for placebo, tolterodine ER, and fesoterodine, respectively. | nocturnal micturitions per 24 hours | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline of Nocturnal Micturitions Per 24 Hours | Baseline, Week 1, Week 4, Week 12 | FAS; (n)=number of participants with baseline nocturnal micturitions \>0 per 24 hours and non-missing change from baseline to the respective post-baseline value (Week 1, Week 4 \[LOCF\], or Week 12 \[LOCF\]) for placebo, tolterodine ER, and fesoterodine, respectively. | percent change | MEDIAN |
| SECONDARY | Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 1 and Week 4 | Baseline, Week 1, Week 4 | FAS; (n)=number of participants with baseline UUI \>0 per 24 hours and non-missing change from baseline to respective post-baseline value (Week 1 or Week 4 \[LOCF\] for placebo, tolterodine ER, and fesoterodine, respectively. | episodes per 24 hours | MEAN |
| SECONDARY | Percent Change From Baseline of UUI Episodes Per 24 Hours | Baseline, Week 1, Week 4, Week 12 | FAS; (n)=number of participants with baseline UUI \>0 per 24 hours and non-missing change from baseline to respective post-baseline value (Week 1, Week 4 \[LOCF\], or Week 12 \[LOCF\]) for placebo, tolterodine ER, and fesoterodine, respectively. | percent change | MEDIAN |
| SECONDARY | Change From Baseline in Mean Number of Urgency Urinary Episodes Per 24 Hours (Urinary Sensation Scale ≥3 in the Diary) | Baseline, Week 1, Week 4, Week 12 | FAS; (n)=number of participants with baseline urgency episodes \>0 per 24 hours and non-missing numerical change from baseline to the respective post-baseline value (Week 1, Week 4 \[LOCF\], or Week 12 \[LOCF\]) for placebo, tolterodine ER, and fesoterodine, respectively. | episodes per 24 hours | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Mean Number of Urgency Urinary Episodes Per 24 Hours (Urinary Sensation Scale ≥3 in the Diary) | Baseline, Week 1, Week 4, Week 12 | FAS; (n)=number of participants with baseline urgency episodes \>0 per 24 hours and non-missing numerical change from baseline to the respective post-baseline value (Week 1, Week 4 \[LOCF\], or Week 12 \[LOCF\]) for placebo, tolterodine ER, and fesoterodine, respectively. | percent change | MEDIAN |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group227
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12 | Placebo | -1.62 | Standard Error 0.07 | episodes per 24 hours | |
| Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12 | Tolterodine ER | -1.74 | Standard Error 0.06 | episodes per 24 hours | |
| Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12 | Fesoterodine | -1.95 | Standard Error 0.05 | episodes per 24 hours | |
| Change From Baseline in Mean Voided Volume Per Micturition | Placebo | Week 1 (n=447, 917, 895) | 9.80 | Standard Error 1.92 | mL |
| Change From Baseline in Mean Voided Volume Per Micturition | Tolterodine ER | Week 1 (n=447, 917, 895) | 15.65 | Standard Error 1.43 | mL |
| Change From Baseline in Mean Voided Volume Per Micturition | Fesoterodine | Week 1 (n=447, 917, 895) | 18.63 | Standard Error 1.55 | mL |
| Change From Baseline in Mean Voided Volume Per Micturition | Placebo | Week 4 [LOCF] (n=452, 927, 909) | 14.27 | Standard Error 2.28 | mL |
| Change From Baseline in Mean Voided Volume Per Micturition | Tolterodine ER | Week 4 [LOCF] (n=452, 927, 909) | 26.43 | Standard Error 1.76 | mL |
| Change From Baseline in Mean Voided Volume Per Micturition | Fesoterodine | Week 4 [LOCF] (n=452, 927, 909) | 32.26 | Standard Error 1.94 | mL |
| Change From Baseline in Mean Voided Volume Per Micturition | Placebo | Week 12 [LOCF] (n=452, 930, 912) | 17.34 | Standard Error 2.40 | mL |
1 to 10 of 227Source ClinicalTrials.gov
See all 227 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Randomized to Double-blind Treatment | STARTED | Placebo | 480 | |
| Randomized to Double-blind Treatment | STARTED | Tolterodine ER | 974 | |
| Randomized to Double-blind Treatment | STARTED | Fesoterodine | 963 | |
| Randomized to Double-blind Treatment | COMPLETED | Placebo | 478 | |
| Randomized to Double-blind Treatment | COMPLETED | Tolterodine ER | 973 | |
| Randomized to Double-blind Treatment | COMPLETED | Fesoterodine | 960 | |
| Randomized to Double-blind Treatment | NOT COMPLETED | Placebo | 2 | |
| Randomized to Double-blind Treatment | NOT COMPLETED | Tolterodine ER | 1 | |
| Randomized to Double-blind Treatment | NOT COMPLETED | Fesoterodine | 3 | |
| Double-blind Treatment Period | STARTED | Placebo | 478 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events168
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 | Constipation | Gastrointestinal disorders | Placebo | 7 | 478 | |
| other | Constipation | Gastrointestinal disorders | Tolterodine ER | 30 | 973 | |
| other | Constipation | Gastrointestinal disorders | Fesoterodine | 42 | 960 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 3 | 478 | |
| other | Diarrhoea | Gastrointestinal disorders | Tolterodine ER | 11 | 973 | |
| other | Diarrhoea | Gastrointestinal disorders | Fesoterodine | 11 | 960 | |
| other | Dry mouth | Gastrointestinal disorders | Placebo | 26 | 478 | |
| other | Dry mouth | Gastrointestinal disorders | Tolterodine ER | 130 | 973 | |
| other | Dry mouth | Gastrointestinal disorders | Fesoterodine | 265 | 960 | |
| other | Dyspepsia | Gastrointestinal disorders | Placebo | 2 | 478 |
1 to 10 of 168Source ClinicalTrials.gov
See all 168 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Tolterodine ER | ||
| Total, all-cause mortality | Fesoterodine | ||
| Total, other adverse events | Placebo | 83 | 478 |
| Total, other adverse events | Tolterodine ER | 261 | 973 |
| Total, other adverse events | Fesoterodine | 375 | 960 |
| Total, serious adverse events | Placebo | 8 | 478 |
| Total, serious adverse events | Tolterodine ER | 6 | 973 |
| Total, serious adverse events | Fesoterodine | 13 | 960 |
Source ClinicalTrials.gov
Papers2
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.
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/NCT00611026
GET https://conductscience.org/api/trials/v1/NCT00611026/results?page=2