Trial · NCT01042236

Evaluation Of The Ability Of Fesoterodine To Increase Urethral Pressure In Stress Urinary Incontinence Patients

NCT01042236, Phase 2, Completed, Pfizer; results first posted 2011-07-01

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Evaluation Of The Ability Of Fesoterodine To Increase Urethral Pressure In Stress Urinary Incontinence Patients. Trials, record NCT01042236. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01042236

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Evaluation Of The Ability Of Fesoterodine To Increase Urethral Pressure In Stress Urinary Incontinence Patients
NCT number: NCT01042236
Status: Completed
Phases: Phase 2
Enrollment: 22 participants, actual
Lead sponsor: Pfizer
Conditions: Stress Urinary Incontinence
Interventions: Fesoterodine
First posted: 2010-01-05
Last updated: 2011-07-22
Results first posted: 2011-07-01

Source ClinicalTrials.gov

Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in Opening Urethral Pressure (OUP) at Day 7	Baseline, Day 7 of each period	OUP measured by urethral reflectometry calculated as the mean of all of the OUP measurements obtained in triplicate at each time point for each participant. Day 7 mean for each treatment period was calculated as the mean of the three measurements taken post-dose on Day 7 of each treatment period separately.
Secondary	Change From Baseline in Closing Urethral Pressure at Day 7	Baseline, Day 7 of each period	Closing urethral pressure measured by urethral reflectometry calculated as the mean of each of the closing urethral pressure measurements obtained in triplicate at each time point for each participant. Day 7 mean for each treatment period was calculated as the mean of the three measurements taken post-dose on Day 7 of each treatment period separately.
Secondary	Change From Baseline in Opening Urethral Elastance at Day 7	Baseline, Day 7 of each period	Opening urethral elastance measured by urethral reflectometry calculated as the mean of each of the opening urethral pressure measurements obtained in triplicate at each time point for each participant. Day 7 mean for each treatment period was calculated as the mean of the three measurements taken post-dose on Day 7 of each treatment period separately.
Secondary	Change From Baseline in Closing Urethral Elastance at Day 7	Baseline, Day 7 of each period	Closing urethral elastance measured by urethral reflectometry calculated as the mean of each of the closing urethral pressure measurements obtained in triplicate at each time point for each participant. Day 7 mean for each treatment period was calculated as the mean of the three measurements taken post-dose on Day 7 of each treatment period separately.
Secondary	Incontinence Episode Frequency Per 24 Hours	Baseline, Day 7 of each period	Incontinence Episode Frequency (IEF) calculated as the average daily total incontinence episodes (stress or urgency) that occurred during the 3 days prior to randomization and the end of each treatment period. Day 7 mean for each treatment period was calculated as the mean daily episode frequency based on the diary completed in the final three days of each treatment period.
Secondary	Percent Change From Baseline in Incontinence Episode Frequency Per 24 Hours	Baseline, Day 7 of each period	Incontinence Episode Frequency (IEF) calculated as the average daily total incontinence episodes (stress or urgency) that occurred during the 3 days prior to randomization and the end of each treatment period. Day 7 mean for each treatment period was calculated as the mean daily episode frequency based on the diary completed in the final three days of each treatment period.
Secondary	Stress Incontinence Episode Frequency Per 24 Hours	Baseline, Day 7 of each period	Stress Incontinence Component of the daily IEF calculated as the average daily number of stress leakage episodes that occurred during the 3 days prior to randomization and the end of each treatment period. Day 7 mean for each treatment period was calculated as the mean daily episode frequency based on the diary completed in the final three days of each treatment period.
Secondary	Percent Change From Baseline in Stress Incontinence Episode Frequency Per 24 Hours	Baseline, Day 7 of each period	Stress Incontinence Component of the daily IEF calculated as the average daily number of stress leakage episodes that occurred during the 3 days prior to randomization and the end of each treatment period. Day 7 mean for each treatment period was calculated as the mean daily episode frequency based on the diary completed in the final three days of each treatment period.
Secondary	Urgency Urinary Incontinence Episode Frequency Per 24 Hours	Baseline, Day 7 of each period	Urgency Urinary Incontinence Component of the daily IEF calculated as the average daily number of urgency leakage episodes that occurred during the 3 days prior to randomization and the end of each treatment period. Day 7 mean for each treatment period was calculated as the mean daily episode frequency based on the diary completed in the final three days of each treatment period.
Secondary	Percent Change From Baseline in Urgency Urinary Incontinence Episode Frequency Per 24 Hours	Baseline, Day 7 of each period	Urgency Urinary Incontinence Component of the daily IEF calculated as the average daily number of urgency leakage episodes that occurred during the 3 days prior to randomization and the end of each treatment period. Day 7 mean for each treatment period was calculated as the mean daily episode frequency based on the diary completed in the final three days of each treatment period.

1 to 10 of 11Source ClinicalTrials.gov

See all 11 registered outcomes

Outcomes11

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 Opening Urethral Pressure (OUP) at Day 7	Baseline, Day 7 of each period	Per Protocol Analysis Set (PPAS): all randomized participants who completed the study, received treatment in all 3 study periods until end of treatment visit in the third study period, and had not violated any of the inclusion / exclusion criteria or deviated from the protocol in a way that could affect the outcome of the study.	centimeter of water (cmH2O)	MEAN
SECONDARY	Change From Baseline in Closing Urethral Pressure at Day 7	Baseline, Day 7 of each period	PPAS	cmH20	MEAN
SECONDARY	Change From Baseline in Opening Urethral Elastance at Day 7	Baseline, Day 7 of each period	PPAS	cmH2O/millimeter(mm)^2	MEAN
SECONDARY	Change From Baseline in Closing Urethral Elastance at Day 7	Baseline, Day 7 of each period	PPAS	cmH2O/mm^2	MEAN
SECONDARY	Incontinence Episode Frequency Per 24 Hours	Baseline, Day 7 of each period	PPAS	Episodes per 24 hours.	MEAN
SECONDARY	Percent Change From Baseline in Incontinence Episode Frequency Per 24 Hours	Baseline, Day 7 of each period	PPAS; (n)=only participants with \>0 episodes at baseline were to be included in the analysis.	Percent	MEDIAN
SECONDARY	Stress Incontinence Episode Frequency Per 24 Hours	Baseline, Day 7 of each period	PPAS	Episodes per 24 hours.	MEAN
SECONDARY	Percent Change From Baseline in Stress Incontinence Episode Frequency Per 24 Hours	Baseline, Day 7 of each period	PPAS; (n)=only participants with \>0 episodes at baseline were to be included in the analysis.	Percent	MEDIAN
SECONDARY	Urgency Urinary Incontinence Episode Frequency Per 24 Hours	Baseline, Day 7 of each period	PPAS	Episodes per 24 hours.	MEAN
SECONDARY	Percent Change From Baseline in Urgency Urinary Incontinence Episode Frequency Per 24 Hours	Baseline, Day 7 of each period	PPAS; (n)=only subjects with \>0 participants at baseline were to be included in the analysis.	Percent	MEDIAN

1 to 10 of 11Source ClinicalTrials.gov

See all 11 outcomes

Results by group76

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 Opening Urethral Pressure (OUP) at Day 7	Fesoterodine (4 mg)	Baseline	49.86	Standard Deviation 14.860	centimeter of water (cmH2O)
Change From Baseline in Opening Urethral Pressure (OUP) at Day 7	Fesoterodine (8 mg)	Baseline	49.86	Standard Deviation 14.860	centimeter of water (cmH2O)
Change From Baseline in Opening Urethral Pressure (OUP) at Day 7	Placebo	Baseline	49.86	Standard Deviation 14.860	centimeter of water (cmH2O)
Change From Baseline in Opening Urethral Pressure (OUP) at Day 7	Fesoterodine (4 mg)	Absolute value at Day 7	47.92	Standard Deviation 12.971	centimeter of water (cmH2O)
Change From Baseline in Opening Urethral Pressure (OUP) at Day 7	Fesoterodine (8 mg)	Absolute value at Day 7	49.16	Standard Deviation 14.406	centimeter of water (cmH2O)
Change From Baseline in Opening Urethral Pressure (OUP) at Day 7	Placebo	Absolute value at Day 7	48.53	Standard Deviation 12.859	centimeter of water (cmH2O)
Change From Baseline in Opening Urethral Pressure (OUP) at Day 7	Fesoterodine (4 mg)	Mean change at Day 7	-1.94	Standard Deviation 4.767	centimeter of water (cmH2O)
Change From Baseline in Opening Urethral Pressure (OUP) at Day 7	Fesoterodine (8 mg)	Mean change at Day 7	-0.70	Standard Deviation 5.512	centimeter of water (cmH2O)
Change From Baseline in Opening Urethral Pressure (OUP) at Day 7	Placebo	Mean change at Day 7	-1.34	Standard Deviation 5.178	centimeter of water (cmH2O)
Change From Baseline in Closing Urethral Pressure at Day 7	Fesoterodine (4 mg)	Baseline	40.62	Standard Deviation 14.379	cmH20

1 to 10 of 76Source ClinicalTrials.gov

See all 76 results by group

Participant flow54

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Treatment Period 1	STARTED	Sequence ABC	3
Treatment Period 1	STARTED	Sequence BCA	4
Treatment Period 1	STARTED	Sequence CAB	3
Treatment Period 1	STARTED	Sequence ACB	5
Treatment Period 1	STARTED	Sequence BAC	4
Treatment Period 1	STARTED	Sequence CBA	3
Treatment Period 1	COMPLETED	Sequence ABC	3
Treatment Period 1	COMPLETED	Sequence BCA	3
Treatment Period 1	COMPLETED	Sequence CAB	3
Treatment Period 1	COMPLETED	Sequence ACB	5

1 to 10 of 54Source ClinicalTrials.gov

See all 54 participant flow

Adverse events66

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
other	Dry Eye	Eye disorders	Fesoterodine (4 mg)	0	20
other	Dry Eye	Eye disorders	Fesoterodine (8 mg)	1	22
other	Dry Eye	Eye disorders	Placebo	0	20
other	Vitreous disorder	Eye disorders	Fesoterodine (4 mg)	0	20
other	Vitreous disorder	Eye disorders	Fesoterodine (8 mg)	0	22
other	Vitreous disorder	Eye disorders	Placebo	1	20
other	Abdominal distension	Gastrointestinal disorders	Fesoterodine (4 mg)	0	20
other	Abdominal distension	Gastrointestinal disorders	Fesoterodine (8 mg)	1	22
other	Abdominal distension	Gastrointestinal disorders	Placebo	1	20
other	Abdominal pain	Gastrointestinal disorders	Fesoterodine (4 mg)	0	20

1 to 10 of 66Source ClinicalTrials.gov

See all 66 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Fesoterodine (4 mg)
Total, all-cause mortality	Fesoterodine (8 mg)
Total, all-cause mortality	Placebo
Total, other adverse events	Fesoterodine (4 mg)	8	20
Total, other adverse events	Fesoterodine (8 mg)	17	22
Total, other adverse events	Placebo	8	20
Total, serious adverse events	Fesoterodine (4 mg)	0	20
Total, serious adverse events	Fesoterodine (8 mg)	1	22
Total, serious adverse events	Placebo	0	20

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
24258099	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 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT01042236

GET https://conductscience.org/api/trials/v1/NCT01042236/results?page=2

API reference For AI assistants