Trial Outcomes & Findings for Study In Patients With Overactive Bladder Treated With Toviaz® After Failure Of Previous Therapy (NCT NCT00691093)

NCT ID: NCT00691093

Last Updated: 2018-11-02

Results Overview

Micturition frequency: mean number of 'day time' (i.e., the time the participant was awake) micturitions per 24 hours and calculated as the total number of 'day time' urinations, divided by the total diary days collected at that visit.

• Recruitment status: COMPLETED
• Target enrollment: 823 participants
• Primary outcome timeframe: Baseline, Month 1, Month 2, Month 3 or Early Termination (ET)
• Results posted on: 2018-11-02

Participant Flow

Participant milestones

Measure	Fesoterodine 4 mg or 8 mg The recommended starting dose was 4 mg once daily. Based upon individual response, the dose was increased to 8 mg once daily.
Overall Study STARTED	823
Overall Study COMPLETED	816
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Measure	Fesoterodine 4 mg or 8 mg The recommended starting dose was 4 mg once daily. Based upon individual response, the dose was increased to 8 mg once daily.
Overall Study Adverse Event	1
Overall Study Lost to Follow-up	1
Overall Study Lack of Efficacy	1
Overall Study Ongoing at Date of Cut-Off	4

Baseline Characteristics

Study In Patients With Overactive Bladder Treated With Toviaz® After Failure Of Previous Therapy

Baseline characteristics by cohort

Measure	Fesoterodine 4 mg n=823 Participants The recommended starting dose was 4 mg once daily. Based upon individual response, the dose was increased to 8 mg once daily.
Age, Customized <18 years	11 participants n=5 Participants
Age, Customized 18-44 years	102 participants n=5 Participants
Age, Customized 44-64	497 participants n=5 Participants
Age, Customized >=65 years	213 participants n=5 Participants
Sex: Female, Male Female	574 Participants n=5 Participants
Sex: Female, Male Male	249 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Month 1, Month 2, Month 3 or Early Termination (ET)

Population: The full analysis set (FAS) included all patients who received at least one dose of the study medication and who had at least one post baseline efficacy measurement.

Micturition frequency: mean number of 'day time' (i.e., the time the participant was awake) micturitions per 24 hours and calculated as the total number of 'day time' urinations, divided by the total diary days collected at that visit.

Outcome measures

Measure	Fesoterodine 4 mg n=754 Participants	Fesoterodine 8 mg n=11 Participants	Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy n=57 Participants
Change From Baseline in Micturition Frequency Per 24 Hours at Each Visit Baseline	11.661 episodes Standard Deviation 2.8565	10.636 episodes Standard Deviation 3.4269	12.664 episodes Standard Deviation 2.7612
Change From Baseline in Micturition Frequency Per 24 Hours at Each Visit Visit 2 (Month 1)	-2.306 episodes Standard Deviation 1.5773	-2.303 episodes Standard Deviation 1.2863	-1.566 episodes Standard Deviation 1.4241
Change From Baseline in Micturition Frequency Per 24 Hours at Each Visit Visit 3 (Month 2)	-3.482 episodes Standard Deviation 1.9022	-2.848 episodes Standard Deviation 1.1772	-3.160 episodes Standard Deviation 1.7571
Change From Baseline in Micturition Frequency Per 24 Hours at Each Visit Visit 4 (Month 3 or ET)	-4.180 episodes Standard Deviation 2.1018	-4.000 episodes Standard Deviation 1.2293	-4.031 episodes Standard Deviation 1.8995

PRIMARY outcome

Timeframe: Baseline, Month 1, Month 2, Month 3 or ET

Population: FAS

Nocturnal frequency: mean number of 'night time' (the time the participant was asleep and the urge to urinate woke him/her up) micturitions and calculated as the total number of 'night time' urinations, divided by the total diary days collected at that visit.

Outcome measures

Measure	Fesoterodine 4 mg n=754 Participants	Fesoterodine 8 mg n=11 Participants	Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy n=57 Participants
Change From Baseline in Nocturnal Micturition Frequency Per 24 Hours at Visit 2, Visit 3, and Visit 4 Baseline	3.027 episodes Standard Deviation 1.2593	4.000 episodes Standard Deviation 1.4220	3.528 episodes Standard Deviation 1.3452
Change From Baseline in Nocturnal Micturition Frequency Per 24 Hours at Visit 2, Visit 3, and Visit 4 Visit 2 (Month 1)	-1.104 episodes Standard Deviation 0.7960	-1.212 episodes Standard Deviation 0.8065	-0.915 episodes Standard Deviation 0.9115
Change From Baseline in Nocturnal Micturition Frequency Per 24 Hours at Visit 2, Visit 3, and Visit 4 Visit 3 (Month 2)	-1.621 episodes Standard Deviation 0.9281	-1.848 episodes Standard Deviation 1.1290	-1.613 episodes Standard Deviation 1.0928
Change From Baseline in Nocturnal Micturition Frequency Per 24 Hours at Visit 2, Visit 3, and Visit 4 Visit 4 (Month 3 or ET)	-1.914 episodes Standard Deviation 1.0820	-2.030 episodes Standard Deviation 1.3035	-2.072 episodes Standard Deviation 1.0907

PRIMARY outcome

Timeframe: Baseline, Month 1, Month 2, Month 3 or ET

Population: FAS

UEF: mean number of micturition related urgency episodes per 24 hours and calculated as the total number of 'urgency' urinations (i.e., sudden urges to urinate and problems to delay micturition) divided by 3 (or if data for 3 days were not available, over the total number of diary days collected at that visit).

Outcome measures

Measure	Fesoterodine 4 mg n=754 Participants	Fesoterodine 8 mg n=11 Participants	Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy n=57 Participants
Change From Baseline in Urgency Episode Frequency (UEF) Per 24 Hours at Visit 2, Visit 3, and Visit 4 Baseline	4.412 episodes Standard Deviation 2.4355	4.697 episodes Standard Deviation 1.9914	5.587 episodes Standard Deviation 3.7759
Change From Baseline in Urgency Episode Frequency (UEF) Per 24 Hours at Visit 2, Visit 3, and Visit 4 Visit 2 (Month 1)	-1.890 episodes Standard Deviation 1.5967	-1.697 episodes Standard Deviation 0.9827	-1.650 episodes Standard Deviation 1.3065
Change From Baseline in Urgency Episode Frequency (UEF) Per 24 Hours at Visit 2, Visit 3, and Visit 4 Visit 3 (Month 2)	-2.736 episodes Standard Deviation 1.9249	-2.182 episodes Standard Deviation 1.4557	-2.895 episodes Standard Deviation 2.6468
Change From Baseline in Urgency Episode Frequency (UEF) Per 24 Hours at Visit 2, Visit 3, and Visit 4 Visit 4 (Month 3 or ET)	-3.127 episodes Standard Deviation 2.0210	-2.636 episodes Standard Deviation 1.7221	-3.814 episodes Standard Deviation 3.0690

PRIMARY outcome

Timeframe: Baseline, Month 1, Month 2, Month 3 or ET

Population: FAS

The mean number of UUI episodes: total number of UUI episodes, divided by the total diary days collected at that visit.

Outcome measures

Measure	Fesoterodine 4 mg n=754 Participants	Fesoterodine 8 mg n=11 Participants	Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy n=57 Participants
Change From Baseline in Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Visit 2, Visit 3, and Visit 4 Baseline	2.601 episodes Standard Deviation 1.7127	2.933 episodes Standard Deviation 1.2551	3.467 episodes Standard Deviation 2.4484
Change From Baseline in Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Visit 2, Visit 3, and Visit 4 Visit 2 (Month 1)	-1.209 episodes Standard Deviation 1.0891	-1.067 episodes Standard Deviation 1.1738	-1.190 episodes Standard Deviation 1.2532
Change From Baseline in Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Visit 2, Visit 3, and Visit 4 Visit 3 (Month 2)	-1.806 episodes Standard Deviation 1.3107	-1.583 episodes Standard Deviation 1.4974	-1.781 episodes Standard Deviation 1.4729
Change From Baseline in Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Visit 2, Visit 3, and Visit 4 Visit 4 (Month 3 or ET)	-2.065 episodes Standard Deviation 1.4582	-1.733 episodes Standard Deviation 1.6836	-2.362 episodes Standard Deviation 1.6477

SECONDARY outcome

Timeframe: Baseline, Month 1, Month 2, Month 3 or ET

Population: FAS

The PVR urine volume: measured by an ultrasound scan.

Outcome measures

Measure	Fesoterodine 4 mg n=754 Participants	Fesoterodine 8 mg n=11 Participants	Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy n=57 Participants
Change From Baseline in Post Void Residual (PVR) Urine Volume at Visit 2, Visit 3, and Visit 4 Baseline	27.932 ml Standard Deviation 27.6079	42.000 ml Standard Deviation 35.6059	24.867 ml Standard Deviation 27.7108
Change From Baseline in Post Void Residual (PVR) Urine Volume at Visit 2, Visit 3, and Visit 4 Visit 2 (Month 1)	-6.650 ml Standard Deviation 16.4784	-12.800 ml Standard Deviation 13.2313	-2.364 ml Standard Deviation 11.2500
Change From Baseline in Post Void Residual (PVR) Urine Volume at Visit 2, Visit 3, and Visit 4 Visit 3 (Month 2)	-9.864 ml Standard Deviation 20.2348	-18.700 ml Standard Deviation 22.2663	-5.791 ml Standard Deviation 17.8493
Change From Baseline in Post Void Residual (PVR) Urine Volume at Visit 2, Visit 3, and Visit 4 Visit 4 (Month 3 or ET)	-12.800 ml Standard Deviation 23.9575	-21.000 ml Standard Deviation 24.3584	-7.415 ml Standard Deviation 21.7658

SECONDARY outcome

Timeframe: Baseline, Month 3 or ET

Population: The safety analysis set (SAS) included all subjects who enrolled in the study, signed informed consent and received at least one dose of study medication.

The patients global evaluation of study medication was assessed via the question 'how would you rate your overall response to the study medication?' and was assessed on the four point categorical scale, ranging from 'Poor' to 'Excellent'.

Outcome measures

Measure	Fesoterodine 4 mg n=823 Participants	Fesoterodine 8 mg	Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy
Patient's Global Evaluation of Fesoterodine Excellent	536 participants	—	—
Patient's Global Evaluation of Fesoterodine Good	252 participants	—	—
Patient's Global Evaluation of Fesoterodine Fair	22 participants	—	—
Patient's Global Evaluation of Fesoterodine Poor	10 participants	—	—
Patient's Global Evaluation of Fesoterodine Missing	3 participants	—	—

SECONDARY outcome

Timeframe: 12 weeks

Population: SAS

Clinical global evaluation of study medication was assessed via the question 'how would you rate the study medication the patient received for overactive bladder?,' and was assessed on the four point categorical scale, ranging from 'Poor' to 'Excellent.'

Outcome measures

Measure	Fesoterodine 4 mg n=823 Participants	Fesoterodine 8 mg	Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy
Clinical Global Evaluation of Fesoterodine Excellent	513 participants	—	—
Clinical Global Evaluation of Fesoterodine Good	274 participants	—	—
Clinical Global Evaluation of Fesoterodine Fair	24 participants	—	—
Clinical Global Evaluation of Fesoterodine Poor	9 participants	—	—
Clinical Global Evaluation of Fesoterodine Missing	3 participants	—	—

SECONDARY outcome

Timeframe: Month 3 or ET

Population: FAS

Overall Treatment Effect Scale: 3 questions from which a numeric score was derived. If a subject answered '(2) About the same' to question 1 then a score of 0 was given. If a subject answered '(1) Worse' to question 1, then a score between -7=a very great deal worse to -1=Almost the same, hardly worse at all was given depending on severity of their symptoms (determined from answer to question 2). If a subject answered '(3) Better' to question 1, then a score ranging from 1=Almost the same, hardly better at all to 7=A very great deal better, depending on their answer to question 3, was given.

Outcome measures

Measure	Fesoterodine 4 mg n=754 Participants	Fesoterodine 8 mg n=11 Participants	Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy n=57 Participants
Efficacy and Tolerability Compared to Previous Medication (Overall Treatment Effect Scale) at Visit 4	5.661 scores on a scale Standard Deviation 1.1663	5.818 scores on a scale Standard Deviation 0.9816	4.702 scores on a scale Standard Deviation 1.7925

SECONDARY outcome

Timeframe: Baseline, Month 3 or ET

Population: FAS

Symptom severity/bother score: sub-section of the OAB-q consists of 8 questions. Each item assessed on ordinal scale (0=Not at all to 5=a very great deal). Score=sum of scores for items 1 to 8 and a further 2 points were added if subject was male. Lowest possible score=0 and highest=42. Data were transformed onto a 0 to 100 scale and analyzed based on the transformed score: Transformed Symptom Bother Score=[(Actual Total Raw Score minus Lowest possible value of raw score) divided by Range] multiplied by 100. Higher scores=greater symptom severity or bother and lower=minimal symptom severity.

Outcome measures

Measure	Fesoterodine 4 mg n=754 Participants	Fesoterodine 8 mg n=11 Participants	Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy n=57 Participants
Overactive Bladder Questionnaire (OAB-q): Symptom Severity/Bother Scale Baseline	59.263 scores on a scale Standard Deviation 17.5239	70.000 scores on a scale Standard Deviation 10.1242	64.737 scores on a scale Standard Deviation 17.1696
Overactive Bladder Questionnaire (OAB-q): Symptom Severity/Bother Scale Visit 4 (Month 3 or ET)	25.147 scores on a scale Standard Deviation 14.3690	35.682 scores on a scale Standard Deviation 12.7520	32.719 scores on a scale Standard Deviation 17.9115

SECONDARY outcome

Timeframe: Baseline, Month 3 or ET

Population: FAS

Symptom severity/bother score: sub-section of the OAB-q consists of 8 questions. Each item assessed on ordinal scale (0=Not at all to 5=a very great deal). Score=sum of scores for items 1 to 8 and a further 2 points were added if subject was male. Lowest possible score=0 and highest=42. Data were transformed onto a 0 to 100 scale and analyzed based on the transformed score: Transformed Symptom Bother Score=[(Actual Total Raw Score minus Lowest possible value of raw score) divided by Range] multiplied by 100. Higher scores=greater symptom severity or bother and lower=minimal symptom severity.

Outcome measures

Measure	Fesoterodine 4 mg n=754 Participants	Fesoterodine 8 mg n=11 Participants	Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy n=57 Participants
Change From Baseline in Total Scores of OAB-q at Visit 4	-34.101 scores on a scale Standard Deviation 16.0799	-34.318 scores on a scale Standard Deviation 9.4928	-32.018 scores on a scale Standard Deviation 17.7183

SECONDARY outcome

Timeframe: Month 1, Month 2, Month 3 or ET

Population: FAS

Participant's perception of treatment response assessment since the previous visit was noted at each visit. Time to onset of response was calculated in weeks from start of treatment.

Outcome measures

Measure	Fesoterodine 4 mg n=754 Participants	Fesoterodine 8 mg n=11 Participants	Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy n=57 Participants
Time To Onset Of Treatment Response	3.0 weeks Full Range 1.27 • Interval 0.0 to 10.0	3.0 weeks Full Range 1.10 • Interval 1.0 to 4.0	3.0 weeks Full Range 2.72 • Interval 1.0 to 13.0

SECONDARY outcome

Timeframe: Month 3 or ET

Population: SAS

Number of subjects that changed doses throughout the study period.

Outcome measures

Measure	Fesoterodine 4 mg n=823 Participants	Fesoterodine 8 mg	Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy
Study Doses Increased	57 participants	—	—
Study Doses Stayed the same	766 participants	—	—
Study Doses Decreased	0 participants	—	—
Study Doses Fluctuated	0 participants	—	—

SECONDARY outcome

Timeframe: Month 3 or ET

Population: SAS

Possible change in the dose and the reasons for the change were collected and documented.

Outcome measures

Measure	Fesoterodine 4 mg n=823 Participants	Fesoterodine 8 mg	Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy
Reasons for Study Treatment Dose Changes Insufficient response	1 participants	—	—
Reasons for Study Treatment Dose Changes Inefectivity, Not Sufficient Effectivity	22 participants	—	—
Reasons for Study Treatment Dose Changes Infectivity	29 participants	—	—
Reasons for Study Treatment Dose Changes Insufficient (efficiency) effect	1 participants	—	—
Reasons for Study Treatment Dose Changes Poor overall response	1 participants	—	—
Reasons for Study Treatment Dose Changes Missing	4 participants	—	—

Adverse Events

Fesoterodine 4 mg or 8 mg

Serious events: 0 serious events

Other events: 78 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Fesoterodine 4 mg or 8 mg n=823 participants at risk All Subjects
Gastrointestinal disorders Constipation	1.3% 11/823
Gastrointestinal disorders Dry mouth	8.0% 66/823
Gastrointestinal disorders Gastrointestinal disorder	0.12% 1/823
General disorders Adverse event	0.24% 2/823
Nervous system disorders Headache	0.12% 1/823

Additional Information

Pfizer ClinicalTrials.gov Call Center

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Phone: 1-800-718-1021

Email: ClinicalTrials.govCallCenter@pfizer.com

Results disclosure agreements

• Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of \< 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), \< 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
• Publication restrictions are in place

Restriction type: OTHER