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

An observational study of Overactive Bladder and Urinary Incontinence, run by Pfizer at 65 sites in Slovakia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This is a observational study in patients treated with fesoterodine (Toviaz), who have failed on previous treatment for overactive bladder. It will collect epidemiological data and investigate the efficacy and tolerability of fesoterodine. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Overactive Bladder, Urinary Incontinence
What is being tested?: fesoterodine
How many people: 823 participants
Where: 65 sitesSlovakia
Study dates: Jul 2008to Jun 2009
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: patients older than 18 years with overactive bladder after failure of previous antimuscarinic therapy (due to lack of efficacy or intolerance)

Who may be able to join

Patients older than 18 years
Patients with OAB after failure of previous antimuscarinic therapy - due to lack of efficacy: persistence of storage symptoms.
Required symptoms: micturition frequency 8 and more / 24 hours and urgency episodes ≥2 per day subjectively perceived as bothersome
Due to intolerance: persistent and/or unacceptable adverse events

Who cannot join

Hypersensitivity to the active substance or to peanut or soya or any of the excipients.
History of acute urinary retention (requiring catheterisation)
Gastric retention
Uncontrolled narrow angle glaucoma
Myasthenia gravis
Severe hepatic impairment (Child Pugh C)

Show all 9Show fewer

Concomitant use of potent CYP3A4 inhibitors in subjects with moderate to severe hepatic or renal impairment
Severe ulcerative colitis
Toxic megacolon.

Trial locations and contacts

65 sites in 1 country.

City, postcode or hospital

65 sites in 1 country

Slovakia65 sites

Pfizer Investigational Site
?a?a
Pfizer Investigational Site
Aa
Pfizer Investigational Site
Adca
Pfizer Investigational Site
B.Bystrica
Pfizer Investigational Site
Banská Bystrica, 974 01
Pfizer Investigational Site
Bardejov
Pfizer Investigational Site
Bratislava, 82109
Pfizer Investigational Site
Bratislava, 82606
Pfizer Investigational Site
Bratislava, 833 05
Pfizer Investigational Site
Bratislava, 851 01
Pfizer Investigational Site
Bratislava, 851 05
Pfizer Investigational Site
Bratislava, 85104
Pfizer Investigational Site
Bratislava, 85107
Pfizer Investigational Site
Bratislava
Pfizer Investigational Site
Dolný Kubín
Pfizer Investigational Site
Dunajská Streda
Pfizer Investigational Site
Hlohovec
Pfizer Investigational Site
Humenné
Pfizer Investigational Site
Ilina
Pfizer Investigational Site
Koice
Pfizer Investigational Site
Koice-aca
Pfizer Investigational Site
Komárno
Pfizer Investigational Site
Košice, 041 90
Pfizer Investigational Site
Košice
Pfizer Investigational Site
Kraovsky Chlmec
Pfizer Investigational Site
Liptovský Hrádok
Pfizer Investigational Site
Liptovský Mikuláš
Pfizer Investigational Site
Luenec
Pfizer Investigational Site
Malacky, 901 01
Pfizer Investigational Site
Malacky, 90122
Pfizer Investigational Site
Martin
Pfizer Investigational Site
Michalovce
Pfizer Investigational Site
Myjava
Pfizer Investigational Site
Námestovo
Pfizer Investigational Site
Nitra, 949 01
Pfizer Investigational Site
Nitra, 951 01
Pfizer Investigational Site
Nitra
Pfizer Investigational Site
Nové Zámky
Pfizer Investigational Site
Piešťany, 921 01
Pfizer Investigational Site
Poprad
Pfizer Investigational Site
Povaska Bystrica
Pfizer Investigational Site
Považská Bystrica, 017 01
Pfizer Investigational Site
Preov
Pfizer Investigational Site
Prievidza
Pfizer Investigational Site
Púchov
Pfizer Investigational Site
Revúca
Pfizer Investigational Site
Rimavská Sobota
Pfizer Investigational Site
Ruomberok
Pfizer Investigational Site
Ružomberok
Pfizer Investigational Site
Senica, 90501
Pfizer Investigational Site
Skalica, 90901
Pfizer Investigational Site
Sobrance
Pfizer Investigational Site
SpisskaNova Ves
Pfizer Investigational Site
Stropkov
Pfizer Investigational Site
Svidník
Pfizer Investigational Site
Topoany
Pfizer Investigational Site
Trebišov
Pfizer Investigational Site
Trenčín, 911 01
Pfizer Investigational Site
Trenin
Pfizer Investigational Site
Trnava
Pfizer Investigational Site
Turianske Teplice
Pfizer Investigational Site
Urany
Pfizer Investigational Site
Vráble
Pfizer Investigational Site
Vranov n/Topou
Pfizer Investigational Site
Zvolen

Other trials in Slovakia

About this study

Official title: Observational Study In Patients With Overactive Bladder (OAB) Treated With Toviaz® After Failure Of Previous Antimuscarinic Therapy Due To Ineffectivity Or Intolerance.

Read the detailed description

patients older than 18 years with overactive bladder after failure of previous antimuscarinic therapy (due to lack of efficacy or intolerance)

Conditions: Overactive Bladder, Urinary Incontinence
Being tested: fesoterodine
Keywords: observational
Medical subject headings: Urinary Bladder, Overactive, Urinary Incontinence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

fesoterodineDrug
Also called TOVIAZ
4 mg per 24 hours, possibility to increase to 8 mg depending on efficacy chronic treatment

Study groups in NCT00691093
Study group	Role	What they receive
fesoterodine		Not described Receives: Drug: fesoterodine

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Micturition Frequency Per 24 Hours at Each Visit
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.
Measured: Baseline, Month 1, Month 2, Month 3 or Early Termination (ET)
Change From Baseline in Nocturnal Micturition Frequency Per 24 Hours at Visit 2, Visit 3, and Visit 4
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.
Measured: Baseline, Month 1, Month 2, Month 3 or ET
Change From Baseline in Urgency Episode Frequency (UEF) Per 24 Hours at Visit 2, Visit 3, and Visit 4
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).
Measured: Baseline, Month 1, Month 2, Month 3 or ET
Change From Baseline in Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Visit 2, Visit 3, and Visit 4
The mean number of UUI episodes: total number of UUI episodes, divided by the total diary days collected at that visit.
Measured: Baseline, Month 1, Month 2, Month 3 or ET

Secondary outcomes (9)

Change From Baseline in Post Void Residual (PVR) Urine Volume at Visit 2, Visit 3, and Visit 4
The PVR urine volume: measured by an ultrasound scan.
Measured: Baseline, Month 1, Month 2, Month 3 or ET
Patient's Global Evaluation of Fesoterodine
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'.
Measured: Baseline, Month 3 or ET
Clinical Global Evaluation of Fesoterodine
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.'
Measured: 12 weeks
Efficacy and Tolerability Compared to Previous Medication (Overall Treatment Effect Scale) at Visit 4
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.
Measured: Month 3 or ET
Overactive Bladder Questionnaire (OAB-q): Symptom Severity/Bother Scale
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.
Measured: Baseline, Month 3 or ET
Change From Baseline in Total Scores of OAB-q at Visit 4
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.
Measured: Baseline, Month 3 or ET
Time To Onset Of Treatment Response
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.
Measured: Month 1, Month 2, Month 3 or ET
Study Doses
Number of subjects that changed doses throughout the study period.
Measured: Month 3 or ET
Reasons for Study Treatment Dose Changes
Possible change in the dose and the reasons for the change were collected and documented.
Measured: Month 3 or ET

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2008Jun 2009

First posted5 Jun 2008 (estimated)
Study startJul 2008
Primary completionJun 2009
Study completionJun 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Overactive BladderStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 823 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00691093
Sponsor's protocol ID: A0221059
Status last verified: Oct 2018
First submitted: 3 Jun 2008
Last updated: 2 Nov 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 2 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Observational Study In Patients With Overactive Bladder (OAB) Treated With Toviaz® After Failure Of Previous Antimuscarinic Therapy Due To Ineffectivity Or Intolerance.
ClinicalTrials.gov ID: NCT00691093
Acronym / sponsor ID: A0221059
Conditions: Overactive Bladder, Urinary Incontinence
Keywords: observational
Study type: Observational
Recruitment status: Completed
Enrolment: 823 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Jul 2008
Primary completion: Jun 2009 (actual)
Study completion: Jun 2009 (actual)
First posted: 5 Jun 2008 (estimated)
Results: Posted 18 Nov 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

patients older than 18 years with overactive bladder after failure of previous antimuscarinic therapy (due to lack of efficacy or intolerance)

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
fesoterodine	–	Drug: fesoterodine

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: patients older than 18 years with overactive bladder after failure of previous antimuscarinic therapy (due to lack of efficacy or intolerance)

Key inclusion criteria (4 listed)

Patients older than 18 years
Patients with OAB after failure of previous antimuscarinic therapy - due to lack of efficacy: persistence of storage symptoms.
Required symptoms: micturition frequency 8 and more / 24 hours and urgency episodes ≥2 per day subjectively perceived as bothersome
Due to intolerance: persistent and/or unacceptable adverse events

Key exclusion criteria (9 listed)

Hypersensitivity to the active substance or to peanut or soya or any of the excipients.
History of acute urinary retention (requiring catheterisation)
Gastric retention
Uncontrolled narrow angle glaucoma
Myasthenia gravis

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
fesoterodineAlso: TOVIAZ4 mg per 24 hours, possibility to increase to 8 mg depending on efficacy chronic treatment	Drug	fesoterodine

Primary outcome

Change From Baseline in Micturition Frequency Per 24 Hours at Each Visit
Time frame: Baseline, Month 1, Month 2, Month 3 or Early Termination (ET)
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.
Change From Baseline in Nocturnal Micturition Frequency Per 24 Hours at Visit 2, Visit 3, and Visit 4
Time frame: Baseline, Month 1, Month 2, Month 3 or ET
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.
Change From Baseline in Urgency Episode Frequency (UEF) Per 24 Hours at Visit 2, Visit 3, and Visit 4
Time frame: Baseline, Month 1, Month 2, Month 3 or ET
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).
Change From Baseline in Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Visit 2, Visit 3, and Visit 4
Time frame: Baseline, Month 1, Month 2, Month 3 or ET
The mean number of UUI episodes: total number of UUI episodes, divided by the total diary days collected at that visit.

9 secondary outcomes

Change From Baseline in Post Void Residual (PVR) Urine Volume at Visit 2, Visit 3, and Visit 4
Time frame: Baseline, Month 1, Month 2, Month 3 or ET
Patient's Global Evaluation of Fesoterodine
Time frame: Baseline, Month 3 or ET
Clinical Global Evaluation of Fesoterodine
Time frame: 12 weeks
Efficacy and Tolerability Compared to Previous Medication (Overall Treatment Effect Scale) at Visit 4
Time frame: Month 3 or ET
Overactive Bladder Questionnaire (OAB-q): Symptom Severity/Bother Scale
Time frame: Baseline, Month 3 or ET
Change From Baseline in Total Scores of OAB-q at Visit 4
Time frame: Baseline, Month 3 or ET
Time To Onset Of Treatment Response
Time frame: Month 1, Month 2, Month 3 or ET
Study Doses
Time frame: Month 3 or ET
Reasons for Study Treatment Dose Changes
Time frame: Month 3 or ET

Results and safety

Results posted to the registry on 18 Nov 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Fesoterodine 4 mg or 8 mg	823	816

Primary outcome: Change From Baseline in Micturition Frequency Per 24 Hours at Each Visit

Time frame: Baseline, Month 1, Month 2, Month 3 or Early Termination (ET). Mean (Standard Deviation). Unit: episodes

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

Population analysed: 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.

Primary outcome: Change From Baseline in Nocturnal Micturition Frequency Per 24 Hours at Visit 2, Visit 3, and Visit 4

Time frame: Baseline, Month 1, Month 2, Month 3 or ET. Mean (Standard Deviation). Unit: episodes

Measure	Fesoterodine 4 mg n = 754	Fesoterodine 8 mg n = 11	Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy n = 57
Baseline	3.027 (1.2593)	4.000 (1.4220)	3.528 (1.3452)
Visit 2 (Month 1)	-1.104 (0.7960)	-1.212 (0.8065)	-0.915 (0.9115)
Visit 3 (Month 2)	-1.621 (0.9281)	-1.848 (1.1290)	-1.613 (1.0928)
Visit 4 (Month 3 or ET)	-1.914 (1.0820)	-2.030 (1.3035)	-2.072 (1.0907)

Population analysed: FAS

Primary outcome: Change From Baseline in Urgency Episode Frequency (UEF) Per 24 Hours at Visit 2, Visit 3, and Visit 4

Time frame: Baseline, Month 1, Month 2, Month 3 or ET. Mean (Standard Deviation). Unit: episodes

Measure	Fesoterodine 4 mg n = 754	Fesoterodine 8 mg n = 11	Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy n = 57
Baseline	4.412 (2.4355)	4.697 (1.9914)	5.587 (3.7759)
Visit 2 (Month 1)	-1.890 (1.5967)	-1.697 (0.9827)	-1.650 (1.3065)
Visit 3 (Month 2)	-2.736 (1.9249)	-2.182 (1.4557)	-2.895 (2.6468)
Visit 4 (Month 3 or ET)	-3.127 (2.0210)	-2.636 (1.7221)	-3.814 (3.0690)

Population analysed: FAS

Primary outcome: Change From Baseline in Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Visit 2, Visit 3, and Visit 4

Time frame: Baseline, Month 1, Month 2, Month 3 or ET. Mean (Standard Deviation). Unit: episodes

Measure	Fesoterodine 4 mg n = 754	Fesoterodine 8 mg n = 11	Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy n = 57
Baseline	2.601 (1.7127)	2.933 (1.2551)	3.467 (2.4484)
Visit 2 (Month 1)	-1.209 (1.0891)	-1.067 (1.1738)	-1.190 (1.2532)
Visit 3 (Month 2)	-1.806 (1.3107)	-1.583 (1.4974)	-1.781 (1.4729)
Visit 4 (Month 3 or ET)	-2.065 (1.4582)	-1.733 (1.6836)	-2.362 (1.6477)

Population analysed: FAS

9 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Fesoterodine 4 mg or 8 mg	0 of 823 (0%)	78 of 823 (9.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

65 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Overactive Bladder and Urinary Incontinence, run by Pfizer at 65 sites in Slovakia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 65 sites in Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Nov 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Micturition Frequency Per 24 Hours at Each Visit (time frame: Baseline, Month 1, Month 2, Month 3 or Early Termination (ET)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00691093.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2018.