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

Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00691093
• Other study ID #: A0221059
• Status: Completed
• Start date: July 2008
• Est. completion date: June 2009

Study information

• Verified date: October 2018
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 823
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

• Concomitant use of potent CYP3A4 inhibitors in subjects with moderate to severe hepatic or renal impairment

• Severe ulcerative colitis

• Toxic megacolon.

Related Conditions & MeSH terms

• Enuresis
• Overactive Bladder
• Urinary Bladder, Overactive
• Urinary Incontinence

Intervention

Drug:
• fesoterodine
4 mg per 24 hours, possibility to increase to 8 mg depending on efficacy chronic treatment

Locations

Country	Name	City	State
Slovakia	Pfizer Investigational Site	?a?a
Slovakia	Pfizer Investigational Site	Aa
Slovakia	Pfizer Investigational Site	Adca
Slovakia	Pfizer Investigational Site	B.Bystrica
Slovakia	Pfizer Investigational Site	Banska Bystrica
Slovakia	Pfizer Investigational Site	Bardejov
Slovakia	Pfizer Investigational Site	Bratislava
Slovakia	Pfizer Investigational Site	Bratislava
Slovakia	Pfizer Investigational Site	Bratislava
Slovakia	Pfizer Investigational Site	Bratislava
Slovakia	Pfizer Investigational Site	Bratislava
Slovakia	Pfizer Investigational Site	Bratislava 2
Slovakia	Pfizer Investigational Site	Bratislava 2
Slovakia	Pfizer Investigational Site	Bratislava 4
Slovakia	Pfizer Investigational Site	Bratislava 5
Slovakia	Pfizer Investigational Site	Bratislava 5
Slovakia	Pfizer Investigational Site	Dolny Kubin
Slovakia	Pfizer Investigational Site	Dunajska Streda
Slovakia	Pfizer Investigational Site	Hlohovec
Slovakia	Pfizer Investigational Site	Humenne
Slovakia	Pfizer Investigational Site	Ilina
Slovakia	Pfizer Investigational Site	Koice
Slovakia	Pfizer Investigational Site	Koice-aca
Slovakia	Pfizer Investigational Site	Komarno
Slovakia	Pfizer Investigational Site	Kosice
Slovakia	Pfizer Investigational Site	Kosice
Slovakia	Pfizer Investigational Site	Kraovsky Chlmec
Slovakia	Pfizer Investigational Site	Liptovsky Hradok
Slovakia	Pfizer Investigational Site	Liptovsky Mikulas
Slovakia	Pfizer Investigational Site	Luenec
Slovakia	Pfizer Investigational Site	Malacky
Slovakia	Pfizer Investigational Site	Malacky
Slovakia	Pfizer Investigational Site	Martin
Slovakia	Pfizer Investigational Site	Michalovce
Slovakia	Pfizer Investigational Site	Myjava
Slovakia	Pfizer Investigational Site	Namestovo
Slovakia	Pfizer Investigational Site	Nitra
Slovakia	Pfizer Investigational Site	Nitra
Slovakia	Pfizer Investigational Site	Nitra
Slovakia	Pfizer Investigational Site	Nove Zamky
Slovakia	Pfizer Investigational Site	Nové Zámky
Slovakia	Pfizer Investigational Site	Piestany
Slovakia	Pfizer Investigational Site	Poprad
Slovakia	Pfizer Investigational Site	Povaska Bystrica
Slovakia	Pfizer Investigational Site	Povazska Bystrica
Slovakia	Pfizer Investigational Site	Preov
Slovakia	Pfizer Investigational Site	Prievidza
Slovakia	Pfizer Investigational Site	Puchov
Slovakia	Pfizer Investigational Site	Revuca
Slovakia	Pfizer Investigational Site	Rimavska Sobota
Slovakia	Pfizer Investigational Site	Ruomberok
Slovakia	Pfizer Investigational Site	Ruzomberok
Slovakia	Pfizer Investigational Site	Senica
Slovakia	Pfizer Investigational Site	Skalica
Slovakia	Pfizer Investigational Site	Sobrance
Slovakia	Pfizer Investigational Site	SpisskaNova Ves
Slovakia	Pfizer Investigational Site	Stropkov
Slovakia	Pfizer Investigational Site	Svidnik
Slovakia	Pfizer Investigational Site	Topoany
Slovakia	Pfizer Investigational Site	Trebisov
Slovakia	Pfizer Investigational Site	Trencin
Slovakia	Pfizer Investigational Site	Trenin
Slovakia	Pfizer Investigational Site	Trnava
Slovakia	Pfizer Investigational Site	Turianske Teplice
Slovakia	Pfizer Investigational Site	Urany
Slovakia	Pfizer Investigational Site	Vrable
Slovakia	Pfizer Investigational Site	Vranov n/Topou
Slovakia	Pfizer Investigational Site	Zvolen

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, Month 1, Month 2, Month 3 or Early Termination (ET)
Primary	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.	Baseline, Month 1, Month 2, Month 3 or ET
Primary	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).	Baseline, Month 1, Month 2, Month 3 or ET
Primary	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.	Baseline, Month 1, Month 2, Month 3 or ET
Secondary	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.	Baseline, Month 1, Month 2, Month 3 or ET
Secondary	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'.	Baseline, Month 3 or ET
Secondary	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.'	12 weeks
Secondary	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.	Month 3 or ET
Secondary	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.	Baseline, Month 3 or ET
Secondary	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.	Baseline, Month 3 or ET
Secondary	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.	Month 1, Month 2, Month 3 or ET
Secondary	Study Doses	Number of subjects that changed doses throughout the study period.	Month 3 or ET
Secondary	Reasons for Study Treatment Dose Changes	Possible change in the dose and the reasons for the change were collected and documented.	Month 3 or ET

External Links

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