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

• ClinicalTrials.gov Identifier: NCT00691093
• Recruitment Status: Completed
• First Posted: June 5, 2008
• Results First Posted: November 18, 2010
• Last Update Posted: November 2, 2018
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Tracking Information

• First Submitted Date: June 3, 2008
• First Posted Date: June 5, 2008
• Results First Submitted Date: March 15, 2010
• Results First Posted Date: November 18, 2010
• Last Update Posted Date: November 2, 2018
• Study Start Date: July 2008
• Actual Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 16, 2011)

• 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.

• Original Primary Outcome Measures (submitted: June 4, 2008): impact of fesoterodine on frequency, urgency, nokturia and urge incontinence [ Time Frame: 12 weeks ]

Current Secondary Outcome Measures (submitted: February 16, 2011)

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

Original Secondary Outcome Measures (submitted: June 4, 2008)

• need for dose change [ Time Frame: 12 weeks ]
• efficacy and tolerability of fesoterodine assessed from the point of view of the patients and of the doctor [ Time Frame: 12 weeks ]
• efficacy and tolerability of Fesoterodine compared to previous treatment from the point of view of the patients [ Time Frame: 12 weeks ]
• time to onset of response to the treatment from the point of view of the patient [ Time Frame: 12 weeks ]
• prematurely stop of the treatment [ Time Frame: 12 weeks ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study In Patients With Overactive Bladder Treated With Toviaz® After Failure Of Previous Therapy
• Official Title: Observational Study In Patients With Overactive Bladder (OAB) Treated With Toviaz® After Failure Of Previous Antimuscarinic Therapy Due To Ineffectivity Or Intolerance.
• Brief 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.
• Detailed Description: patients older than 18 years with overactive bladder after failure of previous antimuscarinic therapy (due to lack of efficacy or intolerance)
• Study Type: Observational
• Study Design: Observational Model: Case-Only; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: patients older than 18 years with overactive bladder after failure of previous antimuscarinic therapy (due to lack of efficacy or intolerance)

Condition

• Overactive Bladder
• Urinary Incontinence

Intervention

Drug: fesoterodine

4 mg per 24 hours, possibility to increase to 8 mg depending on efficacy chronic treatment

Other Name: TOVIAZ

Study Groups/Cohorts

fesoterodine

Intervention: Drug: fesoterodine

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 21, 2010): 823
• Original Estimated Enrollment (submitted: June 4, 2008): 700
• Actual Study Completion Date: June 2009
• Actual Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Slovakia

Administrative Information

• NCT Number: NCT00691093
• Other Study ID Numbers: A0221059
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Pfizer
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: October 2018